Země: Evropská unie
Jazyk: angličtina
Zdroj: 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 Vivanza to be effective, sexual stimulation is required.Vivanza is not indicated for use by women.
Revision: 28
Withdrawn
2003-03-04
47 B. PACKAGE LEAFLET Medicinal product no longer authorised 48 PACKAGE LEAFLET: INFORMATION FOR THE USER VIVANZA 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 Vivanza is and what it is used for 2. What you need to know before you take Vivanza 3. How to take Vivanza 4. Possible side effects 5. How to store Vivanza 6. Contents of the pack and other information 1. WHAT VIVANZA IS AND WHAT IT IS USED FOR Vivanza 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. Vivanza will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Vivanza allows an erection to last long enough for you to satisfactorily complete sexual activity. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIVANZA DO NOT TAKE VIVANZA - 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 me Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Vivanza 5 mg film-coated tablets. Vivanza 10 mg film-coated tablets Vivanza 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. Vivanza 5 mg film-coated tablets Orange round tablets marked with ’v’ on one side and “5” on the other side. Vivanza 10 mg film-coated tablets Orange round tablets marked with ’v’ on one side and “10” on the other side. Vivanza 20 mg film-coated tablets Orange round tablets marked with ’v’ 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 Vivanza 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. Vivanza 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 startin Přečtěte si celý dokument