Kolopatil^® (Powder) Instructions for Use

Marketing Authorization Holder

Pharmaceutical Laboratories Galenica, JSC (Morocco)

ATC Code

A07BC04 (Attapulgite)

Active Substance

Attapulgite (BP British Pharmacopoeia)

Dosage Forms

	Kolopatil®	Powder for oral suspension 1.5 g: sachets 20 pcs.
		Powder for oral suspension 3 g (orange): sachets 30 pcs.

Dosage Form, Packaging, and Composition

Powder for oral suspension cream-colored, finely dispersed with an orange odor.

Excipients: sorbitol, sodium saccharin, orange flavor powder.

1.5 g – sachets (20) – cardboard packs.

Powder for oral suspension cream-colored, finely dispersed with an orange odor.

Excipients: sorbitol, sodium saccharin, orange flavor powder.

3 g – sachets (30) – cardboard packs.

Clinical-Pharmacological Group

Antidiarrheal drug with adsorbent action

Pharmacotherapeutic Group

Antidiarrheal agent

Pharmacological Action

Antidiarrheal agent, a natural purified mixture from the palygorskite group of minerals.

It adsorbs toxins, some bacteria, and gases in the gastrointestinal tract.

It reduces intoxication and normalizes intestinal flora.

It relieves intestinal spasm, promotes the formation of formed stools, and reduces the number of bowel movements.

Due to its astringent effect, it soothes the irritated intestinal mucosa.

It reduces spasms of the intestinal smooth muscles.

Indications

Symptomatic treatment of acute diarrhea of various origins (infectious, allergic, drug-induced), imbalance of intestinal microflora, irritation of the intestinal mucosa (as part of combination therapy).

ICD codes

Dosage Regimen

For adults and children over 12 years, administer 1.5 g at the first symptoms of diarrhea.

After each subsequent loose stool, administer another 1.5 g dose.

Do not exceed the maximum daily dose of 9 g (equivalent to six 1.5 g sachets).

For children aged 6 to 12 years, administer 750 mg at the onset of symptoms.

After each subsequent bowel movement, administer another 750 mg dose.

Do not exceed the maximum daily dose of 4.5 g for this age group.

For children aged 3 to 6 years, use only under direct medical supervision.

Do not administer to children under 3 years of age.

Limit the total duration of treatment to 2 days for acute diarrhea.

Prepare the suspension by mixing the entire contents of a sachet in a glass of water.

Maintain a minimum interval of 2-3 hours between the administration of Kolopatil and other oral medications to prevent adsorption and reduced efficacy.

Adverse Reactions

Rarely constipation, allergic reaction.

Contraindications

Intestinal obstruction, fever, chronic diarrhea, parasitic dysentery, children under 3 years of age, hypersensitivity to attapulgite.

Pediatric Use

Contraindicated in children under 3 years of age. Use with caution and under constant medical supervision in children aged 3 to 6 years.

Geriatric Use

Used as indicated.

Special Precautions

Use with caution and under constant medical supervision in children aged 3 to 6 years.

Drug Interactions

Possible decrease in the absorption from the gastrointestinal tract of other drugs when taken orally concomitantly.

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.