Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ramipril
Waymade Healthcare Plc
C09AA05
Ramipril
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501
89034670 - 756534. 4/4 89034670 - 756534 1/4 _PACK. ITEM:_ ARKHÉ S.N.C. Tel. 0862.404140 fax 0862.090006 1 - Prima realizzazione REFLEX BLUE SANOFI S.P.A. Verificare la corrispondenza dell’artwork approvato - la nostra responsabilità è limitata al rifacimento dei file forniti. 26-06-2019 IST TRITACE GB I02 ISTRUZIONI GB: GREAT BRITAIN 89034670 89031942 62C0007 V.1.0 01100001100 167 X 315MM DP 2 - - 9,5 PT SU 10 PT 756534 2 - Correzione testatina 3 - Modifica testo reg. 4, 1 / 4 PACKAGE LEAFLET: INFORMATION FOR THE USER TRITACE ® 1.25MG - 2.5MG 5MG - 10MG TABLETS TRITACE ® TABLETS TITRATION PACK Ramipril IS THIS LEAFLET HARD TO SEE OR READ? PHONE 0845 372 7101 FOR HELP 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 TRITACE is and what it is used for 2. What you need to know before you take TRITACE 3. How to take TRITACE 4. Possible side effects 5. How to store TRITACE 6. Contents of the pack and other 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 del Perskaitykite visą dokumentą
Reference: 4898 1.3.1.01 - SPC 1 - 2.5mg - 2007-04-19 - CCDS V7.1 1.0 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tritace 2.5 mg Tablets or Ramipril 2.5mg Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets Each tablet contains ramipril 2.5 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets 2.5mg Yellowish to yellow oblong tablet with dimensions of 8 x 4 mm with score- line. Upper stamp: 2.5 & logo ( ) Lower stamp: HMR & 2.5 The tablet can be divided into equal doses. 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), Reference: 4898 1.3.1.01 - SPC 1 - 2.5mg - 2007-04-19 - CCDS V7.1 1.0 • 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 Posology 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. It must not be chewed or crushed. _Adults _ _ _ Diuretic-Treated patients Hypotension may Perskaitykite visą dokumentą