Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
enalapril (enalapril maleate), hydrochlorothiazide
KRKA d.d.
C09BA02
enalapril (enalapril maleate), hydrochlorothiazide
10mg+ 25mg
tablets
(20/2x10/) in blister
Prescription
Registered
2017-02-10
VOL:
I;P:
_110/475_
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Đọc toàn bộ tài liệu
PI_Text005187_1 – Updated: Page 1 of 18 1. NAME OF THE MEDICINAL PRODUCT Enap ® -H 10 mg/25 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Enap-H 10 mg/25 mg tablet contains 10 mg enalapril maleate, which is equivalent to 7.64 mg enalapril, and 25 mg hydrochlorothiazide. Excipients: lactose 114.02 mg quinolone yellow (E104) 0.06 mg sodium 5.1 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Enap-H 10 mg/25 mg tablets: yellow, round, flat, scored on one side with beveled edges. The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arterial hypertension (patients for whom the combination therapy is prescribed). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The drug is intended for oral treatment. The dosage of the drug is based primarily on the experience with its active substance enalapril maleate. The usual dose is one tablet once daily. If required, the dose may be increase to two tablets once daily. For most patients, 20 mg (exceptionally 40 mg) enalapril maleate or 50 mg hydrochlorothiazide a day is sufficient; therefore, not more than two Enap-H 10 mg/25 mg tablets a day are recommended. If no satisfactory response is achieved, addition of a second drug or changed therapy is recommended (see sections 4.3, 4.4, 4.5 and 5.1). _Prior diuretic therapy_ Symptomatic hypotension may occur following the initial dose of the drug; this is more likely in patients who are volume and/or salt depleted as a result of prior diuretic therapy. The diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with Enap-H 10 mg/25 mg. _Dosage in renal insufficiency_ Thiazide diuretics may not be appropriate for patients with renal impairment. They are ineffective in patients with creatinine clearance values of 0.5 ml/s or less (i.e. moderate and severe renal insufficiency). CONFIDENTIAL Enap-H 10 mg/25 mg tablet, Enap-HL 10 mg/12.5 mg tablet VOL: 1; P: 44 / 792 PI_Text005187_1 – Updated: Page 2 of 18 In pat Đọc toàn bộ tài liệu