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Last updated on emc: 06 Apr 2022

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Each film-coated tablet contains 20 mg tadalafil.

Each 20 mg film-coated tablet contains 367.584 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Yellow, capsule shaped, approximately 14.3 mm in length and 7 mm in width, biconvex, bevelled edged, film coated tablet, debossed with “T 20” on one side and plain on other side.

Treatment of erectile dysfunction in adult males.

In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required.

It is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).

Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food.

In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity.

The maximum dose frequency is once per day.

Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.

In patients who anticipate a frequent use of Tadalafil (i.e., at least twice weekly) a once daily regimen with the lowest doses of Tadalafil tablets might be considered suitable, based on patient choice and the physician’s judgement.

In these patients, the recommended dose is 5 mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5 mg once a day based on individual tolerability.

The appropriateness of continued use of the daily regimen should be reassessed periodically.

Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.

The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food.

Dose adjustments are not required in elderly patients.

Adult men with erectile dysfunction: Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with severe renal impairment, 10 mg is the maximum recommended dose for on-demand treatment.

Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment. (See sections 4.4 and 5.2.)

Pulmonary arterial hypertension: In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended. The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability. In patients with severe renal impairment the use of tadalafil is not recommended. (see sections 4.4 and 5.2).

Adult men with erectile dysfunction: For the treatment of erectile dysfunction using on-demand Tadalafil the recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment.

Once-a-day dosing of tadalafil for the treatment of erectile dysfunction has not been evaluated in patients with hepatic impairment; therefore if prescribed, a careful individual benefit/risk evaluation must be undertaken by the prescribing physician. (See sections 4.4 and 5.2.)

Pulmonary arterial hypertension: Due to limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), following single doses of 10 mg, a starting dose of 20 mg once per day may be considered. If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommended. (see sections 4.4 and 5.2).

Adult men with erectile dysfunction: Dose adjustments are not required in diabetic patients.

There is no relevant use of Tadalafil in the paediatric population with regard to the treatment of erectile dysfunction.

The safety and efficacy of tadalafil in the paediatric population has not yet been established. Currently available data are described in section 5.1.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of Tadalafil to patients who are using any form of organic nitrate is contraindicated (See section 4.5).

Tadalafil must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.

The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated:

– patients with myocardial infarction within the last 90 days,

– patients with unstable angina or angina occurring during sexual intercourse,

– patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,

– patients with uncontrolled arrhythmias, hypotension (< 90/50mmHg), or uncontrolled hypertension,

– patients with a stroke within the last 6 months.

Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).

The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.

Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1), and as such potentiates the hypotensive effect of nitrates (see section 4.3).

The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. It is not known if tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.

Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials. Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a combination of these or other factors.

The following groups of patients with cardiovascular disease were not included in PAH clinical studies:

– Patients with clinically significant aortic and mitral valve disease

– Patients with pericardial constriction

– Patients with restrictive or congestive cardiomyopathy

– Patients with significant left ventricular dysfunction

– Patients with life-threatening arrhythmias

– Patients with symptomatic coronary artery disease

– Patients with uncontrolled hypertension.

Since there are no clinical data on the safety of tadalafil in these patients, the use of tadalafil is not recommended.

Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended. Should signs of pulmonary oedema occur when tadalafil is administered, the possibility of associated PVOD should be considered.

Tadalafil has systemic vasodilatory properties that may result in transient decreases in blood pressure. Physicians should carefully consider whether their patients with certain underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by such vasodilatory effects.

In patients who are taking alpha1 blockers, concomitant administration of tadalafil may lead to symptomatic hypotension in some patients (see section 4.5). The combination of tadalafil and doxazosin is not recommended.

Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking Tadalafil and consult a physician immediately (see section 4.3).

Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.

Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of Tadalafil is not recommended in patients with severe renal impairment.

There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh class C). If Tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

Priapism and anatomical deformation of the penis

Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Tadalafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma, or leukaemia).

Use with CYP3A4 inducers or inhibitors

Caution should be exercised when prescribing Tadalafil to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin), as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).

Tadalafil and other treatments for erectile dysfunction

The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. The patients should be informed not to take Tadalafil in such combinations.

The efficacy and safety of tadalafil co-administered with prostacyclin or its analogues has not been studied in controlled clinical studies. Therefore, caution is recommended in case of co-administration.

The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.5 and 5.1).

Tadalafil contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.

Effects of other substances on tadalafil

Tadalafil is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15 %, relative to the AUC and Cmax values for tadalafil alone. Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22 %. Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax. Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32 % and decreased Cmax by 30 %. Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole, and grapefruit juice, should be co-administered with caution, as they would be expected to increase plasma concentrations of tadalafil (see section 4.4).

