País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
telmisartan, Quantity: 40 mg; amlodipine besilate, Quantity: 6.935 mg (Equivalent: amlodipine, Qty 5 mg)
Boehringer Ingelheim Pty Ltd
amlodipine besilate,Telmisartan
Tablet, multilayer
Excipient Ingredients: magnesium stearate; meglumine; sorbitol; sodium hydroxide; microcrystalline cellulose; povidone; colloidal anhydrous silica; maize starch; pregelatinised maize starch; Colour
Oral
28 tablets, 7 tablets, 98 tablets, 56 tablets, 14 tablets, 30 tablets
(S4) Prescription Only Medicine
Treatment of hypertension. Treatment should not be initiated with this fixed-dose combination. (see DOSAGE AND ADMINISTRATION)
Visual Identification: Oval, biconvex, bilayered uncoated tablets, white to off white and blue, debossed with company logo and 'A1' on white layer and plain on blue layer; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2011-02-18
TWYNSTA ® _TABLETS_ _telmisartan/amlodipine besilate_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Twynsta. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking this medicine against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TWYNSTA IS USED FOR Twynsta is used to lower high blood pressure (hypertension). Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm or relaxed. There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated, it can lead to serious health problems, including stroke, heart disease and kidney failure. _HOW TWYNSTA WORKS_ Twynsta contains telmisartan and amlodipine (as the besilate salt) in one single tablet. These two active ingredients help to reduce blood pressure in different ways: • Telmisartan belongs to a group of medicines called angiotensin II receptor blockers. Angiotensin II is a substance in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan works by blocking the e Llegiu el document complet
TWYNSTA PI0134-11 1 AUSTRALIAN PRODUCT INFORMATION – TWYNSTA ® (TELMISARTAN/AMLODIPINE) TABLET 1 NAME OF THE MEDICINE telmisartan and amlodipine (as besilate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TWYNSTA is available in four tablet strengths for oral administration, containing 40 mg or 80 mg telmisartan and 5 mg or 10 mg amlodipine (as besilate), in the following combinations: • TWYNSTA 40/5 mg containing telmisartan 40 mg/amlodipine 5 mg • TWYNSTA 40/10 mg containing telmisartan 40 mg/amlodipine 10 mg • TWYNSTA 80/5 mg containing telmisartan 80 mg/amlodipine 5 mg • TWYNSTA 80/10 mg containing telmisartan 80 mg/amlodipine 10 mg Excipients with known effect: • Each TWYNSTA 40/5 mg and 40/10 mg tablet contains 168.64 mg of sorbitol • Each TWYNSTA 80/5 mg and 80/10 mg tablet contains 337.28 mg of sorbitol For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM TWYNSTA 40/5 mg tablets are oval, biconvex shaped two layer tablets, white to off white on one side and blue on the other side. The white side is debossed with Boehringer Ingelheim company logo and ‘A1’. The blue side is plain. Each tablet contains 40 mg telmisartan and 5 mg amlodipine. TWYNSTA 40/10 mg tablets are oval, biconvex shaped two layer tablets, white to off white on one side and blue on the other side. The white side is debossed with Boehringer Ingelheim company logo and ‘A2’. The blue side is plain. Each tablet contains 40 mg telmisartan and 10 mg amlodipine. TWYNSTA 80/5 mg tablets are oval, biconvex shaped two layer tablets, white to off white on one side and blue on the other side. The white side is debossed with Boehringer Ingelheim company logo and ‘A3’. The blue side is plain. Each tablet contains 80 mg telmisartan and 5 mg amlodipine. TWYNSTA 80/10 mg tablets are oval, biconvex shaped two layer tablets, white to off white on one side and blue on the other side. The white side is debossed with Boehringer Ingelheim company logo and ‘A4’. The blue side is plain. Each tablet Llegiu el document complet