SMECTA® VANILLA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SMECTA® Vanilla

Composition:

Active substance: diosmectite;

1 sachet contains 3 g of diosmectite (octahedral smectite);

Excipients: glucose monohydrate, sodium saccharin, vanillin.

Pharmaceutical form. Powder for oral suspension.

Main physicochemical properties: powder ranging from greyish-white to ochre in colour, with a slight vanilla odour.

Pharmacotherapeutic group. Antidiarrheal agents used in infectious and inflammatory intestinal diseases. Enter sorbents. 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 exhibits strong coating properties on the mucosa of the gastrointestinal tract.

The combined results of two double-blind, randomized studies evaluating the efficacy of the medicinal product SMECTA® Vanilla compared to placebo in 602 patients aged 1 to 36 months with acute diarrhea showed a significant reduction in the frequency of bowel movements during the first 72 hours in the group receiving SMECTA® Vanilla in combination with oral rehydration therapy.

Pharmacokinetics.

Due to its structure, diosmectite in SMECTA® Vanilla 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.

Treatment of acute diarrhea in children from 2 years of age (in addition to oral rehydration) and in adults.

Symptomatic treatment of chronic functional diarrhea in adults.

Symptomatic treatment of pain associated with functional intestinal disorders in adults.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Due to the adsorptive properties of the medicinal product SMECTA® Vanilla, the extent and/or rate of absorption of other substances may be affected. Therefore, it is recommended not to administer other medicinal products simultaneously (an interval of at least 2 hours should be ensured, if possible).

Special precautions for use

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

The use of the medicinal product SMECTA® Vanilla is not recommended for infants and children under 2 years of age. Oral rehydration solution (ORS) is the standard treatment for acute diarrhea.

In children aged 2 years and older, acute diarrhea should be treated in combination with early use of oral rehydration solution (ORS) to prevent dehydration. Chronic use of the medicinal product SMECTA® Vanilla should be avoided.

In adults, treatment does not exclude the need for rehydration when necessary.

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

The patient should be informed about the necessity of:

• rehydration using a significant amount of salty or sweet fluids to compensate fluid loss due to diarrhea (the average daily fluid requirement for an adult is 2 liters);
• maintaining food intake during the episode of diarrhea:
  • excluding certain foods, particularly raw vegetables and fruits, leafy greens, spicy dishes, as well as frozen food or beverages;
  • preferring baked meat and rice.

This medicinal product contains glucose. It is not recommended for patients with glucose-galactose malabsorption syndrome.

This medicinal product contains ethanol (alcohol) in a small amount: less than 100 mg per daily dose.

Use during pregnancy or breastfeeding

Pregnancy

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

Animal studies are insufficient to draw conclusions regarding reproductive toxicity.

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

Breastfeeding

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

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

Fertility

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

Ability to influence the speed of reactions when driving vehicles or operating machinery

Studies on the ability to drive vehicles or operate machinery under the influence of this medicinal product have not been conducted. However, its effect is expected to be negligible or absent.

Method of Administration and Dosage.

Doses

Treatment of acute diarrhea

Children aged 2 years and older: 4 sachets per day for 3 days, followed by 2 sachets per day for 4 days.

Adults: 3 sachets per day for 7 days. If necessary, the dose may be doubled at the beginning of treatment.

Other indications

Adults: on average, 9 g (3 sachets) per day.

Method of administration

For oral use.

The contents of the sachet should be mixed with water or liquid food to form a suspension immediately before administration.

For children, the contents of a sachet may be mixed in a bottle with 50 ml of water for administration at intervals throughout the day, or thoroughly mixed with semi-liquid food such as broth, compote, puree, infant food, etc.

For adults, the contents of a sachet can be mixed with half a glass of water.

Children

To be used for treatment of children aged 2 years and older.

Overdose.

Overdose may lead to severe constipation or formation of bezoar.

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 based on available data).

Adverse reactions identified during clinical trials and the post-marketing period

Frequency determined from clinical trial data.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after marketing authorization of the medicinal product. This enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions in accordance with applicable legislation.

Shelf life. 3 years.

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

Packaging. 3.76 g of powder in a sachet; 10, 12 or 30 sachets in a cardboard box.

Supply category. Over-the-counter (without prescription).

Manufacturer.

BOUHARON IPSEN INDUSTRIE.

Manufacturer's address.

Rue Henri Beaulieu, 28100 Dreux, France.