País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Ramipril
Sanofi-Aventis Ireland Limited T/A SANOFI
C09AA; C09AA05
Ramipril
2.5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; ramipril
Marketed
2003-11-18
PACKAGE LEAFLET: INFORMATION FOR THE USER TRITACE ® 1.25MG TABLETS TRITACE ® 2.5MG TABLETS TRITACE ® 5MG TABLETS TRITACE ® 10MG TABLETS _Ramipril_ IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 4035600 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 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRITACE DO NOT TAKE TRITACE: • If you are allergic to ramipril, any other ACE inhibitor medicine or any of the ingredients of this medicine listed in section 6. Sign Llegiu el document complet
Health Products Regulatory Authority 22 June 2021 CRN00C2LZ Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tritace 2.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets Each tablet contains ramipril 2.5 mg For a 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 and company logo, lower stamp HMR and 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: o manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or o diabetes with at least one cardiovascular risk factor (see section 5.1). - Treatment of renal disease: o Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria, o Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1), o 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 Special populations o _Pregnancy_: ACE inhibitors such as ramipril or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued ACE inhibitor/AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors/ Llegiu el document complet