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

Logo NATRODALE HALIBUT LIVER OIL CAPSULES

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

NATRODALE HALIBUT LIVER OIL CAPSULES

COMPOSITION:
Each capsule contains:
  Vitamin A         5000 iu
  Vitamin D         150 iu
  in natural fish liver oil. 

PHARMACOLOGICAL CLASSIFICATION:
22.1.4 Vitamins –other.

PHARMACOLOGICAL ACTION:
Vitamin A is essential for normal vision, in dim light and for the integrity of epithelial cells. Deficiency may give rise to night-blindness and skin changes with a lowered resistance to minor skin infections, inflammation of the gums and pyorrhoea.
Vitamin D is necessary for the absorption of calcium and phosphate from the gastro-intestinal tract and for their transport. Deficiency of Vitamin D is associated with the occurrence of rickets in children and osteomalacia in adults.

INDICATIONS:
Supplementary Vitamins A and D together are indicated when the intake of these fat-soluble vitamins is low or impaired. Poor absorption may occur in persistent diarrhoea, steatorrhoea and billiary obstruction. Supplementary Vitamin D is indicated for the prevention of rickets due to Vitamin D deficiency.

CONTRA-INDICATIONS:
None in the recommended dose range.

WARNINGS:
None

DOSAGE AND DIRECTIONS FOR USE:
One capsule to be taken twice a day with meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
There are no known side effects at normal dosage.

KNOWN SYMPTOMS OF OVER-DOSAGE AND PARTICULARS OF ITS TREATMENT:
Hypervitaminosis A may be caused by the taking of excessive amounts of Vitamin A over long periods. It is characterised by fatigue, irritability, anorexia, and loss of weight, vomiting and other gastro-intestinal disturbances, low-grade fever, polyuria, hepatosplenomegaly, pruritus, loss of hair, cracking and bleeding lips, and dry skin with peeling, hyperkeratosis and yellow pigmentation. Anaemia, headache and visual disturbances have also been reported. 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. Intercranial hypertension and papilloedema mimicking brain tumours, have been reported, usually in children. Acute Vitamin A intoxication may occur with very high doses and is characterised by sedation, headache, irritability, papilloedema, and generalised peeling of the skin. Hypervitaminosis D shows in anorexia, lassitude, nausea, vomiting, diarrhoea, loss of weight, polyuria, profuse sweating, headache, extreme thirst, and vertigo; the calcium and phosphorus concentrations of serum and urine are increased and calcium may be deposited in many tissues including the arteries and kidneys, which may lead to hypertension and renal failure; the cholesterol concentration of plasma may be increased. Symptoms will subside on cessation of treatment.

CONDITIONS OF REGISTRATION:
None

IDENTIFICATION:
Clear, straw-coloured oval capsules.

PRESENTATION:
Packs of 125 and 300 capsules

STORAGE INSTRUCTIONS:
Store in a cool, dry place.

APPLICATION NUMBER:
T1050 (Act 101 of 1965)

APPLICANT:
Vitalfarm, (Pty) Limited, Kuils River, C.P.

DATE OF PUBLICATION:
September 1985.

Updated on this site: December 1999

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