Consequently, the incidence of the adverse reactions listed in section 4.8 might be increased.

The role of transporters (for example, p-glycoprotein) in the disposition of tadalafil is not known. Therefore, there is the potential of drug interactions mediated by inhibition of transporters.

P-glycoprotein substrates (e.g. digoxin)

Tadalafil (40 mg once per day) had no clinically significant effect on the pharmacokinetics of digoxin.

A CYP3A4 inducer, rifampicin reduced tadalafil AUC by 88 %, relative to the AUC values for tadalafil alone (10 mg). This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude of decreased efficacy is unknown. Other inducers of CYP3A4, such as phenobarbital, phenytoin, and carbamazepine, may also decrease plasma concentrations of tadalafil.

Endothelin-1 receptor antagonists (e.g. bosentan)

Bosentan (125 mg twice daily), a substrate of CYP2C9 and CYP3A4 and a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19, reduced tadalafil (40 mg once per day) systemic exposure by 42 % and Cmax by 27 % following multiple dose co-administration. The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.4 and 5.1). Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites.

The safety and efficacy of combinations of tadalafil and other endothelin-1 receptor antagonists have not been studied.

Effects of tadalafil on other medicinal products

In clinical studies, tadalafil (5 mg, 10 mg and 20 mg) was shown to augment the hypotensive effects of nitrates. Therefore, administration of Tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.3). Based on the results of a clinical study in which 150 subjects received daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose. Thus, in a patient prescribed any dose of Tadalafil (2.5 mg to 20 mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of Tadalafil before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.

Anti-hypertensives (including calcium channel blockers)

The co-administration of doxazosin (4 mg and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner. This effect lasts at least 12 hours and may be symptomatic, including syncope. Therefore, this combination is not recommended (see section 4.4).

In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin. However caution should be exercised when using tadalafil in patients treated with any alpha-blockers, and notably in the elderly. Treatments should be initiated at minimal dosage and progressively adjusted.

In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products were studied, including calcium-channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium-channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10 mg, except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology study, tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not controlled, the reduction was greater, although this reduction was not associated with hypotensive symptoms in the majority of subjects. In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha-blockers -doxazosin see above) is, in general, minor and not likely to be clinically relevant. Analysis of Phase 3 clinical trial data showed no difference in adverse events in patients taking tadalafil with or without antihypertensive medicinal products. However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medicinal products.

Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3).

In a clinical trial that compared tadalafil 5 mg co-administered with finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified. However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is co-administered with 5-ARIs.

When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction. The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate. Although this effect is minor and was of no clinical significance in this study, it should be considered when co-administering these medicinal products.

At steady-state, tadalafil (40 mg once per day) increased ethinylestradiol exposure (AUC) by 26 % and Cmax by 70 % relative to oral contraceptive administered with placebo. There was no statistically significant effect of tadalafil on levonorgestrel which suggests the effect of ethinylestradiol is due to inhibition of gut sulphation by tadalafil. The clinical relevance of this finding is uncertain.

A similar increase in AUC and Cmax seen with ethinylestradiol may be expected with oral administration of terbutaline, probably due to inhibition of gut sulphation by tadalafil. The clinical relevance of this finding is uncertain.

Alcohol concentrations (mean maximum blood concentration 0.08 %) were not affected by co-administration with tadalafil (10 mg or 20 mg). In addition, no changes in tadalafil concentrations were seen 3 hours after co-administration with alcohol. Alcohol was administered in a manner to maximise the rate of alcohol absorption (overnight fast with no food until 2 hours after alcohol).

Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 mL of 40 % alcohol [vodka] in an 80 kg male) but, in some subjects, postural dizziness and orthostatic hypotension were observed. When tadalafil was administered with lower doses of alcohol (0.6 g/kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone. The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).

Cytochrome P450 metabolised medicinal products

Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.

Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.

Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid.

Specific interaction studies with antidiabetic medicinal products were not conducted.

There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Tadalafil during pregnancy.

Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk. A risk to the suckling child cannot be excluded. Tadalafil should not be used during breast-feeding.

Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).

Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to Tadalafil, before driving or using machines.

Summary of the safety profile of tadalafil in erectile dysfunction

The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of tadalafil. The adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with tadalafil once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.

Tabulated summary of adverse reactions

The table below lists the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 8022 patients on tadalafil and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.

Cialis Side Effects Center

Cialis (tadalafil) is a phosphodiesterase inhibitor used for treating impotence (erectile dysfunction, or ED).

