מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
sildenafil citrate
Apotex Pty Ltd
Sildenafil citrate
Registered
APO-SILDENAFIL _(sildenafil citrate)_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. It should be used only under strict medical supervision. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Sildenafil. It contains the active ingredient sildenafil citrate. Sildenafil belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Sildenafil is used to treat erectile dysfunction, more commonly known as impotence, in men. This is when a man cannot get, or keep, a hard erect penis suitable for sexual activity. Sildenafil works by relaxing the blood vessels in your penis when you are sexually excited. This allows blood to flow into your penis, allowing you to get an erection in the natural way. Sildenafil will only work if you are sexually excited. It will not increase your sex drive. Sildenafil is not for use in women. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE THIS MEDICINE YOU MUST NOT TAKE SILDENAFIL IF YOU ARE TAKING NITRATES OR NITRITE MEDICATIONS. IT MAY LEAD TO A SEVERE DROP IN YOUR BLOOD PRESSURE, WHICH MAY BE DIFFICULT TO TREAT. BECAUSE SEXUAL ACTIVITY MAY PLACE A STRAIN ON YOUR HEART, YOUR DOCTOR WILL NEED TO CHECK WHETHER YOU ARE FIT ENOUGH TO TAKE THIS MEDICINE. _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF: • YOU ARE BEING TREATED FOR ANGINA (CHEST PAIN) OR OTHER HEART CONDITIONS WITH CERTAIN MEDICINES CALLED NITRATES. Nitrate medicines include glyceryl trinitrate (also called nitroglycerin). Comm קרא את המסמך השלם
1 AUSTRALIAN PRODUCT INFORMATION APO-SILDENAFIL ( SILDENAFIL CITRATE ) FILM COATED TABLETS 1 NAME OF THE MEDICINE Sildenafil citrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg, 50 mg or 100 mg sildenafil as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 25 MG TABLETS White to off-white diamond shaped, biconvex, film coated tablets, engraved “APO” on one side and “SIL25” on the other side. 50 MG TABLETS White to off-white diamond shaped, biconvex, film coated tablets, engraved “APO” on one side and “SIL50” on the other side. 100 MG TABLETS White to off-white diamond shaped, biconvex, film coated tablets, engraved “APO” on one side and “SIL100” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil is indicated for the treatment of erectile dysfunction in adult males. Sildenafil is not indicated for use by women. 2 4.2 DOSE AND METHOD OF ADMINISTRATION Sildenafil tablets are intended for oral administration. DOSAGE USE IN ADULTS The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on the efficacy and toleration, 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 per day. USE IN THE ELDERLY Since sildenafil clearance is reduced in elderly patients, a first dose of 25 mg should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg. DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT The dosing recommendations for USE IN ADULTS should be followed for patients with mild to moderate renal impairment (Cl cr = 30-80 mL/min). Since sildenafil clearance is reduced in patients with severe renal impairment (Cl cr < 30 mL/min) a 25 mg starting dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg. DOSAGE ADJUSTMENT IN HEPATIC IMPAIRMENT Since sildenafil clearance is קרא את המסמך השלם