Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
vitamin A, vitamin D3, vitamin C, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin PP, folic acid, vitamin B5, calcium phosphate
KRKA d.d.
A11AA03
vitamin A, vitamin D3, vitamin C, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin PP, folic acid, vitamin B5, calcium phosphate
0.35mg+ 0.08mg+ 10mg+ 0.25mg+ 0.3mg+ 0.3mg+ 0.2mg+ 3mg+ 0.04mg+ 1.2mg+ 43mg
pastilles
(30/2x15/) in blister
OTC
Registered
2022-05-03
PI_Text021683_1 – Updated: 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, - 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. PI_Text021683_1 – Updated: Page 2 of 5 Children up to 4 years old. Rare hereditary problems of fructose or galactose intolerance, the Lapp-lactase deficiency, glucose- galactose malabsorption or sucrase-isomaltase deficiency. 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 t Read the complete document