Smectalia®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SMECTALIA® (SMECTALIA®)

Composition:

Active substance: diosmectite;

1 sachet contains diosmectite (diosmectite octahedral) 3 g;

Excipients: xanthan gum; citric acid monohydrate; ascorbic acid; potassium sorbate; sucralose; caramel-cocoa flavour (a mixture of natural and synthetic flavourings, sugar caramel (E 150d), caramelized sugar syrup, propylene glycol (E 1520), water, ethanol, caffeine); purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical properties: a homogeneous suspension of beige to light beige colour with a characteristic caramel odour.

Pharmacotherapeutic group. Antidiarrheal agents; agents used in the treatment of infectious and inflammatory intestinal diseases. Miscellaneous enterosorbents.

ATC code A07BC05.

Pharmacological properties.

Pharmacodynamics.

In clinical pharmacology studies, diosmectite has demonstrated the ability to:

• adsorb intestinal gas in adults;
• restore normal mucosal permeability in a clinical study conducted in children with gastroenteritis.

Due to its lamellar structure and high plastic viscosity, diosmectite has a high coating capacity on the mucous membrane of the gastrointestinal tract.

Pharmacokinetics.

Due to its structure, diosmectite in Smectalia® remains on the luminal side of the epithelium, is neither absorbed nor metabolized.

Diosmectite is excreted in the feces through normal intestinal transit.

Clinical characteristics.

Indications.

Short-term treatment of acute diarrhea in adults and children aged 15 years and older, as an adjunct to diet.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients listed in the section "Composition".

Interaction with other medicinal products and other forms of interaction.

Due to the adsorbing properties of this medicinal product, it may affect the extent and/or rate of absorption of other substances. Therefore, it is recommended not to administer other medicinal products simultaneously with Smectalium® (an interval of more than 2 hours should be ensured whenever possible).

Special precautions for use

Diosmectite should be used with caution in patients with a history of severe chronic constipation.

Smectalia® is not recommended for use in children under 15 years of age.

Adults and children aged 15 years and older should avoid prolonged use of the medicinal product Smectalia®.

Treatment does not exclude rehydration when necessary.

The volume of rehydration using an oral rehydration solution or intravenous rehydration depends on the severity of diarrhea, patient's age, and characteristics of the disease course.

The patient should be informed about the necessity of:

• rehydration using a significant volume of salty or sweet liquids to compensate for fluid loss caused by diarrhea (the average daily water requirement for an adult is 2 liters);
• maintaining food intake while diarrhea persists:
  • excluding certain foods, especially raw vegetables and fruits, leafy vegetables, spicy dishes, as well as frozen foods or beverages;
  • preferring baked meat and rice.

This medicinal product contains glucose and sucrose. It is not recommended for patients with fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

The medicinal product contains a small amount of ethanol (alcohol), less than 100 mg/dose.

The medicinal product contains 22.4 mg of propylene glycol per sachet.

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of the medicinal product Smectalia® in pregnant women are lacking or limited (less than 300 pregnancy cases).

Animal studies are insufficient to draw conclusions regarding reproductive toxicity.

The use of the medicinal product Smectalia® during pregnancy is not recommended.

Breastfeeding

Data on the use of the medicinal product Smectalia® during breastfeeding are limited.

The use of the medicinal product Smectalia® during breastfeeding is not recommended.

Fertility

The effect of this medicinal product on human fertility has not been studied.

Ability to affect reaction speed when driving vehicles or operating machinery.

Smectalia® has no effect or a negligible effect on the ability to drive vehicles or operate machinery.

Dosage and Administration.

For oral use in adults and children aged 15 years and older.

Dosage

1 sachet (diosmectite, 3 g), followed by an additional 1 sachet after each unformed stool; however, not more than 6 sachets per day.

The maximum duration of treatment is 3 days.

Administration

The contents of the sachet should be kneaded with fingers before opening to achieve a liquid consistency. The contents may be swallowed undiluted or mixed with a small amount of water and then taken orally.

The medicinal product should preferably be administered separately from meals.

Children.

Use for treatment of children aged 15 years and older.

Overdose.

Overdose may lead to an increase in adverse effects and constipation.

Adverse reactions.

The most frequently reported adverse reaction during treatment is constipation, which occurs in approximately 7% of adults and approximately 1% of children. If constipation occurs, treatment with diosmectite should be discontinued, and, if necessary, resumed at a lower dose.

The table below lists adverse reactions reported during clinical trials and the post-marketing period. The frequency of adverse reactions is classified as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); not known (cannot be estimated from the available data).

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after marketing authorization of a medicinal product. This enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the Automated Pharmacovigilance Information System (APIS).

Shelf life. 3 years.

Storage conditions. No special storage conditions required. Keep out of reach and sight of children.

Packaging. 10.27 g of oral suspension in a sachet; 12 sachets in a cardboard box.

Classification by prescription. Over-the-counter (without prescription).

Manufacturer.

Farmatis.

Bouhouris Ipsen Industry.

Manufacturer's address and place of business.

Zone d'Activite Est No. 1, Estrées-Saint-Denis, 60190, France.

Rue Hte Verron, 28100 Dreux, France.