Calcyker

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KALCIKAR (CALCICARE)

Composition:

Active substances: 5 ml of oral suspension contains calcium carbonate 625 mg equivalent to elemental calcium 250 mg, vitamin D3 equivalent to cholecalciferol 125 IU;

Excipients: xanthan gum; sorbitol solution, non-crystallizing (70%); methylparahydroxybenzoate (E 218); propylparahydroxybenzoate (E 216); citric acid monohydrate; disodium edetate; colloidal anhydrous silicon dioxide; glycerin; sodium saccharin; strawberry flavor S-3397; purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical characteristics:

white or almost white suspension with a fruity odor.

Pharmacotherapeutic group. Calcium, combinations with vitamin D3 and/or other agents. ATC code A12AX.

Pharmacological Properties

Pharmacodynamics.

A combination drug that regulates calcium and phosphorus metabolism. It replenishes calcium and vitamin D3 deficiency in the body and is required for tooth mineralization. Calcium is involved in the formation of bone tissue, tooth mineralization, blood coagulation, regulation of nerve conduction and muscle contractions, and maintenance of stable nervous activity.

Administration of calcium and vitamin D3 prevents an increase in the production of parathyroid hormone (PTH), which is a stimulator of enhanced bone resorption (leaching of calcium from bones).

Pharmacokinetics.

Calcium.

Absorption: approximately 30% of the administered dose of calcium is absorbed through the gastrointestinal tract.

Distribution and metabolism: 99% of calcium is concentrated in hard tissues of the body (bones, teeth); 1% remains in intracellular and extracellular environments.

Approximately 50% of calcium in blood exists in the physiologically active ionized form. Nearly 10% is found in complexes with citrates, phosphates, and other anions.

The remaining 40% is bound to proteins, primarily albumins.

Excretion: calcium is excreted in feces, urine, and sweat.

Vitamin D3.

Absorption: vitamin D3 is readily absorbed in the small intestine.

Distribution and metabolism: cholecalciferol and its metabolites circulate in the blood bound to specific globulins. Cholecalciferol is converted in the liver into its hydroxylated active form, 25-hydroxycholecalciferol, and then transformed in the kidneys into 1,25-dihydroxycholecalciferol, which is responsible for enhanced calcium absorption. Unmetabolized vitamin D3 is stored in muscle and adipose tissue.

Excretion: vitamin D3 is excreted in feces and urine.

Clinical characteristics.

Indications.

Treatment and prevention of calcium and vitamin D3 deficiency due to inadequate diet and/or malnutrition; for prevention of osteoporosis and as an adjunct to specific osteoporosis therapy; in conditions of increased body demand for calcium and vitamin D3 during pregnancy or breastfeeding, as well as in children from the age of 1 month.

Contraindications.

Hypersensitivity to any component of the medicinal product, primary or secondary hypercalcemia, marked hypercalciuria or nephrolithiasis, decalcifying tumors such as myeloma, bone metastases, sarcoidosis. The drug is also contraindicated in hyperparathyroidism and severe renal insufficiency. Immobilization-induced osteoporosis. Hypervitaminosis D3. Active phase tuberculosis.

Interaction with other medicinal products and other forms of interaction.

Calcium may enhance the absorption of tetracycline derivatives; therefore, the drug should be taken 3 hours before or 3 hours after administration of the above-mentioned agents.

To prevent reduced absorption of bisphosphonates or sodium fluoride, it is recommended to take the drug no sooner than 2 hours after their administration.

The activity of vitamin D3 may be reduced when used concomitantly with phenytoin or barbiturates.

ECG monitoring and clinical condition assessment are required during concomitant treatment with cardiac glycosides, as calcium preparations may potentiate the therapeutic and toxic effects of cardiac glycosides.

Corticosteroids reduce calcium absorption; therefore, corticosteroid therapy may necessitate an increased dose of the drug.

Concomitant treatment with cholestyramine or laxatives based on mineral or vegetable oil may reduce vitamin D absorption.

Concomitant use of thiazide diuretics increases the risk of hypercalcemia, as they enhance tubular reabsorption of calcium. Conversely, furosemide and other loop diuretics increase renal excretion of calcium.

Concomitant use of calcium may reduce the efficacy of levothyroxine due to decreased absorption. Levothyroxine should be taken at least 4 hours after administration of Calciqker.

