Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
ENALAPRIL MALEATE
McDermott Laboratories Ltd t/a Gerard Laboratories
20 Milligram
Tablets
2000-10-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Innopril 20mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20mg Enalapril maleate. For excipients, see 6.1 3 PHARMACEUTICAL FORM Tablets. Innopril 20 mg Tablets are peach, arc triangle shaped, biconvex tablets, debossed with “20” over “G" on one side scoreline on the other side. Approximately 9mm long, 9mm wide and 4mm thick. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o Treatment of Hypertension. o Treatment of Symptomatic Heart Failure. o Prevention of Symptomatic Heart Failure in patients with Asymptomatic Left ventricular Dysfunction (ejection fraction 35%). _(See Section 5.1 Pharmacodynamic properties)_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The absorption of Enalapril is not affected by food. The dose should be individualised according to patient profile (see 4.4 Special warnings and 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). Enalapril is 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 medicinal supervision. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Enalapril. A starting dose of 5 mg or lower is recommended in such patients. If Baca dokumen lengkapnya