Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Felodipine; Ramipril
Sanofi-Aventis Ireland Limited T/A SANOFI
C09BB; C09BB05
Felodipine; Ramipril
5 mg/5 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and calcium channel blockers; ramipril and felodipine
Marketed
1998-07-13
PACKAGE LEAFLET: INFORMATION FOR THE USER TRIAPIN 2.5 MG / 2.5 MG TRIAPIN 5 MG / 5 MG PROLONGED RELEASE TABLETS ramipril/felodipine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. 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 effects, talk to your doctor or pharmacist; this includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Triapin are and what they are used for 2. What you need to know before you take Triapin 3. How to take Triapin 4. Possible side effects 5. How to store Triapin 6. Contents of the pack and other information 1. WHAT TRIAPIN ARE AND WHAT THEY ARE USED FOR Triapin 2.5 mg / 2.5 mg and Triapin 5 mg / 5 mg prolonged release tablets (called also Triapin tablets in this leaflet) 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: o ramipril or any other ACE inhibitor o felodipine or any other calcium antagonists o any of the other ingredients of this med Read the complete document
Health Products Regulatory Authority 23 June 2021 CRN00C0F7 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Triapin 5mg/5mg prolonged release tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of felodipine and 5 mg of ramipril. Excipient(s) with known effect: Each tablet contains 51.5 mg lactose anhydrous. Each tablet contains 5.00 mg macrogolglycerol hydroxystearate (polyoxyl hydrogenated castor oil). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Triapin 5mg/5mg tablets are circular (diameter approx 9 mm), reddish-brown coloured, biconvex and engraved H/OE on one side and marked 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 5mg/5mg once daily. The maximum dose is one tablet Triapin 5mg/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 Health Products Regulatory Authority 23 June 2021 CRN00C0F7 Page 2 of 17 • hypersensitivity to felodipine (or other dihydropyridines) ramipril, other angiotensin converting enzyme Read the complete document