What is CIALIS?
Cialis is a medicine containing the active substance tadalafil. It is available as tablets (2.5, 5, 10 and 20 mg).
What is CIALIS used for?
Cialis is used to treat men with erectile dysfunction (also called impotence), which is the inability to achieve or maintain an erection sufficient for satisfactory sexual activity.
For Cialis to have an effect, sexual stimulation is required.
Cialis can also be used in male patients to treat the signs and symptoms of benign prostatic hyperplasia (enlarged, non-carcinogenic prostate gland), which causes urine leakage problems.
The medicine can only be obtained with a prescription.
How is CIALIS used?
To treat erectile dysfunction, the recommended dose of Cialis is 10 mg taken "as needed" at least 30 minutes before sexual activity. The dose can be increased to 20 mg for men who do not respond to 10 mg.
The maximum recommended dosing frequency is once a day, however the continuous daily intake of 10 or 20 mg of Cialis is not recommended. Cialis can be used at lower doses once a day in men who intend to use it frequently (twice a week or more), depending on the doctor's judgment. The dose is 5 mg once a day, but can be reduced to 2.5 mg once a day based on the degree of tolerance. The drug should be taken at about the same time each day and it is necessary to regularly re-evaluate the dose in the case of a single daily intake.
For the treatment of male patients with benign prostatic hyperplasia or affected by both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.
Patients with severe liver or kidney disease should not take more than 10 mg. Taking a single daily dose is not recommended in patients with serious kidney disease and, for patients with liver disorders, the medicine should only be prescribed after careful consideration of the risks and benefits of taking it.
How does CIALIS work?
The active substance in Cialis, tadalafil, belongs to a group of medicines called "phosphodiesterase type 5 inhibitors (PDE5)". The substance works by blocking the enzyme phosphodiesterase which normally breaks down a substance called cyclic guanosine monophosphate (cGMP).
During normal sexual stimulation the penis produces cGMP which causes the relaxation of the spongy tissue of the penis (cavernous bodies), allowing the inflow of blood into the corpora cavernosa, which produces an erection. By blocking cGMP degradation, Cialis restores erectile function.
However, sexual stimulation is always necessary. By blocking the enzyme phosphodiesterase and avoiding the degradation of cGMP, Cialis also improves the blood supply to the prostate and bladder, relaxing the muscles. This can reduce the problems of urine leakage which are symptoms of benign prostatic hyperplasia.
How has CIALIS been studied?
Cialis, taken "as needed" before sexual activity, has been studied in six main studies involving 1 328 patients with erectile dysfunction. One of these studies included only diabetics.
Single daily administration of Cialis was studied in three additional studies lasting between 12 and 24 weeks involving 853 patients. In all the studies the effects of Cialis were compared with those of a placebo (a dummy treatment) and the main measure of the drug's efficacy was the ability to obtain and maintain an erection, detected by two questionnaires to be filled out at home.
Cialis has also been studied in patients with benign prostatic hyperplasia. Four main studies comparing Cialis with placebo were performed in 1 500 patients with the disease, including some who also had erectile dysfunction. The main measure of effectiveness was the improvement of symptoms after 12 weeks.
What benefit has CIALIS shown during the studies?
Cialis was significantly more effective than placebo in all studies related to erectile dysfunction. In one of the questionnaires, in which the maximum score was 30, patients who had indicated about 15 points before treatment, recorded a score of 22.6 after treatment with Cialis 10 mg and 25 for Cialis 20 mg. Overall, in studies of the general population, 81% of patients reported that Cialis, taken as needed, improved erections compared to 35% with placebo. Patients who took Cialis once a day at doses of 2.5 or 5 mg also reported improved erections compared to those taking placebo.
Cialis administered at a dose of 5 mg was also more effective than placebo in all studies in patients with benign prostatic hyperplasia, with results showing a significant improvement in symptoms after 12 weeks compared to placebo.
What is the risk associated with CIALIS?
The most common side effects of Cialis are headache, dyspepsia (indigestion), back pain and myalgia (muscle pain), which are more common at higher dosages. For the full list of all side effects reported with Cialis, see the package leaflet.
The medicine should not be used in cases where sexual activity is not recommended, for example in the presence of severe heart disease. The medicine should not be taken by patients who have suffered loss of vision in the past due to a deficiency of blood supply to the optic nerve (non-arteritic anterior ischemic optic neuropathy, NAION).
Cialis should not be taken with nitrates (a type of medicine used for angina) or medicines from the "guanilate cyclase stimulators" class such as riocigiuat (a medicine for high blood pressure in the vessels that supply the lungs, known as pulmonary hypertension).
The doctor must consider the potential risk associated with sexual activity in patients who have cardiovascular disease. Because Cialis has not been studied in heart attack patients in the last three months or by stroke in the last six months or even in patients with high blood pressure or heart problems (irregular heartbeat), these individuals should not take the medicine. For the full list of limitations, see the package leaflet
Why has CIALIS been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Cialis's benefits are greater than its risks for the treatment of men with erectile dysfunction and therefore recommended that it be given marketing authorization.
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. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cialis, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on CIALIS
On 12 November 2002, the European Commission issued a marketing authorization for Cialis, valid throughout the European Union. The full EPAR for Cialis can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports
For more information on Cialis therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 07-2015.
To read the Cialis package insert Click here
