País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
SILDENAFIL BASE (AS CITRATE)
Sanofi-Aventis Ireland Limited T/A SANOFI
SILDENAFIL BASE (AS CITRATE)
100 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Reference: 4484 1.3.1.3 - Leaflet Text - PIL - 100mg, 25mg, 50mg - 2013-05-03 - 000000 - MAA 1.1 PACKAGE LEAFLET: INFORMATION FOR THE USER Sildenafil Zentiva 25 mg film-coated tablets Sildenafil Zentiva 50 mg film-coated tablets Sildenafil Zentiva 100 mg film-coated tablets Sildenafil citrate 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 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. WHAT IS IN THIS LEAFLET: 1. What Sildenafil Zentiva is and what it is used for 2. What you need to know before you take Sildenafil Zentiva 3. How to take Sildenafil Zentiva 4. Possible side effects 5. How to store Sildenafil Zentiva 6. Contents of the pack and other information 1. WHAT SILDENAFIL ZENTIVA IS AND WHAT IT IS USED FOR Sildenafil Zentiva 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 Zentiva will only help you to get an erection if you are sexually stimulated. You should not take Sildenafil Zentiva if you do not have erectile dysfunction. You should not take Sildenafil Zentiva if you are a woman. Sildenafil Zentiva is a treatment for Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sildenafil Zentiva 100mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of sildenafil (as citrate). Excipients with known effect: each Sildenafil Zentiva 100 mg film-coated tablet contains 7.44 mg of lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film – coated tablet Blue colored round, biconvex, scored approx. 12.00 mm in diameter film-coated tablets debossed with 126 on one side and J on the other side with the score line 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 Zentiva 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 day. If Sildenafil Zentiva is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). _Use in the elderly:_ Dosage adjustments are not required in elderly patients. _Use in patients with impaired renal function:_ 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 impairment (creatinine clearance <30 ml/min) a 25 mg dose should be considere Leia o documento completo