Enap-HL tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

enalapril (enalapril maleate), hydrochlorothiazide

Available from:

KRKA d.d.

ATC code:

C09BA02

INN (International Name):

enalapril (enalapril maleate), hydrochlorothiazide

Dosage:

10mg+ 12,5mg

Pharmaceutical form:

tablets

Units in package:

(20/2x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-02-10

Patient Information leaflet

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Summary of Product characteristics

PI_Text005185_1
– Updated:
Page 1 of 18
1.
NAME OF THE MEDICINAL PRODUCT
Enap
®
-HL 10 mg/12.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Enap-HL 10 mg/12.5 mg tablet contains 10 mg enalapril maleate and
12.5 mg
hydrochlorothiazide.
Excipients:
lactose
123.58 mg
sodium
1.4 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Round, flat, white, one-side scored tablets with bevelled 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
and shall always be individual for each patient.
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-HL 10 mg/12.5 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-HL 10 mg/12.5 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).
In patients with creatinine clearance between 0.5 ml/s and 1.3 ml/s,
treatment should be started with a
suitable dose of individual active substances.
CONFIDENTIAL
Enap-H 10