INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo COMPLENATAL FF CAPSULES

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

COMPLENATAL FF CAPSULES

COMPOSITION:
Each capsule contains:
Ferrous sulphate (dried) 150,0 mg Riboflavine 5,0 mg
Calcium gluconate 350,0 mg Pyridoxine HCl 25,0 mg
Folic acid 0,5 mg Cyanocobalamin 5,0 mcg
Sodium fluoride 1,0 mg Nicotinamide 15,0 mg
Ascorbic acid 50,0 mg Calcium pantothenate 5,0 mg
Vitamin A acetate 4000 IU Vitamin D 400 IU
Thiamine mononitrate 5,0 mg 

PHARMACOLOGICAL CLASSIFICATION:
22.1.2 Vitamins for prenatal use.

PHARMACOLOGICAL ACTION:
Provides a supplementary source of essential vitamins and minerals during pregnancy and lactation.

INDICATIONS:
Vitamin-mineral supplements especially adapted for use during pregnancy and lactation.

CONTRA-INDICATIONS:
None known.

WARNINGS
KEEP OUT OF REACH OF CHILDREN
Excess fluoride intake may be harmful.

DOSAGE AND DIRECTIONS FOR USE:
1 capsule daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Do not exceed the recommended dose as this may cause vitamin toxicity. The iron may have a tendency to cause constipation which is easily corrected by the use of a mild laxative.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
With overdosage, Hypervitaminosis A (weakness, fatigue, irritability, anorexia, nausea, vomiting and other gastro-intestinal disturbances etc.) and Hypervitaminosis D (anorexia, lassitude, nausea and vomiting, diarrhoea, headache, extreme thirst, vertigo etc.) may occur. Treatment is supportive with immediate withdrawal of the product.

IDENTIFICATION:
Size 0 hard gelatin capsule, light yellow body, light blue cap, filled with speckled granules having a characteristic odour.

PRESENTATION:
Packs of 30 and 90 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H.2468 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmaceutical Enterprises (Pty) Ltd
Howard Studios, Howard Drive, Pinelands 7405

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 1993

Current: March 2004
Source: Pharmaceutical Industry

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