Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
sildenafil
Ratiopharm GmbH
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 to be effective, sexual stimulation is required.
Revision: 19
Authorised
2009-12-23
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILDENAFIL RATIOPHARM 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 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 Sildenafil ratiopharm is and what it is used for 2. What you need to know before you take Sildenafil ratiopharm 3. How to take Sildenafil ratiopharm 4. Possible side effects 5. How to store Sildenafil ratiopharm 6. Contents of the pack and other information 1. WHAT SILDENAFIL RATIOPHARM IS AND WHAT IT IS USED FOR WHAT SILDENAFIL RATIOPHARM IS Sildenafil ratiopharm contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. This medicine allows an erection to last long enough for you to satisfactorily complete sexual activity. It reduces the action of the natural chemical in your body, which makes erections go away. Sildenafil ratiopharm will only work when you are sexually stimulated. WHAT SILDENAFIL RATIOPHARM IS USED FOR Sildenafil ratiopharm 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 RATIOPHARM DO NOT TAKE SILDENAFIL RATIOPHARM - if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6). - if you are taking medicines that contain nitrates (e.g. glycerol trinitrate) or nitric oxide donors (e.g. amyl nitrite, also called “ Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sildenafil ratiopharm 25 mg film-coated tablets Sildenafil ratiopharm 50 mg film-coated tablets Sildenafil ratiopharm 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sildenafil ratiopharm 25 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil. Sildenafil ratiopharm 50 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil. Sildenafil ratiopharm 100 mg film-coated tablets Each film-coated 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 ratiopharm 25 mg film-coated tablets White to off-white, oblong film-coated tablet with edge. Sildenafil ratiopharm 50 mg film-coated tablets White to off-white, oblong film-coated tablet with edge and score line on one side. The tablet can be divided into equal doses. Sildenafil ratiopharm 100 mg film-coated tablets White to off-white, oblong film-coated tablet with edge and score line on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil ratiopharm 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 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 is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). 3 _Special populations _ _ _ Elderl Aqra d-dokument sħiħ