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HIGH STRENGTH CALCIFEROL TABLETS BP

Active substance(s): VITAMIN D2 850000 IU/G BEADS

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
High Strength Calciferol Tablets BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Vitamin D2 Beads (850,000 IU/G) 13.00 mg per tablet

3

PHARMACEUTICAL FORM
High Strength Calciferol tablets are presented as white, deep convex, sugar
coated
tablets.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of hypoparathyroidism.

4.2

Posology and method of administration
In the treatment of hypoparathyroidism, 5 to 20 tablets daily.
Route of administration : Oral

4.3

Contraindications
High Strength Calciferol Tablets are contra-indicated in hypercalcaemia, metastatic
calcification. Hypersensitivity to High Strength Calciferol or any of the other
ingredients.

4.4

Special warnings and precautions for use



patients being treated with cardioactive glycosides or digitalis as hypercalcaemia
may lead to arrhythmia in such patients
patients with nephrolithiasis

During treatment with Vitamin D serum calcium and serum phosphate should be
monitored regularly especially in children, patients with renal impairment and
patients receiving high doses. To maintain serum phosphate at an acceptable level in
patients with renal bone disease a phosphate binding agent may be used.
Hypercalcaemia may appear in patients treated with Vitamin D, the early symptoms
are as follows:
• polyuria
• polydipsia
• weakness, headache, nausea, constipation
• dry mouth
• muscle and bone pain
• metallic taste
Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium
levels return to normal (in about one week). Vitamin D treatment may then be
restarted at a reduced dose (half the previous dose).

4.5

Interaction with other medicinal products and other forms of interaction
Ingestion of large quantities of aluminium containing antacids such as
aluminium hydroxide may precipitate bile acids in the upper small intestine,
thereby decreasing the absorption of fat soluble vitamins.
Concurrent use of anticonvulsants, barbiturates or primidone with vitamin D,
the effects of the latter may be reduced by accelerating metabolism by hepatic
microsomal enzyme induction; patients on long-term anticonvulsant therapy
may require vitamin D supplementation to prevent osteomalacia.
Concurrent use of calcitonin with vitamin D may antagonise the effects of
calcitonin in the treatment of hypercalcaemia. Concurrent use of thiazide
diuretics with vitamin D may increase the risk of hypercalcaemia.
Concurrent use of vitamin D with high doses of phosphorus containing
preparation may increase the potential for hyperphosphataemia.

4.6

Pregnancy and lactation
Problems in humans have not been documented with intake of normal daily
requirements. However large doses have been associated with fetal
abnormalities in animals. Maternal hypercalcaemia during pregnancy in
humans has been associated with increased sensitivity to effects of vitamin D,
suppression of parathyroid function, or a syndrome of peculiar (elfin) facies,

mental retardation and congenital aortic stenosis in infants. Animal studies
have shown vitamin D to be teratogenic in large doses.
4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
The most frequently reported undesirable effects are hypercalcaemia and various skin
reactions. Hypercalcaemia can be rapidly corrected by stopping treatment until
plasma calcium levels return to normal (about 1 week). Vitamin D treatment may
then be re-started at half the previous dose.
Based on data from post-market use the total undesirable effect ‘reporting rate’ is rare
or very rare being approximately 1:10,000 patients treated.
• Metabolism and Nutrition Disorders
Hypercalcaemia*
Hyperphosphataemia
• Skin and Subcutaneous Tissue Disorders
Pruritus
Rash
Urticaria
• Renal and Urinary Disorders
Nephrocalcinosis
Renal impairment
*Excessive intake may result in hypercalcaemia, the symptoms of which are anorexia,
nausea, vomiting, constipation, abdominal pain, muscle weakness, mental
disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis renal calculi and in
severe cases cardiac arrhythmias and coma.

