Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Sildenafil
Accord Healthcare Ireland Ltd.
G04BE; G04BE03
Sildenafil
50 milligram(s)
Film-coated tablet
Drugs used in erectile dysfunction; sildenafil
Not marketed
2019-08-02
2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILDENAFIL 25 MG, 50 MG AND 100 MG FILM-COATED TABLETS SILDENAFIL 25 MG FILM-COATED TABLETS SILDENAFIL 50 MG FILM-COATED TABLETS SILDENAFIL 100 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 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 1. WHAT SILDENAFIL IS AND WHAT IT IS USED FOR Sildenafil 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. 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SILDENAFIL 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”). Lire le document complet
Health Products Regulatory Authority 07 August 2019 CRN008LKX Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sildenafil 50 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil. Excipients with known effect Each 50 mg tablet contains 124.76 mg lactose (as monohydrate) and 0.961 mg of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Sildenafil 50 mg film-coated tablets are blue elliptical, biconvex, 13.0 x 6.5 mm and marked "SL50" on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil 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). Special populations _Elderly_ Dosage adjustments are not required in elderly patients (≥ 65 years old). _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 impairment (creatinine clearance <30 mL/min) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary. _Hepatic impairment_ Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose shou Lire le document complet