ENAPRIL STADA 20 Milligram Tablets
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
13-06-2024
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Aktiva substanser:
ENALAPRIL MALEATE
Tillgänglig från:
Stada Arzneimittel AG
INN (International namn):
ENALAPRIL MALEATE
Dos:
20 Milligram
Läkemedelsform:
Tablets
Receptbelagda typ:
Product subject to prescription which may be renewed (B)
Bemyndigande status:
Withdrawn
Tillstånd datum:
2012-08-02
Produktens egenskaper
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Enapril Stada 20 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg of enalapril maleate.
Excipients: Contains Lactose Monohydrate 117.8mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round, convex 'snap tab' tablets, scored on one side pale orange in colour with individual white spots.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Treatment of Hypertension.
-
Treatment of Symptomatic Heart Failure.
-
Prevention of Symptomatic Heart Failure in patients with Asymptomatic Left Ventricular Dysfunction (ejection
fraction
≤ 35%).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The absorption of Enapril Stada 2.5mg/5mg/10mg/20mg tablets is not affected by food.
The dose should be individualized according to patient profile (see 4.4 Special warnings and special precautions for
use) and blood pressure response.
Hypertension
The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see
below). Enapril Stada 2.5mg/5mg/10mg/20mg tablets are given once daily. In mild hypertension, the recommended
initial dose is 5 to 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (e.g., renovascular
hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an
excessive blood pressure fall following the initial dose. A starting dose of 5 mg or lower is recommended in such
patients and the initiation of treatment should take place under medical supervision.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating
therapy with enapril. A starting dose
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