Simeotik^® bebi (Drops) Instructions for Use

Marketing Authorization Holder

Avva Rus, JSC (Russia)

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Dosage Forms

	Simeotik® bebi	Oral drops 40 mg/ml: 30 ml bottle, 1 pc.
		Oral drops 100 mg/ml: 30 ml bottle, 1 pc.

Dosage Form, Packaging, and Composition

Oral drops – a white or almost white emulsion, homogeneous after shaking, with a characteristic odor.

* – Simeticone is a mixture of polydimethylsiloxane (dimethicone) and silicon dioxide in a ratio of 95:5

Excipients: macrogol stearyl ether 20 – 6.00 mg, macrogol stearyl ether 2 – 3.00 mg, carbomer – 3.00 mg, banana flavor – 2.00 mg, potassium sorbate – 1.42 mg, sucralose – up to 1.00 ml.

30 ml – bottles (1) – cardboard packs with an insert.

Oral drops – a white or almost white emulsion, homogeneous after shaking, with a characteristic odor.

* – Simeticone is a mixture of polydimethylsiloxane (dimethicone) and silicon dioxide in a ratio of 95:5

Excipients: macrogol stearyl ether 20 – 6.00, macrogol stearyl ether 2 – 3.00 mg, carbomer – 3.00 mg, banana flavor – 2.00 mg, potassium sorbate – 1.42 mg, sucralose – 0.10 mg, purified water – up to 1.00 ml.

30 ml – bottles (1) – cardboard packs with an insert.

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 double contrast.

Acute poisoning by detergents containing foaming substances (tensides), as an antifoaming agent.

ICD codes

Dosage Regimen

Administer orally. Shake the bottle vigorously immediately before each use.

For the 40 mg/ml oral drops formulation, use the provided dropper. For infants with intestinal colic, administer 10 drops (equivalent to 40 mg simeticone) before each feeding, up to four times per day.

For children aged 1 to 6 years, administer 16 drops (64 mg) up to four times daily. For children over 6 years and adults, administer 25 drops (100 mg) up to four times daily.

For the 100 mg/ml oral drops formulation, use the provided dropper. For infants with intestinal colic, administer 4 drops (40 mg) before each feeding, up to four times per day.

For children aged 1 to 6 years, administer 6-7 drops (64 mg) up to four times daily. For children over 6 years and adults, administer 10 drops (100 mg) up to four times daily.

For preparation for diagnostic examinations, administer 50 drops (200 mg) of the 40 mg/ml drops or 20 drops (200 mg) of the 100 mg/ml drops the evening before the procedure. Repeat the same dose on the morning of the examination.

When used as an additive to contrast agent suspensions, add 4-8 drops per liter of suspension, ensuring uniform distribution.

In cases of acute poisoning by detergents, the single dose for adults is 50 drops (200 mg) of the 40 mg/ml drops or 20 drops (200 mg) of the 100 mg/ml drops. For children, adjust the dose based on age and body weight.

Drops can be given directly from the dropper or mixed with a small amount of cool water, infant formula, or other non-carbonated liquid. Do not add to hot food or liquids.

The duration of use depends on the symptoms. For persistent symptoms, consult a doctor.

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 8°C (46°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.