Tadalafil – Uses, Side Effects, and More

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

Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial

Background: Erectile dysfunction (ED) is a chronic disease; however, therapy is currently administered as needed with oral phosphodiesterase 5 (PDE5) inhibitors like tadalafil. Because the 17.5-h half-life of tadalafil enables therapeutic plasma levels to be sustained with daily administration, tadalafil is a good candidate for once daily dosing therapy.

Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, 12-week study enrolled 268 men 1:2:2 to placebo, tadalafil 5mg, and tadalafil 10mg taken once daily. Primary efficacy measures included changes in the International Index of Erectile Function Erectile Function domain (IIEF EF), Sexual Encounter Profile diary Questions 2 (SEP2: successful penetration), and 3 (SEP3: successful completion of intercourse), and tolerability. Secondary measures included percentage of patients at endpoint who reported improved erectile function (EF), and percentage who reported “no ED” (IIEF EF score 26-30).

Results: For patients who took placebo, tadalafil 5mg, and tadalafil 10mg, changes from baseline to endpoint were, respectively, 0.9, 9.7, and 9.4 for IIEF EF; 11.2, 36.5, and 39.4 for SEP2; and 13.2, 45.5, and 50.1 for SEP3. At endpoint, 28.3%, 84.5%, and 84.6% reported improved erections, and 8.3%, 51.5%, and 50.5% reported “no ED,” respectively. All comparisons between tadalafil and placebo were significant (p<0.001). Adverse events that occurred in at least 5% of patients were dyspepsia, headache, back pain, upper abdominal pain, and myalgia; nine patients (3.4%) discontinued because of adverse events.

Conclusions: Once-a-day tadalafil 5mg or 10mg was well tolerated and significantly improved EF in men with ED.

Comment in

McMahon CG. McMahon CG. Eur Urol. 2006 Aug;50(2):215-7. doi: 10.1016/j.eururo.2006.03.018. Epub 2006 Mar 29. Eur Urol. 2006. PMID: 16844542 No abstract available.

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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).

Tadalafil 10mg film-coated tablets

Each coated tablet contains 163.40mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

The 10mg tablets are light yellow to yellow, round shaped, film-coated tablets imprinted with ‘338’ on one side.

Treatment of erectile dysfunction in adult males.

In order for Tadalafil to be effective, sexual stimulation is required.

Tadalafil is not indicated for use by women.

In general, the recommended dose is 10mg taken prior to anticipated sexual activity and with or without food. In those patients in whom Tadalafil 10mg does not produce an adequate effect, 20mg might be tried. It may be taken at least 30 minutes prior to sexual activity.

The maximum dose frequency is once per day.

Tadalafil 10mg and 20mg 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 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, 10mg is the maximum recommended dose. Once-a-day dosing tadalafil is not recommended in patients with severe renal impairment. (See sections 4.4 and 5.2.)

The recommended dose of Tadalafil is 10mg 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 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).

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.

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

Interaction studies were conducted with 10mg and/or 20mg tadalafil, as indicated below. With regard to those interaction studies where only the 10mg 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 (200mg daily), increased tadalafil (10mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone. Ketoconazole (400mg daily) increased tadalafil (20mg) exposure (AUC) 4-fold and Cmax by 22%. Ritonavir, a protease inhibitor (200mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20mg) 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 (10mg). 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 (5mg, 10mg and 20mg) 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 20mg for 7 days and 0.4mg 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 (2.5mg – 20mg), 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 8mg daily) and tadalafil (5mg daily dose and 20mg 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 (10mg, except for studies with angiotensin II receptor blockers and amlodipine in which a 20mg dose was applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology study, tadalafil (20mg) 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 20mg 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.

When tadalafil 10mg 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 (10mg or 20mg). 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 (20mg) did not augment the mean blood pressure decrease produced by alcohol (0.7g/kg or approximately 180ml 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 (0.6g/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 (10mg).

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 (10mg and 20mg) 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 (10mg and 20mg) 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 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

Tadalafil 10 mg film-coated tablets

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  • 1. Name of the medicinal product
  • 2. Qualitative and quantitative composition
  • 3. Pharmaceutical form
  • 4. Clinical particulars
  • 4.1 Therapeutic indications
  • 4.2 Posology and method of administration
  • 4.3 Contraindications
  • 4.4 Special warnings and precautions for use
  • 4.5 Interaction with other medicinal products and other forms of interaction
  • 4.6 Fertility, pregnancy and lactation
  • 4.7 Effects on ability to drive and use machines
  • 4.8 Undesirable effects
  • 4.9 Overdose
  • 5. Pharmacological properties
  • 5.1 Pharmacodynamic properties
  • 5.2 Pharmacokinetic properties
  • 5.3 Preclinical safety data
  • 6. Pharmaceutical particulars
  • 6.1 List of excipients
  • 6.2 Incompatibilities
  • 6.3 Shelf life
  • 6.4 Special precautions for storage
  • 6.5 Nature and contents of container
  • 6.6 Special precautions for disposal and other handling
  • 7. Marketing authorisation holder
  • 8. Marketing authorisation number(s)
  • 9. Date of first authorisation/renewal of the authorisation
  • 10. Date of revision of the text

This information is intended for use by health professionals

Each film-coated tablet contains 10 mg tadalafil.

