MULTIVITAMIN SYRUP S.F. 100

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

MULTIVITAMIN SYRUP S.F. 100

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

MULTIVITAMIN SYRUP S.F. 100

COMPOSITION:
Each 5 mL contains:

	Vitamin A	3,000 I.U.
	Vitamin B1	3,000 mg
	Riboflavine Phosphate Sodium	1,425 mg
	Vitamin B6	0,250 mg
	Vitamin C	50,000 mg
	Vitamin D	400 I.U.
	Pantothenol	0,860 mg
	Nicotinamide	10,000 mg
	Flavoured base to	5,000 mL
	Preservatives:
	Benzoic Acid	0,10% m/v
	Propyl Hydroxybenzoate	0,04% m/v
	Methyl Hydroxybenzoate	0,02% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 22.1 Multivitamins and multivitamins with minerals.

PHARMACOLOGICAL ACTION:
Multivitamin supplement where a poor dietary intake of the relevant vitamins exists.

INDICATIONS:
In vitamin deficiencies.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Pantothenol is contra-indicated in haemophiliacs and in patients with ileus due to mechanical obstruction.

WARNINGS:
Excessive doses of Vitamin A should be avoided in pregnancy because of potential teratogenic effects. Lactating women should not take vitamin D if possible, as this may lead to the development of hypercalcaemia in the infant.

DOSAGE AND DIRECTIONS FOR USE:
One medicine measure daily, or as directed by the physician. Do not exceed recommended dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Vitamin A: Absorbtion of vitamin A from the gastro-intestinal tract may be reduced by the presence of neomycin, cholestyramine, or liquid paraffin; absorption may also be impaired in cholestatic jaundice and fat-malabsorption conditions.
Vitamin B6: Reduces the effects of levodopa.
Vitamin C: Large doses may cause diarrhoea and other gastro-intestinal disturbances and are associated with the formation of renal calcium oxalate calculi. Vitamin C should be given with care to patients with hyperoxaluria. Tolerance may be induced with prolonged use of large doses.
Vitamin D: Should not be administered to patients with hypercalcaemia, and be given with caution to infants, as they may have increased sensitivity to its effects. The effects of Vitamin D may be reduced in patients taking barbiturates or anticonvulsants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Vitamin A: Excessive amounts over long periods can lead to toxicity, known as hypervitaminosis A, characterised by fatigue, irritability and loss of weight, vomiting and other gastro-intestinal disturbances, low-grade fever, hepatosplenomegaly, skin changes, alopecia, dry hair, cracking and bleeding lips, anaemia headache, hypercalcaemia, subcutaneous swelling, and pains in bones and joints. Symptoms of chronic toxicity in children may also include raised intracranial pressure and papilloedema mimicking brain tumours, tinnitus visual disturbances which ma be severe, and painful swelling over the long bones. Symptoms usually clear on withdrawal of vitamin A, but in children premature close of the epiphyses of the long bones may result in arrested bone growth. Acute vitamin A intoxication may occur with very high doses and is characterised by sedation, dizziness, nausea and vomiting, erythema, pruritus and desquamation.
Vitamin B6: Long-term administration of large doses of pyridoxine is associated with the development of severe peripheral neuropathies.
Vitamin D: Excessive intake of vitamin D leads to the development of hyper-calcaemia which is characterised by anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, renal calculi, and in severe cases cardiac arrhythmias and coma.

IDENTIFICATION:
Yellow syrupy, cloudy mixture.

PRESENTATION:
Bottles of 100 mL and 200 mL.

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

APPLICATION NUMBER:
H2022 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
South African Druggists Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

30.08.90

M951