What Are Side Effects of Cialis?

  • flushing (redness or warmth of the face, neck, or chest),
  • headaches,
  • stomach upset,
  • diarrhea,
  • flu-like symptoms (such as stuffy nose, sneezing, or sore throat),
  • memory problems,
  • muscle or back pain,
  • nausea, ,
  • dizziness,
  • blurred vision and changes in color vision,
  • abnormal ejaculation, and
  • prolonged erections (priapism).

Tell your doctor if you have rare but serious side effects of Cialis including:

  • a painful or prolonged erection lasting 4 or more hours;
  • sudden decreased vision (including permanent blindness, in one or both eyes);
  • a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness.

Cialis may cause serious side effects including:

  • chest pain,
  • pain spreading to the jaw or shoulder,
  • nausea,
  • sweating,
  • vision changes,
  • sudden vision loss,
  • ringing in your ears,
  • sudden hearing loss, and
  • an erection that is painful or lasts longer than 4 hours

Get medical help right away, if you have any of the symptoms listed above.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Cialis

The recommended dose of Cialis is 5-20 mg per day taken before sexual activity.

What Drugs, Substances, or Supplements Interact with Cialis?

Cialis may interact with rifamycins, antibiotics, antifungals, antidepressants, barbiturates, drugs to treat high blood pressure or a prostate disorder, heart or blood pressure medications, HIV or AIDS medications or seizure medications. Tell your doctor all medications and supplements you use.

Cialis During Pregnancy and Breastfeeding

Cialis is not approved for use in women and has not been evaluated in women who are breastfeeding.

Additional Information

Our Cialis Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tadalafil and call your doctor at once if you have:

  • heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • vision changes or sudden vision loss;
  • ringing in your ears or sudden hearing loss; or
  • an erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis).

Stop and get medical help at once if you have nausea, chest pain, or dizziness during sex. You could be having a life-threatening side effect.

  • headache;
  • flushing (warmth, redness, or tingly feeling);
  • nausea, upset stomach;
  • runny or stuffy nose; or
  • muscle pain, back pain, pain in your arms, legs, or back.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tadalafil was administered to over 9000 men during clinical trials worldwide. In trials of CIALIS for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. ForCIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year ,respectively.

CIALIS For Use As Needed For ED

In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%,compared to 1.4% in placebo treated patients.

When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported ( see Table 1) for CIALIS for use as needed:

Table 1: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS (10or 20 mg) and More Frequent on Drug than Placebo in the Eight Primary Placebo-Controlled ClinicalStudies (Including a Study in Patients with Diabetes) for CIALIS for Use as Needed for ED

Adverse Reaction Placebo
(N=476)
Tadalafil 5 mg
(N=151)
Tadalafil 10 mg
(N=394)
Tadalafil 20 mg
(N=635)
Headache 5% 11% 11% 15%
Dyspepsia 1% 4% % 10%
Back pain 3% 3% 5% 6%
Myalgia 1% 1% 4% 3%
Nasal congestion 1% 2% 3% 3%
Flushing a 1% 2% 3% 3%
Pain in limb 1% 1% 3% 3%
a The term flushing includes: facial flushing and flushing
CIALIS For Once Daily Use For ED

In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82)and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.1%, compared to 2.8%in placebo-treated patients.

The following adverse reactions were reported ( see Table 2) in clinical trials of 12 weeks duration:

Table 2: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS forOnce Daily Use (2.5 or 5 mg) and More Frequent on Drug than Placebo in the Three Primary Placebo-Controlled Phase 3 Studies of 12 weeks Treatment Duration (Including a Study in Patients with Diabetes) for CIALIS for Once Daily Use for ED

Adverse Reaction Placebo
(N=248)
Tadalafil 2.5 mg
(N=196)
Tadalafil 5 mg
(N=304)
Headache 5% 3% 6%
Dyspepsia 2% 4% 5%
Nasopharyngitis 4% 4% 3%
Back pain 1% 3% 3%
Upper respiratory tract infection 1% 3% 3%
Flushing 1% 1% 3%
Myalgia 1% 2% 2%
Cough 0% 4% 2%
Diarrhea 0% 1% 2%
Nasal congestion 0% 2% 2%
Pain in extremity 0% 1% 2%
Urinary tract infection 0% 2% 0%
Gastroesophageal reflux disease 0% 2% 1%
Abdominal pain 0% 2% 1%

The following adverse reactions were reported ( see Table 3) over 24 weeks treatment duration in one placebo-controlled clinical study:

