البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
sildenafil citrate
Apotex Pty Ltd
Sildenafil citrate
Registered
APO-SILDENAFIL PHT _(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 PHT. It contains the active ingredient sildenafil citrate. Sildenafil belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Sildenafil is used to treat pulmonary arterial hypertension (high blood pressure in the blood vessels in the lungs). Sildenafil brings down pulmonary arterial blood pressure by relaxing the blood vessels in the lungs. Do not give sildenafil to children. Sildenafil is not indicated for use in children less than 18 years of age. 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. _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). Common tradenames include tablets; such as Anginine, Lycinate and Nitrostat; patches such as Nitro- Dur, Transiderm-Nitro, Nitroderm TTS and Minitran; sprays such as Nitrolingual and Glytrin and injections such as Gliceryl trinitrate concentrate. Common tradenames for other nitrate preparations includ اقرأ الوثيقة كاملة
1 AUSTRALIAN PRODUCT INFORMATION APO-SILDENAFIL PHT (SILDENAFIL CITRATE) FILM COATED TABLETS 1 NAME OF THE MEDICINE Sildenafil citrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg sildenafil as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM APO-Sildenafil PHT 20 mg tablets are white to off-white round, biconvex, film coated tablets, engraved “APO” on one side and “SIL” over “20” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil is indicated for the treatment of patients with pulmonary arterial hypertension classified as WHO functional classes II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. The efficacy of sildenafil has not been established in patients currently on bosentan therapy (see section 4.4 SPECIAL PRECAUTIONS AND WARNINGS FOR USE). 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Sildenafil PHT tablets are intended for oral administration. DOSAGE Treatment should only be initiated and monitored by a health care professional experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration in spite of sildenafil treatment, alternative therapies should be considered. USE IN ADULTS (≥ 18 YEARS) The recommended dose for sildenafil is 20 mg three times a day (TID). Sildenafil tablets should be taken approximately 6-8 hours apart, with or without food. No greater efficacy was achieved with doses higher than 20 mg TID, therefore, treatment with doses higher than 20 mg TID is not recommended (see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS). Dosages lower than 20 mg TID have not been examined and the efficacy of these doses is not known. USE IN CHILDREN (< 18 YEARS) Sildenafil is not indicated for use in children < 18 years of age. 2 DISCONTINUATION OF TREATMENT Limited data suggests that the abrupt discontinuation of s اقرأ الوثيقة كاملة