Concomitant use of calcium may affect the absorption of quinolone antibiotics. Quinolone antibiotics should be taken 2 hours before or 6 hours after administration of Calciqker.

Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, and strontium ranelate preparations should be taken at least 2 hours before or 2 hours after administration of Calciqker.

Treatment with orlistat may potentially affect the absorption of fat-soluble vitamins (e.g., vitamin D3).

Special precautions for use.

During prolonged treatment with the drug, it is necessary to monitor serum calcium and creatinine levels and kidney function, especially in elderly patients receiving concomitant therapy with cardiac glycosides or thiazide diuretics, and in patients with a high predisposition to dental calculus formation. In case of signs of hypercalcemia or impaired renal function, the dose should be reduced or the drug discontinued.

In patients with mild to moderate renal impairment (commonly observed in elderly individuals) or mild hypercalciuria, periodic monitoring of urinary calcium excretion and plasma calcium levels is required. Additionally, urinary calcium excretion should be monitored in patients with a history of kidney stones to rule out hypercalciuria.

Serum levels of calcium and phosphates should be monitored. The risk of soft tissue calcification should be considered. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol cannot be properly metabolized; therefore, other forms of vitamin D should be used.

To avoid overdose, intake of calcium and vitamin D3 from other sources should be taken into account within the recommended daily allowances for calcium and vitamin D3.

Calciker should be used with caution in patients with sarcoidosis due to the risk of increased metabolism of vitamin D3 into its active form. Serum and urinary calcium levels should be monitored.

Calciker should be used with caution in immobilized patients with osteoporosis due to the risk of developing hypercalcemia. Do not use simultaneously with vitamin supplements containing calcium and vitamin D3.

Foods high in dietary fiber, fats, oxalate-containing foods (such as sorrel, spinach), and phytate-containing foods (cereals) reduce calcium absorption; therefore, an interval of at least 2 hours should be maintained between consumption of such foods and administration of the drug.

Since the formulation contains sorbitol, patients with rare hereditary fructose intolerance should not take this medicinal product. The medicinal product also contains methylparahydroxybenzoate and propylparahydroxybenzoate, which may cause allergic reactions (see section "Adverse reactions*").

Use during pregnancy or breastfeeding.

Pregnancy. The medicinal product Calciker may be used during pregnancy in cases of calcium and vitamin D3 deficiency. Chronic overdose of vitamin D may be harmful to the fetus. To prevent overdose, the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Prolonged use of vitamin D should be avoided due to the possible development of hypercalcemia, which may lead to physical and mental developmental abnormalities, supravalvular and aortic stenosis, and retinopathy in children.

Animal studies have shown that high doses of vitamin D have reproductive toxicity. Pregnant women should avoid overdosing on the drug, as prolonged hypercalcemia may have adverse effects on the fetus. There is no evidence that vitamin D at recommended doses causes teratogenic effects in humans.

Breastfeeding. Chronic overdose of vitamin D3 may be harmful to the newborn.

The drug Calciker may be used during breastfeeding. Calcium, vitamin D3, and its metabolites may pass into breast milk; therefore, intake of calcium and vitamin D3 from other sources into the infant's body should be taken into account.

Ability to influence reaction rate when driving or operating machinery. No effect.

Dosage and Administration

Take orally immediately before or during meals. The package contains a measuring spoon with graduations, where 1 graduation corresponds to 2.5 mL.

For adults in the treatment of osteoporosis: 10 mL 2–3 times daily.

For prevention of calcium and vitamin D3 deficiency due to inadequate diet or impaired nutrition, as well as for prevention of osteoporosis and osteomalacia:

• Adults and children aged 6 years and older – 2.5 mL once daily;
• Children aged 6 months to 6 years – 7.5 mL daily, divided into 3 doses;
• Term infants from 1 to 6 months of age – 7.5 mL daily, divided into 3 doses, previously diluted with milk or boiled water.

Pregnant and breastfeeding women for prevention of osteoporosis – 5 mL twice daily.

Under conditions of increased sun exposure, the above-mentioned doses should be halved.

The duration of Calciker use is determined individually, depending on the clinical situation and daily dosage. Typically, the treatment course lasts 2 months.

Children. May be used in children aged 1 month and older.

Overdose.

