Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
sildenafil
Teva B.V.
G04BE03
sildenafil
Drugs used in erectile dysfunction
Erectile Dysfunction
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Teva to be effective, sexual stimulation is required.,
Revision: 17
Authorised
2009-11-30
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILDENAFIL TEVA 25 MG FILM-COATED TABLETS sildenafil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sildenafil Teva is and what it is used for 2. What you need to know before you take Sildenafil Teva 3. How to take Sildenafil Teva 4. Possible side effects 5. How to store Sildenafil Teva 6. Contents of the pack and other information 1. WHAT SILDENAFIL TEVA IS AND WHAT IT IS USED FOR Sildenafil Teva contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5(PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Sildenafil Teva will only help you to get an erection if you are sexually stimulated. Sildenafil Teva is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SILDENAFIL TEVA DO NOT TAKE SILDENAFIL TEVA − If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6). − If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sildenafil Teva 25 mg film-coated tablets Sildenafil Teva 50 mg film-coated tablets Sildenafil Teva 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sildenafil Teva 25 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil. Sildenafil Teva 50 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil. Sildenafil Teva 100 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Sildenafil Teva 25 mg film-coated tablets White, oval-shaped film-coated tablets, engraved with ‘S 25’ on one side, and plain on the other side. Sildenafil Teva 50 mg film-coated tablets White, oval-shaped film-coated tablets, engraved with ‘S 50’ on one side, and plain on the other side. Sildenafil Teva 100 mg film-coated tablets White, oval-shaped film-coated tablets, engraved with ‘S 100’ on one side, and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil Teva is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Teva to be effective, sexual stimulation is required. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Use in adults _ The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If Sildenafil Teva is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). _ _ 3 Special populations _ _ _Elderly _ Dosage adjustments are not required in elderly patients (≥ 65 Pročitajte cijeli dokument