Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Felodipine; Ramipril
Sanofi
C09BB05
Felodipine; Ramipril
2.5mg ; 2.5mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5013841202378
PACKAGE LEAFL ET: INFORMATION FOR THE USER TRIAPIN 2.5 MG / 2.5 MG AND TRIAPIN 5 MG / 5 MG PROLONGED RELEASE TABLETS ramipril/felodipine READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side eff ects, talk to your doctor or pharmacist. This includes any possible side eff ects not listed in this leafl et. See section 4. WHAT IS IN THIS LEAFL ET: 1. What Triapin is and what it is used for 2. What you need to know before you take Triapin 3. How to take Triapin 4. Possible side eff ects 5. How to store Triapin 6. Contents of the pack and other information 1. WHAT TRIAPIN IS AND WHAT IT IS USED FOR Triapin 2.5 mg / 2.5 mg and Triapin 5 mg / 5 mg prolonged release tablets (also called Triapin tablets in this leafl et) both contain two medicines called ramipril and felodipine. • Ramipril belongs to a group of medicines called ‘angiotensin converting enzyme inhibitors’ (ACE inhibitors). It works by stopping the production of substances that raise blood pressure and makes your blood vessels relax and widen. • Felodipine belongs to a group of medicines called ‘calcium antagonists’. It makes your blood vessels relax and widen. This helps to lower your blood pressure. Triapin tablets are used to treat high blood pressure (hypertension). High blood pressure can mean you are more likely to have problems such as heart disease, kidney disease and stroke. This medicine lowers your blood pressure and lowers the risk of these problems. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIAPIN DO NOT TAKE TRIAPIN TABLETS IF: × You are allergic to: - ramipril or any other ACE inhibitor - felodipine or any other calcium antagonists - any of the other ingredients of Read the complete document
OBJECT 1 TRIAPIN 2.5MG/2.5MG PROLONGED RELEASE TABLETS Summary of Product Characteristics Updated 22-Feb-2018 | SANOFI 1. Name of the medicinal product Triapin 2.5mg/2.5mg prolonged release tablets 2. Qualitative and quantitative composition Each tablet contains 2.5 mg of felodipine and 2.5 mg of ramipril. Each tablet contains 52 mg lactose anhydrous. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Triapin 2.5mg/2.5mg tablets are circular (diameter approx 9 mm), apricot coloured, biconvex and engraved on one side and marked 2.5 on the other side. 4. Clinical particulars 4.1 Therapeutic indications Treatment of essential hypertension. Triapin fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on felodipine or ramipril alone. 4.2 Posology and method of administration Posology _Use in adults, including older people:_ One tablet Triapin 2.5mg/2.5mg once daily. The maximum dose is two tablets Triapin 2.5mg/2.5mg once daily. Special populations _Use in patients with impaired liver function:_ See sections 4.3 and 4.4. _Use in patients with impaired renal function or patients already on diuretic treatment: _ See sections 4.3 and 4.4. Individual dose titration with the components can be recommended and when clinically appropriate, direct change from monotherapy to the fixed combination may be considered. _Paediatric population:_ Triapin is not recommended for use in children due to a lack of data. Method of administration Triapin tablets should be swallowed whole with a sufficient amount of liquid. The tablets must not be divided, crushed or chewed. The tablet can be administered without food or following a light meal not rich in fat or carbohydrate. 4.3 Contraindications • hypersensitivity to felodipine (or other dihydropyridines), ramipril, other angiotensin converting enzyme (ACE) inhibitors or any of the excipients listed in section 6.1. • history of angioedema. • concomitant use with sacubitril/valsartan therapy (see sections 4.4 and 4.5). Read the complete document