Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
sildenafil
Actavis Group PTC ehf
G04BE03
sildenafil
Urologicals
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 Actavis to be effective, sexual stimulation is required.
Revision: 17
Authorised
2009-12-10
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILDENAFIL ACTVIS 25 MG, 50 MG AND 100 MG FILM-COATED TABLETS SILDENAFIL ACTAVIS 25 MG FILM-COATED TABLETS SILDENAFIL ACTAVIS 50 MG FILM-COATED TABLETS SILDENAFIL ACTAVIS 100 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 Actavis is and what it is used for 2. What you need to know before you take Sildenafil Actavis 3. How to take Sildenafil Actavis 4. Possible side effects 5. How to store Sildenafil Actavis 6. Contents of the pack and other information 1. WHAT SILDENAFIL ACTAVIS IS AND WHAT IT IS USED FOR Sildenafil Actavis 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 Actavis will only help you to get an erection if you are sexually stimulated. Sildenafil Actavis 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 ACTAVIS DO NOT TAKE SILDENAFIL ACTAVIS - 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 Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sildenafil Actavis 25 mg film-coated tablets Sildenafil Actavis 50 mg film-coated tablets Sildenafil Actavis 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil. Excipient with known effect Sildenafil Actavis 25 mg tablets Each tablet contains 62.38 mg lactose (as monohydrate). Sildenafil Actavis 50 mg tablets Each tablet contains 124.76 mg lactose (as monohydrate). Sildenafil Actavis 100 mg tablets Each tablet contains 249.52 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Sildenafil Actavis 25 mg film-coated tablets Sildenafil Actavis 25 mg film-coated tablets are blue elliptical, biconvex, 10.0 x 5.0 mm and marked “SL25” on one side. Sildenafil Actavis 50 mg film-coated tablets Sildenafil Actavis 50 mg film-coated tablets are blue elliptical, biconvex, 13.0 x 6.5 mm and marked “SL50” on one side. Sildenafil Actavis 100 mg film-coated tablets Sildenafil Actavis 100 mg film-coated tablets are blue elliptical, biconvex, 17.0 x 8.5 mm and marked “SL100” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil Actavis 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 Actavis 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. 3 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 Actavis is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2) Pročitajte cijeli dokument