Cialis Effects

What Are The Side Effects Of Cialis And Tadalafil?
Tadalafil is a drug belonging to the class of phosphodiesterase type 5 (PDE-5), considered the first line treatment for Erectile Dysfunction. The guidelines of the International Society for Sexual Medicine (ISSM) Standards Committee for Sexual Medicine suggest that treatment with PDE-5-inhibitors can be effective in most Erectile Dysfunction etiologies except after severe damage of the parasympathetic cavernous nerves. The relatively long half-life of Tadalafil (17.5 hours) allowed the confirmation of highest potency for PDE-5 inhibition, successful clinical development and subsequent regulatory approval of Tadalafil. Tadalafil has commercialized in four doses: 2.5 mg, 5 mg, 10 mg and 20 mg.
The number and frequency of the side effects that can appear when taking Tadalafil were obtained from numerous study results, comprising both interventional and observational studies.
An adverse event, as per the definition of European Medicines Agency, is “any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment”.
An adverse event (AE) can, therefore, be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Regarding marketed medicinal products (such as Tadalafil-containing medicinal products), a well-accepted definition of an adverse drug reaction in the post-marketing setting is found in WHO Technical Report 498 (1972) 5 : A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.
What is there to know from the Patient Information Leaflet?
The patient information leaflet will list adverse reactions observed when administering Tadalafil medicinal products, some events appear more frequent and some relatively rare. The most common side effects (seen in 1 to 10 in every 100 patients) with Cialis and Tadalafil are headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion, which are more common at higher doses .
Uncommon side effects (seen in 1 to 10 in every 1,000 patients) include allergic reactions, such as rashes, chest pain, dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Rare side effects (seen in 1 to 10 in every 10,000 patients) are sudden decrease or loss of vision or hearing, a prolonged and possibly painful erection after taking Cialis, fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.
Cialis or Tadalafil must not be used when you have been advised against sexual activity (e.g. in men with heart disease). It must also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION). Cialis or Tadalafil must not be taken with nitrates (a type of medicine used for angina) or medicines of the class ‘guanylate cyclase stimulators’ such as riociguat (a medicine for high blood pressure in the vessels supplying the lungs, known as pulmonary hypertension).
A doctor should consider the potential risks of sexual activity in men who have cardiovascular disease.
What do clinical studies conducted on Tadalafil report?
Cialis, when taken ‘on demand’ before sexual activity, has been studied in six main studies including 1,328 patients with erectile dysfunction. One of these studies contained only diabetic men. Once-a-day dosing of Cialis was studied in three further studies lasting 12 to 24 weeks and involving a total of 853 patients.
In all studies, the effects of Cialis were compared with those of placebo (a dummy treatment), and the main measure of effectiveness was the ability to get and maintain an erection. This was recorded in two questionnaires completed at home. Cialis has also been studied in patients with benign prostatic hyperplasia. Four main studies comparing Cialis with placebo were carried out in 1,500 patients with the condition, including some who also had erectile dysfunction. The main measure of effectiveness was the improvement in symptoms after 12 weeks. 7 Data from long-term studies of up to 2 years suggest Tadalafil once daily provided efficacy for the duration of therapy and had a relatively mild side-effect profile , with no visual side-effects noted. The long-term safety and tolerability of Tadalafil in the treatment of erectile dysfunction has been assessed, in an 18– 24-month open extension trial in 1173 subjects (mean age 57, range 23–83 years). The conclusion of the study was that Tadalafil at doses of 5, 10, or 20 mg taken as needed up to once daily for 18 to 24 months was safe and well tolerated. These findings support the long-term use of Tadalafil in the clinical management of erectile dysfunction.
The most frequently reported treatment-related side effects included headache (15.8%), dyspepsia (11.8%), nasopharyngitis (11.4%), and back pain (8.2%) Most adverse effects were mild or moderate. The percentage of effects reported as mild or moderate was 88% and the percentage of effects reported as severe was 12%.
An analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies explored the administration of Tadalafil 2.5 mg and 5 mg Tadalafil once-daily 12 weeks treatment. The study population consisted of 1913 men with a history of Erectile Dysfunction that were randomized to either once-daily placebo (n = 596), Tadalafil 2.5 mg (n = 394) or Tadalafil 5 mg (n = 923). Clinical factors examined included: ethnicity, age, obesity, alcohol consumption, smoking, comorbidities, concomitant medication, and Erectile Dysfunction characteristics (aetiology, duration, severity). The study results revealed that treatment with Tadalafil 2.5 mg or 5 mg once daily was well tolerated and resulted in clinically important improvements in patients with mild (54.3% and 74.8%, respectively), moderate (51.3% and 63.1%, respectively), or severe (33.7% and 44.5%, respectively) Erectile Dysfunction. 9 No unexpected safety findings were observed.
