Riik: Malta
keel: inglise
Allikas: Medicines Authority
SILDENAFIL
Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece
G04BE03
SILDENAFIL 100 mg
FILM-COATED TABLET
SILDENAFIL 100 mg
POM
UROLOGICALS
Authorised
2011-03-18
Page 1 of 8 B. PACKAGE LEAFLET Page 2 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILDENAFIL UPJOHN 25 MG, 50 MG OR 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, 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 Upjohn is and what it is used for 2. What you need to know before you take Sildenafil Upjohn 3. How to take Sildenafil Upjohn 4. Possible side effects 5. How to store Sildenafil Upjohn 6. Contents of the pack and other information 1. WHAT SILDENAFIL UPJOHN IS AND WHAT IT IS USED FOR Sildenafil Upjohn contains the active substance sildenafil (as citrate), 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. This medicine will only help you to get an erection if you are sexually stimulated. This medicine 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 UPJOHN DO NOT TAKE SILDENAFIL UPJOHN − 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 angin Lugege kogu dokumenti
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 15 1. NAME OF THE MEDICINAL PRODUCT Sildenafil Upjohn 25 mg film-coated tablets Sildenafil Upjohn 50 mg film-coated tablets Sildenafil Upjohn 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as citrate) Excipient with known effect: Lactose (as monohydrate) 0.9 mg per 25 mg tablet 1.7 mg per 50 mg tablet 3.5 mg per 100 mg tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 25 mg: White to off-white, rounded diamond-shaped tablets, of dimensions 9.2 x 6.7 mm, marked “25”on one side. 50 mg: White to off-white, rounded diamond-shaped tablets, of dimensions 11.2 x 8.1 mm, marked “50” on one side. 100 mg: White to off-white, rounded diamond-shaped tablets, of dimensions 14.1 x 10.2 mm, marked “100” on one 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 Upjohn 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 Page 3 of 15 per day. If Sildenafil Upjohn 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 Lugege kogu dokumenti