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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teveten Plus 600 mg/12.5 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains eprosartan mesylate equivalent to 600 mg eprosartan and 12.5 mg
hydrochlorothiazide.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Film-coated tablet.
Butterscotch-coloured, capsule-shaped film-coated tablets.
The inscription of the tablet is ‘5147’ on one side and no inscription on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension. Teveten Plus 600 mg/12.5 mg is indicated in patients whose blood pressure is not adequately
controlled on eprosartan alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is one tablet Teveten Plus 600 mg/12.5 mg once daily, which should be taken in the morning.
The switch from eprosartan monotherapy to the fixed combination can be considered after 8 weeks of blood pressure
stabilization. Teveten Plus 600 mg/12.5 mg can be taken with or without food.
ELDERLY
No dose adjustment is required in the elderly, although limited information is available in this population.
CHILDREN
As safety and efficacy of administration to children have not been established, treatment of children and adolescents <
18 years with Teveten Plus 600 mg/12.5 mg is not recommended.
HEPATIC IMPAIRMENT
The use of Teveten Plus in patients with mild to moderate hepatic impairment is not recommended since there is
currently only limited experience of eprosartan mesylate in this patient group. In patients with severe hepatic
impairment Teveten Plus is contraindicated _(see sections 4.3 and 4.4)._
RENAL IMPAIRMENT
In patients with mild to moderate renal impairment (creatinine clearance
≥ 30 ml/min) dose adjustment
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