BYTRITE 2.5MG CAPSULES 2.5mg Milligram Capsule
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
19-04-2024
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Virkt innihaldsefni:
RAMIPRIL
Fáanlegur frá:
Sinclair IS Pharma Limited
INN (Alþjóðlegt nafn):
RAMIPRIL
Skammtar:
2.5mg Milligram
Lyfjaform:
Capsule
Gerð lyfseðils:
Product subject to prescription which may be renewed (B)
Leyfisstaða:
Withdrawn
Leyfisdagur:
2012-09-01
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ByTrite 2.5mg Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 2.5mg ramipril.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Capsules, hard._
Opaque light orange cap and opaque white body, hard gelatin capsules (No. 4), printed in black ink 93 and 7210 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
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