Each film-coated tablet contains 183.144 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Light yellow, capsule shaped, approximately 11 mm in length and 5.5 mm in width, biconvex, bevelled edged, film coated tablet, debossed with “T 10” 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.

Tadalafil10 mg is not indicated for use by women.

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.

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 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.)

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.)

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 (< 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.

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.

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.

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 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.

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.

Tadalafil10 mg 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.

CIALIS 10mg / 20mg tadalafil 4/8 tablets erectile dysfunction

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CIALIS 10mg / 20mg tadalafil 4/8 erectile dysfunction tablets in our pharmacy bio, Comment on the advice of use and dosage with our Verified Reviews partner after your purchase.

Only available in “withdrawal store” on presentation of the original of your medical prescription at the Pharmacy Mailloles in Perpignan (France)

For warnings, precautions for use, composition, dosage, contraindications, please consult the instructions for use.

If your symptoms persist, consult your doctor.

Warning ! This product is a prescription drug. To be able to order it, you must follow the following procedure:

You must obtain a prescription from your doctor . This prescription must absolutely be written and signed by a doctor practicing in the European Union . The prescription date must not be earlier than 3 months before the date of the order.

  • exact contact details and doctor’s signature
  • your name and exact address
  • the name of the medication, the amount needed and the dosage to be applied
  • duration of treatment

You must download the medical prescription by pressing the Personalize your product button.

If all these conditions are not respected, we will be under the legal obligation not to be able to give a favorable result to the order of this medicine. The order of this product will be canceled, and the amount of its purchase will be fully refunded.

CIALIS 10mg / 20mg tadalafil 4/8 erectile dysfunction tablets

CIALIS is a treatment for men with erectile dysfunction ; that is, when a man cannot achieve or maintain an erection sufficient for sexual activity .

Description of CIALIS 10mg / 20mg tadalafil 4/8 erectile dysfunction tablets

CIALIS belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, CIALIS works by helping the relaxation of the blood vessels in your penis , thereby promoting blood flow. This results in an improvement in erection . CIALIS will not help you if you do not have an erection problem.

It is important to know that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay as you would if you were not taking medication for your erection problem.

Directions for use and dosage

Always take the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is one 10 mg tablet to be taken before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. CIALIS tablets are to be swallowed. Swallow the tablet whole with a little water. You can take CIALIS with or without food.

You can take one CIALIS tablet at least 30 minutes before sexual activity. CIALIS can remain effective for up to 36 hours after taking the tablet. It is important to know that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay as you would if you were not taking erectile dysfunction medication.

Drinking alcohol can affect your ability to get an erection. Drinking alcohol can also temporarily lower your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive alcohol consumption (blood alcohol concentration of 0.08% or more), this may increase the risk of feeling dizzy when switching to the position standing.

You should NOT take CIALIS more than once a day.
CIALIS 10 mg or 20 mg is taken before sexual activity.
Long-term daily use of CIALIS 10 mg and 20 mg is not recommended.

If you take more CIALIS than you should
Tell your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist for more information.

Give your opinion on the advice for use and dosage of CIALIS 10mg / 20mg tadalafil 4/8 erectile dysfunction tablets with our partner Avis checked after your purchase.

Composition

The active substance is : tadalafil.
Each tablet contains 20 mg of tadalafil.

The other components are :
Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.
Film coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), talc.

Precautions for use

  • if you are allergic (hypersensitive) to tadalafil or any of the other ingredients of CIALIS.
  • if you are taking medicines that contain nitrates or nitrogen monoxide donors like amyl nitrite in any form. This group of drugs (“nitrates”) is used to treat attacks of angina pectoris (“chest pain”). CIALIS has been shown to increase the effects of these drugs. If you take nitrates in any form or have any doubts, tell your doctor.
  • if you have severe heart disease or have recently had a heart attack.
  • if you have recently had a stroke.
  • if you have low blood pressure or uncontrolled high blood pressure.
  • if you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition sometimes described as “stroke”.

Take care with CIALIS
Please note that sexual activity poses a potential risk in patients with heart disease, due to the extra effort involved in the heart. If you have a heart problem, talk to your doctor.

