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

Logo CLUSIVOL® CHEW TABLETS

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

CLUSIVOL® CHEW TABLETS

COMPOSITION:
Each tablet contains:
Vitamin A 5 000 IU
Vitamin D 400 IU
Vitamin C 45,0 mg
Vitamin B1 1,5 mg
Vitamin B2 1,5 mg
Vitamin B6 1,0 mg
Niacinamide 15,0 mg
Contains no TARTRAZINE.

PHARMACOLOGICAL CLASSIFICATION:
Category A, 22.1 Multivitamins.

PHARMACOLOGICAL ACTION:
A dietary supplement.

INDICATIONS:
CLUSIVOL CHEW TABLETS is a dietary supplement for the prophylaxis and treatment of the relevant vitamin deficiency states.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE:
Children of 4 years and older: One Chew Tablet daily or as directed by a doctor.
Do not exceed the recommended dosage.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
There are no known side-effects with the use of the vitamins contained in CLUSIVOL CHEW TABLETS at the recommended dosage level. However, certain vitamins do exert toxicity in massive doses - refer below and to KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT.

Vitamin A:
Hypervitaminosis A, caused by the administration of excessive amounts of vitamin A over long periods, is characterised by fatigue, irritability, anorexia, loss of mass, vomiting and other gastro-intestinal tract disturbances, low-grade fever, polyuria, hepatosplenomegaly, pruritis, loss of hair, cracking and bleeding lips, dry skin, hyperkeratosis, and yellow pigmentation. Anaemia, headache, and visual disturbances may occur. These symptoms usually disappear rapidly on withdrawal of vitamin A. Subcutaneous swelling, pains in bones and joints, and tenderness over the long bones commonly occur. In children, premature closure of the epiphyses of the long bones may result in arrested bone growth.

Vitamin D:
Hypervitaminosis D, caused by the administration of excessive amounts of vitamin D over long periods, may occur. Excessive intake may cause hypercalcaemia.

Niacinamide:
Flushing and dryness of the skin, urticaria, pruritis, furunculosis, other skin lesions, abdominal cramps diarrhoea, nausea and vomiting, malaise, anorexia, activation of peptic ulcer, amblyopia, jaundice and impairment of liver function, decrease in glucose tolerance, mild diabetes and hyperuricaemia may occur. Most of these effects subside on withdrawal of niacinamide. It should be given cautiously to patients with a history of peptic ulceration.

Vitamin C:
Large doses may cause diarrhoea and the formation of calcium oxalate renal stones. Doses of 600 mg or more daily have a diuretic action. Vitamin C should be administered with care to patients with hyperoxaluria. Tolerance may be induced in patients taking high doses.

Vitamin B6:
It reduces the effects of levodopa.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Vitamin A:
Acute intoxication is characterised by sedation, headache, irritability, papilloedema, and generalised peeling of the skin.

Vitamin D:
Symptoms of overdosage are anorexia, lassitude, nausea, vomiting, diarrhoea, mass loss, polyuria, sweating, headache, extreme thirst and vertigo. Calcium and phosphorous levels in serum and urine are raised, followed by hypertension and renal failure. Vitamin D therapy must be withdrawn immediately, and large quantities of fluid and electrolytes given. Concomitant administration of furosemide promotes urinary calcium excretion. Low calcium diet to be given and non-exposure to sunlight ensured.

Generally:
Treatment is symptomatic and supportive.

IDENTIFICATION:
Orange, round, biconvex tablets with an orange flavour.

PRESENTATION:
CLUSIVOL CHEW TABLETS are presented in securitainers of 30 tablets.

STORAGE INSTRUCTIONS:
To be kept tightly closed and stored in a cool (below 25°C) dry place.
Keep out of reach of children.

REFERENCE NUMBER:
H2377 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
AKROMED PRODUCTS
Electron Avenue, ISANDO, 1600
Trademark and product, under licence from
WYETH-AYERST LABORATORIES, U.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4 October 1993
        587-9246
        Davbar Dbn

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