Simethicone

Instruction manual

For medical use of the drug

Structure:

Active ingredient: Simethicone;

1 capsule contains Simethicone 125 mg;

excipients: gelatin, glycerin.

Dosage form.

The capsules are soft.

Basic physical and chemical properties: soft gelatin capsules of spherical or spherical shape, with a seam, light yellow in color, filled with a viscous, opalescent liquid, from colorless to grayish-white.

Pharmacotherapeutic group.

Means used for functional gastrointestinal disorders. silicones. code akh a03a x13.

Pharmacological properties.

Pharmacodynamics

Simethicone, which is part of the drug, is a non-toxic inert surfactant made on the basis of silicon, an antifoam. It changes the surface tension of gas bubbles formed in the intestine, and causes their destruction. The gases that are released in this case can either be absorbed by the intestinal walls or excreted from the body due to intestinal motility. The use of Simethicone before the start of diagnostic tests of the abdominal cavity prevents the occurrence of image defects caused by gas bubbles; promotes thorough irrigation of the mucous membrane of the colon with a contrast agent, which prevents the rupture of the contrast film even in case of bloating.

Pharmacokinetics

Simethicone acts exclusively on the surface of gas bubbles and is not absorbed by the mucous membrane of the digestive tract. Simethicone after oral administration is excreted unchanged. Simethicone has no central effect.

Clinical characteristics.

Indications.

• Symptomatic treatment of disorders of the gastrointestinal tract associated with gas formation, such as flatulence, including in the postoperative period. as an aid in conducting diagnostic tests of the abdominal organs (radiography, ultrasound) and in preparation for gastroduodenoscopy. as an antifoam for intoxication with surface-active substances (washing powders or other detergents).

Contraindications

Hypersensitivity to the drug and its components; intestinal obstruction; obstructive diseases of the digestive tract.

Interaction with other drugs and other types of interactions.

Levothyroxine may bind to Simethicone. absorption of levothyroxine in the intestine may be impaired while taking it with Simethicone.

Features of the application.

In case of repeated complaints or prolonged complaints from the digestive tract, consult a doctor.

Use during pregnancy or lactation.

There are no clinical data on the use of the drug afletin by pregnant women. since the active component is not absorbed by the mucous membrane of the digestive tract, one should not expect any effect of the drug on the fetus or the accumulation of the drug in breast milk.

The use of the drug Afletin during pregnancy or lactation is possible only when the expected benefit for the woman exceeds the potential risk to the fetus or child.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Since Simethicone is an inert substance that is not absorbed, the effect on driving vehicles or other mechanisms is practically excluded.

Dosage and administration.

The drug is administered orally to adults and children from 12 years of age. taking the drug is independent of food intake.

Symptomatic treatment of disorders of the gastrointestinal tract: 1 capsule 3 times a day.

As an aid in carrying out diagnostic tests: 1 capsule 3 times a day the day before the study and another 1 capsule in the morning on the day it is carried out.

As an antifoam for intoxication with surface-active substances (washing powders or other detergents): the dosage depends on the severity of intoxication.

The minimum recommended dose is 3 capsules.

The duration of treatment is set individually. If necessary, the drug can be taken for a long time.

Children.

The drug is used in children from 12 years old.

For children under 12 years of age, the drug is prescribed in the form of liquid dosage forms.

Overdose.

By this time, cases of overdose are unknown. since Simethicone is chemically and physiologically inert, intoxication is practically excluded. in the case of the use of doses higher than recommended, you should consult a doctor.

Adverse Reactions

On the part of the immune system: allergic manifestations, hypersensitivity reactions, including itching, rash, urticaria.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 os.

Keep out of the reach of children.

Packaging.

10 capsules in a blister; 2 blisters in a pack.

20 capsules per blister; 1 blister in a pack.

Vacation category.

Over the counter.

Manufacturer.

AO Kiev Vitamin Plant.

The location of the manufacturer and the address of the place of business.

04073, Ukraine, Kiev, st. Kopylovskaya, 38.

Website: www.vitamin.com.ua.