Table 3: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS forOnce Daily Use (2.5 or 5 mg) and More Frequent on Drug than Placebo in One Placebo-ControlledClinical Study of 24 Weeks Treatment Duration for CIALIS for Once Daily Use for ED

Adverse Reaction Placebo
(N=94)
Tadalafil 2.5 mg
(N=96)
Tadalafil 5 mg
(N=97)
Nasopharyngitis 5% 6% 6%
Gastroenteritis 2% 3% 5%
Back pain 3% 5% 2%
Upper respiratory tract infection 0% 3% 4%
Dyspepsia 1% 4% 1%
Gastroesophageal reflux disease 0% 3% 2%
Myalgia 2% 4% 1%
Hypertension 0% 1% 3%
Nasal congestion 0% 0% 4%
CIALIS For Once Daily Use For BPH And For ED And BPH

In three placebo-controlled clinical trials of 12 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 63 years (range 44 to 93) and the discontinuation rate due to adverse events in patients treated with tadalafil was 3.6% compared to 1.6% in placebo-treated patients. adverse reactions leading to discontinuation reported by at least 2 patients treated with tadalafil included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported ( see Table 4).

Table 4: Treatment-Emergent Adverse Reactions Reported by ≥1% of Patients Treated with CIALIS forOnce Daily Use (5 mg) and More Frequent on Drug than Placebo in Three Placebo-Controlled ClinicalStudies of 12 Weeks Treatment Duration, including Two Studies for CIALIS for Once Daily Use for BPHand One Study for ED and BPH

Adverse Reaction Placebo
(N=576)
Tadalafil 5 mg
(N=581)
Headache 2.3% 4.1%
Dyspepsia 0.2% 2.4%
Back pain 1.4% 2.4%
Nasopharyngitis 1.6% 2.1%
Diarrhea 1.0% 1.4%
Pain in extremity 0.0% 1.4%
Myalgia 0.3% 1.2%
Dizziness 0.5% 1.0%

Across placebo-controlled studies with CIALIS for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with CIALIS (2.5% of patients) [see Use In Specific Populations] .

Across all studies with any CIALIS dose, reports of changes in color vision were rare (

Body as a Whole – asthenia, face edema, fatigue, pain, peripheral edema

Cardiovascular – angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension ,palpitations, syncope, tachycardia

Digestive – abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage

Musculoskeletal – arthralgia, neck pain

Nervous – dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo

Renal and Urinary – renal impairment

Respiratory – dyspnea, epistaxis, pharyngitis

Skin and Appendages – pruritus, rash, sweating

Ophthalmologic – blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia),eye pain, lacrimation increase, swelling of eyelids

Otologic – sudden decrease or loss of hearing, tinnitus

Urogenital – erection increased, spontaneous penile erection

Postmarketing Experience

The following adverse reactions have been identified during post approval use of CIALIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.

Cardiovascular And Cerebrovascular

Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of CIALIS without sexual activity. Others were reported to have occurred hours to days after the use of CIALIS and sexual activity. It is not possible to determine whether these events are related directly to CIALIS, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS] .

Body as a Whole – hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis

Nervous – migraine, seizure and seizure recurrence, transient global amnesia

Ophthalmologic – visual field defect, retinal vein occlusion, retinal artery occlusion

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including CIALIS. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking [see WARNINGS AND PRECAUTIONS] .

Otologic – Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including CIALIS. In some of the cases, medical conditions andother factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of CIALIS, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS] .

Urogenital – priapism [see WARNINGS AND PRECAUTIONS] .

DRUG INTERACTIONS

Potential For Pharmacodynamic Interactions With CIALIS

Nitrates

Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated.In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and CLINICAL PHARMACOLOGY] .

Alpha-Blockers

Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5inhibitors, including CIALIS, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin. [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY] .

Anti hypertensives

PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected anti hypertensive medications (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo. [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY] .

Alcohol

Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased.Substantial consumption of alcohol (e.g., 5 units or greater) in combination with CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY] .

Potential For Other Drugs To Affect CIALIS

[See DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS] .

Antacids

Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil.

H2 Antagonists (e.g. Nizatidine)

An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.

Cytochrome P450 Inhibitors

CIALIS is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.

Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4,increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see DOSAGE AND ADMINISTRATION] .

Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.

Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4,CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20-mg single-dose exposure (AUC) by 32% with a 30%reduction in Cmax , relative to the values for tadalafil 20 mg alone. Ritonavir (200 mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax , relative to the values for tadalafil 20 mg alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see DOSAGE AND ADMINISTRATION] .

