Tadalafil

EMA/475324/2015 EMEA/H/C/000436 EPAR Summary of the Public Cialis Tadalafil This is a summary of Cialis' European Public Assessment Report (EPAR). It explains how the Human Drugs Committee (CHMP) evaluates drugs to reach their opinions, and approves the grant of marketing approvals and recommendations for the use of Cialis. What is Cialis? Cialis is a drug containing the active substance tadalafil. It can be used as a tablet (2.5, 5, 10 and 20 mg). What is Cialis for? Cialis is used to treat men with erectile dysfunction (sometimes called impotence) when they are unable to obtain or maintain a hard penis (erection) that is sufficient for satisfactory sexual activity. In order for Cialis to be effective in this situation, sexual stimulation is required. Cialis can also be used in men to treat the symptoms and signs of benign prostatic hyperplasia (prostatic hypertrophy, non-cancer), which involves problems with urinary flow. This medicine is only available by prescription. How is Cialis used? For the treatment of erectile dysfunction, the recommended dose of Cialis is 10 mg "on demand" for at least 30 minutes prior to sexual activity. For men who did not respond to the 10 mg dose, the dose could be increased to 20 mg. The recommended maximum dosing frequency is once a day, but it is not recommended to use 10 or 20 mg Cialis daily for continuous use. At the discretion of the doctor, Cialis can be used at a lower dose once a day for men who plan to use it regularly (twice a week or longer). The dose is 5 mg once a day, but can be reduced to 2.5 mg once a day, depending on the degree of tolerance. The drug should be taken at the same time every day and the appropriateness of the once-a-day dosing should be re-evaluated on a regular basis. For men with benign prostatic hyperplasia, or men with benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day. Patients with severe liver problems or kidney problems should not take more than 10 mg at a time. For patients with severe kidney problems, daily dosing is not recommended, and patients with liver problems should be prescribed only after careful evaluation of the benefits and risks of taking the drug. How does Cialis work? Cialis' active substance, tadalafil, belongs to a group of drugs called "phosphodiesterase type 5 (PDE5) inhibitors." It acts by blocking phosphodiesterase, which usually breaks down substances called cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes muscles in the penile sponge tissue to radiate the corpus cavernosum, allowing blood to flow into the corpus, creating an erection. Cialis resumes erectile function by preventing the decomposition of cGMP. However, sexual stimulation is still needed. By blocking phosphodiesterase and preventing the breakdown of cGMP, Cialis can also improve blood flow and relax the muscles of the prostate and bladder. This can reduce the problem of urinary flow as a symptom of benign prostatic hyperplasia. How was Cialis studied? Cialis was “on demand” prior to sexual activity and has been studied in six major studies, including 1,328 patients with erectile dysfunction. One of the studies included only men with diabetes. One day of Cialis administration was studied in three further studies that lasted 12 to 24 weeks, involving a total of 853 patients. In all studies, the effect of Cialis was compared to the effect of placebo (virtual therapy), and the primary measure of effectiveness was the ability to acquire 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 major studies comparing Cialis with placebo were performed in 1,500 patients with this disease, including some patients with erectile dysfunction. The primary measure of effectiveness is the improvement in symptoms after 12 weeks. What benefits did Cialis show during the study? In all studies of erectile dysfunction, Cialis was significantly more effective than placebo. For one of the questionnaires, the highest score was 30, and the patient recorded a score of approximately 15 before treatment, with a score of 22.6 or 25 after receiving Cialis 10 mg or 20 mg, respectively. Overall, in the general population study, 81% of patients reported that Cialis 'on-demand' improved erections, compared with 35% of patients taking placebo. Patients who took a 2.5 or 5 mg dose of Cialis a day also reported an improvement in erection compared to patients taking placebo. In all studies of patients with benign prostatic hyperplasia, Cialis administered at a dose of 5 mg was also more effective than placebo, and the results showed a significant improvement in symptoms after 12 weeks compared with placebo. What are the risks associated with Cialis? The most common side effects of Cialis are headache, indigestion (dyspepsia), back pain and myalgia (muscle pain), which are more common at higher doses. For a complete list of all side effects reported using Cialis, please refer to the package insert. Cialis should not be used where it is not suitable for sexual activity (such as men with heart disease). Due to the problem of blood flow to the ocular nerve (non-arteritic anterior ischemic optic neuropathy, NAION), patients with visual loss cannot take it. Cialis must not take nitrates (a drug for angina) or "guanylate cyclase stimulator" drugs, such as riociguat (a type of hypertension drug used for pulmonary blood vessels, called pulmonary hypertension). Physicians should consider the potential risks of sexual activity in men with cardiovascular disease. Because Cialis has not been studied in patients who have had heart disease in the past three months or have had a stroke in the past six months or in patients with high blood pressure or heart disease (arrhythmia), these men should not use medicine. For a complete list of restrictions, see the package booklet. Why is Cialis approved? CHMP believes that Cialis' benefits outweigh its risks and recommends a marketing approval. What measures are being taken to ensure the safe and effective use of Cialis? A risk management plan has been developed to ensure that Cialis is used as safely as possible. Under this program, safety information is included in the product feature summary and the Cialis package insert, including appropriate precautions for health care professionals and patients. Additional information about Cialis The European Commission granted an effective listing permit for the entire European Union Cialis on November 12, 2002. The complete EPAR of Cialis can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicine / European public assessment Read more...