PREGNACARE Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BETACAROTENE COLECALCIFEROL TOCOPHERYL ACID SUCCINATE THIAMINE MONONITRATE RIBOFLAVIN PYRIDOXINE HYDROCHLORIDE CYANOCOBALAMIN PHYTOMENADIONE FOLIC ACID NICOTINAMIDE ASCORBIC ACID FERROUS FUMARATE ZINC SULFATE MAGNESIUM OXIDE POTASSIUM IODIDE COPPER SULPHATE MONOHYDRATE

Available from:

Vitabiotics Limited

INN (International Name):

BETACAROTENE COLECALCIFEROL TOCOPHERYL ACID SUCCINATE THIAMINE MONONITRATE RIBOFLAVIN PYRIDOXINE HYDROCHLORIDE CYANOCOBALA

Pharmaceutical form:

Capsules Hard

Prescription type:

Product not subject to medical prescription

Authorization status:

Withdrawn

Authorization date:

2010-08-25

Summary of Product characteristics

IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0256/005/001
Case No: 2049567
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
VITABIOTICS LIMITED
1 BERESFORD AVENUE, WEMBLEY, MIDDLESEX HA0 1NU, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
PREGNACARE 30 CAPSULES
the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in
the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 11/01/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/08/2010_
_CRN 2049567_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pregnacare 30 Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Dark brown, size 0, hard gelatin capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin and mineral deficiencies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Only one capsule per day with your main meal, with a full glass of water or a cold drink. Not to be
chewed.
Children:
Not recommended.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the constituents.
Ascorbic acid should not be given to patients with hyperoxaluria, reduced renal function or a deficiency of glucose 6-
Betacarotene
4