Cytochrome P450 Inducers

Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure.

Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. No dose adjustment is warranted. The reduced exposure of tadalafil with the coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of CIALIS for once daily use; the magnitude of decreased efficacy is unknown.

Potential For CIALIS To Affect Other Drugs

Aspirin

Tadalafil did not potentiate the increase in bleeding time caused by aspirin.

Cytochrome P450 Substrates

CIALIS is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Studies have shown that tadalafil doe snot inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.

Tadalafil had no significant effect on the pharmacokinetics of theophylline.When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed.

Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin.

Tadalafil had no significant effect on exposure (AUC) to midazolamor lovastatin.

P-Glycoprotein (e.g. Digoxin)

Coadministration of tadalafil (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0.25 mg/day) in healthy subjects.

Read the entire FDA prescribing information for Cialis (Tadalafil)

© Cialis Patient Information is supplied by Cerner Multum, Inc. and Cialis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Tadalafil (Oral Tablet): Side Effects, Dosage, and Review

Tadalafil oral tablet doesn’t usually cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects that can occur with tadalafil include:

  • headache
  • upset stomach
  • back pain
  • muscle aches
  • flushing (reddish skin)
  • stuffy or runny nose
  • diarrhea

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Priapism (in men). Symptoms can include:
    • a painful erection that won’t go away
    • seeing a shade of blue when looking at objects
    • trouble telling the difference between the colors blue and green
    • a sudden decrease or loss of vision in one or both eyes
    • a sudden loss or decrease in hearing
    • ringing in the ears
    • dizziness
    • feeling lightheaded or dizzy
    • fainting
    • angina (chest pain

    Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

    Tadalafil is a prescription drug. It comes as an oral tablet.

    Tadalafil oral tablet is available as the brand-name drugs Cialis and Adcirca. It’s also available in a generic form. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

    Why it’s used

    Tadalafil (Cialis) is used for treatment of benign prostatic hyperplasia (BPH) or erectile dysfunction (ED), or both conditions. Tadalafil (Adcirca) is used to treat pulmonary arterial hypertension (PAH).

    With BPH, the prostate gland is enlarged but isn’t cancerous. It can pinch or squeeze your urethra (the tube that carries urine from the kidneys out of the body). Symptoms of BPH include trouble urinating, painful urination, and a frequent or urgent need to urinate.

    With ED, the penis doesn’t fill up with enough blood to harden and expand when a man is sexually excited. ED can also prevent a man from keeping an erection.

    PAH is a rare but serious form of high blood pressure. It occurs in the pulmonary arteries, which are blood vessels in your lungs.

    How tadalafil is used

    How long before sex should you take tadalafil? Tadalafil can be prescribed in two different ways, either a daily dosage or on an as-needed basis. Your doctor will prescribe either one. If you’re taking tadalafil on an as-needed basis, you should take it at least 30 minutes before sex. If you’re taking it daily, try to take it around the same time every day.

    How often should you take tadalafil? Tadalafil should not be taken more than once in a 24-hour period. If you miss a dose during this period, take the missed dose as soon as possible. However, never double your dosages. If you miss a dose and you’re already due for the next one, skip the missed dose.

    Should tadalafil be taken with food? Tadalafil can be taken with or without food and is not affected by the type of food you take with it.

    How it works

    Tadalafil belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

    Tadalafil may help relax the muscle in your prostate and bladder. This could help improve your BPH symptoms.

    To improve ED symptoms, tadalafil helps increase blood flow to the penis. This can help you get and keep an erection. For tadalafil to help you have an erection, you need to be sexually aroused.

    For PAH, tadalafil works to improve your ability to exercise by relaxing blood vessels in your lungs. This increases blood flow.

    • Heart disease warning. You shouldn’t use tadalafil if you have a heart condition and your doctor has advised against sexual activity. Call your doctor right away if you have symptoms during sex such as chest pain, dizziness, or nausea. Sexual activity can put an extra strain on your heart. This is especially true if your heart is already weak from a heart attack or heart disease.
    • Priapism warning.Priapism is an erection that won’t go away. Without treatment, this condition could cause permanent damage to your penis. This damage includes impotence (not being able to have an erection). If you get an erection that lasts more than 4 hours, call your doctor right away.

    Tadalafil oral tablets can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

    To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist.

    Examples of drugs that can cause interactions with tadalafil are listed below.

