Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SILDENAFIL CITRATE
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
SILDENAFIL CITRATE
4tablet Tablets
Sandoz Private Limited
_Consumer Medication Information Leaflet (RiMUP)_ 1 SILDEGRA Sildenafil citrate (100 mg tablets) WHAT IS IN THIS LEAFLET 1. What Sildegra is used for 2. How Sildegra works 3. Before you use Sildegra 4. How to use Sildegra 5. While you are using it 6. Side effects 7. Storage and Disposal of Sildegra 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SILDEGRA IS USED FOR Sildegra is a treatment for 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. HOW SILDEGRA WORKS Sildegra belongs to a group of medicines called phosphodiesterase type 5 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. Sildegra will only help you to get an erection if you are sexually stimulated. You should not take Sildegra if you do not have erectile dysfunction. You should not take Sildegra if you are a woman. BEFORE YOU USE SILDEGRA_ _ - _When you must not take it _ Do not take Sildegra • If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Sildegra. • If you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrite ("poppers"). These medicines are often given for relief of angina pectoris (or "chest pain"). Sildegra can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist. • If you have a severe heart or liver problem. • If you have recently had a stroke or a heart attack, or if you have low blood pressure. • If you have certain rare inherited eye diseases (such as retinitis pigmentosa). • If you have ever had loss of vision because of non-arteritic anterior ischaemic optic neuropathy (NAION) _ _ - _Before you start to use it _ Tell your doctor • If you have sickle cell anaemia (an abnormality of red blood cells সম্পূর্ণ নথি পড়ুন
1. NAME OF THE MEDICINAL PRODUCT Sildegra ® 100 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sildegra ® 100 mg tablets Each tablet contains 100 mg of sildenafil (as citrate). 3. PHARMACEUTICAL FORM Tablet. Sildegra ® 100 mg tablets are light blue, round, slightly dotted tablets, with cross breaking notch on both sides and debossment “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. In order for sildenafil to be effective, sexual stimulation is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Use in Adults For most patients, the recommended dose is 50 mg taken as needed, approximately 1 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended daily 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). Use in Patients with Impaired Renal Function Dose adjustments are not required in 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. Use in Patients with Impaired Hepatic Function Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis), a 25 mg dose should be considered. Use in Patients Using Other Medications Given the extent of the interaction with patients receiving concomitant therapy with ritonavir (see section 4.5), it is recommended not to exceed a maximum single dose of 25 mg of sildenafil in a 48- hour period. A starting dose of 25 mg should be considered in patien সম্পূর্ণ নথি পড়ুন