SORMIN

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

Composition:

Active substance: diosmectite;

1 sachet contains 3 g of diosmectite;

Excipients: glucose monohydrate, sodium saccharin, "Natural orange" flavor, "Vanilla" flavor.

Pharmaceutical form. Powder for oral suspension.

Main physicochemical properties: greyish or yellowish or reddish fine powder with a characteristic orange and vanilla odor.

Pharmacotherapeutic group. Antidiarrheal agents used in infectious and inflammatory intestinal diseases. Enterosorbents. ATC code A07BC05.

Pharmacological properties.

Pharmacodynamics.

Diosmectite, the active substance of the medicinal product SORMIN®, has demonstrated the ability to adsorb intestinal gas in adults and to restore normal mucosal permeability (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.

Results from placebo-controlled clinical trials involving patients aged 1 to 36 months with acute diarrhea showed that treatment with diosmectite-containing medicinal products in combination with oral rehydration led to a significant reduction in defecation frequency within the first 72 hours.

Pharmacokinetics.

Due to its structure, diosmectite in SORMIN® 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.

The medicinal product SORMIN® is indicated for:

• treatment of acute diarrhea in children aged 2 years and older (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 of the medicinal product SORMIN®.

Interaction with other medicinal products and other forms of interaction.

Due to the adsorptive properties of diosmectite, 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 SORMIN® (if possible, an interval of more than 2 hours should be maintained).

Special precautions for use.

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

The use of SORMIN® should be avoided in infants and children under 2 years of age. The standard treatment for acute diarrhea is the use of an oral rehydration solution (ORS).

In children aged 2 years and older, acute diarrhea should be treated in combination with early administration of ORS to prevent dehydration. Prolonged use of SORMIN® should be avoided.

In adults, treatment does not exclude rehydration when necessary.

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

This medicinal product contains less than 1 mmol (23 mg) of sodium, i.e. it is practically sodium-free.

This medicinal product contains glucose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicinal product.

Use during pregnancy or breastfeeding.

Pregnancy.

Data on the use of medicinal products containing dioctahedral smectite in pregnant women are lacking or limited (fewer than 300 pregnancy cases). Animal studies are insufficient to draw conclusions regarding reproductive toxicity. The use of SORMIN® during pregnancy is not recommended.

Breastfeeding.

Data on the use of medicinal products containing dioctahedral smectite during breastfeeding are limited. The use of SORMIN® during breastfeeding is not recommended.

Fertility.

The effect of medicinal products containing dioctahedral smectite on human fertility has not been studied.

Ability to affect reaction speed when driving or operating machinery.

Studies on the ability to drive vehicles or operate machinery under the influence of medicinal products containing dioctahedral smectite have not been conducted. However, a negligible or no effect is expected.

Dosage and Administration.

The medicinal product SORMIN® is intended for oral administration.

The contents of the sachet should be dissolved immediately before use.

For adults, mix the contents of one sachet with half a glass of water to form a suspension.

For children, the contents of the sachet can be mixed in a bottle with 50 mL of water or semi-liquid food (e.g., broth, compote, puree, infant formula, etc.).

Treatment of acute diarrhea.

Children aged 2 years and older: 12 g (4 sachets) per day for 3 days, followed by 6 g (2 sachets) per day for 4 days.

Adults: 9 g (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.

Children.

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

Overdose .

Overdose may lead to severe constipation or formation of a bezoar.

Adverse Reactions

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

The adverse reactions listed below are categorized by organ systems and frequency:

very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000, including isolated cases), unknown (frequency cannot be estimated from available data).

Gastrointestinal disorders: common – constipation; uncommon – vomiting.

Skin and subcutaneous tissue disorders: uncommon – rash; rare – urticaria; unknown – angioneurotic edema, pruritus.

Immune system disorders: unknown – hypersensitivity.

Reporting of suspected adverse reactions.

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

Shelf life.

2 years.

Storage conditions.

Store at temperatures not exceeding 25 °C in the original packaging.

Keep out of reach and sight of children.

Packaging.

3.72 g of powder in sachets; 10 or 30 sachets in a cardboard pack.

Supply classification.

Over-the-counter (without prescription).

Manufacturer.

Kusum Healthcare Pvt Ltd.

Manufacturer's address and site of operations.

SP-289 (A), RIICO Industrial Area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.