SANDOCAL 1000 TAB
Calcium lactate gluconate 2263mg Calcium carbonate 1750mg (equivalent to 1000 mg or 25 mmol of calcium). Pack quantity: 30
USES: Prevention and treatment of calcium deficiency Pack quantity: 30
Therapeutic indications
- Prevention and treatment of calcium deficiency
- Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis
- Rickets and osteomalacia, in addition to vitamin D3 therapy
Posology and method of administration
Adults and children: 1000mg per day.
The effervescent tablets should be dissolved in a glass of water (approx. 200 ml) and drunk immediately. Sandocal 1000 effervescent tablet may be taken with or without food.
Contraindications
- Hypersensitivity to the active substances or to any of the excipients of the effervescent tablet
- Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
- Nephrocalcinosis, nephrolithiasis
Special warnings and precautions for use
For patients with mild hypercalciuria (exceeding 300 mg/24 hours or 7.5 mmol/24 hours), or with a history of urinary calculi, monitoring of calcium excretion in the urine is required. If necessary, the calcium dose should be reduced or therapy should be discontinued. An increased fluid intake is recommended for patients prone to formation of calculi in the urinary tract.
In patients with impaired renal function, calcium salts should be taken under medical supervision with monitoring of calcium and phosphate serum levels.
During high dose therapy and especially during concomitant treatment with vitamin D, there is a risk of hypercalcaemia with subsequent kidney function impairment. In these patients serum calcium levels should be followed and renal function should be monitored.
There have been literature reports alluding to possible increased absorption of aluminium with citrate salts. Sandocal 1000 effervescent tablet (which contains citric acid) should be used with caution in patients with severely impaired renal function, especially those also receiving aluminium-containing preparations.
Each Sandocal 1000 effervescent tablet contains aspartame, a source of phenylalanine equivalent to 15 mg/dose, and may be harmful for people with phenylketonuria.
Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.
Sandocal 1000 contains 5.95 mmol (corresponding to 136.90 mg) of sodium per tablet.
Sandocal 1000 effervescent tablets should be kept out of the reach of children.
Information for diabetics:
One effervescent tablet contains 0.002 Carbohydrate Units and is therefore suitable for diabetics.
Interaction with other medicinal products and other forms of interaction
Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Sandocal 1000.
Tetracycline preparations administered concomitantly with calcium preparations may not be well-absorbed. For this reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium.
Cardiac glycoside toxicity may increase with hypercalcaemia resulting from treatment with calcium. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.
If an oral bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of Sandocal 1000 since gastrointestinal absorption of either oral bisphosphonate or sodium fluoride may be reduced.
Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble compounds with calcium ions. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.
Pregnancy and lactation
The adequate daily intake (including food and supplementation) for normal pregnant and lactating women is 1000-1300 mg calcium.
During pregnancy, the daily intake of calcium should not exceed 1500 mg. Significant amounts of calcium are secreted in milk during lactation but do not cause any adverse effects to the neonate.
Sandocal 1000 effervescent tablets can be used during pregnancy and lactation in case of a calcium deficiency
Effects on ability to drive and use machines
Sandocal 1000 has no influence on the ability to drive and use machines.
Undesirable effects
Immune system disorders:
Rare: Hypersensitivity, such as rash, pruritus, urticaria.
Very rare: Isolated cases of systemic allergic reactions (anaphylactic reaction, face oedema, angioneurotic oedema) have been reported
