Pajjiż: Malta
Lingwa: Ingliż
Sors: Malta Medicines Authority
SILDENAFIL
Torrent Pharma GmbH Südwestpark 50, 90459 Nürnberg, Germany
G04BE03
SILDENAFIL 25 mg
FILM-COATED TABLET
SILDENAFIL 25 mg
POM
UROLOGICALS
Withdrawn
2013-01-02
Sildenafil Torrent 25 mg - 50 mg - 100 mg film-coated tablets – AT/H/0408/001-003/DC Page 1 MT pl mt/p/004/13/3 PACKAGE LEAFLET: INFORMATION FOR THE USER SILDENAFIL TORRENT 25 MG FILM-COATED TABLETS SILDENAFIL TORRENT 50 MG FILM-COATED TABLETS SILDENAFIL TORRENT 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, please 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. WHAT IS IN THIS LEAFLET 1. What Sildenafil Torrent is and what it is used for 2. What you need to know before you take Sildenafil Torrent 3. How to take Sildenafil Torrent 4. Possible side effects 5. How to store Sildenafil Torrent 6. Contents of the pack and other information 1. WHAT SILDENAFIL TORRENT IS AND WHAT IT IS USED FOR Sildenafil Torrent 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 Torrent will only help you to get an erection if you are sexually stimulated. You should not take Sildenafil Torrent if you do not have erectile dysfunction. You should not take Sildenafil Torrent if you are a woman. Sildenafil Torrent is a treatment for 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 YO Aqra d-dokument sħiħ
SmPC_Sildenafil 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sildenafil Torrent 25 mg film-coated tablets Sildenafil Torrent 50 mg film-coated tablets Sildenafil Torrent 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of sildenafil (as citrate) Each tablet contains 50 mg of sildenafil (as citrate) Each tablet contains 100 mg of sildenafil (as citrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Sildenafil Torrent 25 mg film-coated tablets Blue, round (diameter approx. 7.1 mm), biconvex, film coated tablets, debossed with ‘86’on one side and plain on the other side Sildenafil Torrent 50 mg film-coated tablets Blue, round (diameter approx. 9.6 mm), biconvex, film coated tablets, debossed with ‘8’ Bisect ‘7’ on one side and plain on the other side. The tablet can be divided into equal doses. Sildenafil Torrent 100 mg film-coated tablets Blue, round (diameter approx. 12.3 mm), biconvex, film coated tablets, debossed with ‘8’ Bisect ‘8’ on one side and plain on the other side. The tablet can be divided into equal doses. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 Torrent to be effective, sexual stimulation is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. _ _ USE IN ADULTS: The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and toleration, 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 SmPC_Sildenafil 2 day. If Sildenafil Torrent is taken wit Aqra d-dokument sħiħ