Calcium carbonate + Magnesium carbonate (Tablets) Instructions for Use

Marketing Authorization Holder

Biopharmkombinat, LLC (Russia)

ATC Code

A02AX (Antacids in combination with other agents)

Active Substances

Calcium carbonate (Ph.Eur. European Pharmacopoeia)

Magnesium carbonate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Calcium Carbonate + Magnesium carbonate

Chewable tablets 680 mg+80 mg: 8, 16, 24, 32, 40, or 48 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets oval, biconvex, white or almost white with a minty odor.

Excipients: sorbitol – 369.5 mg, pregelatinized corn starch – 20 mg, potato starch – 13 mg, maltodextrin – 35.5 mg, talc – 35.5 mg, magnesium stearate – 10.7 mg, peppermint leaf oil – 10 mg, sodium saccharin – 0.8 mg.

6 pcs. – blister packs (1, 2, 3, 4, 5, 6, or 10 pcs.) – cardboard packs.
10 pcs. – blister packs (1, 2, 3, 4, 5, 6, or 10 pcs.) – cardboard packs.
12 pcs. – blister packs (1, 2, 3, 4, 5, 6, or 10 pcs.) – cardboard packs.
24 pcs. – polyethylene jars (1) – cardboard packs.
36 pcs. – polyethylene jars (1) – cardboard packs.
48 pcs. – polyethylene jars (1) – cardboard packs.
50 pcs. – polyethylene jars (1) – cardboard packs.
60 pcs. – polyethylene jars (1) – cardboard packs.
100 pcs. – polyethylene jars (1) – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Antacid agent

Pharmacological Action

Antacid drug. Contains Calcium Carbonate and Magnesium carbonate, which provide rapid and prolonged neutralization of excess hydrochloric acid in gastric juice, thereby exerting a protective effect on the gastric mucosa.

Achievement of the therapeutic effect within 3-5 minutes is due to the good solubility of the tablets and the high calcium content.

Pharmacokinetics

As a result of the interaction of the drug with gastric juice, soluble salts of calcium and magnesium are formed in the stomach. The degree of absorption of calcium and magnesium from these compounds depends on the dose of the drug. Maximum absorption is 10% for calcium and 15-20% for magnesium.

A small amount of absorbed calcium and magnesium is excreted by the kidneys. In the intestine, insoluble compounds are formed from the soluble salts, which are excreted in the feces.

Pharmacokinetics in special clinical cases

In case of impaired renal function, the concentration of calcium and magnesium in plasma may increase.

Indications

Symptoms associated with increased acidity of gastric juice and reflux esophagitis: heartburn, sour belching, occasional stomach pain, feeling of fullness or heaviness in the epigastric region, dyspepsia (including those caused by dietary errors, medication use, alcohol abuse, coffee, nicotine); dyspepsia in pregnant women.

ICD codes

Dosage Regimen

The drug is taken orally by chewing the tablets thoroughly.

For adults and children over 12 years of age, take 1 to 2 tablets when symptoms of hyperacidity appear.

Chew each tablet completely or hold it in the mouth until it is fully dissolved; do not swallow the tablets whole.

If symptoms persist, you may repeat the dose after an interval of 2 hours.

Do not exceed a maximum daily intake of 11 tablets.

For occasional, as-needed use to relieve heartburn, sour belching, or epigastric discomfort.

For dyspepsia associated with dietary errors, medication, alcohol, coffee, or nicotine.

For pregnant women experiencing dyspepsia, adhere to the standard adult dosage.

To avoid drug interactions, take other medications 1 to 2 hours before or after taking this antacid.

In patients with impaired renal function, avoid long-term use at high doses and monitor serum calcium and magnesium levels.

Discontinue use and consult a physician if symptoms worsen or do not improve after several days of self-medication.

Adverse Reactions

Allergic reactions very rarely – rash, angioedema, anaphylactic reactions.

When taken at recommended doses, the drug is well tolerated.

Contraindications

Severe renal failure; hypercalcemia; hypophosphatemia; nephrocalcinosis; children under 12 years of age; sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption syndrome; hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

When used in recommended doses, the drug does not pose a danger to the fetus or child.

Use in Renal Impairment

Contraindicated in severe renal failure, nephrocalcinosis.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

When prescribing the drug to patients with impaired renal function, the concentration of magnesium, phosphorus, and calcium in the blood serum should be regularly monitored.

Patients with impaired renal function are not recommended to take the drug for a long time in high doses.

Use of the drug in high doses may increase the risk of kidney stone formation.

Effect on ability to drive vehicles and operate machinery

The use of the drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Changes in gastric juice acidity caused by taking antacids may lead to a decrease in the rate and extent of absorption of other drugs taken simultaneously; therefore, medications should be taken 1-2 hours before or after taking antacids.

With simultaneous use, antacids reduce the absorption of tetracycline antibiotics, fluoroquinolones, cardiac glycosides, levothyroxine, iron preparations, phosphates, fluorides.

With simultaneous use with thiazide diuretics, the concentration of calcium in the blood serum should be regularly monitored.

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.