Calcium D3 Actavis (Tablets) Instructions for Use

Marketing Authorization Holder

Actavis Group hf. (Iceland)

Manufactured By

Actavis Indonesia, Pt. (Indonesia)

ATC Code

A12AX (Calcium preparations in combination with vitamin D and/or other drugs)

Dosage Forms

	Calcium D3 Actavis	Chewable tablets (chocolate): 30 pcs.
		Chewable tablets (mint): 30 pcs.

Dosage Form, Packaging, and Composition

Mint chewable tablets are round, white in color, marked “ALPHARMA” on one side, with a characteristic minty odor.

Excipients: mannitol, povidone K90, aspartame, lactose, povidone (K-30), mint flavor, magnesium stearate, talc.

30 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.

Chocolate chewable tablets are round, brown in color, marked “ALPHARMA” on one side, with a characteristic chocolate odor; inclusions may be present.

Excipients: mannitol, aspartame, povidone K90, lactose, cocoa bean powder, vanillin, chocolate brown color, chocolate flavor, magnesium stearate, talc.

30 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Calcium-phosphorus metabolism regulator

Pharmacological Action

A combined drug that regulates the metabolism of calcium and phosphorus in the body.

It reduces resorption and increases bone density, replenishing the deficiency of calcium and vitamin D₃ in the body. It is necessary for the mineralization of teeth and bones.

Calcium
Regulator of calcium-phosphorus metabolism. It replenishes calcium deficiency in the body, normalizes the electrolyte balance of calcium and phosphorus.

Calcium is involved in the regulation of nerve conduction, muscle contractions and is a component of the blood coagulation system.

Colecalciferol (Vitamin D3)
Regulator of calcium-phosphorus metabolism, enhances the absorption of calcium ions (Ca²⁺) and phosphates in the intestine (by increasing the permeability of cellular and mitochondrial membranes of the intestinal epithelium) and their reabsorption in the renal tubules of the kidneys; promotes bone mineralization, enhances the ossification process, and is necessary for the normal functioning of the parathyroid glands.

Pharmacokinetics

Absorption is rapid (in the distal part of the small intestine), enters the lymphatic system, reaches the liver and the systemic circulation.

In the blood, it binds to alpha₂-globulins and partially to albumin. It accumulates in the liver, bones, skeletal muscles, kidneys, adrenal glands, myocardium, and adipose tissue.

The time to reach maximum concentration in tissues is 4-5 hours, then the concentration of the drug decreases somewhat, remaining constant for a long time.

In the form of polar metabolites, it is localized mainly in the membranes of cells and microsomes, mitochondria, and nuclei. It crosses the placental barrier and passes into breast milk. It is deposited in the liver.

It is metabolized in the liver and kidneys: in the liver, it is converted into an inactive metabolite calcifediol (25-dihydroxycholecalciferol); in the kidneys, calcifediol is converted into an active metabolite calcitriol (1,25-dihydroxycholecalciferol) and an inactive metabolite 24,25-dihydroxycholecalciferol.

It undergoes enterohepatic recirculation.

Vitamin D and its metabolites are excreted in the bile, a small amount – by the kidneys. It accumulates in the body.

Calcium is absorbed in ionized form in the proximal part of the small intestine via an active, vitamin D-dependent transport mechanism.

Indications

Replenishment of calcium and vitamin D₃ deficiency in the body, especially during periods of increased demand

• Childhood during periods of intensive growth;
• Old age;
• Menopause period;
• Pregnancy and lactation.

ICD codes

Dosage Regimen

For adults and children over 12 years of age, take 1 tablet once a day to replenish calcium and vitamin D₃ deficiency.

During pregnancy and lactation, the dosage is 1 tablet once a day.

Chew or swallow the tablet whole; administration with a meal may improve tolerability.

Do not exceed the recommended daily dose.

For geriatric patients, ensure total daily calcium intake does not exceed 1.5 g and vitamin D₃ intake is between 500-1000 IU from all sources.

Avoid concomitant use within 2 hours of consuming foods high in oxalates (sorrel, spinach) or phytic acid (cereals) to prevent reduced calcium absorption.

Do not use with other vitamin complexes containing calcium and/or vitamin D₃ due to the risk of overdose.

Monitor plasma calcium and creatinine levels periodically during long-term therapy.

Discontinue use and consult a physician if calciuria exceeds 7.5 mmol/day (300 mg/day).

This product contains aspartame, a source of phenylalanine; it is contraindicated in patients with phenylketonuria.

Adverse Reactions

From the digestive system: decreased appetite, constipation or diarrhea, flatulence, epigastric pain, nausea.

From the urinary system: polyuria, impaired renal function.

