Carminat^® Baby (Drops) Instructions for Use

Marketing Authorization Holder

Iris, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Dosage Forms

	Carminat® Baby	Oral drops 40 mg/ml: 30 ml bottle
		Oral drops 100 mg/ml: 30 ml bottle

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 – 14 mg, macrogol stearyl ether 2 – 11 mg, carbomer – 3 mg, banana flavor – 2 mg, potassium sorbate – 1.42 mg, sucralose – 0.1 mg, purified water up to 1 ml.

30 ml – dark glass bottle (1) – cardboard packs (with a polypropylene measuring cup included).

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 – 14 mg, macrogol stearyl ether 2 – 11 mg, carbomer – 3 mg, banana flavor – 2 mg, potassium sorbate 1.42 mg, sucralose – 0.1 mg, purified water up to 1 ml.

30 ml – dark glass bottle (1) – cardboard packs (with a polypropylene measuring cup included).

Clinical-Pharmacological Group

A drug reducing flatulence

Pharmacotherapeutic Group

Carminative agent

Pharmacological Action

An agent 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 double-contrast imaging.

Acute poisoning with 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: For infants and children up to 6 years of age, administer 10-16 drops (0.5-0.8 ml) per dose. For children aged 6 to 14 years, administer 16-24 drops (0.8-1.2 ml) per dose. For adolescents over 14 years and adults, administer 24-32 drops (1.2-1.6 ml) per dose.

For the 100 mg/ml oral drops: For infants and children up to 6 years of age, administer 4-6 drops (0.2-0.3 ml) per dose. For children aged 6 to 14 years, administer 6-10 drops (0.3-0.5 ml) per dose. For adolescents over 14 years and adults, administer 10-16 drops (0.5-0.8 ml) per dose.

Administer up to four times daily, typically after meals and at bedtime. Use the provided measuring cup for accurate dosing; drops can be administered directly into the infant’s mouth or mixed with a small amount of cool, boiled water or infant formula.

For preparation for diagnostic examinations, follow the specific instructions provided by the healthcare professional. The dosage is typically administered the evening before the examination and again on the morning of the procedure.

In cases of acute poisoning with detergents, the dosage for adults is 50-100 ml of the 40 mg/ml emulsion; for children, the dose is 2.5-10 ml, depending on age and severity.

The duration of use depends on the indication. For symptomatic relief of flatulence and colic, use as needed. Discontinue use and consult a physician if symptoms persist or worsen.

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.