País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
tadalafil, Quantity: 20 mg
Cipla Australia Pty Ltd
Tadalafil
Tablet
Excipient Ingredients: sodium lauryl sulfate; croscarmellose sodium; magnesium stearate; lactose monohydrate; hyprolose; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide yellow; iron oxide red
Oral
28, 14, 56, 60
(S4) Prescription Only Medicine
TADALIS is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Visual Identification: Brown coloured, capsule shaped, biconvex film coated tablets with "T20" debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-03-27
Version 1.0 ‐ 1 ‐ TADALIS 20 _tadalafil _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TADALIS 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 you taking TADALIS 20 against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TADALIS 20 IS USED FOR TADALIS 20 is used in adults as a treatment for pulmonary arterial hypertension. TADALIS 20 belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TADALIS 20 HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. TADALIS 20 is available only with a doctor's prescription. TADALIS 20 is not intended for use by children under the age of 18 years. BEFORE YOU TAKE TADALIS 20 _ _ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE TADALIS 20 IF YOU ARE CURRENTLY TAKING ANY NITRATES OR AMYL NITRITE. Nitrates are medicines used for the treatment of angina ("chest pain") or other heart conditions. TADALIS 20 has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure talk to your doctor. DO NOT TAKE TADALIS 20: IF YOU HAVE SUFFERED A HEART ATTACK IN THE LAST 3 MONTHS IF YOU HAVE VISION LOSS IN ONE EYE BECAUSE OF NON-ARTERITIC ANTERIOR ISCHAEMIC OPTIC NEUROPATHY (NAION) SEVERE HYPOTENSION IF YOU USE GUANYLATE CYCLASE STIMULATORS SUCH AS RIOCIGUAT, USED TO TREAT PULMONARY ARTERIAL HYPOTENSION DO NOT TAKE TADALIS 20 IF YOU HAVE AN ALLERGY TO: any of the ingredients listed at the en Leia o documento completo
AUSTRALIAN PRODUCT INFORMATION TADALIS 20 (TADALAFIL) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Tadalafil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg tadalafil. Excipient with known effect Contains sugars as lactose. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Film-coated tablet. TADALIS 20 film-coated tablets are brown coloured, capsule shaped, biconvex film coated tablets with “T20” debossed on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TADALIS 20 is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food. Patients with renal impairment In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended based on data from clinical pharmacology studies. Although clinical pharmacology studies in patients with renal impairment have not been performed with 40 mg the dose may be increased to 40 mg once per day, based on individual efficacy and tolerability. In patients with severe renal impairment the use of tadalafil is not recommended due to limited clinical experience in these patients (see sections 4.4 Special warnings and precautions for use and 5.2 Pharmacokinetic properties). Patients with hepatic impairment Based on data obtained in a clinical pharmacology study performed using single doses of 10 mg in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), a starting dose of 20 mg once per day may be considered. If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the p Leia o documento completo