Pikovit pastilles

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

vitamin A, vitamin D3, vitamin C, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin PP, folic acid, vitamin B5, calcium phosphate

Available from:

KRKA d.d.

ATC code:

առկա չէ (A11B)

INN (International Name):

vitamin A, vitamin D3, vitamin C, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin PP, folic acid, vitamin B5, calcium phosphate

Dosage:

0.35mg+ 0.08mg+ 10mg+ 0.25mg+ 0.3mg+ 0.3mg+ 0.2mg+ 3mg+ 0.04mg+ 1.2mg+ 43mg

Pharmaceutical form:

pastilles

Units in package:

(30/2x15/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2016-12-08

Summary of Product characteristics

PI_Text003432_1
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Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Pikovit pastilles
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pastille contains:
-
0.35 mg - vitamin A palmitate concentrate, synthetic, oily form (1.7
Mio IU/g),
-
0.08 mg - cholecalciferol concentrate (oily form) (1 Mio IU/g)(vitamin
D
3
),
-
10 mg - ascorbic acid (vitamin C),
-
0.25 mg - thiamine mononitrate (vitamin B
1
),
-
0.3 mg - riboflavin (vitamin B
2
),
-
0.3 mg - pyridoxine hydrochloride (vitamin B
6
),
-
0.2 mg - cyanocobalaminum 0.1 % in mannitol (vitamin B
12
),
-
3 mg - nicotinamide,
-
0.04 mg - folic acid,
-
1.2 mg - calcium pantothenate (vitamin B
5
),
-
43 mg - calcium phosphate (anhydrous)
For list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pastilles.
The pastilles are: round, biconvex pastilles, red, yellow, green and
orange coloured.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pikovit pastilles are intended mainly for children:
-
in decreased appetite,
-
in excessive tiredness in school children,
-
in cases of insufficient physical development (growth retardation),
-
as an adjunct after antibiotic therapy,
-
as a dietary vitamin-mineral supplement, especially during winter and
spring.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Children 4 to 6 years of age: 1 pastille 4 times, maximum 5 times, a
day.
Children 7 to 14 years of age: 1 pastille 5 times, maximum 7 times, a
day.
Children should dissolve the pastilles in the mouth.
Pikovit pastilles should be taken for a period of 20 to 30 days. The
course of treatment may be
repeated after 1-3 months or on doctor’s advice.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or any of the excipients.
Hypervitaminosis A and D.
CONFIDENTIAL
Pikovit pastilles
VOL: 1; P: 13 / 80
PI_Text003432_1
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Page 2 of 5
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If a hypersensitivity reaction occurs, the drug should be withdrawn.
Yellow discoloration of the urine may occur due to riboflavin content.
This effect is harmless.
Prior to concomitant