Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMLODIPINE BESILATE; TELMISARTAN
BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.
AMLODIPINE BESILATE; TELMISARTAN
10Tablet Tablets; 30Tablet Tablets
CIPLA LTD
TWYNSTA ® Telmisartan/Amlodipine besilate (40/5mg, 40/10mg, 80/5mg, 80/10mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What TWYNSTA is used for 2. How TWYNSTA works 3. Before you use TWYNSTA _ _ 4. How to use TWYNSTA 5. While you are using it 6. Side effects 7. Storage and Disposal of TWYNSTA 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT TWYNSTA IS USED FOR TWYNSTA is a prescription medicine that contains telmisartan and amlodipine. TWYNSTA tablets may be used to treat high blood pressure (hypertension): • in adult patients whose blood pressure is not controlled enough with amlodipine or telmisartan alone. • in adult patients who already receive telmisartan and amlodipine from separate tablets and who wish to take instead the same doses in one tablet for convenience. • as the first medicine to lower your high blood pressure if your doctor decides you are likely to need more than one medicine. High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range. 2. HOW TWYNSTA WORKS TWYNSTA tablets contain two active substances called telmisartan and amlodipine. Both of these substances help to control your high blood pressure: - Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II. - Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening. This means that both of these Baca dokumen lengkap
1 TWYNSTA ® Abcd 1. NAME OF THE MEDICINAL PRODUCT TWYNSTA 40 mg/5 mg tablets TWYNSTA 40 mg/10 mg tablets TWYNSTA 80 mg/5 mg tablets TWYNSTA 80 mg/10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg or 80 mg telmisartan and 5 mg or 10 mg amlodipine (as amlodipine besilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM The tablets are for oral administration. TWYNSTA 40 mg/5 mg tablets are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipine layer is blue. The white layer is debossed with the Boehringer Ingelheim company symbol and the code A1. TWYNSTA 40 mg/10 mg tablets are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipine layer is blue. The white layer is debossed with the Boehringer Ingelheim company symbol and the code A2. TWYNSTA 80 mg/5 mg tablets are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipine layer is blue. The white layer is debossed with the Boehringer Ingelheim company symbol and the code A3. TWYNSTA 80 mg/10 mg tablets are layered tablets of oval, biconvex shape. The two layers have different colours with the telmisartan layer being white to off- white, the amlodipine layer is blue. The white layer is debossed with the Boehringer Ingelheim company symbol and the code A4. 4. CLINICAL PARTICULARS 4.1 INDICATIONS Treatment of essential hypertension in adults. Replacement Therapy Patients receiving telmisartan and amlodipine from separate tablets may instead receive TWYNSTA containing the same component doses. Add on therapy TWYNSTA is indicated in patients whose blood pressure is not adequately controlled on telmisartan or amlodipine monotherapy. Initial therapy TWYNSTA may also be used as initial therapy in patients who are likely to need multiple drug Baca dokumen lengkap