BAYER MULTIVITAMIN & MINERAL FILM COATED TABLETS %v/v Tablets Chewable

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ASCORBIC ACID THIAMINE HYDROCHLORIDE RIBOFLAVIN NICOTINAMIDE CALCIUM PANTOTHENATE PYRIDOXINE HYDROCHLORIDE CYANOCOBALAMIN FOLIC ACID BIOTIN CALCIUM CARBONATE MAGNESIUM CARBONATE MAGNESIUM OXIDE ZINC CITRATE TRIHYDRATE

Available from:

Bayer PLC

INN (International Name):

ASCORBIC ACID THIAMINE HYDROCHLORIDE RIBOFLAVIN NICOTINAMIDE CALCIUM PANTOTHENATE PYRIDOXINE HYDROCHLORIDE CYANOCOBALAMIN

Dosage:

%v/v

Pharmaceutical form:

Tablets Chewable

Authorization status:

Withdrawn

Authorization date:

2008-05-16

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bayer Multivitamin & Mineral Film Coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains:
Ascorbic acid (vitamin C)
500 mg
Thiamine nitrate
14.57 mg
Corresponding to 15 mg thiamine hydrochloride
Riboflavin
15 mg
Nicotinamide
50 mg
Pantothenic acid
23 mg
In form of calcium pantothenate (25 mg)
1)
Pyridoxine hydrochloride
10 mg
Cyanocobalamin
0.01 mg
Folic acid
0.4 mg
Biotin 0.15 mg
Calcium carbonate
244 mg
In form of calcium carbonate
1)
Magnesium carbonate, heavy
122 mg
In form of magnesium carbonate, heavy
2)
Magnesium
115 mg
In form of magnesium oxide, light
2)
Zinc
32 mg
In form of zinc citrate trihydrate
3)
1)
Total calcium content 100 mg
2)
Total magnesium content 100 mg
3)
Total zinc content 10 mg
Excipients:
Lactose
90 mg
as lactose monohydrate
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/02/2009_
_CRN 2061611_
_page number: 1_
3 PHARMACEUTICAL FORM
Film coated tablet.
Oblong, biconvex, light orange or greyish orange, odourless or almost odourless tablet. Size: 19 mm x 8.8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Deficiency and increased requirement of vitamin C and B vitamins.
Deficiency and increased requirement of Zinc.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents: 1 film-coated tablet daily.
The recommended daily dose of one tablet per day must not be exceeded.
This medicinal product is not recommended for children below 11 years.
4.3 CONTRAINDICATIONS
Known allergy or hypersensitivity to the active substances or to any of the excipients in Bayer Multivitamin & Mineral
Film Coated Tablets. Hypercalcemia. Hyper