Descrizione Clinica
CALCIUM SANDOZ COMPRESENT EFFERENCES
active ingredients
Each 500 mg effervescent tablet contains: 1.132 mg of calcium gluconate and 875 mg of calcium carbonate (equivalent to 500 mg or 12.5 mmol of calcium). Excipients with known effects: Each 500 mg effervescent tablet contains 30 mg of aspartame (E 951), 68.45 mg of sodium (2.98 mmol), 30 mg of orange aroma powder (containing 630 micrograms of sorbitol (E 420), 180 nanograms of benzilic alcohol, 210 nanograms of sulphur dioxide (E 220) and 13,08 mg of glucose). Each 1,000 mg effervescent tablet contains: 2.263 mg of calcium gluconate and 1.750 mg of calcium carbonate (equivalent to 1,000 mg or 25 mmol of calcium). Excipients with known effects: Each effervescent tablet of 1000 mg contains) 30 mg of aspartame (E 951), 136,90 mg of sodium (5.95 nmol), 30 mg of orange aroma powder (containing 630 micrograms of sorbitol (E 420), 180 nanograms of benzilic alcohol, 210 nanograms of sulphur dioxide (E220) and 13,08 mg of glucose). For the full list of excipients, see paragraph 6.1.
Excellent
Citric acid anidro (fine granulate); Orange aroma powder (contains: benzyl alcohol, sorbitol (E 420), glucose and sulfur dioxide (E 220)); Aspartame (E951); Macrogol 6000; Sodium bicarbonate.
Therapeutic indications
- Prevention and treatment of calcium deficiency. - Calcium supplementation as a supplement to specific therapy in the prevention and treatment of osteoporosis. - Rachythism and osteomalacia, in addition to vitamin D3 therapy.
Contraindications
- Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1 of the effervescent tablet. - Pathologies and/or conditions that involve hypercalcemia and/or hypercalciuria. - Nephrocyccinosis, nephrolysis.
Population
Adults: 500 - 1,500 mg per day. Children: 500 - 1,000 mg per day. The effervescent tablets must be dissolved in a glass of water (about 200 ml) and the solution obtained to drink immediately. The effervescent tablet of Calcium Sandoz can be taken with or without food.
Conservation
Keep the pipe tight. Store in the original packaging.
Warnings
In patients with mild hypercalciuria (over 300 mg/24 hours or 7.5 mmol/24 hours), or with a history of urinary stones, it is required to monitor calcium excretion in the urine. If necessary, the calcium dose must be reduced or the therapy must be stopped. An increase in fluid in patients prepared for the formation of stones in the urinary tract is recommended. In patients with kidney function impairment, calcium salts must be taken under medical control with monitoring of serum levels of calcium and phosphate. In the course of high dose therapy and especially in case of concomitant treatment with vitamin D, there is a risk of hypercalcemia resulting in impairment of kidney function. In these patients the serum levels of calcium must be kept under control and the kidney function must be monitored. There have been reports from literature that refer to a possible increase in aluminum absorption with citrate salts. The effervescent tablet of Calcium Sandoz (which contains 1662.00 mg (500 mg tablets) or 3323.0 mg (1000 mg tablets) of citric acid) should be used with caution in patients with severely compromised kidney function, especially in those who also take preparations containing aluminum. This medicine contains aspartame, sodium, sorbitol, benzyl alcohol, sulphur dioxide and glucose. This medicine contains 630 micrograms of sorbitol (E 420) per tablet. This medicine contains 2.98 mmol (corresponding to 68.45 mg) of sodium per effervescent tablet, equivalent to 3.4% of the maximum daily intake recommended by the WHO of 2 g sodium for an adult. This medicine contains 180 nanograms of benzilic alcohol in each tablet. Benzyl alcohol can cause allergic reactions. The intravenous administration of benzyl alcohol has been associated with severe adverse events and death in infants (agonal breathing syndrome). It is not known the slightest amount of benzile alcohol for which toxicity is manifested. Increased risk due to accumulation in small children. High voltages should be used with caution and only if necessary, especially in pregnant or breastfeeding patients and in subjects with liver or kidney failure due to the risk of accumulation and toxicity ( metabolic acidosis). This drug contains 210 nanograms of sulphur dioxide which can rarely cause serious reactions of hypersensitivity and bronchospasm. This medicine contains 30 mg of aspartame in each effervescent tablet. Aspartame is a source of phenylalanine and can be harmful to people with phenylketonuria. This medicine contains glucose. Patients suffering from rare problems of glucose-galactose mal absorption should not take this medicine. It