    Angina drugs (nitrates)

    If you take tadalafil with nitrates, your blood pressure could suddenly drop to dangerously low levels. This could make you dizzy or cause you to faint. Examples of nitrates include:

    High blood pressure or prostate drugs (alpha-blockers)

    If you take tadalafil with certain alpha-blockers, your blood pressure could suddenly drop to low levels that are dangerous. This could make you dizzy or cause you to faint. Examples of these drugs include:

    Certain HIV drugs

    Taking tadalafil with certain HIV drugs could increase tadalafil levels in your blood. This can lead to low blood pressure, dizziness and fainting, and vision problems. In men, it can also lead to priapism. These drugs are protease inhibitors and include ritonavir and lopinavir/ritonavir.

    Oral antifungal drugs

    Taking certain antifungal drugs with tadalafil may increase levels of tadalafil in your blood. This can lead to low blood pressure, dizziness and fainting, and vision problems. In men, it can also lead to priapism. Examples of these drugs include ketoconazole and itraconazole.

    Antibiotics

    Taking certain antibiotics with tadalafil may raise the level of tadalafil in your blood. This can lead to low blood pressure, dizziness and fainting, and vision problems. In men, it can also lead to priapism. Examples of these drugs include:

    Other types of antibiotics may lower the level of tadalafil in your blood. This could prevent tadalafil from working well. This includes drugs such as rifampin.

    Other erectile dysfunction (ED) drugs

    These medications work in the same way as tadalafil. If you take them with tadalafil, it increases your risk for side effects. Examples of these drugs include sildenafil and vardenafil.

    Other pulmonary arterial hypertension (PAH) drugs

    If you take tadalafil with other types of PAH drugs, your blood pressure could suddenly drop to dangerously low levels. The drug riociguat is in this drug class.

    Stomach acid drugs

    Taking these medications with tadalafil may keep your body from absorbing tadalafil well. An example of this type of drug is magnesium hydroxide/aluminum hydroxide.

    Epilepsy drugs

    Taking certain anti-seizure drugs with tadalafil may lower the level of tadalafil in your blood. This could prevent tadalafil from working well. Examples of these drugs include:

    Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you’re taking.

    Allergy warning

    Tadalafil can cause a severe allergic reaction. Symptoms can include:

    If you develop these symptoms, call 911 or go to the nearest emergency room.

    Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

    Grapefruit interaction warning

    Eating grapefruit or drinking grapefruit juice may increase the levels of tadalafil in your blood. This raises your risk for side effects.

    Alcohol interaction warning

    Don’t drink large amounts of alcohol when taking tadalafil. Both alcohol and tadalafil can dilate (widen) your blood vessels. When used together, they can cause your blood pressure to drop.

    Warnings for people with certain health conditions

    For people with heart disease: Sexual activity creates a risk for your heart. Using tadalafil may increase that risk. Don’t use tadalafil if you have a heart condition and your doctor has advised against sexual activity.

    For people at risk for prolonged erections: Tadalafil may cause priapism. This condition causes a painful, long-lasting erection. It is a medical emergency. Talk with your doctor before using tadalafil if you have a condition that puts you at higher risk for priapism. These conditions include blood cell conditions such as sickle cell anemia, multiple myeloma, or leukemia Peyronie’s disease (a curved or deformed penis).

    For people with vision problems: Retinitis pigmentosa is a rare genetic eye disease. Tadalafil hasn’t been studied in people with this condition, and its use isn’t recommended. Tell your doctor if you’ve ever had severe vision loss, including a condition called NAION (non-arteritic anterior ischemic optic neuropathy). If you’ve had NAION and take tadalafil, you may be at increased risk for having NAION again.

    For people with kidney disease or on dialysis: Your body may not be able to get rid of tadalafil correctly. This means the drug would stay in your body longer and raise your risk for side effects. Your doctor may start you on a lower dosage, have you take it less often, or not prescribe it at all.

    For people with liver problems: Your body may not process tadalafil correctly. This means the drug would stay in your body longer and raise your risk for side effects. Your doctor may start you on a lower dosage, have you take it less often, or not prescribe it at all.

    For people with bleeding disorders or peptic ulcers: Tadalafil hasn’t been studied in people with these conditions. Using tadalafil may cause or worsen bleeding or ulcers. If you take tadalafil, your doctor may monitor you more closely.

    Warnings for other groups

    For pregnant women: Studies of this drug in pregnant animals haven’t shown risk to the fetus. However, there aren’t enough studies done in pregnant women using the drug for PAH to show whether the drug poses a risk to a human fetus.

    Talk with your doctor if you’re pregnant or planning to become pregnant. Animal studies don’t always predict the way humans would respond. Therefore, this drug should only be used in pregnancy if clearly needed.

