Simeotic^® (Capsules, Drops) Instructions for Use

Instructions
Dosage forms

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Myotropic antispasmodic with a component reducing gas formation in the intestine

Pharmacotherapeutic Group

Carminative agent

Pharmacological Action

A means that reduces flatulence. Simeticone is a chemically inert methylsiloxane polymer 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

Open the list of ICD codes

ICD-10 code	Indication
K30	Functional dyspepsia (digestive disorder)
R10.4	Other and unspecified abdominal pain (colic)
R14	Flatulence and related conditions (including abdominal bloating, belching)
T55	Toxic effect of soaps and detergents
Z51.4	Preparatory procedures for subsequent treatment or examination, not elsewhere classified

ICD-11 code	Indication
DD90.0	Globus sensation
DD90.1	Functional dysphagia
DD90.3	Functional dyspepsia
DD90.Z	Functional disorders of esophagus or gastroduodenal system, unspecified
DD93.1	Infantile colic
MD81.4	Other and unspecified abdominal pain
ME08	Flatulence and related conditions
NE61	Toxic effect of poisonous substances, chiefly nonmedicinal, not elsewhere classified
QB9A	Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally with a small amount of water during or after meals.

For flatulence and functional dyspepsia in adults and children over 6 years: take 120-240 mg (1-2 capsules) up to four times daily.

For preparation for diagnostic examinations: take 240 mg (2 capsules) the evening before the procedure and 240 mg on the morning of the examination.

When used as a contrast medium additive: add 4-8 capsules (480-960 mg) to one liter of suspension.

For acute poisoning with detergents: administer a single dose of 1000-1500 mg to adults; adjust dose for children based on age and weight.

For infant colic using oral drops: administer 0.25 ml (equivalent to 10 mg of simeticone) per dose before each feeding, up to eight times per 24 hours.

For children aged 1 to 6 years using drops: administer 0.5 ml (20 mg) per dose, up to four times daily.

Shake the dropper bottle vigorously before each use. Use the provided measuring dropper for accurate dosing.

The maximum daily dose for adults should not exceed 1600 mg.

Do not exceed the recommended duration of use without medical consultation. If symptoms persist beyond one week, discontinue use and seek medical advice.

Adverse Reactions

Possible angioneurotic edema, rash, allergic reactions, vomiting.

Contraindications

Hypersensitivity to simeticone; intestinal obstruction; childhood – 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 are 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Simeotic^® [Avva Rus, JSC (Russia)]
Oral drops 40 mg/ml
Oral drops 100 mg/ml

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Dosage Forms

	Simeotic^®	Oral drops 40 mg/ml
		Oral drops 100 mg/ml

Dosage Form, Packaging, and Composition

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

	1 ml (20 drops)
Simeticone*	40 mg

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.

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

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

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

	1 ml (20 drops)
Simeticone*	100 mg

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.

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

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

Simeotic^® [Avva Rus, JSC (Russia)]
Capsules 40 mg: 25 or 50 pcs.
Capsules 80 mg: 30 pcs.

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Manufactured By

Minskintercaps Up (Republic Of Belarus)

Dosage Forms

	Simeotic^®	Capsules 40 mg: 25 or 50 pcs.
		Capsules 80 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules from yellow to orange, spherical or almost spherical, soft, gelatinous, with a seam and smooth surface; the capsule contents are a colorless, viscous, opalescent liquid.

	1 caps.
Simeticone	40 mg

Excipients: gelatin – 24.67 mg, glycerol – 11.36 mg, purified water – 3.14 mg, sodium benzoate – 0.047 mg, dye quinoline yellow E-104 – 0.027 mg, dye sunset yellow E-110 – 0.007 mg.

25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.

Capsules from yellow to orange, spherical or almost spherical, soft, gelatinous, with a seam and smooth surface; the capsule contents are a colorless, viscous, opalescent liquid.

	1 caps.
Simeticone	80 mg

Excipients: gelatin – 25.14 mg, glycerol – 11.58 mg, purified water – 3.2 mg, sodium benzoate – 0.048 mg, dye quinoline yellow E-104 – 0.028 mg, dye sunset yellow E-110 – 0.007 mg.

15 pcs. – contour cell packs (2) – cardboard packs.