Calcex (Tablets) Instructions for Use

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

ATC Code

J01XX (Other antibacterial drugs)

Dosage Form

Calcex

Tablets 500 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score line.

Excipients: tannin, calcium stearate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Systemic antibacterial agents; other antibacterial agents

Pharmacological Action

The action of this complex drug is due to its components. Methenamine belongs to the class of antiseptics and disinfectants, to the group of aldehydes. Its action is based on the ability of the drug to decompose in an acidic environment with the formation of formaldehyde, which in this case has antiseptic and anti-inflammatory properties.

The complex salt of methenamine is present to replenish the deficiency of calcium ions and to reduce the permeability of the vascular wall (which is characteristic of any inflammation).

Indications

• Symptomatic treatment of acute respiratory diseases and “common cold” diseases (as part of complex therapy).

ICD codes

Dosage Regimen

Take the drug orally at the first signs of illness. Adults should take 1 to 2 tablets three to four times daily.

The total duration of therapy should not exceed 3 to 5 days. Do not exceed the recommended dosage or duration of treatment.

Adverse Reactions

Discontinue use immediately upon the appearance of any adverse effects. Dyspeptic disorders, such as nausea or stomach discomfort, are the most commonly reported reactions.

In rare cases, hypersensitivity reactions may occur. Report any persistent or severe side effects to a healthcare professional.

Contraindications

• Do not use in patients with known hypersensitivity to methenamine, calcium chloride, or any excipient of the drug.
• Contraindicated in conditions of hypoacidity of gastric juice, as the drug requires an acidic environment for activation.
• Use is prohibited in patients with hepatic insufficiency or chronic renal failure.
• Do not administer during pregnancy or the lactation period.
• Contraindicated for use in childhood.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in chronic renal failure.

Pediatric Use

Contraindicated in childhood.

Overdose

Symptoms of overdose include severe irritation of the conjunctiva and respiratory tract mucous membranes. Gastrointestinal effects such as nausea, vomiting, and diarrhea are common.

In severe cases, glomerulonephritis may develop. Treatment is supportive and includes administration of thioctic acid, folic acid, ascorbic acid, pyridoxine, and nicotinic acid preparations.

Drug Interactions

Avoid concurrent use with sulfonamides due to the risk of crystallization in the urinary tract. Exercise caution when administering with other drugs that affect urinary pH.

Formal interaction studies have not been conducted. Inform your physician about all concomitant medications.

Storage Conditions

In a dry place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 4 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.