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Patient information leaflet

for Russia only

Indications for the use of medicinal product Enterosgel

Registration number:
P N003719/02-19.07.2016.

Trade name: Enterosgel®.

INN: polymethylsiloxane polyhydrate.

Chemical name: product of nonlinear polycondensation 1,1,3,3-tetrahydroxy-1,3-dimethyldisiloxane polyhydrate.

Description: Homogeneous paste-like mass from white to almost white, odourless.

 

Dosage form: paste for oral administration.

Composition:

100 g of the preparation contain:
Active substance: Polymethylsiloxane polyhydrate 70 g.
Excipient: Purified water 30 g.

Pharmacotherapeutic group:
oral intestinal adsorbent.

ATC Code: A07B.

 

Pharmacological properties

Enterosgel has a porous structure of a silicone matrix (molecular sponge) of a hydrophobic nature, which is characterized by a sorption action with respect only to medium molecular toxic metabolites (m.m.  from 70 to 1000). Enterosgel has a pronounced sorption and detoxification properties. In the lumen of the gastrointestinal tract it binds and removes from the body endogenous and exogenous toxic substances of various nature, including bacteria and bacterial toxins, antigens, food allergens, drugs and poisons, heavy metal salts, radionuclides, alcohol. Enterosgel also adsorbs some metabolic products of the body, including excess bilirubin, urea, cholesterol and lipid complexes, as well as metabolites responsible for the development of endogenous toxicosis. Enterosgel does not reduce the absorption of vitamins and microelements, it helps to restore the damaged intestinal microflora and does not affect its propulsory function.

Pharmacokinetics

Enterosgel is not absorbed in the gastrointestinal tract, it is excreted unchanged.

Indications and usage

In adults and children as a detoxification agent:

  • Acute and chronic intoxications of different origin;
  • Acute poisoning with strong and poisonous substances, including drugs and alcohol, alkaloids, heavy metals salts;
  • Acute intestinal infections of any origin as part of complex therapy (toxic infection, salmonellosis, dysentery, diarrhoeal syndrome of non-infectious origin, dysbacteriosis);
  • Purulent-septic diseases, accompanied by severe intoxication, as part of combined therapy;
  • Food and drug allergies;
  • Hyperbilirubinemia (viral hepatitis) and hyperazotemia (chronic renal failure);
  • To prevent chronic intoxications in employees engaged in harmful industries (occupational intoxication with chemical agents of polytropic action, xenobiotics, incorporated radionuclides, lead compounds, mercury, arsenic, petroleum products, organic solvents, nitrogen oxides, carbon, fluorides, heavy metal salts).

Contraindications

Individual intolerance of the medicinal product, intestinal atony.

Use in pregnancy and during breastfeeding

Enterosgel is not contraindicated in pregnancy and during breastfeeding.

Dosage and Administration

Enterosgel paste is taken orally 1-2 hours before or after the meal or intake of other drugs, with water.

It is recommended to stir up the necessary amount of the medicinal product in a triple volume of water at room temperature in a glass or take the paste orally and wash with water.

  • Dosage for adults: 15 - 22.5 g (1-1.5 tablespoon) 3 times a day. The daily dose is 45 - 67.5 g.
  • Children aged from 5 to 14 years - 15 g (1 tablespoon) 3 times a day. The daily dose is 45 g.
  • Children under 5 years - 7.5 g (0.5 tablespoon) 3 times a day. The daily dose is 22.5 g.
  • For newborns it is recommended that 2.5 grams (0.5 teaspoon) of the drug be mixed in triple volume of breast milk or water and given before each feeding (6 times a day).
  • For the prevention of chronic intoxications - 22.5 g 2 times a day for 7-10 days monthly. In severe intoxication the dose of the medicinal product can be doubled during the first three days.
  • The duration of treatment for acute poisoning is 3-5 days, and for chronic intoxications and allergic conditions 2-3 weeks. Repeated course upon the prescription of a healthcare professional.

Adverse reactions

Possible nausea, constipation. Sometimes, in a condition of severe renal and/or liver failure, it is possible that a feeling of disgust towards the medication may appear.

Overdose

Cases of an overdose have not been observed.

Interaction with other medicinal products

Simultaneous intake of Enterosgel with other medicines may reduce the absorption of the latter.

Special indications

Enterosgel can be used in complex therapy with other medicines, only if it is used 1-2 hours before or after taking other medications.

Form of issue

Production site at the address: 399851, Russia, Lipetsk region, Dankov, Zaitsev st., 8.

Paste for oral administration 225 g in tubes of laminated composite materials.

Each tube of 225 g, together with the PIL, is placed in a pack of cardboard.

Production site at the address: 399851, Russia, Lipetsk region, Dankov, L. Tolstoy st., 32/2.

Paste for oral administration 90 g and 225 g in tubes of laminated composite materials.

22.5 g sachets of composite two-layer material on the basis of aluminum foil and film.

Each tube of 90 g or 225 g or 2, 10, 20 packages of 22.5 grams together with the PIL are placed in a pack of cardboard. 

Storage conditions

Store at temperatures not lower than 4°C (39.2°F) and not higher than 30°C (86°F). Keep out of the reach of children. Protect from drying after opening the package. Protect from freezing.

Shelf life

3 years. Do not use after the expiry date printed on the package.

Dispensing conditions

Over the counter.

Producer:

TNK SILMA LLC

  • 399851, Russia, the Lipetsk region, Dankov, L. Tolstoy st., 32/2.
  • 399851, Russia, the Lipetsk region, Dankov, Zaitsev st., 8.

Phone/fax: (495) 223-91-00, www.enterosgel.ru, e-mail: contact@enterosgel.ru

Owner of CPP:

TNK SILMA LLC

115573 Moscow, Shipilovskaya st., 50, block 1, building 2.

Phone/fax (495) 223-91-00, www.enterosgel.ru, e-mail: contact@enterosgel.ru