Glycerol Avexima (Suppositories) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

ATC Code

A06AX01 (Glycerin)

Active Substance

Glycerol (Rec.INN registered by WHO)

Dosage Forms

	Glycerol Avexima	Rectal suppositories 1.24 g: 10 pcs.
		Rectal suppositories 2.11 g: 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories semi-transparent, almost colorless or with a slight yellowish tint, torpedo-shaped, with an oily smooth surface; the presence of a funnel-shaped depression and an air core is allowed.

Excipients: macrogol 400, stearic acid, sodium carbonate decahydrate.

5 pcs. – contour cell packaging (2) – cardboard packs.

Rectal suppositories semi-transparent, almost colorless or with a slight yellowish tint, torpedo-shaped, with an oily smooth surface; the presence of a funnel-shaped depression and an air core is allowed.

Excipients: macrogol 400, stearic acid, sodium carbonate decahydrate.

5 pcs. – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Laxative drug that promotes stool softening

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Laxative for topical use. It has a mild irritant effect on the rectal mucosa and reflexively stimulates peristalsis. It helps to soften stool.

When applied externally, it has a dermatoprotective effect, softens the skin and mucous membranes.

Indications

• Constipation of various origins, including habitual constipation, age-related constipation, and constipation associated with limited mobility.

• For external application to manage symptoms of dryness of the skin and mucous membranes.

ICD codes

Dosage Regimen

For rectal administration, insert one suppository into the rectum once daily. Administer the dose 15-20 minutes after breakfast to utilize the gastrocolic reflex for optimal effect.

For external use, apply a thin layer to the affected areas of skin or mucous membranes as needed to relieve dryness. Avoid systematic long-term use without medical supervision.

Adverse Reactions

During prolonged rectal use, local symptoms of rectal irritation may occur, including discomfort, burning, or itching. Long-term use can lead to a weakening of the physiological defecation process and dependence.

With prolonged or frequent external application, local skin irritation or allergic reactions such as redness, rash, or itching may develop. Discontinue use if any adverse reactions occur.

Contraindications

• Hypersensitivity to glycerol or any of the excipients in the suppository formulation, including macrogol 400, stearic acid, or sodium carbonate decahydrate.

• Presence of hemorrhoids in the acute phase, anal fissures, inflammatory diseases of the rectum such as proctitis, or diagnosed tumors of the rectum.

Use in Pregnancy and Lactation

Glycerol can be used during pregnancy and lactation (breastfeeding) if indicated.

Special Precautions

Systematic use is not recommended. When used as a laxative, treatment is stopped after normal intestinal peristalsis is restored.

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.