Krajina: Arménsko
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
enalapril (enalapril maleate), hydrochlorothiazide
Arpimed LLC
C09BA02
enalapril (enalapril maleate), hydrochlorothiazide
10mg+ 25mg
tablets
(20/2x10/) in blister
Prescription
Registered
2019-11-05
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 Prečítajte si celý dokument