Gastomizan (Drops) Instructions for Use

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Dosage Form

Gastomizan

Oral drops 100 mg/ml: 30 ml or 50 ml bottle

Dosage Form, Packaging, and Composition

Oral drops in the form of a slightly viscous white liquid with a characteristic odor.

Excipients: sorbitol 70% (non-crystallizing) – 199.17 mg, macrogol stearate 40 – 6.17 mg, carbomer 974R – 5.98 mg, sodium citrate – 4.19 mg, banana flavor – 3.98 mg, glycerol monostearate – 3.78 mg, sorbic acid – 1.06 mg, sodium hydroxide – 0.67 mg, sodium chloride – 0.67 mg, acesulfame potassium – 0.3 mg, purified water – up to 1 ml.

* Simeticone consists of dimeticone (polydimethylsiloxane (PDMS)) and silicon dioxide in a ratio of 96:4.

30 ml – brown glass bottles (1) – cardboard boxes.
50 ml – brown glass bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

A drug reducing flatulence

Pharmacotherapeutic Group

Drugs for the treatment of functional gastrointestinal disorders; other drugs for the treatment of functional gastrointestinal disorders

Pharmacological Action

A drug that reduces flatulence. Simeticone is a chemically inert polymer of methylsiloxane, containing about 5% silicon dioxide.

It has surfactant properties and the ability to reduce surface tension at the liquid/gas interface, which impedes the formation of gas bubbles and also promotes their coalescence and the destruction of foam in the intestine, as a result of which the released gas is absorbed or eliminated naturally under the influence of intestinal peristalsis.

The use of simeticone in preparation for diagnostic examinations of the abdominal organs prevents the occurrence of image defects caused by gas bubbles.

Pharmacokinetics

Due to physiological and chemical inertness, it is not absorbed in the body; after passing through the gastrointestinal tract, it is excreted unchanged.

Indications

Excessive formation and accumulation of gases in the gastrointestinal tract (flatulence, increased gas formation in the postoperative period); symptoms of excessive gas formation caused by functional dyspepsia; symptoms of intestinal colic in newborns and infants – depending on the dosage form.

Preparation for diagnostic examinations of the abdominal and pelvic organs (ultrasound, radiography, esophagogastroduodenoscopy, etc.), including as an additive to contrast agent suspensions for imaging by double-contrast method.

Acute poisoning with detergents containing foaming substances (tensides), as a defoaming agent.

ICD codes

Dosage Regimen

Administer orally. Shake the bottle vigorously before each use.

For newborns and infants with intestinal colic, administer 4 drops (16 mg) mixed in a small amount of water or infant formula, four times daily after feeding.

For children aged 1 to 6 years, administer 6 drops (24 mg) four times daily.

For children aged 6 to 14 years, administer 10-16 drops (40-64 mg) three to four times daily.

For adults and children over 14 years, administer 16-24 drops (64-96 mg) three to four times daily.

For preparation for diagnostic examinations, administer 50 drops (200 mg) the evening before the procedure and the same dose on the morning of the examination.

For use during examinations, add 4-8 drops (16-32 mg) per 1 liter of contrast suspension to reduce gas artifacts.

For acute poisoning with detergents, the dose for adults is 50-100 drops (200-400 mg); for children, the dose is determined by the physician based on body weight.

Doses may be adjusted by a physician based on clinical response. The maximum single dose is 100 drops (400 mg); the maximum daily dose is 400 drops (1600 mg).

Administer during or after meals and at bedtime. If symptoms persist after one week of therapy, reassess the clinical situation.

Adverse Reactions

Possible angioedema, rash, allergic reactions, vomiting.

Contraindications

Hypersensitivity to simeticone; intestinal obstruction; pediatric age – depending on the dosage form.

Use in Pregnancy and Lactation

Due to the lack of absorption of the active substance, the risk to the fetus and the penetration of simeticone into breast milk is unlikely. It can be used during pregnancy and breastfeeding according to indications, in recommended doses.

Pediatric Use

It can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the simeticone drug labels regarding contraindications for the use of specific simeticone dosage forms in children of different ages.

Special Precautions

If symptoms of excessive gas formation and/or intestinal colic persist for a long time, it is necessary to consult a doctor.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.