Calcium Sandoz^® Forte (Tablets) Instructions for Use

ATC Code

A12AA20 (Combination of various calcium salts)

Active Substances

Calcium carbonate (Ph.Eur.)

Calcium lactate gluconate (BP)

Clinical-Pharmacological Group

Drug replenishing calcium deficiency in the body

Pharmacotherapeutic Group

Calcium-phosphorus metabolism regulator

Pharmacological Action

A means for replenishing calcium deficiency in the body, contains two calcium salts – Calcium carbonate and Calcium lactate gluconate.

Calcium is a vital mineral element necessary for maintaining electrolyte balance in the body and the adequate functioning of numerous regulatory mechanisms.

It participates in phosphate-calcium metabolism and has vitamin, anti-rachitic, anti-inflammatory, and anti-allergic effects.

Pharmacokinetics

Approximately 25-50% of the orally administered dose of calcium is absorbed, primarily in the proximal part of the small intestine, and enters the metabolic calcium depots.

99% of the body’s calcium reserves are contained in bones and teeth, 1% is found in intra- and extracellular fluid.

Approximately 50% of the total calcium content in the blood is present in the physiologically active ionized form, approximately 5% forms complexes with citrate, phosphate, and other anions.

The remaining 45% of calcium in the blood serum is bound to proteins, mainly albumin.

About 20% of calcium is excreted through the kidneys and 80% through the intestines.

The level of renal excretion depends on glomerular filtration and tubular reabsorption.

Both non-absorbed calcium and that absorbed portion which is secreted with bile and pancreatic secretion are excreted through the intestines.

Indications

Prevention and treatment of calcium deficiency (including pregnancy, lactation period, period of intensive growth in children); addition of calcium to specific therapy for the prevention and treatment of osteoporosis; allergic reactions (supportive therapy); osteomalacia (as an addition to the main therapy, including with vitamin D₃).

ICD codes

Dosage Regimen

Administer orally, regardless of meals.

For adults and adolescents over 12 years, the typical dose is one to two tablets daily.

For children aged 3 to 12 years, the typical dose is one tablet daily.

Adjust the exact dose and duration of therapy based on the severity of the calcium deficiency and the patient’s clinical response.

For pregnancy and lactation, use only as recommended by a physician; the total daily calcium intake from all sources should not exceed 1500 mg.

For osteoporosis prevention and treatment, use as an adjunct to specific therapy.

For allergic reactions, use as supportive therapy.

Swallow the effervescent tablet whole after it has completely dissolved in a glass of water.

In patients with a history of urolithiasis or mild to moderate renal impairment, monitor urinary calcium excretion regularly.

In patients with renal impairment, administer under medical supervision with monitoring of serum calcium and phosphate levels.

Do not exceed the recommended daily dose to avoid the risk of hypercalcemia or other adverse effects.

Adverse Reactions

Very rarely hypersensitivity reactions, including rash, itching, urticaria, hypercalcemia. In isolated cases, systemic allergic reactions (anaphylactic reactions, facial swelling, angioneurotic edema) have been reported.

In individual medical publications, the development of hypercalciuria against the background of calcium supplement intake has been reported.

Rarely flatulence, constipation, diarrhea, nausea, vomiting, epigastric pain.

When taken in high doses (2000 mg/day with daily intake for several months) headache, increased fatigue, thirst, polyuria may be observed.

Contraindications

Hypersensitivity to the components of the combination, hypercalcemia, hypercalciuria, chronic renal failure, nephrourolithiasis, nephrocalcinosis, children under 3 years of age (depending on the used dosage form).

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding as recommended by a doctor. Calcium passes into breast milk.

During pregnancy, the daily dose of calcium should not exceed 1500 mg. Hypercalcemia during pregnancy can cause developmental disorders in the fetus.

Use in Renal Impairment

Contraindicated in severe renal failure.

In patients with mild or moderately impaired renal function, as well as with a history of urolithiasis, regular monitoring of urinary calcium excretion is required.

In patients with impaired renal function, the intake of calcium salts should be carried out under medical supervision. Monitoring of serum calcium and phosphate levels is necessary.

Pediatric Use

Use in children over 3 years of age is possible in appropriate dosage forms.

Geriatric Use

Use with caution in elderly patients to avoid the risk of exacerbation of chronic diseases.

Special Precautions

In patients with slight hypercalciuria (exceeding 300 mg or 7.5 mmol/day), with mild or moderately impaired renal function, as well as with a history of urolithiasis, regular monitoring of urinary calcium excretion is required.

If necessary, the dose of the used drug should be reduced or discontinued.

Patients prone to the formation of calculi in the urinary tract are recommended to increase fluid intake.

In patients with impaired renal function, the intake of calcium salts should be carried out under medical supervision. Monitoring of serum calcium and phosphate levels is necessary.

When treating with calcium preparations, the intake of vitamin D or its derivatives in high doses should be avoided, unless there are special indications for this.

Drug Interactions

The combination of Calcium carbonate+Calcium lactate gluconate may reduce the absorption of estramustine, etidronate and possibly other bisphosphonates, phenytoin, quinolones, oral tetracycline antibiotics, and fluoride preparations.

Concomitant administration of vitamin D and its derivatives increases the absorption of calcium. When prescribed in high doses together with vitamin D and its derivatives, calcium may reduce the effect of verapamil and possibly other calcium channel blockers.

With the simultaneous use of this combination and tetracycline antibiotics, the absorption of the latter may be impaired. For this reason, tetracyclines should be taken at least 2 hours before or 4-6 hours after oral intake of calcium preparations.

Thiazide diuretics reduce the urinary excretion of calcium, therefore, with their simultaneous use with this combination, regular monitoring of serum calcium concentration should be carried out, since there is a risk of developing hypercalcemia.

Systemic corticosteroids reduce the absorption of calcium.

When taking this combination in patients receiving cardiac glycosides, an increase in the toxicity of cardiac glycosides due to the development of hypercalcemia is possible. In such patients, regular monitoring of ECG and serum calcium levels is required.

With the simultaneous oral intake of a bisphosphonate or sodium fluoride, an interval of 3 hours before taking this combination must be observed, as the absorption of the bisphosphonate or sodium fluoride from the gastrointestinal tract may decrease.

The absorption of calcium from the gastrointestinal tract may decrease with the simultaneous intake of certain types of food containing oxalic acid (for example, spinach, rhubarb) or phytic acid (in all grains), due to the formation of insoluble complexes with calcium ions.

Patients should not take this combination 2 hours before or after consuming food rich in oxalic or phytic acid.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.