Enalapril-H tablets

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

enalapril (enalapril maleate), hydrochlorothiazide

זמין מ:

Arpimed LLC

קוד ATC:

C09BA02

INN (שם בינלאומי):

enalapril (enalapril maleate), hydrochlorothiazide

כמות:

10mg+ 25mg

טופס פרצבטיות:

tablets

יחידות באריזה:

(20/2x10/) in blister

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2019-11-05

מאפייני מוצר

SUMMARY PRODUCT CHARACTERISTIC (SPC)
ENALAPRIL – H
TABLETS
1.1 BRAND NAME – ENALAPRIL-H
1.2 INTERNATIONAL NON-PROPERTY NAME - ENALAPRIL / HYDROCHLOROTHIAZIDE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
active ingredients: enalapril maleate – 10 mg, hydrochlorothiazide
– 25 mg.
_For a full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM
White biconvex scored odorless tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Enalapril – H (enalapril and hydrochlorothiazide) is indicated for:
• Treatment of essential hypertension in patients for whom this
combination therapy is appropriate.
In using Enalapril – H consideration should be given to the risk of
angioedema (see Special warnings
and precautions for use).
Enalapril – H is not indicated for initial therapy. Patients in whom
enalapril and diuretic are initiated
simultaneously can develop symptomatic hypotension (see Interaction
with other medicinal products
and other forms of interaction).
Patients should be titrated on individual drugs. If the fixed
combination represents the dose and dosing
frequency determined by this titration, the use of Enalapril – H may
be more convenient in the
management of patients. If during maintenance therapy dosage
adjustment is necessary it is advisable
to use the individual drugs.
_GERIATRICS (> 65 YEARS OF AGE):_
See
Posology and method of administration
_PEDIATRICS (< 18 YEARS OF AGE):_
Enalapril – H is not recommended in this age group.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSING CONSIDERATIONS
1. DOSAGE MUST BE INDIVIDUALIZED.
2. THE FIXED COMBINATION IS NOT FOR INITIAL THERAPY.
3. THE DOSE OF ENALAPRIL – H SHOULD BE DETERMINED BY THE TITRATION
OF THE INDIVIDUAL COMPONENTS.
4. SPECIAL ATTENTION FOR DIALYSIS PATIENTS.
5. THE SPLITTING OF ENALAPRIL – H 10 MG/25 MG TABLETS IS NOT
ADVISED.
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
Once the patient has been successfully titrated with the individual
components as described below,
Enalapril – H may be substituted