SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Calcium and Ergocalciferol Tablets.

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains calcium lactate pentahydrate 300 mg, calcium phosphate 150 mg and ergocalciferol 400i.u

For excipients, see 6.1.

3.    PHARMACEUTICAL FORM

The product is presented in the form of a white, circular, normal convex tablet, engraved with Company logo on one side and A021 on the other.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment of calcium and vitamin D deficiency.

4.2 Posology and Method of Administration

Route of administration.: Oral Dosage - adults

Normal deficiency = One tablet daily.

Severe deficiency = As directed by the physician.

Children =As directed by the physician.

Do not use during late pregnancy, breast feeding or in the elderly without medical advice.

4.3 Contra-indications

Hypersensitivity to any of the ingredients listed above.

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

Hypercalcaemia, hypercalciuria, renal calculi, renal function impairment, sarcoidosis, hypoparathyroidism.

4.4 Special warnings and precautions for use

Risk-benefit should be considered in the following medical conditions: dehydration, electrolyte imbalance, diarrhoea or chronic gastro-intestinal malabsorption.

Hypercalcaemic effect should be borne in mind when prescribing these tablets and the role of the liver and kidney on the different forms of vitamin D.

Extreme care should be exercised to ensure that correct dosage is delivered to infants.

4.5 Interaction with Other Medicaments and other Forms of Interaction

Concurrent use with:

-    excessive amounts of alcohol, caffeine or tobacco decreases calcium absorption.

-    fibre, oxalates, phytates may reduce calcium absorption.

-    calcitonin may antagonise the effect of calcitonin in the treatment of hypercalcaemia.

-    other calcium and magnesium-containing medications may increase serum calcium or

magnesium concentrations leading to hypercalcaemia or hypermagnesemia respectively.

-    cellulose sodium phosphate may decrease effectiveness of cellulose sodium phosphate.

-    oestrogens or oestrogen-containing oral contraceptives may increase calcium absorption.

-    thiazides may result in hypercalcaemia.

-    etidronate may prevent absorption of etidronate.

-    iron supplements will decrease the absorption of iron.

-    phenytoin decreases the bioavailability of both phenytoin and calcium.

-    potassium phosphates or potassium and sodium phosphates may increase the potential for

deposition of calcium in soft tissues if serum ionized calcium is high.

-sodium fluoride may cause them to complex and inhibit absorption of both

fluoride and

calcium.

-    oral tetracyclines may decrease absorption of tetracyclines.

-    more than 5,000 iu Vitamin A per day may stimulate bone loss and counteract the effects

of calcium supplementation.

large doses of Vitamin D especially calcifediol and calcitriol may increase intestinal

absorption of calcium, increasing risk of chronic hypercalcaemia.

- Vitamin D activity may be reduced in patients taking barbiturates or

anticonvulsants

concomitantly.

4.6    Pregnancy and Lactation

The tablets should be used in only the second and third trimester of pregnancy but not in lactation as it may cause hypercalcaemia in the infant, since calcium is excreted in the breast milk.

In the neonate problems in nursing babies have not been documented.

4.7    Effects on Ability to Drive and Use Machines

None known.

4.8    Undesirable effects

Undesirable effects are more likely if larger than recommended doses are taken, if taken for a longer period of time or if taken by patients with renal function impairment. Constipation, drowsiness, headache, loss of appetite, unusually dry mouth, tiredness or weakness are early signs of hypercalcaemia.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9    Overdose

Late signs of hypercalcaemia are confusion, high blood pressure, increased thirst, irritability, irregular or slow heart beat, mental depression, muscle or bone pain, nausea and vomiting, frequency of urination.

Nausea, vomiting, depression and headache may occur, stop medication.

Large amounts of fluid should be administered to combat dehydration and reduce renal calcium deposition.

Severe hypercalcaemia should be actively treated.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties CALCIUM

Calcium is essential for the functional integrity of the nervous, muscular, and skeletal systems. It plays a role in normal cardiac function, renal function, respiration, blood coagulation, and cell membrane and capillary permeability. Also, calcium helps to regulate the release and storage of neurotransmitters and hormones, the uptake and binding of amino acids, absorption of Vitamin B12 and gastrin secretion. The calcium of bone is in a constant exchange with the calcium of plasma. Since the metabolic functions of calcium are essential for life, when there is a disturbance in the calcium balance because of dietary deficiency or other causes, the stores of calcium in bone may be depleted to fill the body’s more acute needs.

ERGOCALCIFEROL

Ergocalciferol is an antirachitic substance obtained from ergosterol by ultraviolet irradiation. It 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 six 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 CALCIUM

Approximately one-fifth to one-third of orally administered calcium is absorbed in the small intestine, depending on the presence of Vitamin D metabolites, pH in lumen, amount of protein in diet, and on dietary factors, such as calcium binding to fibre, phytates or oxalates.

80% of calcium is eliminated in faeces, and small amounts are excreted in the urine, varying directly with degree of calcium absorption.

ERGOCALCIFEROL

Ergocalciferol is absorbed through the gastro intestinal tract and is hydroxylated in the liver to 25-hydroxycholecalciferol, the most abundant form in the circulation. It is subjected to enterohepatic circulation and is hydroxylated to 1 ,25-dihydroxycholecalciferol in the renal tubule cells, this production being regulated by the concentration 1,25-dihydroxycholecalciferol, parathyroid hormone, calcium phosphate and prolactin in the circulation. 1 ,25-dihydroxycholecalciferol is the active metabolite of Vitamin D and is considered to be hormonal.

The metabolism of ergocalciferol has been less extensively studied than that of cholecalciferol but is believed to be similar. Vitamin D 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.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Active ingredient Ergocalciferol preparation containing:

Butylated Hydroxytoluene

Sucrose

Gelatin

Triglycerides, Medium Chain Modified Maize Starch Sodium Aluminium Silicate

Other tablet ingredients:

Lactose Maize Starch Talc

Magnesium Stearate

6.2 Incompatibilities

None

6.3    Shelf life

3 years

6.4    Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light

and moisture.

6.5    Nature and contents of container

The product may be packed in the following containers:

1.    Opaque plastic containers composed of polypropylene tubes and

polyethylene tamper evident closures in pack sizes of 28, 30, 42, 50, 56, 60,

84, 90, 100, 112, 250, 500 and 1000 tablets.

2.    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 with a packing inclusion of standard polyether foam or polyethylene or polypropylene filler in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000 tablets.

3.    Blister packs of aluminium/opaque PVC in pack sizes of 28, 30, 56, 60,

84, 90 and 112 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No specific instructions for use/handling

7    MARKETING AUTHORISATION HOLDER