Cialis

What is CIALIS?

Cialis is a drug containing the active ingredient tadalafil. It is available in 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 take 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-cancerous prostate gland), which causes problems with passing urine.

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 frequency of administration is once daily, however continuous daily intake of 10 or 20 mg of Cialis is not recommended. Cialis can be used at lower doses once daily in men who intend to use it frequently (twice per week or more), depending on the physician's judgment. The dose is 5 mg once a day, but it can be reduced to 2.5 mg once a day depending on the degree of tolerance. "at approximately the same time each day and it is necessary to regularly re-evaluate the dose in the case of single daily intake.

For the treatment of male patients with benign prostatic hyperplasia or with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once daily.

Patients with severe liver or kidney disease should not take a dose higher than 10 mg. The intake of a single daily dose is not recommended in patients with severe kidney disease and, for patients with liver disorders, the medicine should only be prescribed after a careful evaluation of the risks and benefits derived from the intake.

How does CIALIS work?

The active substance in Cialis, tadalafil, belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors'. The substance works by blocking the phosphodiesterase enzyme which normally breaks down a substance called cyclic guanosine monophosphate (cGMP).

During normal sexual stimulation the penis produces cGMP which causes the muscles of the spongy tissue of the penis (corpora cavernosa) to relax, allowing blood to flow into the corpora cavernosa, which produces an erection. By blocking the breakdown of cGMP, Cialis restores erectile function.

However, sexual stimulation is always necessary. By blocking the phosphodiesterase enzyme and preventing the breakdown of cGMP, Cialis also improves the blood supply to the prostate and bladder, relaxing the muscles. This can reduce urine leakage problems that 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 1,228 patients with erectile dysfunction. One of these studies included only diabetics.

Once daily administration of Cialis was studied in three additional studies lasting 12 to 24 weeks involving 853 patients. In all studies the effects of Cialis were compared with those of a placebo (a dummy treatment) and the main measure of the drug's effectiveness was the ability to get and maintain an erection, which was measured 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 carried out in 1,500 patients with the disease, including some who also had erectile dysfunction. The main measure of effectiveness was the improvement in symptoms after 12 weeks.

What benefit has CIALIS shown during the studies?

Cialis was shown to be significantly more effective than placebo in all studies related to erectile dysfunction. In one of the questionnaires, where the maximum score was 30, patients who had indicated about 15 points before treatment scored 22.6 after treatment with Cialis 10 mg and 25 for Cialis 20 mg. Overall, in general population studies, 81% of patients reported that Cialis, taken as needed, improved erections compared to 35% with placebo. Patients who took Cialis once daily in 2.5 or 5 mg dosages also reported improved erections compared to those taking placebo.

Cialis given at a dose of 5 mg was also shown to be more effective than placebo in all studies in patients with benign prostatic hyperplasia, with results showing 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 side effects seen with Cialis, see the package insert.

The medicine should not be used in cases where sexual activity is not recommended, for example in the presence of severe heart problems. The medicine should not be taken by patients who have experienced loss of vision in the past due to a lack of blood flow. blood 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 of the class of 'guanylate cyclase stimulators' such as riocigiuat (a medicine for high blood pressure in the vessels that supply the lungs, known as pulmonary hypertension).

Physicians should consider the potential risk associated with sexual activity in patients who have cardiovascular disease. Because Cialis has not been studied in patients who have had a heart attack within the past three months or have had a stroke within the past six months, nor in patients with high blood pressure. problems or heart problems (irregular heartbeat), these people should not take the medicine. For the full list of restrictions, 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 a marketing authorization for the medicine.

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 added to the summary of product characteristics and package leaflet for Cialis, including the appropriate precautions to be followed by healthcare professionals and patients.

More information about CIALIS

On November 12, 2002, the European Commission issued a "Marketing Authorization" for Cialis, valid throughout the European Union. For the full version of the Cialis EPAR please visit the Agency's website: ema.europa.eu / Find medicine / Human medicines / European public assessment reports

For more information about Cialis therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last updated on 07-2015.

The information about Cialis published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.