PERINDOPRIL TERT-BUTYLAMINE/INDAPAMIDE GLENMARK 4/1.25 mg/mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PERINDOPRIL TERT-BUTYLAMINE INDAPAMIDE

Available from:

Glenmark Pharmaceuticals Europe Limited

INN (International Name):

PERINDOPRIL TERT-BUTYLAMINE INDAPAMIDE

Dosage:

4/1.25 mg/mg

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Withdrawn

Authorization date:

2014-09-10

Patient Information leaflet

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DOCUMENT OUTLINE * Perindopril-Indapamide Tablets_Front_V16
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril tert-butylamine/Indapamide Glenmark 4 mg/1.25 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg perindopril tert-butylamine salt, equivalent to 3.338 mg perindopril and 1.25mg indapamide.
Excipient: each tablet contains 58.47mg of lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, rod shaped tablets having ‘PI’ debossed on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension for patients whose blood pressure is not adequately controlled on perindopril alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral use
It is recommended that one Perindopril tert-butylamine/Indapamide Glenmark 2 mg/0.625 mg Tablet is taken daily,
preferably in the morning before a meal. The dose should be adjusted according to the patient profile and blood
pressure response. If blood pressure is not adequately controlled the dose may be increased to one Perindopril tert-
butylamine/Indapamide Glenmark 4 mg/1.25 mg Tablet daily.
When clinically appropriate, direct change from monotherapy with perindopril to Perindopril tert-
butylamine/Indapamide Glenmark may be considered. Individual dose titration with the components may be required.
Elderly (See 4.4)
Treatment should be initiated at a dose of 2 mg/0.625 mg daily with consideration of the blood pressure response and
renal function.
Patients with renal impairment (See 4.3 & 4.4)
In severe renal failure, (creatinine clearance below 30ml/min) treatment is contraindicated.
In patients with moderate renal impairment (creatinine clearance 30 to 60ml/min), it is recommended to start treatment
with the