Skopryl plus tablets

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

lisinopril (lisinopril dihydrate), hydrochlorothiazide

Verfügbar ab:

Alkaloid AD Skopje

ATC-Code:

C09BA03

INN (Internationale Bezeichnung):

lisinopril (lisinopril dihydrate), hydrochlorothiazide

Dosierung:

20mg+ 12,5mg

Darreichungsform:

tablets

Einheiten im Paket:

(20/2x10/) and (30/3x10/) in blister

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2019-12-11

Fachinformation

Skopryl plus

20 mg/12.5 mg tablets
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Skopryl plus
®
20 mg/12.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate
21.78 mg) and 12.5 mg
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Round, biconvex, ochre-violet tablets with bisection line on one side.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the management of mild to moderate hypertension in patients who
have been stabilised on
the individual components given in the same proportions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
ADULTS
Essential hypertension: The usual dosage is 1 tablet, administered
once daily. If necessary, the
dosage may be increased to 2 tablets, administered once daily.
Dosage in renal insufficiency: Thiazides may not be appropriate
diuretics for use in patients
with renal impairment and are ineffective at creatinine clearance
values of 30 ml/min or below
(i.e. moderate or severe renal insufficiency).
Skopryl Plus is not to be used as initial therapy in any patient with
renal insufficiency.
In patients with creatinine clearance of >30 and <80 ml/min, Skopryl
Plus may be used, but
only after titration of the individual components.
Skopryl plus

20 mg/12.5 mg tablets
Summary of Product Characteristics
2
Prior diuretic therapy:
Symptomatic hypotension may occur following the initial dose of
Skopryl Plus: this is more
likely in patients who are volume and/or salt depleted as a result of
prior diuretic therapy. If
possible, the diuretic therapy should be discontinued for 2-3 days
prior to initiation of therapy
with lisinopril alone, in a 2.5 mg dose.
USE IN THE ELDERLY
Lisinopril was equally effective in elderly (65 years or older) and
non-elderly hypertensive
patients. In elderly hypertensive patients, monotherapy