Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
SILDENAFIL CITRATE
1 A Pharma GmbH
G04BE03
SILDENAFIL CITRATE
TABLET
SILDENAFIL CITRATE 25 milligram(s)
POM
UROLOGICALS
Authorised
2017-02-01
PACKAGE LEAFLET: INFORMATION FOR THE USER SILDENAFIL SANDOZ 25 MG TABLETS SILDENAFIL SANDOZ 50 MG TABLETS SILDENAFIL SANDOZ 100 MG 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 of the side effects, talk to your doctor, pharmacist or nurse. This includes and possible side effects not listed in this leaflet.. See section 4. WHAT IS IN THIS LEAFLET: 1. What Sildenafil Sandoz is and what it is used for 2. What you need to know before you take Sildenafil Sandoz 3. How to take Sildenafil Sandoz 4. Possible side effects 5. How to store Sildenafil Sandoz 6. Contents of the pack and other information 1. WHAT SILDENAFIL SANDOZ IS AND WHAT IT IS USED FOR Sildenafil Sandoz 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 Sandoz will only help you to get an erection if you are sexually stimulated. Sildenafil Sandoz 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 SANDOZ DO NOT TAKE SILDENAFIL SANDOZ - if you are allergic to sildenafil or any 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”). Baca dokumen lengkapnya
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sildenafil Sandoz 25 mg tablets Sildenafil Sandoz 50 mg tablets Sildenafil Sandoz 100 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _Sildenafil Sandoz 25 mg tablets _ Each tablet contains 25 mg of sildenafil (as citrate). _Sildenafil Sandoz 50 mg tablets _ Each tablet contains 50 mg of sildenafil (as citrate). _Sildenafil Sandoz 100 mg tablets _ Each tablet contains 100 mg of sildenafil (as citrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet _Sildenafil Sandoz 25 mg tablets _ Sildenafil Sandoz 25 mg tablet is a light blue round slightly dotted tablet, with breaking notch on one side and embossment “25” on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. _Sildenafil Sandoz 50 mg tablets _ Sildenafil Sandoz 50 mg tablet is a light blue round slightly dotted tablet, with cross breaking notch on one side and embossment “50” on the other side. The tablet can be divided into equal quarters. Only intake of the whole tablet or concomitant intake of two quarters is covered by posology. _Sildenafil Sandoz 100 mg tablets _ Sildenafil Sandoz 100 mg tablet is a light blue round slightly dotted tablet, with cross breaking notch on both sides and embossment “100” on one side. The tablet can be divided into equal quarters. 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. Page 2 of 15 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 m Baca dokumen lengkapnya