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

Logo PRELAFAL FORTE® Tablets

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

PRELAFAL FORTE® Tablets

COMPOSITION:
Each tablet contains:     Minerals: 
Vitamin A 6 000 I.U.   Ferrous fumarate 200,0 mg
Vitamin D 400 I.U.   Calcium carbonate praec. 500,0 mg
Thiamine mononitrate 3,0 mg   Sodium iodide 88,0 µg
Riboflavine 3,0 mg   Manganese sulphate 1,5 mg
Pyridoxine hydrochloride 3,0 mg   Potassium sulphate 5,6 mg
Niacinamide 20,0 mg   Sodium molybdate 0,25 mg
dl-Panthenol 4,0 mg   Zinc sulphate 1,37 mg
Ascorbic acid 100,0 mg   Magnesium oxide 5,0 mg
Folic acid 2,0 mg   Cupric hydroxide 0,806 mg
Vitamin B12 2,0 µg   Calcium fluoride 31,0 µg
PHARMACOLOGICAL CLASSIFICATION:
Category A,22.1 Multivitamins with minerals.

PHARMACOLOGICAL ACTION:
PRELAFAL FORTE is a vitamin-mineral dietary supplement containing those vitamins and minerals known to be essential for basic prenatal nutrition and to prevent iron deficiency anaemia during pregnancy and/or lactation.

INDICATIONS:
1. PRELAFAL FORTE Tablets are indicated as a basic dietary supplement.
2. As a prophylactic treatment of the relevant vitamin and mineral deficiency states during pregnancy and/or lactation.
CONTRA-INDICATIONS:
Sensitivity to any of the ingredients.
Not to be used by persons who are allergic to iodine.
Iron-containing preparations are contra-indicated in the presence of haemochromatosis, haemosiderosis and haemolytic anaemia. Not intended for use in patients with pernicious anaemia.
Potassium salts are not to be used in patients with gastro-intestinal ulceration or obstruction.

WARNINGS:
There is evidence that a daily intake of Vitamin A in excess of 10 000 IU is potentially teratogenic.
Excess fluoride intake can be harmful.
Excessive doses of iron preparations are toxic, especially in children. 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:
Twelve years and older:
1 tablet daily, or as directed by a doctor.
Do not exceed the recommended dosage - refer “WARNINGS”.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Vitamin A:
Hypervitaminosis A, caused by the administration of excessive amounts of vitamin A over long periods, is characterized 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 the 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 large doses of 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.

Pyridoxine hydrochloride (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.

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.

Ascorbic acid (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. Ascorbic acid should be administered with care to patients with hyperoxaluria. Tolerance may be induced in patients taking high doses.

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.

Ferrous fumarate (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 incolour. 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 iron storage and absorption diseases and with gastro-intestinal diseases. See “WARNINGS”for details on iron overload.

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.

Sodium iodine (Iodine):
Hypersensitivity, or iodism, include metallic taste, increased salivation, burning or pain, coryza; swelling and inflammation of the throat. The eyes may be irritated and swollen. Pulmonary oedema may develop. Acneform skin eruptions or ioderma, gastro-intestinal upsets and diarrhoea may also occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Vitamin A:
Acute intoxication is characterized by sedation, dizziness, nausea and vomiting, headache, irritability, papilloedema, erythema, pruritus, and generalized 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 phosphorus 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 should be given and non-exposure to sunlight ensured. Careful monitoring of serum electrolytes is essential throughout therapy.

Ferrous fumarate (Iron):
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.

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 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.

Sodium iodide (Iodine):
The symptoms of acute poisoning are mainly due to its corrosive effect on the gastro-intestinal tract. Anuria may occur 1 to 3 days later; death may be due to circulatory failure; oedema of the glottis result in asphyxia, aspiration pneumonia or pulmonary oedema. Oesophageal stricture may develop if the patient survives the acute stage. The fatal dose is usually about 2 to 3 g.

GENERAL:
Treatment is symptomatic and supportive.

IDENTIFICATION:
PRELAFAL FORTE is a round, mauve, film-coated tablet.

PRESENTATION:
PRELAFAL FORTE Tablets are presented in securitainers of 30 and 100 tablets.

STORAGE INSTRUCTIONS:
Keep tightly closed, store in a cool (below 25°C) dry place.
Keep out of reach of children.

REFERENCE NUMBER:
H2379 (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:
November 1989

        24740 AG310
        Davbar Dbn.

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