INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
CLUSIVOL® Tablets

SCHEDULING STATUS:
Unscheduled.

PROPRIETARY NAME
(and dosage form):

CLUSIVOL^® Tablets

COMPOSITION:

Each tablet contains:		Minerals:
Vitamin A	8 000 IU	Elemental iron+	15,0 mg
Vitamin D	400 IU	Calcium+	120,0 mg
Vitamin C	150,0 mg	Manganese+	0,5 mg
Vitamin B1	10,0 mg	Zinc+	0,6 mg
Vitamin B2	5,0 mg	Magnesium+	3,0 mg
Vitamin B6	0,5 mg	+Supplied as ferrous fumarate, calcium
Vitamin B12	2,5µg	carbonate, manganese gluconate, zinc oxide
Niacinamide	50,0 mg	and magnesium oxide.
d-Panthenol	1,0 mg
Vitamin E	0,5 IU

PHARMACOLOGICAL CLASSIFICATION:
Category A,22.1 Multivitamins with minerals.

PHARMACOLOGICAL ACTION:
A dietary supplement.

INDICATIONS:
CLUSIVOL Tablets are indicated as a dietary supplement for the prophylaxis and treatment of iron and the relevant vitamin and mineral deficiency states.

CONTRA-INDICATIONS:
Hypersensitivity to any of the active ingredients.
Iron-containing preparations are contra-indicated in the presence of haemochromatosis, haemosiderosis and haemolytic anaemia.
Not intended for use in patients with pernicious anaemia.

WARNINGS:
Iron overload with increased storage of iron in the tissues (haemosiderosis) may occur as a result of excessive oral and parenteral therapy, or excessively prolonged oral therapy. Patients mistakenly given iron therapy when not suffering from iron-deficiency anaemia are also at risk, as are those with pre-existing iron storage and absorption diseases.

DOSAGE AND DIRECTIONS FOR USE:
12 years and older:
1 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 to the use of the vitamins and trace elements contained in CLUSIVOL Tablets at the recommended dosage levels. However, certain vitamins and trace elements 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, pruritus, 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.
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 the long bones. Symptoms usually clear on withdrawal of 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 D:
Hypervitaminosis D, caused by the administration of excessive amounts of vitamin D over long periods, may occur. Excessive intake may cause hypercalcaemia.
Vitamin D should not be prescribed to patients with hypercalcaemia. It should be administered with caution in infants as they may be more sensitive to its effects. If possible, women who have to take vitamin D, should not breast-feed their infants, as this may lead to hypercalcaemia in the infant. The effects of vitamin D may be reduced in patients receiving barbiturates or anticonvulsants.

Niacinamide:
Flushing, a sensation of heat, faintness, pounding in the head, urticaria, pruritus, 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 renal calcium oxalate calculi. 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:
Long-term administration of large doses of pyridoxine is associated with the development of severe peripheral neuropathies. Pyridoxine reduces the effects of levodopa, but this does not occur if a dopa decarboxylase inhibitor is also given.

Vitamin B₁₂:
It can mask symptoms of subacute degeneration of the spinal cord. Allergic hypersensitivity reactions have been reported following the administration of vitamin B₁₂ compounds, cyanocobalamin and hydrocobalamin. Cyanocobalamin and hydrocobalamin should, if possible, not be given to patients without first confirming the diagnosis, and should not be used to treat megaloblastic anaemia of pregnancy. Administration of doses greater than 10 µg may produce a haematological response in patients with a folate deficiency; indiscriminate use may mask the precise diagnosis. Serum concentrations may be decreased by the concurrent administration of oral contraceptives.

Vitamin E:
Large doses occasionally cause gastro-intestinal disturbances, fatigue and weakness.

Iron:
Gastro-intestinal discomfort, diarrhoea, constipation and vomiting may occur. Side-effects may be reduced by taking the medication with or immediately after food. Stools may become darkened or black in colour. The absorption of iron and tetracyclines is diminished when administered concomitantly. Antacids reduce absorption of iron.
Iron salts should not be given to patients receiving repeated blood transfusions or in anaemias not produced by iron deficiency. Oral and parenteral iron should not be administered concurrently. Care should be taken in administration to patients with gastro-intestinal diseases.

Calcium:
Oral administration may cause gastro-intestinal irritation and constipation. Excessive doses lead to hypercalcaemia. Calcium salts should be given with care to patients with impaired renal function, cardiac disease or sarcoidosis. Calcium enhances the effects of digitalis on the heart and may precipitate digitalis intoxication; calcium salts inhibit absorption of tetracyclines.

Magnesium:
Hypermagnesaemia has been reported after excessive use and in renal insufficiency.

Zinc:
Chelation may occur with tetracycline. Concurrent administration with penicillamine may diminish the effect of the latter substance.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Vitamin A
Acute intoxication is characterised by sedation, dizziness, nausea and vomiting, headache, irritability, papilloedema, erythema, pruritus, 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. Careful monitoring of serum electrolytes is essential throughout therapy.

Calcium:
Excessive use leads to hypercalcaemia. Symptoms may include weakness, nausea, vomiting, constipation, abdominal pain, muscle weakness, thirst, polyuria, drowsiness, confusion, bone pain, renal calculi, and in severe cases; cardiac arrhythmia, coma and cardiac arrest. Calcium therapy must be withdrawn immediately, serum m electrolytes and kidney function determined and intravenous infusion of sodium chloride given, to expand the extracellular fluid. If unsuccessful, calcitonin, the biphosphonates and corticosteroids may be employed.

Iron (Ferrous fumarate):
Symptoms of overdosage include: Epigastric pain, diarrhoea, vomiting and haematemesis. Circulatory collapse may follow. Metabolic acidosis, convulsions, coma, eventual hepatic coma and subsequent death, may occur. Acute liver necrosis may develop. Possible corrosive effects on the gastro-intestinal mucosa, necrosis and perforation may occur, stricture formation may subsequently follow. Patients mistakenly given iron therapy when not suffering from iron-deficiency anaemia, are also at risk as are those with pre-existing iron storage or absorption diseases.

Speed is essential in treating iron poisoning, in order to block absorption from the alimentary tract. In acute poisoning, desferrioxamine, an iron chelating agent, should be given. If not available the stomach should be emptied by emesis and lavage, using a 1 to 5% solution of sodium bicarbonate, leave about 300 mL of the solution in the stomach. Other measures include correction of lost fluids.

Magnesium:
Symptoms include: Flushing of the skin, thirst, hypotension due to vasodilation, drowsiness, loss of tendon reflexes due to neuromuscular blockade, weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest. Fluid deficit and electrolytes must be corrected.

Zinc:
Ingestion of large quantities of zinc is rapidly followed by nausea and vomiting. Due to its corrosive action, it causes a burning sensation in the oesophagus and stomach. Colic and diarrhoea with blood may follow, with convulsions, hypotension, coma and death. Treatment consists of emptying the stomach by aspiration and lavage, and demulcents such as milk or egg white should be given freely. Sodium calcium edetate may be administered. Morphine or pethidine may be given to relieve pain. Fluid and electrolyte balance should be corrected.

GENERAL:
Treatment is symptomatic and supportive.

IDENTIFICATION:
A brown oblong film-coated tablet.

PRESENTATION:
CLUSIVOL 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:
H2382 (Act 101/1965)

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1989

        429–9037
        Davbar Dbn.
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