TEVETEN 600 MG, FILM-COATED TABLETS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
02-05-2024
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Ingredient activ:
EPROSARTAN MESYLATE
Disponibil de la:
Abbott Healthcare Products Ltd
Dozare:
600 Milligram
Forma farmaceutică:
Film Coated Tablet
Data de autorizare:
2000-01-21
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teveten 600 mg, film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains eprosartan mesylate equivalent to 600 mg eprosartan.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Film-coated tablet
Capsule-shaped, white, film-coated tablet marked “5046” on one side and no inscription on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eprosartan is indicated for the treatment of essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is 600 mg eprosartan once daily.
Achievement of maximal blood pressure reduction in most patients may take 2 to 3 weeks of treatment.
Eprosartan may be used alone or in combination with other anti-hypertensives. In particular, addition of a thiazide-type
diuretic such as hydrochlorothiazide or a calcium channel blocker such as sustained release nifedipine has been shown
to have an additive effect with eprosartan.
Eprosartan may be taken with or without food.
Duration of treatment is not limited.
GERIATRIC PATIENTS
No dose adjustment is required in the elderly.
DOSAGE IN HEPATICALLY IMPAIRED PATIENTS
There is limited experience in patients with hepatic insufficiency _(see section 4.3)._
DOSAGE IN RENALLY IMPAIRED PATIENTS
In patients with moderate or severe renal impairment (creatinine clearance
<
60 ml/min), the daily dose should not
exceed 600 mg.
PAEDIATRIC PATIENTS
Teveten is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/11/2011_
_CRN 2096371_
_page number: 1_
4.3 CONTRAINDICATIONS
Known hypersen
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