SMECTA® STRAWBERRY

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SMECTA® Strawberry (SMECTA® Strawberry)

Composition:

Active substance: diosmectite;

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

Excipients: glucose monohydrate, sodium saccharin, strawberry flavour (maltodextrin, propylene glycol, gum arabic, mixture of natural and synthetic flavourings).

Pharmaceutical form. Powder for oral suspension.

Main physicochemical characteristics: powder from greyish-white to ochre colour with a slight strawberry odour.

Pharmacotherapeutic group. Drugs affecting the digestive system and metabolism. Antidiarrheal agents; agents used in the treatment of infectious and inflammatory intestinal diseases. Other enterosorbents. Diosmectite.

ATC code A07BC05.

Pharmacological Properties

Pharmacodynamics

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

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

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

The combined results of two double-blind, randomized studies evaluating the efficacy of the medicinal product SMECTA® Strawberry 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® Strawberry in combination with oral rehydration therapy.

Pharmacokinetics

Due to its structure, diosmectite in SMECTA® Strawberry 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.

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

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® Strawberry should be avoided in 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® Strawberry 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 disease course characteristics.

Patients should be informed about the necessity of:

• rehydration using a significant volume of salty or sweet liquids to compensate fluid loss due to diarrhea (the average daily water requirement for an adult is 2 liters);
• maintaining food intake during diarrhea:
  • excluding certain foods, especially raw vegetables and fruits, leafy greens, spicy dishes, as well as frozen foods 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 0.128 mg of propylene glycol in each sachet.

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of the medicinal product SMECTA® Strawberry 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® Strawberry during pregnancy is not recommended.

Breastfeeding

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

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

Fertility

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

Ability to affect reaction speed while driving 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.

Dosage and Administration

Dosage

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.

Administration method

For oral use.

The contents of the sachet should be mixed to form a suspension immediately before administration.

For children, the contents of the 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 the sachet may 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 bezoar formation.

Adverse Reactions

The most commonly 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 list of adverse drug reactions reported during clinical trials and in the post-marketing period is presented in the table below.

The frequency of adverse reactions is classified as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); not known (cannot be estimated based on available data).

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

* Frequency determined from clinical trial data.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the use of this medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

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; 12 sachets in a cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

BOUHARIES IPSEN INDUSTRIE

Manufacturer's address.

Rue Hte Viron 28100 Dreux, France

Marketing Authorization Holder.

IPSEN CONSUMER HEALTHCARE, Simplified Joint Stock Company, France

Address of the Marketing Authorization Holder and/or its representative.

65 Quai Georges Gorse, 92100 Boulogne-Billancourt, France