Երկիր: Մալթա
Լեզու: անգլերեն
Աղբյուրը: Malta Medicines Authority
SILDENAFIL
Jubilant Pharmaceuticals nv Axxes Business Park, Guldensporenpark 22 – Block C, 9820 Merelbeke, Belgium
G04BE03
SILDENAFIL 100 mg
FILM-COATED TABLET
SILDENAFIL 100 mg
POM
UROLOGICALS
Withdrawn
2013-04-09
Jubilant Pharmaceuticals nv Sildenafil Jubilant 25 mg film-coated tablets Sildenafil Jubilant 50 mg film-coated tablets Sildenafil Jubilant 100 mg film-coated tablets PIL – p. 1/7 January 2014 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SILDENAFIL JUBILANT 25 MG FILM-COATED TABLETS SILDENAFIL JUBILANT 50 MG FILM-COATED TABLETS SILDENAFIL JUBILANT 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 Jubilant is and what it is used for 2. What you need to know before you take Sildenafil Jubilant 3. How to take Sildenafil Jubilant 4. Possible side effects 5. How to store Sildenafil Jubilant 6. Contents of the pack and other information 1. WHAT SILDENAFIL JUBILANT IS AND WHAT IT IS USED FOR Sildenafil Jubilant 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 Jubilant will only help you to get an erection if you are sexually stimulated. Sildenafil Jubilant 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 BEFO Կարդացեք ամբողջական փաստաթուղթը
Jubilant Pharmaceuticals nv Sildenafil Jubilant 25 mg film-coated tablets Sildenafil Jubilant 50 mg film-coated tablets Sildenafil Jubilant 100 mg film-coated tablets SPC – p. 1/16 January 2014 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sildenafil Jubilant 25 mg film-coated tablets Sildenafil Jubilant 50 mg film-coated tablets Sildenafil Jubilant 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of sildenafil (as citrate). Each tablet contains 50 mg of sildenafil (as citrate). Each tablet contains 100 mg of sildenafil (as citrate). Excipient with known effect: Each tablet contains 1.8 mg lactose monohydrate. Each tablet contains 3.6 mg lactose monohydrate. Each tablet contains 7.2 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Sildenafil Jubilant 25 mg film-coated tablets are white coloured, oval shaped, biconvex, film coated tablets, of 2.9 mm thickness, 10.4 mm length and 5.6 mm width, plain on one side and debossed with ‘B9’ on one the other side. Sildenafil Jubilant 50 mg film-coated tablets are white coloured, oval shaped, biconvex, film coated tablets, of 3.8 mm thickness, 12.8 mm length and 7.4 mm width, plain on one side and debossed with ‘C1’ on one the other side. Sildenafil Jubilant 100 mg film-coated tablets are white coloured, oval shaped, biconvex, film coated tablets, of 5.0 mm thickness, 16.2 mm length and 8.1 mm width, plain on one side and debossed with ‘436’ on one the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil Jubilant 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 Jubilant to be effective, s Կարդացեք ամբողջական փաստաթուղթը