Simetikotik Baby (Drops) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

EVALAR CJSC (Russia)

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Dosage Form

Simetikotik Baby

Oral drops 100 mg/1 ml: 20 ml bottle with dropper and measuring cup

Dosage Form, Packaging, and Composition

Oral drops as a milky-white emulsion with a banana odor; separation may occur, which disappears after shaking.

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

Excipients: macrogol stearate 40, glyceryl monostearate 40-55, carbomer, natural flavor “Banana” [natural flavoring substances, maltodextrin, gum arabic, propylene glycol], acesulfame potassium, liquid sorbitol (non-crystallizing) (including sorbitol – 199.17 mg (0.017 XE)), sodium chloride, sodium citrate, sodium hydroxide, sorbic acid, purified water.

20 ml – dark glass bottles (1) with a dropper and a measuring cup – cardboard packs.

Clinical-Pharmacological Group

A drug reducing flatulence

Pharmacotherapeutic Group

Carminative agent

Pharmacological Action

Simeticone reduces the amount of gas in the gastrointestinal tract: it has surfactant properties and the ability to reduce surface tension at the liquid/gas interface, which promotes the coalescence of gas bubbles 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.

Preclinical safety data

Preclinical data obtained from standard studies of pharmacological safety, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive and ontogenetic toxicity did not reveal any specific hazard to humans.

Pharmacokinetics

Simeticone is chemically inert, after oral administration it is not absorbed from the gastrointestinal tract and acts only in its lumen.

It does not interact with microorganisms and enzymes and does not affect digestion processes.

It is excreted by the intestine unchanged.

Indications

The drug Simetikotik Baby is indicated for use in infants, children under 18 years of age and adults for

• Symptoms of infantile colic in infants;
• Symptoms of excessive gas formation and accumulation in the gastrointestinal tract (including flatulence, increased gas formation in the postoperative period);
• Symptoms of excessive gas formation caused by functional dyspepsia;
• 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

For complaints associated with infant colic and excessive gas formation

For preparation for diagnostic examinations (radiography, ultrasound, etc.)

25 drops (1 ml) of the drug 3 times/day after meals one day before the examination and 25 drops (1 ml) of the drug in the morning on the day of the examination.

To obtain a double-contrast image, 2-4 ml of the drug is added to 1 liter of contrast suspension.

For preparation for esophagogastroduodenoscopy

2-3 ml of the drug before the examination. During endoscopy, if necessary, several milliliters of the emulsion can be introduced through the endoscope channel to eliminate gas bubbles that interfere with the examination.

For acute poisoning with detergents containing tensides

Children 1-4 ml of the drug; adults 4-8 ml of the drug are prescribed by a doctor depending on the severity of the poisoning.

Method of administration

Orally.

Before use, the bottle must be shaken. The drug is dosed in drops, holding the bottle vertically with the opening down. For convenience, it can also be dosed in milliliters using a measuring cup.

25 drops are equivalent to 1 ml (or 100 mg of simeticone).

The drug is taken before, during or after each meal and, if necessary, before bedtime.

The frequency of administration and duration of use depend on the severity of symptoms.

If necessary, the drug can be taken for a long time.

After surgical interventions, the drug should be taken under medical supervision.

Adverse Reactions

To date, no adverse reactions have been observed as a result of using the drug.

Possible development of allergic reactions to the components of the drug.

Contraindications

• Hypersensitivity to simeticone or to any of the excipients included in the drug;
• Intestinal obstruction;
• Hereditary fructose intolerance.

Use in Pregnancy and Lactation

Pregnancy

Since Simeticone is not absorbed in the gastrointestinal tract, no negative impact is expected when using the drug during pregnancy.

However, as with the use of any other medicines, the drug should be prescribed with caution during pregnancy.

Breastfeeding period

Since Simeticone is not absorbed in the gastrointestinal tract, no negative impact is expected when using the drug during breastfeeding.

However, as with the use of any other medicines, the drug should be prescribed with caution during breastfeeding.

Fertility

No data available.

Pediatric Use

The drug Simetikotik Baby is used according to indications in infants and children under 18 years of age.

Special Precautions

If gastrointestinal symptoms persist for a long time (more than 14 days of therapy) or new symptoms occur, a medical examination is necessary.

The drug contains sorbitol (sorbitol), therefore its use in patients with hereditary fructose intolerance is contraindicated.

Information for patients with diabetes: 1 ml of the drug (25 drops) contains 199.17 mg of sorbitol, which corresponds to 0.017 XE.

Effect on the ability to drive vehicles and mechanisms

The drug Simetikotik Baby does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher, operator).

Overdose

Cases of overdose are not known.

Drug Interactions

No clinically significant interaction of simeticone with other drugs has been established.

Storage Conditions

The drug should be stored at a temperature not exceeding 25°C (77°F). Do not freeze.

Shelf Life

Shelf life – 2 years.

After first opening the bottle, the drug should be used within 6 months.

Dispensing Status

The drug is available without a prescription.

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.