    For women who are breastfeeding: It isn’t known if tadalafil passes into breast milk. If it does, it may cause serious effects in a child who is breastfed. Talk with your doctor if you’re taking tadalafil and you want to breastfeed.

    For seniors: If you are age 65 years or older, your body may process this drug more slowly. Your doctor may start you on a lower dosage so that tadalafil doesn’t build up too much in your body. High levels of the drug in your body can be dangerous.

    For children: Children younger than 18 years old shouldn’t use tadalafil. It’s not known if tadalafil is safe and effective in children.

    Tadalafil 20mg film-coated tablets

    Yellow coloured, capsule shaped, biconvex film-coated tablet with “T20” debossed on one side and plain on other side.

    Treatment of erectile dysfunction in adult males.

    In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required.

    Tadalafil is not indicated for use by women.

    Erectile dysfunction in adult men

    In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food.

    In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity.

    The maximum dose frequency is once per day.

    Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.

    In patients who anticipate a frequent use of tadalfil (i.e., at least twice weekly) a once daily regimen with the lowest doses of tadalafil might be considered suitable, based on patient choice and the physician’s judgement.

    In these patients, the recommended dose is 5mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5mg once a day based on individual tolerability.

    The appropriateness of continued use of the daily regimen should be reassessed periodically.

    Dose adjustments are not required in elderly patients.

    Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with severe renal impairment, 10 mg is the maximum recommended dose.

    Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment (see sections 4.4 and 5.2).

    For the treatment of erectile dysfunction using on-demand tadalafil the recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10mg of tadalafil to patients with hepatic impairment.

    Once-a-day dosing of tadalafil has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see sections 4.4 and 5.2).

    Dose adjustments are not required in diabetic patients.

    There is no relevant use of tadalafil in the paediatric population with regard to the treatment of erectile dysfunction.

    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

    In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.5).

    Tadalafil must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.

    The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated:

    • patients with myocardial infarction within the last 90 days,

    • patients with unstable angina or angina occurring during sexual intercourse,

    • patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,

    • patients with uncontrolled arrhythmias, hypotension (

    • patients with a stroke within the last 6 months

    Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).

    The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).

    Before treatment with tadalafil tablets

    A medical history and physical examination should be undertaken to diagnose erectile dysfunction or benign prostatic hyperplasia and determine potential underlying causes, before pharmacological treatment is considered.

    Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1) and as such potentiates the hypotensive effect of nitrates (see section 4.3).

    The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. It is not known if tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.

    Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials. Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a combination of these or other factors.

    In patients who are taking alpha1 blockers, concomitant administration of tadalafil may lead to symptomatic hypotension in some patients (see section 4.5). The combination of tadalafil and doxazosin is not recommended.

    Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking tadalafil and consult a physician immediately (see section 4.3).

    Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.

    There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C). If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

    Priapism and anatomical deformation of the penis

    Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

    Tadalafil, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).

    Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin), as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).

    Tadalafil tablets and other treatments for erectile dysfunction

    The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. The patients should be informed not to take tadalafil in such combinations.

    Tadalafil 20 mg film-coated tablet contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

    This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

    Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.

    Effects of other substances on tadalafil

    Tadalafil is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone. Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22%. Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax. Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole, and grapefruit juice, should be co-administered with caution, as they would be expected to increase plasma concentrations of tadalafil (see section 4.4). Consequently, the incidence of the adverse reactions listed in section 4.8 might be increased.

    The role of transporters (for example, p-glycoprotein) in the disposition of tadalafil is not known. Therefore, there is the potential of drug interactions mediated by inhibition of transporters.

    A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil alone (10 mg). This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude of decreased efficacy is unknown. Other inducers of CYP3A4, such as phenobarbital, phenytoin, and carbamazepine, may also decrease plasma concentrations of tadalafil.

    Effects of tadalafil on other medicinal products

    In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates. Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.3). Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose. Thus, in a patient prescribed any dose of tadalafil (2.5 mg- 20 mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.

    Anti-hypertensives (including calcium channel blockers)

    The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner. This effect lasts at least twelve hours and may be symptomatic, including syncope. Therefore, this combination is not recommended (see section 4.4).

    In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin. However, caution should be exercised when using tadalafil in patients treated with any alpha-blockers, and notably in the elderly. Treatments should be initiated at minimal dosage and progressively adjusted.

