TEVETEN 600 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-05-2024
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Active ingredient:
EPROSARTAN MESYLATE
Available from:
Chemilines Healthcare (Ireland) Limited
ATC code:
C09CA02
INN (International Name):
EPROSARTAN MESYLATE
Dosage:
600 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Angiotensin II antagonists, plain
Authorization status:
Authorised
Authorization date:
2013-08-02
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teveten 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains Eprosartan mesylate, equivalent to 600 mg Eprosartan.
Contains lactose monohydrate.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Imported from Italy:_
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 Contraindications).
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.
Film-coated tablet.
Teveten 600 is a capsule-shaped white film-coated tablet marked 5046 on one side and
SOLVAY on the other.
Eprosartan is indicated for the treatment of essential hypertension.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 03/08/2013_
_CRN 2135195_
_page number: 1_
PAEDIATRIC PATIENTS
Teveten is not recommended for use in children and adolescents
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