Levitra

vardenafil

This is a summary of the European public assessment report (EPAR) for Levitra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levitra.

What is Levitra?

Levitra is a medicine that contains the active substance vardenafil. It is available as round, orange film-coated tablets (5, 10 and 20 mg) and as round, white orodispersible tablets (10 mg). Orodispersible tablets are tablets that dissolve in the mouth.

What is Levitra used for?

Levitra is used to treat adult men (aged 18 years or over) with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Levitra to be effective, sexual stimulation is required.

The medicine can only be obtained with a prescription.

How is Levitra used?

The recommended dose of Levitra is 10 mg, taken as one or two film-coated tablet about 25 to 60 minutes before sexual activity or as an orodispersible tablet (taken without liquid) about 60 minutes before sexual activity. If Levitra film-coated tablets are taken with a high fat meal, the onset of activity may be delayed. The dose of the film-coated tablets may be increased to a maximum of 20 mg or decreased to 5 mg, depending on the effectiveness of treatment and any side effects.

A starting dose of 5 mg should be considered for patients with mild and moderate liver problems or severe kidney problems. The dose may need to be adjusted in patients taking other medicines that block enzymes that break down Levitra. For full details, see the package leaflet.

The maximum recommended dosing frequency is one film-coated tablet or orodispersible tablet per day.

How does Levitra work?

The active ingredient of Levitra, vardenafil, 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. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Levitra restores erectile function. Sexual stimulation is still needed to produce an erection.

How has Levitra been studied?

Levitra tablets were compared with placebo (a dummy treatment) in four main studies including a total of 2,431 men with erectile dysfunction aged 20 to 83 years. One of these studies was carried out in diabetic men and another in men who had had their prostate gland removed.

The effectiveness of orodispersible tablets and placebo were compared in two main studies involving a total of 686 men with erectile dysfunction aged 21 to 84 years.

In all of the studies, the main measure of effectiveness was the ability to get and maintain an erection. This was recorded in two questionnaires completed at home. The studies lasted 12 weeks.

What benefit has Levitra shown during the studies?

Levitra tablets and orodispersible tablets were significantly more effective than placebo for all measures in all of the studies.

What is the risk associated with Levitra?

The most common side effect with Levitra (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with Levitra, see the package leaflet.

Levitra should not be used in people who may be hypersensitive (allergic) to vardenafil or any of the other ingredients. It must not be used when sexual activity is inadvisable, such as in men with severe heart disease. It must also not be used in 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 or NAION). Levitra must not be taken with nitrates (medicines used to treat angina).

Because Levitra has not been studied in the following group patients, they should not use the medicine:

• patients with severe liver or end-stage kidney disease requiring dialysis;
• patients who have hypotension (low blood pressure);
• patients who have had a stroke or a heart attack within the last six months;
• patients with unstable angina and hereditary eye problems known as ‘retinal degenerative disorders’.

Levitra must not be taken with ketoconazole and itraconazole (used to treat fungal infections) in men over 75 years of age, or with ritonavir or indinavir (used to treat HIV infection).

Why has Levitra been approved?

The CHMP decided that Levitra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Levitra:

The European Commission granted a marketing authorisation valid throughout the European Union for Levitra on 6 March 2003. The marketing authorisation is valid for an unlimited period.

For more information about treatment with Levitra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 20/03/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

21/02/2012  Levitra -EMEA/H/C/000475 -WS/0207

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Urologicals

Therapeutic indication

Treatment of erectile dysfunction in adult men.

Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

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

Levitra is not indicated for use by women.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents