Smecta Forte^® (Paste) Instructions for Use

Marketing Authorization Holder

Ipsen Consumer Healthcare SAS (France)

Manufactured By

Beaufour Ipsen Industrie (France)

ATC Code

A07BC05 (Diosmectite)

Active Substance

Diosmectite (Ph.Eur. European Pharmacopoeia)

Dosage Form

Smecta Forte®

Oral paste 6 g: sachets 20 g 6 pcs.

Dosage Form, Packaging, and Composition

Oral paste from light grayish-brown to grayish-brown in color, homogeneous, with a characteristic lemon and mint odor.

Excipients: lemon-mint flavor¹ – 0.06 g, xanthan gum – 0.04 g, hydrochloric acid 37% – 0.04 g, potassium sorbate – 0.03 g, sodium benzoate – 0.03 g, sucralose – 0.006 g, purified water – up to 20 g.

¹ Lemon-mint flavor consists of a mixture of natural flavors and flavoring substances, propylene glycol (E1520), water, triacetin (E1518), acetic acid (E260), menthofuran.

20 g – sachets made of polyethylene terephthalate, aluminum, and polyethylene (6) – cardboard packs.

The secondary packaging may have a first-opening control.

Clinical-Pharmacological Group

Antidiarrheal drug with adsorbent action

Pharmacotherapeutic Group

Antidiarrheal agent

Pharmacological Action

An adsorbent and antidiarrheal agent of natural origin. It has a protective effect on the intestinal mucosa, possesses a pronounced adsorbent and a mild enveloping action.

It is a stabilizer of the mucous barrier, penetrates into the mucus and increases its lifespan, forming a physical barrier that protects the mucous membrane of the digestive tract from the negative effects of H⁺ ions, intestinal microorganisms and their toxins.

Pharmacokinetics

Not absorbed, excreted unchanged.

Indications

Acute and chronic diarrhea (allergic, drug-induced; due to dietary regimen violations and qualitative composition of food), diarrhea of infectious origin – as part of complex therapy.

Treatment of symptoms associated with gastric and intestinal diseases: heartburn, feeling of heaviness, bloating, abdominal discomfort and other dyspeptic symptoms.

ICD codes

Dosage Regimen

Administer orally. Determine the dose individually based on indication and patient age.

For acute diarrhea in adults: take 6 sachets per day.

For children over 12 years: take 6 sachets per day.

For children 2 to 12 years: take 4 sachets per day.

For children 1 to 2 years: take 2 sachets per day.

For infants under 1 year: take 1 sachet per day.

For other indications like heartburn or dyspepsia in adults: take 3 sachets per day.

For children over 12 years with other indications: take 3 sachets per day.

For children 2 to 12 years with other indications: take 2-3 sachets per day.

For children under 2 years with other indications: take 1-2 sachets per day.

Mix the contents of a single sachet in 50 mL of water immediately before use.

For children under 12, mix the paste into a semi-liquid food like porridge, puree, or infant formula.

Distribute the total daily dose evenly between meals.

In acute diarrhea, initiate rehydration at the first signs.

Maintain a 1-2 hour interval between taking diosmectite and any other oral medication.

The usual treatment duration for acute diarrhea is 3 days.

For chronic symptoms, treatment duration may be extended as advised by a physician.

Do not exceed the recommended daily dose.

Adverse Reactions

From the digestive system: common – constipation; uncommon – flatulence, vomiting.

Allergic reactions frequency unknown – urticaria, rash, pruritus and angioedema.

Contraindications

Hypersensitivity to diosmectite; intestinal obstruction.

With caution in patients with severe chronic constipation.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding according to indications, in recommended doses.

Pediatric Use

In children, use according to indications, in recommended doses, in appropriate dosage forms.

When used in children under 12 years of age, the drug in the appropriate dosage form can be dissolved in a liquid or mixed with a semi-liquid food (porridge, puree, baby food).

Special Precautions

The interval between the intake of diosmectite and other medicinal products should be 1-2 hours.

In children with acute diarrhea, Diosmectite should be used in combination with rehydration measures. If necessary, adults may also be prescribed diosmectite therapy in combination with rehydration measures. The complex of rehydration measures is prescribed depending on the course of the disease, age and characteristics of the patient.

Drug Interactions

When taken concomitantly orally, Diosmectite reduces the rate and/or extent of absorption of other drugs.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.