Contraindications:
It is advised that you tell your healthcare provider about all your medical problems, particularly if you have or ever had:
heart problems such as chest pain (angina), heart failure, irregular heartbeats, or have had a heart attack; high or low blood pressure or have high blood pressure that is not controlled; stroke; liver or kidney problems or require dialysis; retinitis pigmentosa, a rare genetic (runs in families) eye disease; severe vision loss, including a condition called NAION; stomach ulcers or a bleeding problem; a deformed penis shape or Peyronie’s disease; an erection that lasted more than 4 hours; blood cell problems such as sickle cell anaemia, multiple myeloma, or leukaemia.
Also, other medications that you are taking can affect the appearance of side effects . It is advised that you tell your healthcare provider about all the medicines you take especially if you take:
medicines called “nitrates” which are often prescribed for chest pain; alpha-blockers often prescribed for prostate problems; blood pressure medications; medicines for HIV or some types of oral antifungal medications; some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine); other medicines or treatments for Erectile Dysfunction.
Please talk to our Pharmacy staff or to our Doctor by calling 01625 460 621.
Conclusions:
Tadalafil appears to have a relatively mild side-effect profile. The most common side effects with Cialis/Tadalafil are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking Cialis. Back pain and muscle aches usually go away within 2 days. Uncommon but serious side effects include:
An erection that won’t go away. If you get an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury. In rare instances, men taking prescription Erectile Dysfunction tablets, including Cialis, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It’s not possible to determine if these events are related directly to the Erectile Dysfunction tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any Tadalafil product, including Cialis and call a healthcare provider right away.
Call us on 01625 460 621 if you get any side effect that bothers you or one that does not go away.
Cialis & Tadalafil (As Needed)
Cialis works in a similar way to Viagra and is quicker acting and lasts longer. It can be taken when needed, 30 minutes before intercourse.
Product Description.
About Cialis.
At least one in ten men has trouble getting an erection at some time. Cialis helps men to get and maintain an erection when sexually stimulated and/or excited. The medicine relaxes the blood vessels in the penis which results in more blood flowing to the penis. It reduces the action of the natural chemical in your body that makes erections go away.
How to take it?
You should take Cialis at least 30 minutes before intercourse. Cialis remains effective for 36 hours, meaning it will be easier to keep and maintain an erection when you are sexually excited. It doesn’t matter if you take this medicine with or without food; food has no impact on its effectiveness.
This medicine will only work when you’re sexually excited. You won’t get an erection just by taking Cialis.
What dose should I take?
The recommended starting dose for Cialis is 10mg tablets. If this dose is not effective you can try 20mg tablets. A maximum of one tablet should be taken in 24 hours, however it’s not recommended to take either the 10mg or 20mg tablet every day.
For patients who anticipate sexual activity at least twice weekly, the 5mg “daily” Cialis dose is more appropriate.
Patient Information Leaflet.
Always read the patient information leaflet before commencing treatment. The Patient Information leaflets can be found here for 10mg and 20mg dosages.
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Related Products.
Cialis & Tadalafil (Once a Day)
References:
Porst H, Burnett A, Brock G, et al. SOP conservative (medical and mechanical) treatment of erectile dysfunction. J Sex Med 2013;10: 130–71 Tadalafil 10 mg film-coated tablets- Summary of Product Characteristics Eli Lilly Corporation 2006. Cialis (Tadalafil HCl) tablets: Prescribing information [online]. Accessed 14 February 2006. URL: http://www.cialis.com/ http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500143294.pdf https://www.who-umc.org/media/2680/who-technical-report-498.pdf Cialis/Tadalafil- Package leaflet: Information for the user http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Summary_for_the_public/human/000436/WC500026312.pdf Montorsi F, Verheyden B, Meuleman E, Jünemann KP, Moncada I, Valiquette L, Casabé A, Pacheco C, Denne J, Knight J, Segal S, Watkins VS. Long-term safety and tolerability of Tadalafil in the treatment of erectile dysfunction. Eur Urol.2004 Mar;45(3):339-44; discussion 344-5. PubMed PMID: 15036680. Hartmut Porst, Mauro Gacci, Hartwig Buttner, Carsten Henneges, Frank Boess- Tadalafil Once Daily in Men with Erectile Dysfunction: An Integrated Analysis of Data Obtained from 1913 Patients from Six Randomized, Double-blind, Placebo-controlled, Clinical Studies.
Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected] .