Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SILDENAFIL CITRATE
VIATRIS SDN. BHD.
SILDENAFIL CITRATE
4Tablet Tablets; 1Tablet Tablets
Fareva Amboise
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ VIAGRA ® TABLETS Sildenafil Citrate (50 mg, 100 mg) 1 WHAT IS IN THIS LEAFLET: 1. What VIAGRA is used for 2. How VIAGRA works 3. Before you use VIAGRA 4. How to use VIAGRA 5. While you are using it 6. Side effects 7. Storage and Disposal of VIAGRA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT VIAGRA IS USED FOR VIAGRA 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. HOW VIAGRA WORKS VIAGRA contains the active substance sildenafil, which 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. VIAGRA will only help you to get an erection if you are sexually stimulated. BEFORE YOU USE VIAGRA - _When you must not use it_ - If you are taking medicines containing nitrates, nitrites or nitric oxide donors. - If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of VIAGRA. - If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). _Pregnancy and lactation_ VIAGRA is not indicated for use by women. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ Tell your doctor - If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow) or any disease or deformity of your penis. These conditions may require special care when taking medicines for erectile dysfunction. - If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of hav Belgenin tamamını okuyun
1 VIAGRA ® 50MG & 100MG Sildenafil Citrate 1. NAME OF THE MEDICINAL PRODUCT VIAGRA ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION VIAGRA 50 mg: Each tablet contains sildenafil citrate equivalent to 50 mg sildenafil. VIAGRA 100 mg: Each tablet contains sildenafil citrate equivalent to 100 mg sildenafil. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Blue, rounded-diamond shaped film-coated tablets equivalent to 50 mg and 100 mg of sildenafil for oral administration, marked “PFIZER” on one side and “VGR 50”, or “VGR 100” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil is indicated for the treatment of 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 Sildenafil tablets are for oral administration. 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. USE IN PATIENTS WITH IMPAIRED RENAL FUNCTION Dosage 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 2 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 Belgenin tamamını okuyun