4.9

Overdose
Overdose with vitamin D results in anorexia, nausea, vomiting, diarrhoea,
weight loss, lassitude, polyuria, profuse sweating, headache, extreme thirst and
vertigo. Calcium and phosphorus concentrations in serum and urine are

increased with calcium depositing in various tissues including the arteries and
kidneys resulting in hypertension and renal failure. The concentration of
cholesterol may also be raised in plasma. The treatment involves withdrawal
of Vitamin D.
Excessive exposure to sunlight should be avoided. Large amounts of fluid is
administered to combat dehydration and reduce renal calcium deposition.
Mild to moderate hypercalcaemia is treated by sodium phosphate by mouth.
More severe hypercalcaemia is treated by intravenous infusion of sodium
phosphate, sodium sulphate, sodium chloride or sodium citrate. Sodium
chloride and sodium sulphate promote calciuresis which can be enhanced by
concomitant administration of frusemide or ethacrynic acid. This treatment
should be used with care in patients with impaired renal or cardiac function.
Disodium edetate can also be used but renal damage can occur with high
doses. Calcitonin and corticosteroids are effective in reducing serum calcium
concentration in a variety of hypercalcaemic states.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Calciferol is an antirachitic substance obtained from ergosterol, a sterol
present in fungi and yeasts by ultraviolet irradiation. Calciferol takes slightly
longer to act than dihydrotachysterol and its effects last longer. It has
cumulative action and dosage must be carefully controlled. The effects of
changes in dosage may not be apparent for about 6 weeks. It is necessary for
the absorption of calcium and phosphate from the gastro-intestinal tract and
for their transport. Deficiency results in rickets in children and osteomalacia
in adults and is a factor in the production of tetany.

5.2

Pharmacokinetic properties
Calciferol is absorbed through the gastro-intestinal tract. The presence of bile
is essential for adequate absorption. It is hydroxylated in the liver to 25 hydroxyergocalciferol the most abundant form in the circulation; it is

subjected to enterohepatic circulation and is hydroxylated to 1,25 dihydroxyergocalciferol in the renal tubule cells, this production being
regulated by the concentration of 1,25 - dihydroxyergocalciferol, parathyroid
hormone, calcium phosphate and prolactin in the circulation.
1,25 - dihydroxyergocalciferol is the active metabolite of vitamin D and is
considered to be hormonal.
Vitamin D and its metabolites are bound to specific plasma proteins. Poor
absorption may occur in persistent diarrhoea, steatorrhoea and biliary
obstruction and therefore the dosage may need to be increased in these
conditions.
It is advisable to monitor serum-calcium concentrations during treatment with
Vitamin D.
Vitamin D compounds and their metabolites are excreted mainly in the bile
and faeces with minute quantities appearing in urine.
Certain Vitamin D substances may be excreted into breast milk.

5.3

Preclinical safety data
Not applicable

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose BP
Lactose Powder BP
Maize Starch BP
Sucrose Powder BP
Acacia Powder BP
Pregelatinised Maize Starch BP
Syrup BP

Potable Water
Magnesium Stearate BP
Coating Varnish
Talc BP
Standard Coating Cream
Titanium dioxide (E171)

6.2

Incompatibilities
None

6.3

Shelf life
2 years

6.4

Special precautions for storage
Store below 25°C.
Protect from light and moisture.
Keep out of the reach of children.

6.5

Nature and contents of container
The product is packed in opaque plastic containers in pack sizes of 28, 30, 42,
50, 56, 60, 84, 90, 100, 112, 250, 500,1000 and bulk tablets.

Opaque plastic containers composed of either high density polypropylene or
high density polyethylene with a tamper evident or child resistant tamper
evident closure composed of high density polyethylene in all pack sizes (28,
30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500, 1000 and bulk).
Packing Inclusion: Standard Polyether foam or Polyethylene or
Polypropylene made filler..
Blister packs of aluminium /opaque PVC. It is subsequently packed in printed
boxboard cartons in pack sizes of 28, 30, 56, 60, 84, 90, and 112.

6.6

Special precautions for disposal
No special instructions for use/handling.

7

MARKETING AUTHORISATION HOLDER
Auden Mckenzie Limited
Mckenzie Street
Ruislip
HA4 7TL
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 17507/0170

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/09/1981 / 04/02/2010

10

DATE OF REVISION OF THE TEXT
09/10/2012

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Source: Medicines and Healthcare Products Regulatory Agency

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