Skopryl Combo tablets

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

lisinopril (lisinopril dihydrate),amlodipine (amlodipine besilate)

Disponibil de la:

Alkaloid AD Skopje

Codul ATC:

C09BB03

INN (nume internaţional):

lisinopril (lisinopril dihydrate),amlodipine (amlodipine besilate)

Dozare:

20mg+ 10mg

Forma farmaceutică:

tablets

Unități în pachet:

(30/2x15/) in blister, (90/6x15/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2021-08-19

Caracteristicilor produsului

Skopryl
®
Combo 10 mg/5 mg; 20 mg/10 mg and 20 mg/5 mg tablets
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Skopryl
®
Combo 10 mg/5 mg tablets
Skopryl
®
Combo 20 mg/10 mg tablets
Skopryl
®
Combo 20 mg/5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Skopryl Combo 10 mg/5 mg tablets
Each tablet contains 10 mg of lisinopril (as dihydrate) and 5 mg of
amlodipine (as besilate).
Skopryl Combo 20 mg/10 mg tablets
Each tablet contains 20 mg of lisinopril (as dihydrate) and 10 mg of
amlodipine (as besilate).
Skopryl Combo 20 mg/5 mg tablets
Each tablet contains 20 mg of lisinopril (as dihydrate) and 5 mg of
amlodipine (as besilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Skopryl Combo 10 mg/5 mg tablets
Round, white to off white, flat tablets with diameter of 8.00 ± 0.15
mm, with facet and break mark on one
side, debossed with “L A” on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Skopryl Combo 20 mg/10 mg tablets
Round, white to off white, biconvex tablets with diameter of 11.00 ±
0.15 mm, with break mark on one
side, debossed with “L A 2” on the other side.
The tablet can be divided into equal doses.
Skopryl Combo 20 mg/5 mg tablets
Round, white to off white, biconvex tablets with diameter of 11.00 ±
0.15 mm, with break mark on one
side, debossed with “L A 1” on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Skopryl Combo is indicated as substitution therapy of adult patients
with blood pressure adequately
controlled with lisinopril and amlodipine given concurrently at the
same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one tablet daily. The maximum daily dose is
one tablet.
In general, fixed dose combination