Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
RAMIPRIL
Sinclair IS Pharma Limited
RAMIPRIL
10 Milligram
Capsule
Product subject to prescription which may be renewed (B)
Withdrawn
2012-02-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ByTrite 10mg Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 10mg ramipril For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsules, hard. Opaque rich yellow cap and opaque white body, hard gelatin capsules (No. 4), printed in black ink 93 and 7212 on opposing cap and body portions of the capsules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of hypertension. - 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 Oral use. It is recommended that ByTrite is taken each day at the same time of the day. ByTrite can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). ByTrite has to be swallowed with liquid. It must not be chewed or crushed. _Adults_ Diuretic-Treated patients: Hypotension may occur following initiation of therapy with ByTrite; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted. If possible, the diuretic should be discon Baca dokumen lengkap