IRBESARTAN DEXCEL 75 Milligram Film Coated Tablet
Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Résumé des caractéristiques du produit
(SPC)
09-06-2024
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Ingrédients actifs:
IRBESARTAN
Disponible depuis:
Dexcel-Pharma Limited
DCI (Dénomination commune internationale):
IRBESARTAN
Dosage:
75 Milligram
forme pharmaceutique:
Film Coated Tablet
Type d'ordonnance:
Product subject to prescription which may be renewed (B)
Statut de autorisation:
Withdrawn
Date de l'autorisation:
2014-06-18
Résumé des caractéristiques du produit
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irbesartan Dexcel 75 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 75 mg of irbesartan
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
White, film-coated, oval shaped tablets.
The dimensions are approximately 10.7 x 6.0 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irbesartan is indicated in adults for the treatment of essential hypertension.
It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as
part of an
antihypertensive medicinal product regimen (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual recommended initial and maintenance dose is 150 mg once daily.
Irbesartan tablets at a dose of 150 mg once daily generally provide a better 24 hour blood pressure control than 75 mg.
However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the
elderly over 75 years.
In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan tablets can be increased to 300 mg,
or other antihypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has
been shown to have an additive effect with Irbesartan tablets (see section 4.5).
In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to
300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit
of Irbesartan tablets in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to
other antihypertensive
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