    In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products were studied, including calcium-channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium-channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10 mg, except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology study, tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not controlled, the reduction was greater, although this reduction was not associated with hypotensive symptoms in the majority of subjects. In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha-blockers – see above) is, in general, minor and not likely to be clinically relevant. Analysis of Phase 3 clinical trial data showed no difference in adverse events in patients taking tadalafil with or without antihypertensive medicinal products. However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medicinal products.

    Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3).

    In a clinical trial that compared tadalafil 5 mg coadministered with finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified. However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is co-administered with 5-ARIs.

    CYP1A2 substrates (e.g. theophylline)

    When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction. The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate. Although this effect is minor and was of no clinical significance in this study, it should be considered when co-administering these medicinal products.

    Tadalafil has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a similar increase may be expected with oral administration of terbutaline, although the clinical consequence of this is uncertain.

    Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co-administration with tadalafil (10 mg or 20 mg). In addition, no changes in tadalafil concentrations were seen 3 hours after co-administration with alcohol. Alcohol was administered in a manner to maximise the rate of alcohol absorption (overnight fast with no food until 2 hours after alcohol). Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40% alcohol [vodka] in an 80 kg male) but, in some subjects, postural dizziness and orthostatic hypotension were observed. When tadalafil was administered with lower doses of alcohol (0.6 g/kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone. The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).

    Cytochrome P450 metabolised medicinal products

    Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.

    Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.

    Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid.

    Specific interaction studies with antidiabetic medicinal products were not conducted.

    Tadalafil is not indicated for use by women.

    There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of tadalafil during pregnancy.

    Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk. A risk to the suckling child cannot be excluded. Tadalafil should not be used during breast feeding.

    Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).

    Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to tadalafil before driving or using machines.

    The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of tadalafil. The adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with tadalafil once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.

    Tabulated summary of adverse reactions

    The table below lists the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 8022 patients on tadalafil and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.

    Tadalafil – Uses, Side Effects, and More

    Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection.Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder.This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice “safe sex” such as using latex condoms. Consult your doctor or pharmacist for more details.

    How to use Tadalafil

    Read the Patient Information Leaflet provided by your pharmacist before you start taking tadalafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

    Take this medication by mouth, with or without food, as directed by your doctor. Do not take tadalafil more often than once daily.

    The manufacturer directs to swallow this medication whole. However, many similar drugs (immediate-release tablets) can be split/crushed. Follow your doctor’s directions on how to take this medication.

    The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    To treat the symptoms of BPH, take this medication as directed by your doctor, usually once a day. If you are also taking finasteride with this medication to treat symptoms of BPH, talk with your doctor about how long you should continue taking this medication.

    To treat erectile dysfunction-ED, there are 2 ways that tadalafil may be prescribed. Your doctor will determine which is the best way for you to take tadalafil. Follow your doctor’s directions exactly since your dosage depends on how you are taking it. The first way is to take it as needed, usually at least 30 minutes before sexual activity. Tadalafil’s effect on sexual ability may last up to 36 hours.

    The second way to treat ED is to take tadalafil regularly, once a day every day. If you take it this way, you may attempt sexual activity at any time between your doses.

    If you are taking tadalafil to treat both ED and BPH, take it as directed by your doctor, usually once a day. You may attempt sexual activity at any time between your doses.

    If you are taking tadalafil once daily for BPH, or for ED, or for both, take it regularly to get the most benefit from it. To help you remember, take it at the same time each day.

    Tell your doctor if your condition does not improve or if it worsens.

    Side Effects

    Headache, stomach upset, back pain, muscle pain, stuffy nose, flushing, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

    To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

    Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea.

    Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking tadalafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems (“crowded disk”), high blood pressure, if you are over 50, or if you smoke.

    Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking tadalafil and get medical help right away if these effects occur.

    In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

    In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Precautions

    Before taking tadalafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months, kidney disease, liver disease, high or low blood pressure, dehydration, penis conditions (such as angulation, fibrosis/scarring, Peyronie’s disease), history of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma), eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION), bleeding disorders, active stomach ulcers.

    This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

    Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    This brand of the drug is not usually used in women. During pregnancy, tadalafil should be used only when clearly needed. Discuss the risks and benefits with your doctor.

    It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

    Interactions

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

    A product that may interact with this drug is: riociguat.

    Tadalafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use any of the following with tadalafil or within 48 hours of your last dose of tadalafil: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called “poppers” containing amyl or butyl nitrite.

    If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of tadalafil or adjust your alpha blocker medication to minimize your risk of low blood pressure.

    Other medications can affect the removal of tadalafil from your body, which may affect how tadalafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as fosamprenavir, ritonavir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), rifampin, among others.

    Do not take this medication with any other product that contains tadalafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil).

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