CIALIS may also not be indicated to you for the following reasons. If you are affected by any of them, talk to your doctor before taking this medicine:

  • you have sickle cell anemia (a malformation of the red blood cells), multiple myeloma (cancer of the bone marrow), leukemia (cancer of the blood cells) or a deformation of the penis,
  • you have a serious liver problem.
  • you have a serious kidney problem.

The efficacy of CIALIS in patients who have undergone pelvic surgery or prostate surgery (radical prostatectomy without preserving the nerve strips) is not known.

In case of sudden decrease or loss of vision, you should stop your treatment with CIALIS and contact your doctor immediately.

Presentation of CIALIS 10mg / 20mg tadalafil 4/8 erectile dysfunction tablets

Our advice and opinions from pharmacy experts

Still too often qualified pejoratively as “impotence”, erectile dysfunction affects one in three men after 40 years. Due to its impact on quality of life, this problem is not so trivial.
Erectile dysfunction is defined as the constant or recurrent inability to obtain and / or maintain a penile erection sufficient to allow intercourse.

What are the causes of erectile dysfunction ?

  • Erectile dysfunction can simply be caused by psychological disorders : anxiety, stress, a new sexual partner, a new sexual situation, depression, etc. This form of erectile dysfunction is much more common in men 20 to 40 years of age. Sometimes a first episode can lead to a certain “anticipatory anxiety” causing a problem experienced once to become a recurring problem.
  • Vascular problems are the most common organic cause. In this situation, erectile dysfunction is due to the narrowing of blood vessels – the penile tubes cannot get enough blood, erections therefore become inadequate. This problem is called arteriosclerosis (narrowing of blood vessels) and is often associated with smoking, diabetes, high blood pressure (high pressure) and increased cholesterol (unhealthy lifestyle habits).

VIDAL OF THE FAMILY

PRESENTATIONS (summary)

CIALIS 2.5 mg: tablet (light orange); box of 28.
Not refunded – Free price –
Prescription (List I)

CIALIS 5 mg: tablet (light yellow); box of 28.
Not refunded – Free price –
Prescription (List I)

CIALIS 5 mg: tablet (light yellow); box of 84.
Not refunded – Free price –
Prescription (List I)

CIALIS 10 mg: tablet (light yellow); box of 4.
Not refunded – Free price –
Prescription (List I)

CIALIS 20 mg: tablet (yellow); box of 4.
Not refunded – Free price –
Prescription (List I)

CIALIS 20 mg: tablet (yellow); box of 8.
Not refunded – Free price –
Prescription (List I)

COMPOSITION (summary)
INDICATIONS (summary)

This medicine is a vasodilator that acts specifically on the penis. Its action on the rest of the cardiovascular system is minimal and is of consequence only in the case of a combination of nitrated vasodilator drugs (see Interactions). It can only work in cases of sexual desire and does not usually trigger erection alone. Its effect is shown no later than one hour after taking and may last another 36 hours after. Erection is improved or restored in 75% of users, all causes of impotence combined (except local radiotherapy and some surgical procedures).
It is used in the treatment of erectile dysfunction.
The 5 mg dosage is also used in the treatment of urinary disorders related to prostate adenoma .

CONTRAINDICATIONS (summary)
  • Cardiovascular fragility contraindicates the effort of the sexual act (severe angina pectoris, severe heart failure . );
  • situations in which the effect of the drug has not been studied: arterial hypertension or uncontrolled cardiac arrhythmias , severe hypotension, recent history of stroke or myocardial infarction ;
  • impaired vision due to optic nerve damage;
  • in combination with nitrated vasodilators (see Interactions).
ATTENTION (summary)

The resumption of a sexual activity in a man weakened by age or a chronic disease can be at the origin of a cardiovascular accident. A medical check-up is necessary before using this medication.
Precautions are necessary in men with penile malformation or those who have predisposed priapism (sickle cell disease, multiple myeloma, leukemia).
The medical treatment of erectile dysfunction is conceivable only when the curable causes of impotence have been sought. The impotences of psychological origins can be improved or healed by specific therapies.
In the event of a sudden decline in vision or a decrease or loss of hearing, stop taking the medicine and contact your doctor promptly.
Because of its potential side effects, this medication may not be compatible with driving or handling dangerous machinery in some people. Make sure that you take this medication for the first time before driving or using a machine.

