COEPRATENZ PLUS 600/12.5 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
EPROSARTAN MESYLATE HYDROCHLOROTHIAZIDE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
EPROSARTAN MESYLATE HYDROCHLOROTHIAZIDE
Dosage:
600/12.5 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2014-03-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coepratenz 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 the 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 'SOLVAY' on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension. Coepratenz 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 Coepratenz 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. Coepratenz 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 Coepratenz Plus 600 mg/12.5 mg is not recommended.
Hepatic Impairment
The use of Coepratenz 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 Coepratenz Plus is contraindicated (see section 4.3).
Renal Impairment
In patients with mild to moderate renal impairment (creatinine clearance
30 ml/min) dose adjustment is not
ne
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