Land: Storbritannien
Språk: engelska
Källa: myHealthbox
Sildenafil
Milpharm Limited
G04BE03
Sildenafil
50mg
Film-coated tablets
Oral use
1, 2, 4, 8 & 12 film-coated tablets
POM - Prescription Only Medicine
APL Swift Services (Malta) Limited
Urologicals; Drugs used in 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.
Authorised
2013-08-12
SILDENAFIL 50 MG FILM-COATED TABLETS SILDENAFIL 100 MG FILM-COATED TABLETS Sildenafil PACKAGE LEAFLET: INFORMATION FOR THE USER 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 is and what it is used for 2. What you need to know before you take Sildenafil 3. How to take Sildenafil 4. Possible side effects 5. How to store Sildenafil 6. Contents of the pack and other information Sildenafil 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. Sildenafil will only help you to get an erection if you are sexually stimulated. Sildenafil 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. DO NOT TAKE SILDENAFIL: - 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 amyl nitrite (“poppers Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sildenafil 50 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg Sildenafil (as sildenafil citrate). Excipient with known effect: Each 50 mg film-coated tablet contains 3.7 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off-white, round (9.6 mm diameter), biconvex film-coated tablets debossed with “SL” on one side and 50 on the other side. 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 to be effective, sexual stimulation is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology This strength is not suitable for dosages below 50 mg Other medicinal products of Sildenafil in adequate strength are available. USE IN ADULTS The recommended dose is 50mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100mg or decreased to 25mg. 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). _Special populations _ _ _ ELDERLY PATIENTSDosage adjustments are not required in elderly patients ( ≥ 65 years old).. PATIENTS WITH RENAL IMPAIRMENT The dosing recommendations described in “Use in adults” apply to patients with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min). Since sildenafil clearance is reduced in patients with severe renal im Läs hela dokumentet