Calcium sandoz 500 mg - calcium deficiency treatment 20 tablets

Product Description

Prevention and treatment of calcium deficiency.

Indications

Calcium Sandoz contains a rich source of calcium, which is an essential mineral necessary for bone formation and maintenance.

Calcium Sandoz is indicated for the prevention and treatment of calcium deficiency and can be used, together with other medicines, to prevent and treat a condition called osteoporosis (thinning of the bones).

Calcium Sandoz is also used, in addition to vitamin D3, for the treatment of rickets (weakness of growing bones in children) and osteomalacia (weakness of bones in adults). Calcium is absorbed from the intestine and distributed through the blood throughout the body.

Calcium plays an important role in numerous functions in the body. It is essential for nerve, muscle, and heart function, as well as for blood clotting. It is also necessary for the proper functioning of the immune system. Many hormones work properly in the body. To perform these different functions, calcium must be available in adequate concentrations.

Composition

Active ingredients

Each 500 mg effervescent tablet contains: 1,132 mg of calcium lactate gluconate and 875 mg of calcium carbonate (equivalent to 500 mg or 12.5 mmol of calcium). Excipients: 1662 mg of anhydrous citric acid (fine granules), 30 mg of aspartame (E 951), 250 mg of sodium bicarbonate, 30 mg of orange flavouring powder (containing sorbitol (E 420) and dextrose).

Excipients

Anhydrous citric acid (fine granules) Orange flavouring powder (contains: orange essential oils, maltodextrin, gum arabic, sorbitol (E 420), dextrose) Aspartame (E951) Macrogols 6000 Sodium bicarbonate

Directions for use and Dosage

Adults: 500 – 1,500 mg per day Children: 500 – 1,500 mg per day 1,000 mg daily. The effervescent tablets should be dissolved in a glass of water (approximately 200 ml) and the resulting solution drunk immediately. Calcium Sandoz effervescent tablets can be taken with or without food.

Warnings

In patients with mild hypercalciuria (over 300 mg/24 hours or 7.5 mmol/24 hours), or with a history of urinary stones, monitoring of urinary calcium excretion is required. If necessary, the calcium dose should be reduced or therapy should be discontinued. Increased fluid intake is recommended in patients predisposed to urinary tract stone formation. In patients with impaired renal function, calcium salts should be taken under medical supervision with monitoring of serum calcium and phosphate levels. During high-dose therapy, especially when concomitantly treated with vitamin D, there is a risk of hypercalcemia with consequent impairment of renal function. Serum calcium levels should be monitored in these patients, and renal function should be monitored. There have been reports in the literature of a possible increase in aluminum absorption with citrate salts. Calcium Sandoz effervescent tablet (which contains citric acid) should be used with caution in patients with severely impaired renal function, especially those also taking aluminum-containing preparations. Each Calcium Sandoz 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. Calcium Sandoz 500 mg contains 2.967 mmol (corresponding to 68.45 mg) sodium per tablet. Calcium Sandoz 1,000 mg contains 5.95 mmol (corresponding to 136.90 mg) sodium per tablet. Calcium Sandoz 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.

Interactions

Thiazide diuretics reduce urinary calcium excretion. Due to the increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics. Systemic corticosteroids reduce calcium absorption. During concomitant use, the dose of Calcium Sandoz may need to be increased. Tetracycline preparations administered simultaneously with calcium preparations may not be well absorbed. For this reason, preparations containing tetracyclines should be administered at least 2 hours before or 4–6 hours after oral calcium intake. Hypercalcemia resulting from calcium treatment may increase the toxicity of cardiac glycosides. Patients should be monitored for electrocardiogram (ECG) and serum calcium levels. If concomitant oral treatment with bisphosphonates or sodium fluoride is taking place, this preparation should be administered at least 3 hours before taking Calcium Sandoz, as gastrointestinal absorption of both bisphosphonates and sodium fluoride may be reduced. Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains) can inhibit calcium absorption by forming insoluble compounds with calcium ions. Patients should not take calcium-containing products within 2 hours of consuming foods rich in oxalic and phytic acid.

Contraindications

• Hypersensitivity to the active substances or to any of the excipients of the effervescent tablet;
• Pathologies and/or conditions leading to hypercalcaemia and/or hypercalciuria;
• Nephrocalcinosis, nephrolithiasis.

Undesirable effects

Adverse reactions are listed below, according to system organ class and frequency. Frequency is defined as: uncommon (>1/1,000, < 1/100), rare (>1/10,000, < 1/1,000) or very rare (< 1/10,000), including isolated reports. Immune system disorders: Rare: hypersensitivity, such as rash, pruritus, urticaria. Very rare: isolated cases of systemic allergic reactions (anaphylactic reactions, facial edema, angioneurotic edema) have been reported. Metabolism and nutrition disorders: Uncommon: hypercalcemia, hypercalciuria. Gastrointestinal disorders: Rare: flatulence, constipation, diarrhea, nausea, vomiting, abdominal pain.

Overdose

Overdose leads to hypercalciuria and hypercalcemia. Symptoms of hypercalcemia may include nausea, vomiting, thirst, polydipsia, polyuria, dehydration, and constipation. Chronic overdose resulting in hypercalcemia can cause vascular and organ calcification. The threshold for calcium intoxication is from supplements exceeding 2,000 mg per day, taken for many months. Overdose Treatment: In case of intoxication, treatment must be immediately discontinued and fluid deficiencies corrected. In chronic overdose with hypercalcemia, the initial therapeutic phase consists of hydration with saline solution. A loop diuretic (e.g., furosemide) may then be used to further increase calcium excretion and prevent volume overload, but thiazide diuretics should be avoided. In patients with renal insufficiency, hydration is ineffective and they must undergo dialysis. In case of persistent hypercalcemia, contributing factors should be excluded, such as vitamin A or D, hypervitaminosis, primary hyperparathyroidism, malignant tumors, renal insufficiency, or immobilization.

Pregnancy and breastfeeding

The adequate daily intake (including food and supplements) for women with a normal pregnancy and breastfeeding is 1,000–1,300 mg of calcium. During pregnancy, the daily calcium intake should not exceed 1,500 mg. Significant amounts of calcium are secreted into breast milk during breastfeeding but do not cause adverse effects on the newborn. In case of calcium deficiency, Calcium Sandoz effervescent tablets can be used during pregnancy and breastfeeding.

Format

20 tablets