Cialis

Active Substance: tadalafil
Common Name: tadalafil
ATC Code: G04BE08
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Active Substance: tadalafil
Status: Authorised
Authorisation Date: 2002-11-12
Therapeutic Area: Erectile Dysfunction
Pharmacotherapeutic Group: Urologicals

Therapeutic Indication

Treatment of erectile dysfunction.

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

Cialis is not indicated for use by women.

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 (sometimes called impotence) when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity. For Cialis to be effective, sexual stimulation is required.

The medicine can only be obtained with a prescription.

How is Cialis used?

The recommended dose of Cialis is 10 mg, taken with or without food, ‘on demand’ at least 30 minutes before sexual activity. The dose may be increased to 20 mg for men who do not respond to the 10-mg dose. The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg Cialis is not recommended.

Cialis can be used once a day in men who intend to use it frequently (twice a week or more), based on the doctor’s judgement. The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day depending on how well it is tolerated. The medicine should be taken around the same time every day and the appropriateness of the once-a-day dosing should be re-assessed regularly.

Patients with severe liver problems or kidney problems should not take more than 10 mg in one dose. Once-a-day dosing is not recommended in patients with severe kidney problems, and should only be prescribed to patients with liver problems after a careful evaluation of the benefits and risks of taking the medicine.

How does Cialis work?

The active substance of Cialis, tadalafil, belongs to a group of medicines called 'phosphodiesterase-type-5 (PDE5) inhibitors'. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection. By blocking the breakdown of cGMP, Cialis restores erectile function. However, sexual stimulation is still needed.

How has Cialis been studied?

Cialis, when taken ‘on demand’ before sexual activity, has been studied in six main studies including 1,328 patients. 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 to 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.

What benefit has Cialis shown during the studies?

Cialis was significantly more effective than placebo in all studies. For one of the questionnaires, where the maximum score is 30, patients who recorded scores of about 15 before treatment, recorded scores of 22.6 or 25 after receiving Cialis 10 mg or 20 mg, respectively. Overall, in the studies of general populations, 81% of patients reported that Cialis ‘on demand’ improved their erections as compared to 35% of those taking placebo.

Patients taking Cialis once a day at doses of 2.5 or 5 mg also reported improved erections compared with those taking placebo.

What is the risk associated with Cialis?

The most common side effects (seen in more than 1 patient in 10) are headache and dyspepsia (indigestion). For the full list of all side effects reported with Cialis, see the package leaflet.

Cialis should not be used in people who may be hypersensitive (allergic) to tadalafil or any of the other ingredients, or where sexual activity is inadvisable (e.g. in men with heart disease). It should 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 ischaemic optic neuropathy, NAION). Cialis should not be taken with nitrates (a type of medicine used for angina). A doctor should consider the potential risks of sexual activity in men who have cardiovascular disease. Because Cialis has not been studied in patients who have had a heart attack within the last three months or a stroke within the last six months, or those who have high blood pressure or heart disorders (irregular heart beat), these men should not use 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. The Committee recommended that Cialis be given marketing authorisation.

Other information about Cialis

The European Commission granted a marketing authorisation valid throughout the European Union for Cialis to Lilly ICOS Limited on 12 November 2002. The marketing authorisation was renewed on 12 November 2007.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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