BELLRAMIL Capsules Hard 2.5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
RAMIPRIL
Available from:
Ranbaxy Ireland Limited
Dosage:
2.5 Milligram
Pharmaceutical form:
Capsules Hard
Authorization date:
2011-10-07
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bellramil 2.5 mg Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contians ramipril 2.5 mg.
Excipients: each capsule contains Sunset yellow (E 110) and Ponceau 4R (E 124)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard Capsules.
Size 4 with orange cap/white body imprinted with "R" on cap and '2.5' on body.
Contains white to off-white granular powder.
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
IRISH MEDICINES BOARD
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_Date Printed 07/10/2011_
_CRN 2106147_
_page number: 1_
It is recommended that Bellramil is taken each day at the same time
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