Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
sildenafil
Upjohn EESV
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 Viagra to be effective, sexual stimulation is required.
Revision: 45
Authorised
1998-09-13
65 B. PACKAGE LEAFLET 66 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VIAGRA 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 VIAGRA is and what it is used for 2. What you need to know before you take VIAGRA 3. How to take VIAGRA 4. Possible side effects 5. How to store VIAGRA 6. Contents of the pack and other information 1. WHAT VIAGRA IS AND WHAT IT IS USED FOR VIAGRA 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. VIAGRA will only help you to get an erection if you are sexually stimulated. VIAGRA 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 VIAGRA DO NOT TAKE VIAGRA 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 or pharmacist. If you are using any of the medicines known as nitric oxide donors such as amy Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT VIAGRA 25 mg film-coated tablets VIAGRA 50 mg film-coated tablets VIAGRA 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil. Excipient with known effect _VIAGRA 25 mg tablets _ Each film-coated tablet contains 0.9 mg lactose (as monohydrate). _VIAGRA 50 mg tablets _ Each film-coated tablet contains 1.7 mg lactose (as monohydrate). _VIAGRA 100 mg tablets _ Each film-coated tablet contains 3.5 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). VIAGRA 25 mg tablets Blue, rounded diamond-shaped film-coated tablets, marked “PFIZER” on one side and “VGR 25” on the other. VIAGRA 50 mg tablets Blue, rounded, diamond-shaped film-coated tablets, marked “PFIZER” on one side and “VGR 50” on the other. VIAGRA 100 mg tablets Blue, rounded diamond-shaped film-coated tablets, marked “PFIZER” on one side and “VGR 100” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VIAGRA 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 VIAGRA to be effective, sexual stimulation is required. 3 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 VIAGRA is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). Special populations _ _ _Elderly _ Dose adjustments are not required in elderly patients (≥ 65 years old). _Renal impairment _ The dosing recommendations Lestu allt skjalið