Bionorm® detox

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BIONORM® DETOKS (BIONORM DETOKS)

Composition:

Active substance: diosmectite;

1 tablet contains diosmectite (dihexahedral smectite) 1.5 g;

Excipients: microcrystalline cellulose, sodium starch glycolate (type A), sodium saccharin, aspartame (E 951), magnesium stearate.

Pharmaceutical form. Dispersible tablets.

Main physicochemical properties: flat cylindrical tablets with beveled edges, gray to reddish in color, specks may be present.

Pharmacotherapeutic group. Antidiarrheal agents; drugs used for the treatment of infectious and inflammatory intestinal diseases. Other enterosorbents.

ATC code A07BC05.

Pharmacological properties.

Pharmacodynamics.

Diosmectite is a double silicate of aluminium and magnesium.

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

By interacting with glycoproteins of the mucous membrane, diosmectite increases mucus resistance to irritants. By affecting the barrier function of the gastrointestinal mucosa and having a high capacity for binding to the mucosa, it protects the gastrointestinal mucous membrane. Diosmectite is radiolucent, does not stain feces, and at usual doses does not affect the physiological intestinal transit time.

Combined results of comparative studies on the efficacy of diosmectite versus placebo in patients suffering from acute diarrhea showed a significant reduction in defecation frequency within the first 72 hours in the group receiving diosmectite treatment in combination with oral rehydration.

Pharmacokinetics.

Due to its structure, diosmectite is neither absorbed nor metabolized. Diosmectite is excreted in feces through normal intestinal transit.

Clinical characteristics.

Indications.

• For the treatment of acute diarrhea in children aged 2 years and older (in addition to oral rehydration) and in adults.
• For symptomatic treatment of chronic functional diarrhea in adults.
• For 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 interactions.

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 Bionorm® Detox (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 Bionorm® Detox 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 Bionorm® Detox 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.

Patients should be advised about the necessity of:

• Rehydration using a significant amount of salty or sweet fluids to compensate fluid loss due to diarrhea (average daily fluid requirement in adults 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, medical advice should be sought.

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

The medicinal product contains aspartame, a source of phenylalanine, which is harmful for patients with phenylketonuria.

Use during pregnancy or breastfeeding

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

Animal studies are insufficient to draw conclusions regarding reproductive toxicity. Bionorm® Detox is not recommended for use during pregnancy.

Breastfeeding. Data on the use of diosmectite during breastfeeding are limited. Bionorm® Detox is not recommended for use during breastfeeding.

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.

Method of Administration and Dosage

Dosage

Treatment of Acute Diarrhea

Children from 2 years of age: 8 tablets per day for 3 days, followed by 4 tablets per day for 4 days.

Adults: 6 tablets per day for 7 days. If necessary, the dose may be doubled at the beginning of treatment.

Other Indications

Adults: on average, 9 g (6 tablets) per day.

Method of Administration

For oral use.

For adults, one tablet should be mixed with half a glass of water to form a suspension immediately before administration.

For children, one tablet should be mixed in a bottle with 50 ml of water to form a suspension, to be administered at intervals throughout the day; alternatively, the tablet may be crushed (to a powder) and thoroughly mixed with semi-liquid food such as broth, compote, puree, infant formula, etc.

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

Overdose.

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

Adverse reactions.

The most frequently reported adverse reaction during treatment is constipation. If constipation occurs, treatment with dioctahedral smectite should be discontinued and, if necessary, resumed at a lower dose. 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).

Gastrointestinal disorders: common – constipation; uncommon – vomiting.

Skin and subcutaneous tissue disorders: uncommon – rash; rare – urticaria; not known – angioedema, pruritus.

Immune system disorders: not known – hypersensitivity.

Reporting suspected adverse reactions

It is important to report suspected adverse reactions during the use of the medicinal product. This allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national pharmacovigilance 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.

6 tablets in a blister; 1 blister per carton.

6 tablets in a blister; 3 blisters per carton.

Supply category. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua