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