Simicol (Drops) Instructions for Use

Marketing Authorization Holder

CTS Chemical Industries Ltd. (Israel)

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Dosage Form

Simicol

Oral drops 40 mg/0.6 ml: bottle 30 ml

Dosage Form, Packaging, and Composition

30 ml – dark glass bottles (1) with a graduated syringe – cardboard packs.

Clinical-Pharmacological Group

A drug reducing flatulence

Pharmacotherapeutic Group

Carminative agent

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 suspensions of contrast agents for imaging by the double-contrast method.

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

ICD codes

Dosage Regimen

Administer orally. Use the provided graduated syringe for accurate dosing.

For newborns and infants with colic: administer 0.6 ml (1 drop = 40 mg) before each feeding, up to four times daily.

For children aged 1 to 6 years: administer 1.2 ml (2 drops = 80 mg) up to four times daily after meals and at bedtime.

For children over 6 years and adults: administer 1.8 ml to 2.4 ml (3-4 drops = 120-160 mg) up to four times daily after meals and at bedtime.

For preparation for diagnostic examinations: take 1.8 ml to 2.4 ml (3-4 drops) the evening before the procedure and the same dose on the morning of the examination.

For use as a contrast agent additive: add 2.4 ml to 4.8 ml (4-8 drops) per liter of contrast suspension.

For acute poisoning with detergents: administer a single dose of 30 ml to 50 ml (50-83 drops) for adults; for children, the dose is 2.5 ml to 10 ml (4-17 drops) based on age and severity.

Shake the bottle well before use. The maximum daily dose for adults should not exceed 400 mg.

If symptoms persist beyond one week, consult a physician for reevaluation.

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 leaflets 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.