TEVETEN 400 MG, FILM-COATED TABLETS 400 Milligram Film Coated Tablet
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
08-05-2024
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Składnik aktywny:
EPROSARTAN MESYLATE
Dostępny od:
Abbott Healthcare Products Ltd
INN (International Nazwa):
EPROSARTAN MESYLATE
Dawkowanie:
400 Milligram
Forma farmaceutyczna:
Film Coated Tablet
Typ recepty:
Product subject to prescription which may be renewed (B)
Status autoryzacji:
Authorised
Data autoryzacji:
0000-00-00
Charakterystyka produktu
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TEVETEN 400 mg, film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains eprosartan mesylate equivalent to 400 mg eprosartan.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oval, light to moderately pink film-coated tablet marked “5044” 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, 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.
PAEDIATRIC PATIENTS
Teveten is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
4.3 CONTRAINDICATIONS
Known hypersensitivity to eprosartan or to any of the excipients.
Severe hepatic impairment.
IRISH MEDICINES BOARD
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