Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
sildenafil citrate, Quantity: 28.1 mg (Equivalent: sildenafil, Qty 20 mg)
Accord Healthcare Pty Ltd
Sildenafil citrate
Tablet, film coated
Excipient Ingredients: magnesium stearate; microcrystalline cellulose; hypromellose; croscarmellose sodium; calcium hydrogen phosphate; titanium dioxide; lactose monohydrate; triacetin
Oral
90 Tablets in blister pack
(S4) Prescription Only Medicine
Used to treat 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 Citrate 20 mg has not been evaluated in patients currently on bosentan therapy.
Visual Identification: White to off white, round shaped, biconvex, film coated tablets, debossed with '20' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-09-10
SILDENAFIL PHT APOTEX – CONSUMER MEDICINE INFORMATION Sildenafil PHT Apotex oct 18 – v1 Page 1 of 4 SILDENAFIL PHT APOTEX (SILDENAFIL (AS CITRATE) 20 MG FILM COATED TABLETS) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about sildenafil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking sildenafil 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 SILDENAFIL PHT IS USED FOR Sildenafil PHT is used to treat P ulmonary arterial H yper T ension (“PHT” - high blood pressure in the blood vessels in the lungs). Sildenafil brings down the blood pressure by relaxing these vessels. This medicine contain the active ingredient sildenafil (present as sildenafil citrate) which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SILDENAFIL HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE SILDENAFIL WHEN YOU MUST NOT TAKE IT DO NOT TAKE SILDENAFIL IF: 1. 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 and Tridil; patches such as Nitro- Dur, Nitradisc, Transiderm- Nitro, Nitrocor, Nitroderm TTS and Minitran; sprays such as Nitrolingual and injections such as Nitronal. Common tradenames for other nitrate preparations include tablets such as Imdur Durule, Sorbidin, Isordil, Carvasin, Corangin, ISMO 20, Imtrate, Coronex, Duride, Ikorel and Sodium Nitroprusside. There may be other trade nam Läs hela dokumentet
1 AUSTRALIAN PRODUCT INFORMATION – SILDENAFIL PHT APOTEX (SILDENAFIL CITRATE) 1 NAME OF THE MEDICINE Sildenafil citrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg sildenafil (as citrate) Ingredients with known effects: lactose For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM 20 mg: white to off white, round shaped, biconvex, film coated tablets, debossed with ‘20’ on one side and plain on other side (AUST R 188717). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sildenafil PHT tablets are 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 evaluated in patients currently on bosentan therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION TREATMENT SHOULD ONLY BE INITIATED AND MONITORED BY A PHYSICIAN 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 THE ELDERLY (OVER 65 YEARS OF AGE) In general, dose selection of sildenafil for elderly PAH patients should be undertaken cautiously due to higher incidence of compromised renal, hepatic or cardiac function, and of concomitant disease or drug therapy (see Section 5.2 Pharmacokinetic Properties – Elderly). 2 USE IN PATIENTS WITH I Läs hela dokumentet