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

Logo COMBIVITE® TABLETS

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

COMBIVITE® TABLETS

COMPOSITION:
Each tablets contains:
       
Vitamin A        5000,0 I.U.
       
Vitamin B1        2,0 mg
       
Vitamin B2        3,0 mg
       
Vitamin B6        0,5 mg
       
Vitamin C        75,0 mg
       
Vitamin D        80,0 I.U.
       
Calcium-D-Pantothenate        ,0 mg
       
Nicotinamide        15,0 mg
        Food
Yeast        113,4 mg

PHARMACOLOGICAL CLASSIFICATION:
A 22.1 Multivitamins and Multivitamins with Minerals.

PHARMACOLOGICAL ACTION:
Vitamin supplement.

INDICATIONS:
Combivite Tablets are indicated as a means of overcoming an all-round dietary vitamin deficiency, thereby strengthening resistance, restoring vitality and ensuring good health. Each tablet contains eight essential vitamins, which are valuable food factors.

Among the more familiar symptoms of a possible vitamin deficiency are the following: reduced resistance to infection; loss of appetite; headaches; dizziness; insomnia; nervousness; lack of concentration and dental decay in children.

In all these cases a regular daily dose of Combivite will correct the deficiencies and supply the vitamins necessary to regain and maintain proper physical and mental health.

WARNING:
Do not exceed the recommended dose, as this may cause vitamin toxicity.

DOSAGE AND DIRECTIONS FOR USE:
One to two tablets 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.

There have been numerous reports of reactions to tartrazine and these cover angioedema, asthma, urticaria, thrombocytopenic purpura, and anaphylactic shock. Cross sensitivity, especially with aspirin, has been reported.

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 every 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:
Orange, sugar-coated tablet.

PRESENTATION:
Packs of 100 and 1000 tablets.

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

APPLICATION NUMBER:
H.2051 (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

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