The most serious consequence of acute or chronic overdose is hypercalcemia caused by hypersensitivity to vitamin D. Signs of hypercalcemia include anorexia, thirst, nausea, constipation, vomiting, abdominal pain, dizziness, confusion, weakness, muscle weakness, fatigue, headache; bone pain, salt deposition in the kidneys, kidney stone formation, hypercalcemia, hypercalciuria, hypercreatinemia, and in severe cases, cardiac arrhythmias. Severe hypercalcemia may lead to coma and fatal outcome. Polydipsia and polyuria may indicate possible kidney damage.

In patients taking large amounts of calcium and absorbable alkalis, milk-alkali syndrome (food-induced hypercalcemia syndrome), alkalosis, and renal failure may occur. Such patients require hospitalization.

Treatment. Discontinue the medication. Administer large amounts of fluid and follow a diet low in calcium. Therapy with thiazide diuretics and cardiac glycosides should also be discontinued (see section "Interaction with other medicinal products and other types of interactions"). Gastric lavage should be performed in patients with impaired consciousness. Depending on the severity of overdose, treatment may require the use of loop diuretics, bisphosphonates, calcitonin, corticosteroids, either alone or in combination. Serum electrolyte levels, kidney function, and diuresis should be monitored. In severe cases, continuous monitoring of electrocardiogram (ECG) and central venous pressure (CVP) is required.

Side effects.

Immune system disorders: hypersensitivity reactions, including angioneurotic edema, laryngeal edema.

Metabolic disorders: hypercalcemia, hypercalciuria, milk-alkali syndrome (frequent need to urinate, persistent headache, persistent loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcemia, alkalosis, renal failure) – occurs only in cases of overdose (see section "Overdose").

Gastrointestinal disorders: constipation, dyspepsia, flatulence, nausea, abdominal pain, diarrhea.

Skin and subcutaneous tissue disorders: pruritus, rash, urticaria.

Patients with renal insufficiency: possible risk of developing hyperphosphatemia, nephrolithiasis, and nephrocalcinosis (see section "Special precautions").

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 120 ml in a bottle; 1 bottle with a measuring spoon in a cardboard box.

Availability. Over-the-counter.

Manufacturer.

Indoco Remedies Limited.

Manufacturer's address and place of business.

L-14, Verna Industrial Area, Verna, Goa IN-403 722, India.

INSTRUCTIONS

for medical use of medicinal product

CALCICARE

(CALCICARE)

Composition:

Active substances: 5 ml of oral suspension contains calcium carbonate 625 mg equivalent to elemental calcium 250 mg, vitamin D3 equivalent to cholecalciferol 125 IU;

Excipients: xanthan gum; sorbitol solution, non-crystallizing (70%); methylparahydroxybenzoate (E 218); propylparahydroxybenzoate (E 216); citric acid monohydrate; disodium edetate; colloidal silicon dioxide anhydrous; glycerol; sodium saccharin; strawberry flavor S-3397; purified water.

Pharmaceutical form. Oral suspension.

Main physico-chemical properties:

white or almost white suspension with a fruity odor.

Pharmacotherapeutic group. Calcium, combinations with vitamin D3 and/or other agents. ATC code A12AX.

Pharmacological Properties

Pharmacodynamics.

A combined agent that regulates calcium and phosphorus metabolism. It replenishes calcium and vitamin D3 deficiency in the body and is required for tooth mineralization. Calcium is involved in bone tissue formation, tooth mineralization, blood coagulation, regulation of nerve conduction and muscle contractions, and maintenance of stable nervous activity.

Administration of calcium and vitamin D3 prevents increased production of parathyroid hormone (PTH), which is a stimulator of enhanced bone resorption (leaching of calcium from bones).

Pharmacokinetics.

Calcium.

Absorption: approximately 30% of the administered calcium dose is absorbed through the gastrointestinal tract.

Distribution and metabolism: 99% of calcium is concentrated in hard body structures (bones, teeth); 1% remains in intracellular and extracellular environments.

Approximately 50% of calcium in the blood exists in the physiologically active ionized form. Nearly 10% is found complexed with citrates, phosphates, and other anions.

The remaining 40% is bound to proteins, primarily albumins.

Excretion: calcium is excreted in feces, urine, and sweat.

Vitamin D3.

Absorption: vitamin D3 is readily absorbed in the small intestine.

Distribution and metabolism: cholecalciferol and its metabolites circulate in the blood bound to specific globulins. Cholecalciferol is converted in the liver into the hydroxylated active form, 25-hydroxycholecalciferol, and then transformed in the kidneys into 1,25-dihydroxycholecalciferol, which is responsible for enhanced calcium absorption. Unmetabolized vitamin D3 is stored in muscle and adipose tissue.

