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

Logo COMBIVITE® SYRUP

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

COMBIVITE® SYRUP

COMPOSITION:
Each 5 mL contains:
       
Vitamin A        2500,00 I.U.
       
Vitamin B1        1,00 mg
       
Vitamin B6        0,25 mg
       
Vitamin C        37,50 mg
       
Vitamin D        250,00 I.U.
       
Riboflavine Phosphate Sodium        1,50 mg
       
Pantothenol        0,86 mg
       
Nicotinamide        7,50 mg

Preservatives:
        Methyl Hydroxybenzoate        0,020 %m/v
        Propyl Hydroxybenzoate        0,040 %m/v
        Benzoic Acid        0,104 %m/v

PHARMACOLOGICAL CLASSIFICATION:
A 22.1 Multivitamins and Multivitamins with Minerals.

PHARMACOLOGICAL ACTION:
Vitamin supplement.

INDICATIONS:
Indicated as a vitamin supplement where a poor dietary intake of the relevant vitamins exists.

CONTRA-INDICATIONS:
Allergy to any of the ingredients.

WARNINGS:
Do not exceed the recommended dose, as this may cause vitamin toxicity.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
One or two 5 mL medicine measures daily, or as directed by the physician.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Vitamin A :
Absorption 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, anorexia 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 may be severe, and painful swelling over long bones. Symptoms usually clear on withdrawal of vitamin A, but in children premature closure 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 hypercalcaemia 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:
A yellow to orange syrupy, cloudy liquid with an orange flavour and odour.

PRESENTATION:
Packs of 50 mL, 100 mL, 200 mL, 500 mL and 2,5 litres.

STORAGE INSTRUCTIONS:
Store below 25 °C.
Protect from light.
Shake the bottle before use.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
H.2048 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
Co. Reg. No. 92/04769/07
Robbie de Lange Road, Wilsonia, EAST LONDON, 5201
P O Box 422, EAST LONDON, 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11 December 1974

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998