Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sildenafil citrate
Pfizer Ltd
G04BE03
Sildenafil citrate
25mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040500; GTIN: 5013457010800 5013457010817
VIAGRA ® 25 MG, 50 MG OR 100 MG FILM-COATED TABLETS_ _ Sildenafil _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 (PDE 5) 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 don Přečtěte si celý dokument
OBJECT 1 VIAGRA 25MG FILM-COATED TABLETS Summary of Product Characteristics Updated 23-Jun-2016 | Pfizer Limited 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 tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil. Excipient with known effect: VIAGRA 25 mg film-coated tablets Each tablet contains 0.834 mg lactose (as monohydrate). VIAGRA 50 mg film-coated tablets Each tablet contains 1.667 mg lactose (as monohydrate). VIAGRA 100 mg film-coated tablets Each tablet contains 3.334 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. VIAGRA 25 mg film-coated tablets Blue rounded diamond-shaped tablets, marked "PFIZER" on one side and "VGR 25" on the other. VIAGRA 50 mg film-coated tablets Blue rounded diamond-shaped tablets, marked "PFIZER" on one side and "VGR 50" on the other. VIAGRA 100 mg film-coated tablets Blue rounded diamond-shaped 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. 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_ Dosage adjustments are not required in elderly patients (≥ 65 years old). _Renal impairment_ The dosing recommen Přečtěte si celý dokument