Excretion: vitamin D3 is excreted in feces and urine.

Clinical characteristics.

Indications.

Treatment and prevention of calcium and vitamin D3 deficiency due to inadequate diet and/or malnutrition; for prevention of osteoporosis and as an adjunct to specific osteoporosis therapy; in cases of increased body requirements for calcium and vitamin D3 during pregnancy or breastfeeding, as well as in children from the age of 1 month.

Contraindications.

Hypersensitivity to any component of the drug, primary or secondary hypercalcemia, marked hypercalciuria or nephrolithiasis, decalcifying tumors such as myeloma, bone metastases, sarcoidosis. The drug is also contraindicated in hyperparathyroidism and severe renal insufficiency. Osteoporosis caused by immobilization. Hypervitaminosis D3. Active phase tuberculosis.

Interaction with other medicinal products and other forms of interaction.

Calcium may enhance the absorption of tetracycline derivatives; therefore, the drug should be taken 3 hours before or 3 hours after taking the above-mentioned agents.

To prevent reduced absorption of bisphosphonates or sodium fluoride, it is recommended to take the drug no sooner than 2 hours after their administration.

The activity of vitamin D3 may be reduced when used concomitantly with phenytoin or barbiturates.

ECG monitoring and clinical condition control are required when treating concomitantly with cardiac glycosides, as calcium preparations may potentiate therapeutic and toxic effects of cardiac glycosides.

Corticosteroids reduce calcium absorption; therefore, corticosteroid therapy may require an increased dose of the drug.

Concomitant treatment with cholestyramine or laxatives based on mineral or vegetable oil may reduce vitamin D absorption.

When used concomitantly with thiazide diuretics, the risk of hypercalcemia increases because they enhance tubular reabsorption of calcium. Conversely, furosemide and other loop diuretics increase renal excretion of calcium.

When used concomitantly with calcium, the efficacy of levothyroxine may be reduced due to decreased absorption. Levothyroxine should be taken at least 4 hours after taking Calciqcer.

Concomitant use of calcium may affect the absorption of quinolone antibiotics. Quinolone antibiotics should be taken 2 hours before or 6 hours after taking Calciqcer.

Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, and strontium ranelate preparations should be taken at least 2 hours before or 2 hours after taking Calciqcer.

Treatment with orlistat may potentially affect the absorption of fat-soluble vitamins (e.g., vitamin D3).

Special precautions for use.

During prolonged treatment with the drug, it is necessary to monitor serum calcium and creatinine levels and kidney function, especially in elderly patients receiving concomitant therapy with cardiac glycosides or thiazide diuretics, and in patients with a high predisposition to dental calculus formation. In case of signs of hypercalcemia or impaired kidney function, the dose should be reduced or the drug discontinued.

In patients with mild to moderate renal impairment (common in elderly individuals) or mild hypercalciuria, periodic monitoring of urinary calcium excretion and plasma calcium levels is required. Additionally, urinary calcium excretion should be monitored in patients with a history of kidney stones to rule out hypercalciuria.

Serum levels of calcium and phosphates should be monitored. The risk of soft tissue calcification should be considered. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol cannot be properly metabolized; therefore, alternative forms of vitamin D should be used.

To avoid overdose, intake of calcium and vitamin D3 from other sources should be taken into account within the recommended daily allowances for calcium and vitamin D3.

Calciker should be used with caution in patients with sarcoidosis due to the risk of increased metabolism of vitamin D3 into its active form. Serum and urinary calcium levels should be monitored.

Calciker should be used with caution in immobilized patients with osteoporosis due to the risk of developing hypercalcemia. Do not use simultaneously with vitamin supplements containing calcium and vitamin D3.

Foods high in dietary fiber and fats, as well as foods containing oxalates (sorrel, spinach) and phytates (cereals), reduce calcium absorption; therefore, an interval of at least 2 hours should be maintained between consumption of such foods and administration of the drug.

Since the formulation contains sorbitol, patients with rare hereditary fructose intolerance should not take this medicinal product. The medicinal product also contains methylparahydroxybenzoate and propylparahydroxybenzoate, which may cause allergic reactions (see section "Adverse reactions*").

Use during pregnancy or breastfeeding.

