Calcium with vitamin D3 (Tablets) Instructions for Use

Marketing Authorization Holder

Daru Pahsh Pharmaceutical Mfg. The Company (Iran)

ATC Code

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

Active Substances

Colecalciferol (Rec.INN registered by WHO)

Calcium carbonate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Calcium with vitamin D3

Film-coated tablets, 200 IU+500 mg: 20, 50, or 1000 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets matte pink, capsule-shaped; on the break – a homogeneous white mass surrounded by a thin pink shell.

Excipients: corn starch, polyvinylpyrrolidone, magnesium stearate, hypromellose, titanium dioxide, purified talc, polyethylene glycol, iron oxide brown, carnauba wax.

20 pcs. – plastic bottles (1) – cardboard packs.
50 pcs. – plastic bottles (1) – cardboard packs.
1000 pcs. – plastic bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug replenishing calcium deficiency in the body, used for the treatment of osteoporosis

Pharmacotherapeutic Group

Calcium-phosphorus metabolism regulator

Pharmacological Action

A combined drug, a regulator of calcium and phosphorus metabolism in the body.

It reduces bone resorption and increases bone density, replenishing calcium deficiency.

Colecalciferol (vitamin D₃) is necessary for the mineralization of teeth.

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

Pharmacokinetics

Colecalciferol and calcium (in ionized form) are absorbed in the proximal small intestine via an active vitamin D-dependent transport mechanism.

Indications

As a therapeutic and prophylactic agent for conditions of calcium and vitamin D₃ deficiency in the body associated with inadequate nutrition or with increased need for calcium and vitamin D₃, including:

• Pregnancy;
• Lactation period;
• Prevention and treatment of postmenopausal and senile osteoporosis, osteomalacia (as part of combination therapy).

ICD codes

Dosage Regimen

The drug is prescribed for adults orally.

For prophylaxis – 1-2 tablets/day. To improve calcium absorption, it is preferable to take the tablet with acidic drinks (orange or lemon juice).

For course prophylaxis of osteoporosis, 2 tablets/day (morning and evening) are prescribed, preferably with meals.

For the treatment of osteoporosis, the daily dose of the drug and the duration of the course are established individually by the doctor.

Adverse Reactions

From the digestive system constipation, diarrhea, flatulence, nausea, abdominal pain are possible.

Other allergic reactions are possible; with long-term use, hypercalcemia, hypercalciuria are possible.

Contraindications

• Severe renal impairment;
• Hypercalcemia (in hyperparathyroidism);
• Hypercalciuria;
• Urolithiasis;
• Decalcifying tumors (myeloma, bone metastases, sarcoidosis);
• Immobilization osteoporosis;
• Pulmonary tuberculosis (active form);
• Childhood;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

During pregnancy and lactation, the need for calcium and vitamin D increases.

When taking the drug, it is necessary to take into account the additional intake of calcium and vitamin D₃ from other sources and carry out constant medical monitoring.

To avoid toxic effects on the fetus, it is not recommended to take more than 1500 mg of calcium and 600 IU of vitamin D per day.

Calcium and vitamin D are excreted in breast milk.

In case of pregnancy, overdose can lead to impaired mental and physical development of the child.

Use in Renal Impairment

Use with caution in patients with renal insufficiency.

The use of the drug is contraindicated in severe renal impairment, hypercalciuria, urolithiasis.

Pediatric Use

The drug is contraindicated in childhood.

Geriatric Use

In elderly individuals, the need for calcium is 1.5 g/day, for vitamin D₃ – 500-1000 IU/day.

Special Precautions

Use with caution in patients with renal insufficiency.

During treatment, it is necessary to constantly monitor urinary calcium excretion and plasma calcium and creatinine concentrations.

If calciuria appears, exceeding 7.5 mmol/day (300 mg/day), it is necessary to reduce the dose or stop taking the drug.

To avoid overdose, it is necessary to take into account the additional intake of vitamin D₃ from other sources.

Do not use simultaneously with vitamin complexes containing calcium and vitamin D₃.

In elderly individuals, the need for calcium is 1.5 g/day, for vitamin D₃ – 500-1000 IU/day.

Overdose

Symptoms hypercalcemia and/or hypercalciuria, which are accompanied by anorexia, nausea, vomiting, dizziness, weakness, headache.

Treatment stop taking the drug, introduce a large amount of fluid into the body and adhere to a diet with limited calcium content.

Drug Interactions

A decrease in the activity of vitamin D₃ is possible when it is used simultaneously with phenytoin or barbiturates.

Calcium preparations enhance the effect of cardiac glycosides (when used simultaneously, monitoring of ECG and the patient’s clinical condition is necessary).

The drug slows down the absorption from the gastrointestinal tract of antibiotics of the tetracycline group, acetylsalicylic acid and other salicylates, sulfonamides, beta-blockers and indirect anticoagulants.

In this regard, the drug is recommended to be taken 2 hours before or 2 hours after taking other medicines.

Cholestyramine, laxatives based on mineral or vegetable oil may reduce the absorption of vitamin D₃.

With simultaneous use of diuretics from the thiazide group, the risk of hypercalcemia increases.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 15°C (59°F) to 30°C (86°F).

Shelf Life

Shelf life – 2 years.

Pharmacy supply terms

The drug is approved for use as an over-the-counter product.

Dispensing Status

Over-the-Counter

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.