Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
RAMIPRIL
PCO Manufacturing
RAMIPRIL
5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2013-12-31
PACKAGE LEALFET: INFORMATION FOR THE USER TRITACE ® 5MG TABLETS Ramipril READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What TRITACE is and what it is used for 2. Before you take TRITACE 3. How to take TRITACE 4. Possible side effects 5. How to store TRITACE 6. Further information 1. WHAT TRITACE IS AND WHAT IT IS USED FOR? TRITACE contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). TRITACE works by: • Decreasing your body’s production of substances that could raise your blood pressure • Making your blood vessels relax and widen • Making it easier for your heart to pump blood around your body. TRITACE can be used: • To treat high blood pressure (hypertension) • To reduce the risk of you having a heart attack or stroke • To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes) • To treat your heart when it cannot pump enough blood to the rest of your body (heart failure) • As treatment following heart attack (myocardial infarction) complicated with heart failure. 2. BEFORE YOU TAKE TRITACE DO NOT TAKE TRITACE • If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tritace 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets Each tablet contains 5 mg ramipril. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Tablet. _Product as imported from the Netherlands and Poland:_ Red, oblong tablets marked with ‘5’ and ‘HMP’ on either side of a scoreline on one side and ‘5’and the Aventis logo on either side of a scoreline on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: • manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or • diabetes with at least one cardiovascular risk factor (see section 5.1). Treatment of renal disease: • Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria, • Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1) • Manifest glomerular non diabetic nephropathy as defined by macroproteinuria 3 g/day (see section 5.1). Treatment of symptomatic heart failure. Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oraluse It is recommended that TRITACE is taken each day at the same time of the day. TRITACE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). TRITACE has to be swallowed with liquid. I Διαβάστε το πλήρες έγγραφο