Pregnancy. The medicinal product Calciker may be used during pregnancy in cases of calcium and vitamin D3 deficiency. Chronic overdose of vitamin D may be harmful to the fetus. To prevent overdose, the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Prolonged use of vitamin D should be avoided due to the risk of hypercalcemia, which may lead to physical and mental developmental abnormalities, subvalvular and aortic stenosis, and retinopathy in children.

Animal studies have shown that high doses of vitamin D have reproductive toxicity. Pregnant women should avoid overdosing on the drug, as prolonged hypercalcemia may have adverse effects on the fetus. There is no evidence that vitamin D at recommended doses causes teratogenic effects in humans.

Breastfeeding. Chronic overdose of vitamin D3 may be harmful to the newborn.

The drug Calciker may be used during breastfeeding. Calcium, vitamin D3, and its metabolites may pass into breast milk; therefore, intake of calcium and vitamin D3 from other sources into the infant's body should be taken into account.

Ability to influence reaction rate when driving or operating machinery. No effect.

Dosage and Administration

The medication is taken orally immediately before or during meals. The package contains a measuring spoon with graduations, where 1 graduation corresponds to 2.5 mL.

For adults, for the treatment of osteoporosis: 10 mL 2–3 times daily.

For the prevention of calcium and vitamin D3 deficiency in case of inadequate diet or impaired nutrition, as well as for the prevention of osteoporosis and osteomalacia:

• Adults and children aged 6 years and older: 2.5 mL once daily;
• Children aged 6 months to 6 years: 7.5 mL daily, divided into 3 doses;
• Full-term infants aged 1 to 6 months: 7.5 mL daily, divided into 3 doses, previously diluted with milk or boiled water.

For pregnant and breastfeeding women, for the prevention of osteoporosis: 5 mL twice daily.

Under conditions of increased sun exposure, the above-mentioned doses should be halved.

The duration of Calciker use is determined individually, depending on the clinical situation and daily dosage. Typically, the treatment course lasts 2 months.

Children. The medication can be administered to children from 1 month of age.

Overdose.

The most serious consequence of acute or chronic overdose is hypercalcemia caused by hypersensitivity to vitamin D. Symptoms of hypercalcemia include anorexia, thirst, nausea, constipation, vomiting, abdominal pain, dizziness, confusion, weakness, muscle weakness, fatigue, headache; bone pain, salt deposition in the kidneys, kidney stone formation, hypercalcemia, hypercalciuria, hypercreatinemia, and in severe cases, cardiac arrhythmias. Severe hypercalcemia may lead to coma and fatal outcome. Polydipsia and polyuria may indicate possible kidney damage.

In patients taking large amounts of calcium and absorbable alkalis, milk-alkali syndrome (also known as absorbable alkali hypercalcemia syndrome), alkalosis, and renal failure may occur. Such patients require hospitalization.

Treatment. Discontinue the medication. Administer large amounts of fluids and follow a diet low in calcium. Discontinue therapy with thiazide diuretics and cardiac glycosides (see section "Interaction with other medicinal products and other forms of interaction"). Gastric lavage should be performed in patients with impaired consciousness. Depending on the severity of overdose, treatment may require the use of loop diuretics, bisphosphonates, calcitonin, and corticosteroids, either alone or in combination. Monitor serum electrolyte levels, kidney function, and diuresis. In severe cases, continuous monitoring of electrocardiogram (ECG) and central venous pressure (CVP) is required.

Side effects.

Immune system side effects: hypersensitivity reactions, including angioneurotic edema, laryngeal edema.

Metabolic side effects: hypercalcemia, hypercalciuria, milk-alkali syndrome (frequent urination, persistent headache, persistent loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcemia, alkalosis, renal failure) — occurs only in cases of overdose (see section "Overdose").

Gastrointestinal side effects: constipation, dyspepsia, flatulence, nausea, abdominal pain, diarrhea.

Skin and subcutaneous tissue side effects: itching, rash, urticaria.

Patients with renal insufficiency: possible risk of developing hyperphosphatemia, nephrolithiasis, and nephrocalcinosis (see section "Special instructions").

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 120 ml in a bottle; 1 bottle with a measuring spoon in a cardboard box.

Availability. Over-the-counter.

Manufacturer.

Next Wave (India),

Manufacturer's address and location of business activity.

Village Rampurghat, Tehsil Paonta Sahib, District Sirmur, Himachal Pradesh, 173025, India