can also be harmful to teeth. Calcium Sandoz 1000 mg contains aspartame, sodium, sorbitol, benzyl alcohol, sulphur dioxide and glucose. This medicine contains 630 micrograms of sorbitol (E 420) in each tablet. This medicine contains 5.95 mmol (corresponding to 136,90 mg) of sodium per tablet equivalent to 6.9% of the maximum daily intake recommended by the WHO of 2 g sodium for an adult. This medicine contains 180 nanograms of benzilic alcohol in each tablet. Benzyl alcohol can cause allergic reactions. The intravenous administration of benzyl alcohol has been associated with severe adverse events and death in infants (agonal breathing syndrome). It is not known the slightest amount of benzile alcohol for which toxicity is manifested. Increased risk due to accumulation in small children. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney failure due to the risk of accumulation and toxicity ( metabolic acidosis). This drug contains 210 nanograms of sulphur dioxide which can rarely cause serious reactions of hypersensitivity and bronchospasm. This medicine contains 30 mg of aspartame in each effervescent tablet. Aspartame is a source of phenylalanine and can be harmful to people with phenylchetonuria. This medicine contains glucose. Patients suffering from rare problems of glucose-galactose mal absorption should not take this medicine. It can also be harmful to teeth. Calcium Sandoz effervescent tablets should be kept out of the reach of children. Information for Diabetics: An effervescent tablet contains 0.002 carbohydrates and is therefore suitable for diabetics.
Interactions
Tiazide diuretics reduce urinary excretion of calcium. Due to the increased risk of hypercalcemia, serum calcium must be regularly monitored during the concomitant use of thiazide diuretics. Systemic corticosteroids reduce calcium absorption. During concurrent use, it may be necessary to increase the dose of Calcium Sandoz. Prepared based on tetracycline administered simultaneously to 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 can increase the toxicity of heart glycosides. Patients should be monitored with regard to electrocardiogram (ECG) and calcium serum levels. In case of oral treatment concurrent with biphosphonates or fluoride sodium, this preparation should be administered at least 3 hours before taking Calcium Sandoz, as gastrointestinal absorption of both biphosphonates and fluoride sodium may be reduced. Oxalic acid (present in spinach and rhubarb) and phytic acid (present in whole grains) can inhibit calcium absorption through the formation of insoluble compounds with calcium ions. Patients should not take calcium-containing products within 2 hours of taking foods rich in oxalic and phytic acid.
Effects
The adverse reactions are shown below, according to the systemic organic classification and frequency. The frequency is defined as: not common (>1/1.000, rare (>1/10.000, very rare (Disorders of the immune system. Rare: hypersensitivity, such as rash, itching, hives. Very rare: isolated cases of systemic allergic reactions were reported (anaphylactic reactions, facial edema, anjourotic edema). Disorders of metabolism and nutrition. . Not common: hypercalcemia, hypercalciuria. Gastrointestinal disorders. . Rare: flatulence, constipation, diarrhea, nausea, vomiting, abdominal pain. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any adverse reaction suspects the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 additions that exceed 2,000 mg per day, taken for many months. Treatment of overdose In case of intoxication, the treatment must be immediately interrupted and the lack of liquid must be corrected. In case of chronic overdose in which hypercalcemia is present, the initial therapeutic phase consists of hydration with saline solution. Thus, an anaesthetic diuretic (e.g. furosemide) can be used to further increase calcium excretion and to prevent a volume overload, but thiazide diuretics must be avoided. In patients with kidney failure, hydration is ineffective and must undergo dialysis. In case of persistent hypercalcemia, factors such as vitamin A or D, hypervitaminosis, primary hyperparathyroidism, malignant tumors, kidney failure or immobilization must be excluded.
The appropriate daily contribution (including food and integration) for women with normal pregnancy and nursing, is of 1.000-1.300 calcium mg. During pregnancy, the daily calcium intake must not exceed 1,500 mg. Significant amounts of calcium are secreted in breast milk during lactation but do not cause adverse effects to the newborn. In case of calcium deficiency, Calcium Sandoz effervescent tablets can be used during pregnancy and nursing.
Source: Farmadati
