Ergocalciferol Tablets BP 1.25mg

Ergocalciferol 1.25 mg as Vitamin D₂ (gelatin coated) 62 mg

White biconvex sugar coated tablets

For the treatment of hypocalcaemia caused by of hypoparathyroidism or in patients with renal osteodystrophy.

Adults, Children and Elderly

A dose of 1.25 to 5mg daily is recommended. The dose should be adjusted according to the severity of the condition.

This medicine is delivered by oral administration

Renal insufficiency, Hypercalcaemia, evidence of vitamin D toxicity and metastatic calcification.

Ergocalciferol Tablets BP 1.25mg are unsuitable for use in vitamin D deficiency diseases such as rickets.

Vitamin D should be administered with caution to infants and patients who may have an increased sensitivity to its effects. Use with care in patients with renal impairment, renal calculi or heart disease or arteriosclerosis who might be at increased risk of organ damage if hypercalcaemia were to occur.

All patients receiving pharmacological doses of vitamin D should have their plasma calcium concentration checked at intervals and whenever nausea and vomiting are present.

Patients with rare hereditary problems of galactose intolerance, fructose intolerance, glucose-galactose malabsorption, the Lapp-lactase deficiency or sucrase-isomaltase insufficiency should not take this medicine.

Adequate fluid intake should be maintained.

Phosphate infusions should not be administered to lower hypercalcaemia of hypervitaminosis D because of the dangers of metastatic calcification.

Vitamin D requirements may be increased in patients taking anti-convulsants (e.g. carbamazepine, phenobarbital, phenytoin, and primidone).

Absorption of calcium may be reduced by oral sodium sulphate or parenteral magnesium sulphate.

Concurrent use of Vitamin D analogues and cardiac glycosides may result in cardiac arrhythmias due to hypercalcaemia.

There is an increased risk of hypercalcaemia if vitamin D is administered with thiazide diuretics and calcium.

Pregnancy: There are no adequate data on the use of Ergocalciferol in pregnant women. Ergocalciferol should not be used in pregnancy unless the potential benefit outweighs the potential hazards to the foetus.

Animal studies have shown foetal abnormalities associated with hypervitaminosis D. Calcifediol and calcitriol are teratogenic in animals when given in doses several times the human dose. The offspring of a woman administered 17-144 times the recommended dose of calcitriol during pregnancy manifested mild hypercalcaemia in the first 2 days of life, which returned to normal at day 3.

Lactation : Ergocalciferol is excreted in breast milk in limited amounts. In a mother given large doses of Ergocalciferol, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcaemia in the child. Monitoring of the infants serum calcium is required in such cases. Ergocalciferol should not be administered to breast-feeding mothers.

None documented.

Adverse events are generally associated with excessive intake of ergocalciferol leading to the development of hypercalcaemia. The symptoms of hypercalcaemia can include; anorexia, nausea, vomiting, diarrhoea, loss of weight, headache, polyuria, thirst, vertigo, constipation, fatigue, bone pain, muscle weakness, abdominal pain, mental disturbances, impaired renal function, kidney stones and cardiac arrhythmias.

A single acute overdose is virtually non-toxic and requires supportive treatment with liberal fluids only.

Chronic administration to patients in excess of their daily requirement can cause hypercalcaemia (see Section 4.8 undesirable effects), hypercalciuria and hyperphosphataemia. Concomitant high intake of calcium and phosphate may lead to similar abnormalities.

Treatment of chronic overdose with resulting hypercalcaemia consists of immediate withdrawal of the vitamin, a low calcium diet, and generous fluid intake. Severe cases may require hydration with intravenous saline together with symptomatic and supportive treatment as indicated by the patient's clinical condition. Plasma calcium and U&E's should be monitored.

ATC code : A11CC01.

Ergocalciferol, an oil soluble vitamin, increases the intestinal absorption of dietary calcium and increases the release of calcium from bone. These effects combine to raise the plasma calcium concentration.

Hyperparathyroidism causes a fall in plasma calcium concentration. Large doses of ergocalciferol control plasma calcium levels and is the preferred maintenance therapy of this disease.

Ergocalciferol is well absorbed after oral administration. The half-life is about 960 hours, with protein binding in the blood to alpha and beta-lipoproteins. It is secreted in milk and stored in the liver. Metabolism is by 25 hydroxylation in the liver, followed by hydroxylation at positions 12 or 24 by the kidney. The rate of kidney metabolism is controlled by parathyroid hormone. There is possible conjugation with sulphate or glucuronic acid and decreased absorption may result from impaired liver or biliary function.

Not applicable.

None stated.

36 months

Store below 25° C in a well closed container.

Containers of pigmented polypropylene having snap secure closure of pigmented low density polyethylene, containing 100 tablets.

No special precautions are required.

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE

PL 00039/0546

April 2007

November 2007.