Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sanofi
C09AA05
Not applicable
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 02050501; GTIN: 5000283653165 5000283658238
89031942. 4/4 89031942 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. 05-02-2018 IST TRITACE GB I02 ISTRUZIONI GB: GREAT BRITAIN 89031942 89031227 62C0007 V.1.0 1101100101 167 X 315MM DP 7 - - 9,5 PT SU 10 PT 2 - Modifica testo reg. 3 - Modifica testo reg. 4 - Modifica testo reg. 5 - Modifica testo reg. 6 - Modifica testo reg. 7 - Modifica testo reg. 8 - 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 Прочитать полный документ
OBJECT 1 TRITACE TABLET TITRATION PACK Summary of Product Characteristics Updated 22-Feb-2018 | SANOFI 1. Name of the medicinal product Tritace Tablet Titration Pack 2.5 mg, 5 mg, 10 mg tablets 2. Qualitative and quantitative composition Tablets Each 2.5 mg tablet contains ramipril 2.5 mg Each 5 mg tablet contains ramipril 5 mg Each 10 mg tablet contain ramipril 10 mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablets 2.5 mg 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. Tablets 5 mg Pale red oblong tablet with dimensions of 8 x 4 mm with score-line. Upper stamp: 5 & logo ( ) Lower stamp: HMP & 5 The tablet can be divided into equal doses. Tablets 10 mg White to almost white oblong tablet with dimensions of 7 x 4.5 mm with score-line. Upper stamp: HMO/HMO 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), • 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 metho Прочитать полный документ