Other: allergic reactions; hypercalcemia, hypercalciuria, headache, myalgia, arthralgia, increased blood pressure, arrhythmias, exacerbation of the tuberculous process in the lungs.

Contraindications

• Hypersensitivity to the components of the drug;
• Hypercalcemia (including as a result of primary or secondary hyperparathyroidism);
• Hypercalciuria;
• Nephrolithiasis;
• Active form of tuberculosis;
• Hypervitaminosis of vitamin D3;
• Concomitant use with other vitamin complexes containing calcium and vitamin D3;
• Decalcifying tumors (myeloma, bone metastases, sarcoidosis);
• Osteoporosis due to prolonged immobilization;
• Phenylketonuria (contains aspartame);
• Severe chronic renal failure;
• Children under 12 years of age;
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

With caution: pregnancy and lactation period.

Use in Pregnancy and Lactation

The daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Hypercalcemia developing due to overdose during pregnancy can cause defects in the mental and physical development of the child.

Vitamin D and its metabolites can pass into breast milk, so the intake of calcium and vitamin D from other sources in the mother and child must be taken into account.

Use in Renal Impairment

Contraindicated in severe chronic renal failure.

Pediatric Use

Contraindicated in children under 12 years of age.

Geriatric Use

Approved for use. In elderly people, the requirement for Ca²⁺ is 1.5 g/day, for vitamin D3 – 0.5-1 thousand IU/day.

Special Precautions

During treatment, it is necessary to constantly monitor the excretion of Ca²⁺ in the urine and the concentration of Ca²⁺ and creatinine in plasma (if calciuria appears, exceeding 7.5 mmol/day (300 mg/day), it is necessary to reduce the dose or stop taking the drug).

It contains aspartame, which is metabolized in the body to phenylalanine, which must be taken into account in patients with phenylketonuria.

To avoid overdose, additional intake of vitamin D3 from other sources must be taken into account. Do not use simultaneously with vitamin complexes containing Ca²⁺ and vitamin D3. The drug should not be taken within 2 hours after consuming sorrel, spinach, or cereals.

In elderly people, the requirement for Ca²⁺ is 1.5 g/day, for vitamin D3 – 0.5-1 thousand IU/day.

Effect on ability to drive vehicles and operate machinery

The drug does not affect the speed of psychomotor reactions when driving and working with machinery.

Overdose

The following symptoms are possible in case of overdose: thirst and polyuria (as signs of chronic renal failure), decreased appetite, nausea, vomiting, constipation, dizziness, weakness, headache, fainting, coma; with long-term use: calcification of blood vessels and tissues.

Laboratory parameters in case of overdose: hypercalciuria, hypercalcemia (Ca²⁺ in plasma about 2.6 mmol/l).

Treatment: rehydration, “loop” diuretics, glucocorticosteroids (GCS), calcitonin, bisphosphonates, hemodialysis.

Drug Interactions

Consumption of foods containing oxalates (sorrel, spinach) and phytic acid (cereals) reduces the absorption of calcium.

In case of hypervitaminosis D, the effect of cardiac glycosides may be enhanced and the risk of their toxicity may increase, including an increased risk of arrhythmia due to the development of hypercalcemia (adjustment of the cardiac glycoside dose is advisable). When used concomitantly with cardiac glycosides, it is necessary to monitor the ECG and the patient’s clinical condition.

Under the influence of barbiturates (including phenobarbital), phenytoin and primidone, the need for colecalciferol may significantly increase (they increase the metabolic rate). Calcitonin, etidronic acid, pamidronic acid, and plicamycin reduce the effect. GCS reduce the absorption of calcium, so in patients receiving GCS, an increase in the dose of Calcium-D3 Actavis may be required.

Cholestyramine, colestipol and mineral oils reduce the absorption of vitamin D₃ in the gastrointestinal tract and require an increase in its dose.

When used concomitantly with sodium fluoride and bisphosphonates, the interval between doses should be at least 2 hours, as their absorption is reduced. Calcium and vitamin D3 preparations may reduce the absorption of tetracyclines from the gastrointestinal tract, so the interval between taking Calcium-D3 Actavis and tetracycline antibiotics should be at least 3 hours.

Concomitant use with other analogues of vitamin D increases the risk of hypervitaminosis.

Thiazide diuretics increase the risk of hypercalcemia due to increased tubular reabsorption of calcium. Furosemide and other “loop” diuretics, on the contrary, increase the excretion of calcium by the kidneys.

Storage Conditions

In a dry place, protected from light, at a temperature not exceeding 30°C (86°F). Keep out of reach of children!

Shelf Life

Shelf life – 3 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.