Calinate is recommended as a supplementary source of calcium when normal requirements are high and in the correction of calcium deficiency in the diet. They can be used in osteoporosis therapy as an adjunct to more specific conventional treatments. Calinate tablets can be used as a phosphate binding agent in the management of renal failure

Oral

Adults, elderly and children

Dietary deficiency and as an adjunct in osteoporosis therapy; 2 tablets per day, preferably one tablet each morning and evening

For use in binding phosphate in the management of renal failure in patients on renal dialysis, the dose should be adjusted for the individual patient and is dependent on the serum phosphate level

The tablets should be swallowed whole and taken just prior to, during or immediately following a meal

Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure untreated by renal dialysis. Hypersensitivity to any of the tablet ingredients Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria

Urinary calcium excretion should also be measured. In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria

With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5mmol/24 hours Allowances should be made for calcium and vitamin D supplements from other sources. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine

The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcaemia must be avoided in digitalized patients

The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium

Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium

Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone and tetracycline antibiotics or iron. It is advisable to allow a minimum period of four hours before taking the calcium

Calcium absorption is reduced in patients receiving systemic corticosteroid therapy. This should be taken in to account when patients are receiving concomitant therapy

During pregnancy and lactation treatment with Calcinate should be under the direction of a physician. During pregnancy and lactation, requirements for calcium are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources. If Calcinate and iron supplements are both required to be administered to the patient, they should be taken at different times (see Section 4.5

None known

The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhea

To report any side effects

- National Pharmacovigilance and Drug Safety Center (NPC)

• Fax: +966-11-205-7662
• To call the executive management of vigilance and crisis management: +966-11-2038222 ext.: 2353 – 2356 – 2317 – 2354 – 2334 – 2340
• Toll-free: 8002490000
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc

Overdosage may cause gastro-intestinal disturbances but would not be expected to cause hypercalcaemia except in patients treated with excessive doses of vitamin D. Treatment should be aimed at lowering serum calcium levels through a high fluid intake and low calcium diet.I In severe cases treatments with corticosteroid and other specialist treatment may be necessary

Alkalosis is a potential but rare risk

Calcium carbonate is a well-established medicinal material and is used extensively for supplementation in deficiency states. Calcium carbonate is also widely used as an antacid

The pharmacokinetic profiles of calcium and its salts are well known. Calcium carbonate is converted to calcium chloride by gastric acid. Calcium is absorbed to the extent of about 15-25% from the gastrointestinal tract while the remainder reverts to insoluble calcium carbonate and calcium stearate, and is excreted in the faeces

Calcium carbonate is a well-known and widely used material and has been used in clinical practice for many years. As such toxicity is only likely to occur in chronic overdosage where hypercalcaemia could result

Povidone K30
Microcrystalline Cellulose PH101
Crospovidone
Microcrystalline Cellulose PH102
Sodium Lauryl Sulphate
Croscarmellose Sodium
Magnesium Stearate
Film Coating : Hypromellose

Not applicable

3 years

Store below 30°C

Keep in the original package to protect from light & moisture

Polypropylene Tracer pack with HDPE cap containing 60 tablets and Transparent PVC-PVDC film/Aluminum foil blister pack of 10 Tablets

No special conditions