Kraj: Australia
Język: angielski
Źródło: 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: croscarmellose sodium; magnesium stearate; hypromellose; calcium hydrogen phosphate; microcrystalline cellulose; 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
Registered
2012-09-10
SILDENAFIL SANDOZ PHT 20 1 SILDENAFIL SANDOZ PHT 20 _sildenafil (as citrate) 20 mg film-coated Tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sildenafil Sandoz PHT 20. 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 your taking Sildenafil Sandoz PHT 20 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 SANDOZ PHT 20 IS USED FOR Sildenafil Sandoz PHT 20 is used to treat pulmonary arterial hypertension (high blood pressure in the blood vessels in the lungs). Sildenafil Sandoz PHT 20 brings down the blood pressure by relaxing these vessels. Sildenafil Sandoz PHT 20 tablet 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 SANDOZ PHT 20 HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE SILDENAFIL SANDOZ PHT 20 _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE SILDENAFIL SANDOZ PHT 20 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 Nitropr Przeczytaj cały dokument
1 v2.2 AUSTRALIAN PRODUCT INFORMATION – SILDENAFIL SANDOZ PHT 20 (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 188702). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SILDENAFIL SANDOZ PHT 20 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 v2. Przeczytaj cały dokument