SORBIPLYUS

APPROVED INSTRUCTION for medical use of the medicinal product SORBIPPLUS (SORBIPLUS)

Composition:

Active substance: diosmectite;

1 sachet contains diosmectite calculated as 100% dry substance – 3.0 g;

Excipients: glucose monohydrate; sodium saccharin; vanillin.

Pharmaceutical form. Powder for oral suspension.

Main physicochemical properties: powder from almost white to beige color with a slight vanilla odor.

Pharmacotherapeutic group. Antidiarrheal agents used in infectious and inflammatory intestinal diseases. 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 layered structure and high plastic viscosity, diosmectite exhibits strong coating properties on the mucosa of the gastrointestinal tract.

The pooled results of two double-blind, randomized studies evaluating the efficacy of diosmectite versus placebo in 602 patients aged 1 to 36 months with acute diarrhea showed a significant reduction in defecation frequency during the first 72 hours in the diosmectite group receiving oral rehydration therapy.

Pharmacokinetics.

Due to its structure, diosmectite Sorbipius 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 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.
• Intestinal obstruction.

Interaction with other medicinal products and other forms of interaction.

The adsorptive 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 Sorbipulus (an interval of at least 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.

The use of Sorbipulus medicinal product 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 Sorbipulus should be avoided.

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

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

Patients should be advised about the necessity of:

• rehydration by consuming a sufficient amount of salty or sweet liquids to compensate fluid loss due to diarrhea (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.

If symptoms do not resolve within 7 days, consult a physician.

If pain is associated with high fever or vomiting, seek immediate medical attention.

If you have known sugar intolerances, consult your doctor before taking this medicinal product.

Use during pregnancy or breastfeeding

Pregnancy

Data on the use of diosmectite in pregnant women are lacking or limited (fewer than 300 cases of pregnancy).

Animal studies are insufficient to draw conclusions regarding reproductive toxicity.

The use of Sorbipulus medicinal product during pregnancy is not recommended.

Breastfeeding

Data on the use of diosmectite during breastfeeding are limited. The use of Sorbipulus medicinal product 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 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 from 2 years of age: 4 sachets per day for 3 days, then 2 sachets per day.

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

Other indications

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

Administration

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 can be mixed in a bottle with 50 mL of water and administered 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 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 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 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 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

* Frequency determined from clinical trial data.

Reporting of adverse reactions

Reporting of suspected adverse reactions after marketing authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging.

3.76 g of powder in sachets, with 10, 20 or 30 sachets per pack.

Classification by prescription.

Over-the-counter (without prescription).

Manufacturer. JSC "Kyivmedpreparat".

Manufacturer's address and place of business.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.