País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
vardenafil
Bayer AG
G04BE09
vardenafil
Urologicals
Erectile Dysfunction
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.
Revision: 33
Authorised
2003-03-06
48 B. PACKAGE LEAFLET 49 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVITRA 5 MG FILM-COATED TABLETS vardenafil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Levitra is and what it is used for 2. What you need to know before you take Levitra 3. How to take Levitra 4. Possible side effects 5. How to store Levitra 6. Contents of the pack and other information 1. WHAT LEVITRA IS AND WHAT IT IS USED FOR Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection. At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard. Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Levitra allows an erection to last long enough for you to satisfactorily complete sexual activity. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVITRA DO NOT TAKE LEVITRA - If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath. - If you are taking medicines containing nitrates, such as gl Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Levitra 5 mg film-coated tablets Levitra10 mg film-coated tablets Levitra 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of 5 mg film-coated tablets contains 5 mg of vardenafil (as hydrochloride). Each tablet of 10 mg film-coated tablets contains 10 mg of vardenafil (as hydrochloride). Each tablet of 20 mg film-coated tablets contains 20 mg of vardenafil (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Levitra 5 mg film-coated tablets Orange round tablets marked with the BAYER-cross on one side and “5” on the other side. Levitra 10 mg film-coated tablets Orange round tablets marked with the BAYER-cross on one side and “10” on the other side. Levitra 20 mg film-coated tablets Orange round tablets marked with the BAYER-cross on one side and “20” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Use in adult men _ The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg. The maximum recommended dosing frequency is once per day. Levitra can be taken with or without food. The onset of activity may be delayed if taken with a high fat meal (see section 5.2). _ _ _Special populations _ _Elderly (>65 years old) _ Dose adjustments are not required in elderly patients. However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8). _Hepatic impairment _ A starting dose of 5 Llegiu el document complet