DRUG INTERACTIONS (summary)

The combination of tadalafil with nitrated vasodilators can cause severe hypotension. These vasodilators may be drugs for the heart: nitroprusside, nitrite, nitrates, trinitrin, linsidomine, molsidomine, nicorandil. It can also be products sold in sex shops: “poppers”, “boosts”, “snappers”, which contain nitrites and are used as amplifiers of orgasm or to dilate the anus.
The effect of tadalafil may be increased by drugs that contain ritonavir, saquinavir, itraconazole, ketoconazole or erythromycin: a decrease in the dosage of tadalafil may be necessary.
Tadalafil may also interact with alpha-blockers , particularly those used in the treatment of urinary disorders due to prostate adenoma .

PREGNANCY and BREASTFEEDING (summary)
DIRECTIONS AND DOSAGE (summary)
  • Male over 18:
    • Erectile dysfunction: 1 tablet 10 mg, between 30 minutes and 12 hours before intercourse. In case of insufficient effect, this dose may be increased to 20 mg. The effect of the drug may persist for up to 36 hours after dosing. It is recommended not to exceed one dose per day. For men who expect frequent use of this medication (at least twice a week), it is possible to take 1 tablet at 2.5 mg or 5 mg daily. The decision should be made with the doctor.
    • Urinary disorders due to prostate adenoma : 1 tablet 5 mg daily, to be taken if possible at the same time each day.
    TIPS (summary)

    This medicine is not an aphrodisiac, it does not create the sexual desire, but allows to concretize it.

    ADVERSE POSSIBLE EFFECTS (summary)

    Frequent (1 to 10% of users): headache, redness of the face, stuffy nose, difficult digestion, back or muscle pain, extremity pain.
    Uncommon (less than 1 user in 100): dizziness, blurred vision, eye pain, ringing of ears, palpitations , tachycardia, shortness of breath, nosebleeds, abdominal pain, vomiting, nausea, heartburn, redness, allergic reaction , presence of blood in the urine.
    Rare (less than 1 user in 1000): swollen eyelids, red eyes, sudden loss of hearing; Sudden loss of vision, painless, most often affecting only one eye, and requiring urgent medical advice.
    The risk of priapism is low. If the erection exceeds four hours, the doctor must be contacted urgently for appropriate treatment to be implemented.

    LEXICON (summary)

    stroke
    Brain injury due to haemorrhage or abrupt obstruction of an artery. Depending on the size of the lesion, the consequences are more or less serious: passenger discomfort, paralysis, coma.
    Abbreviation: stroke.

    • Difficulty urinating (slow, weak jet)
    • the need to get up several times a night to urinate;
    • urges to urinate imperious and difficult to control.

    alpha
    Alpha receptors, present especially on the blood vessels and the urinary system, are responsible for their contraction. An alphablocker is a substance that blocks these receptors and thus causes vasodilatation (by loosening muscle fibers in the vessel wall) or opening the sphincter of the urethra.

    angina pectoris
    Oppressive pain due to partial obstruction of the coronary arteries that irrigate the heart muscle. It can manifest in the chest, arms or jaw.
    Synonym: angor.

    antecedent
    Affection healed or still evolving. The antecedent can be personal or family. The antecedents are the story of a person’s health.

    high blood pressure
    Excess pressure (tension) of the blood in the arteries. This pressure is provided by the heart and is expressed by two numbers. It is maximal during the contraction of the heart, or systole (first digit), and minimum during the cardiac rest, or diastole (second digit). Hypertension is characterized by a maximum (systolic) pressure greater than or equal to 16, or a minimum (diastolic) pressure greater than or equal to 9.5. Treatment is initiated when these numbers are exceeded or for lower voltages in some people with cardiovascular risk factors: heredity, smoking, diabetes, excess cholesterol. Permanent antihypertensive therapy can reduce the damage to the heart and blood vessels caused by high blood pressure.

    myocardial infarction
    Destruction of part of the heart muscle (myocardium), deprived of blood by obstruction of its arteries.

    heart failure
    Inability of the heart to fulfill its pump function. The main symptoms of heart failure are fatigue and shortness of breath during exercise.

    palpitations
    Abnormal perception of irregular heartbeat.

    dosage
    Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.

    priapism
    Erection abnormally prolonged and painful.

    allergic reaction
    Reaction due to the hypersensitivity of the body to a drug. Allergic reactions can be very varied: urticaria, angioedema, eczema, rash of measles-like pimples, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort by sudden drop in blood pressure.

    heart rhythm disorders
    Serious or benign abnormality of the frequency of contractions of the heart. Extrasystole is a contraction occurring just before or after a normal contraction, often perceived as a slight shock in the chest. Fibrillation is an irregular and disordered contraction. Other disorders include torsades de pointes, Wolf-Parkinson-White syndrome, Bouveret’s disease, tachysystole, flutter and atrioventricular block, etc.

    vasodilator
    Drug capable of dilating the blood vessels (artery, vein), as opposed to vasoconstrictor.