Ergocalciferol Tablets BP 0.25 mg

Vitamin D₂ 11.8 mg equivalent to 10,000 iu of Vitamin D. Ergocalciferol 0.25 mg.

For excipients, see 6.1.

White biconvex sugar coated tablets with white cores.

Simple Vitamin D deficiency

Vitamin D deficiency caused by intestinal malabsorption or chronic liver disease.

Hypocalcaemia of hypoparathyroidism.

In the treatment of Vitamin D deficiency conditions 0.25 mg (10 000 units or one tablet) daily.

Vitamin D deficiency caused by intestinal malabsorption or chronic liver disease usually requires doses of up to 1 mg ( 40,000 iu or 4 tablets) daily in divided doses.

In the treatment of hypoparathyroidism 1.25 mg to 5 mg (50 000 to 200 000 units or 5 to 20 tablets) daily.

The hypocalcaemia of hypoparathyroidism often requires doses of up to 5 mg (200,000 iu or 20 tablets ) daily in divided doses.

Patients with renal osteodystrophy may require as much as 5 mg (200 000 units or 20 tablets) daily.

For children and the elderly the adult dosage may require adjustment according to the severity of the condition.

This medicine is taken by mouth.

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

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 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.

Vitamin D₂ is a steroid derivative which controls the calcification of bones in both the young and old.

Although naturally produced under normal conditions, pharmacological doses are often required in disease states.

Vitamin D₂ is partly esterified during its absorption and is blood borne bound to α₂-globulins and albumin. About ½ of the ingested oral dose is excreted into the bile and lost with the faeces.

Not applicable since ergocalciferol has been used in clinical practice for many years and its effects in man are well known.

Avicel PH 101 (microcrystalline cellulose),

Magnesium Stearate,

Lactose DCL 11,

Acacia,

Sugar,

Talc,

Gelatin,

Titanium Dioxide,

Opaglos AG 7350.

None stated.

36 months.

Store below 25°C in a well closed container protected from light.

1.) Containers having snap-on Polythene lids, with integral tear-off security seals eg Jaycare "securitainer" or Wragby "snap-secure" container containing 100 tablets.

2.) Blister packs of 28 or 50 tablets in cartons which are white folding box board printed on white, the blister comprises 250 micron white rigid UPVC backed by 20 micron hard tempered aluminium foil, bearing a 6-8 gm^-2 vinyl heat seal coating on the inner surface and printed / over lacquered on the reverse.

No special precautions are required.

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE

PL 00039/0545

April 2007

November 2007