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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
LOAVEL 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
Yellowish to yellow oblong tablet with score line, upper stamp 2.5 and company logo, lower stamp HMR and 2.5. The
tablet can be divided into equal halves.
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
Oral use.
It is recommended that LOAVEL is taken each day at the same time of the day.
LOAVEL can be taken before, with or after meals, because food intake does not modify its bioavailability (see section
5.2).
LOAVEL has to be swallowed with liquid. It must not be chewed or crushed.
IRISH MEDICINES BOARD
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