Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Sildenafil
Clonmel Healthcare Ltd
G04BE; G04BE03
Sildenafil
25 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Drugs used in erectile dysfunction; sildenafil
Marketed
2011-05-03
Page 1 of 6 CORRECTPACKAGE LEAFLET: INFORMATION FOR THE USER SILDENAFIL CLONMEL 25MG FILM-COATED TABLETS SILDENAFIL CLONMEL 50MG FILM-COATED TABLETS SILDENAFIL CLONMEL 100MG 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 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 Clonmel is and what it is used for 2. What you need to know before you take Sildenafil Clonmel 3. How to take Sildenafil Clonmel 4. Possible side effects 5. How to store Sildenafil Clonmel 6. Contents of the pack and other information 1. WHAT SILDENAFIL CLONMEL IS AND WHAT IT IS USED FOR Sildenafil Clonmel 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 Clonmel will only help you to get an erection if you are sexually stimulated. Sildenafil Clonmel 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 CLONMEL DO NOT TAKE SILDENAFIL CLONMEL • If you are allergic to sildenafil, peanut or soya, 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 medicine Прочитајте комплетан документ
Health Products Regulatory Authority 01 December 2022 CRN00CZF5 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sildenafil Clonmel 25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 mg film-coated tablet contains 25 mg of sildenafil (as citrate). Excipients with known effect: Each 25 mg film-coated tablet contains 72.9 mg lactose monohydrate, 0.2 mg glucose, 0.004 mg Ponceau 4R aluminium lake, 0.1 mg soya lecithin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Sildenafil Clonmel 25 mg film-coated tablets are light blue pearlescent film-coated tablets, round and biconvex in shape with approx. diameter of 8 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil Clonmel 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 Clonmel to be effective, sexual stimulation is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _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. _Hep Прочитајте комплетан документ