Simeticone (Capsules, Drops, Suspension) Instructions for Use

Instructions
Dosage forms

ATC Codes

A03AX (Other drugs for functional gastrointestinal disorders)

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug reducing flatulence

Pharmacotherapeutic Group

Drugs for the treatment of functional gastrointestinal disorders; other drugs for the treatment of functional gastrointestinal disorders

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 suspensions of contrast agents for imaging by double contrast method.

Acute poisoning with detergents containing foaming substances (tensides), as a defoaming 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. Determine the dosage individually based on the indication, patient age, and specific pharmaceutical formulation.

For capsules in adults and children over 6 years: take 120 mg to 240 mg orally, up to four times daily, following meals and at bedtime.

For oral suspension in adults and children over 6 years: take 40 mg to 80 mg orally, up to four times per day, after meals and at bedtime.

For oral drops in infants and children: administer 20 mg per dose, up to four times daily. Mix the drops with a small amount of cool, non-carbonated water or infant formula.

For preparation for diagnostic procedures: take 240 mg the evening before the examination and 240 mg on the morning of the procedure.

For use as a defoaming agent with contrast media, follow the specific radiological protocol for additive concentration.

Shake the suspension or drops well before each use. Do not exceed the maximum daily dose unless directed by a physician.

Adverse Reactions

Possible angioedema, 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 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.

Medical Disclaimer

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

Simeticone [Avva Pharmaceuticals, Ltd. (Cyprus)]
Oral drops 40 mg/1 ml: 30 ml bottle
Oral drops 100 mg/ml: bottle 30 ml

Marketing Authorization Holder

Avva Pharmaceuticals, Ltd. (Cyprus)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Forms

	Simeticone	Oral drops 40 mg/1 ml: 30 ml bottle
		Oral drops 100 mg/ml: bottle 30 ml

Dosage Form, Packaging, and Composition

Oral drops in the form of a white or almost white emulsion, homogeneous after shaking, with a characteristic odor.

	1 ml (20 drops)
Simeticone*	40 mg

* 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 bottles with a dropper cap (1) complete with a measuring cup – cardboard packs.

Oral drops in the form of a white or almost white emulsion, homogeneous after shaking, with a characteristic odor.

	1 ml (20 drops)
Simeticone*	100 mg

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

30 ml – dark glass bottles with a dropper cap (1) complete with a measuring cup – cardboard packs.

Simeticone [Artelar, LLC (Russia)]
Oral drops 40 mg/ml: 30 ml bottle
Oral drops 100 mg/ml: bottle 30 ml

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Forms

	Simeticone	Oral drops 40 mg/ml: 30 ml bottle
		Oral drops 100 mg/ml: bottle 30 ml

Dosage Form, Packaging, and Composition

Oral drops in the form of a white or almost white emulsion, homogeneous after shaking, with a characteristic odor.

	1 ml (20 drops)
Simeticone*	40 mg

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

30 ml – bottles (1) – cardboard packs (1) (complete with a measuring cup).

Oral drops in the form of a white or almost white emulsion, homogeneous after shaking, with a characteristic odor.

	1 ml (20 drops)
Simeticone*	100 mg

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

30 ml – bottles (1) – cardboard packs (1) (complete with a measuring cup).

Simeticone [Ivanovo Pharmaceutical Factory PJSC (Russia)]
Oral suspension 69.19 mg/ml: jars, fl. or dropper bottles 25 ml, 30 ml, 50 ml, 100 ml, 125 ml, 150 ml or 200 ml

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Simeticone

Oral suspension 69.19 mg/ml: jars, fl. or dropper bottles 25 ml, 30 ml, 50 ml, 100 ml, 125 ml, 150 ml or 200 ml

Dosage Form, Packaging, and Composition

Oral suspension from white to grey-white with a brownish tint, a slightly viscous suspension with a characteristic fruity odor (vanilla-raspberry).

	1 ml (1020 mg)
Simeticone	69.19 mg
(calculated as simeticone emulsion)	345.95 mg

Excipients: hypromellose, carbomer, sodium citrate dihydrate, citric acid monohydrate, vanilla flavor, raspberry flavor, sodium cyclamate, sodium saccharin, sodium benzoate, polyglycostearylic acid ester, sorbic acid, purified water.

25 ml – jars (1) – cardboard packs (1).
30 ml – jars (1) – cardboard packs (1).
50 ml – jars (1) – cardboard packs (1).
100 ml – jars (1) – cardboard packs (1).
125 ml – jars (1) – cardboard packs (1).
150 ml – jars (1) – cardboard packs (1).
200 ml – jars (1) – cardboard packs (1).
25 ml – jars (1) – cardboard packs (1) (complete with a dosing pipette or measuring syringe).
30 ml – jars (1) – cardboard packs (1) (complete with a dosing pipette or measuring syringe).
50 ml – jars (1) – cardboard packs (1) (complete with a dosing pipette or measuring syringe).
100 ml – jars (1) – cardboard packs (1) (complete with a dosing pipette or measuring syringe).
125 ml – jars (1) – cardboard packs (1) (complete with a dosing pipette or measuring syringe).
150 ml – jars (1) – cardboard packs (1) (complete with a dosing pipette or measuring syringe).
200 ml – jars (1) – cardboard packs (1) (complete with a dosing pipette or measuring syringe).
25 ml – dropper bottle (1) – cardboard packs (1).
30 ml – dropper bottle (1) – cardboard packs (1).
50 ml – dropper bottle (1) – cardboard packs (1).
100 ml – dropper bottle (1) – cardboard packs (1).
125 ml – dropper bottle (1) – cardboard packs (1).
150 ml – dropper bottle (1) – cardboard packs (1).
200 ml – dropper bottle (1) – cardboard packs (1).
25 ml – dropper bottle (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
30 ml – dropper bottle (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
50 ml – dropper bottle (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
100 ml – dropper bottle (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
125 ml – dropper bottle (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
150 ml – dropper bottle (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
200 ml – dropper bottle (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
25 ml – bottles (1) – cardboard packs (1).
30 ml – bottles (1) – cardboard packs (1).
50 ml – bottles (1) – cardboard packs (1).
100 ml – bottles (1) – cardboard packs (1).
125 ml – bottles (1) – cardboard packs (1).
150 ml – bottles (1) – cardboard packs (1).
200 ml – bottles (1) – cardboard packs (1).
25 ml – bottles (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
30 ml – bottles (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
50 ml – bottles (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
100 ml – bottles (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
125 ml – bottles (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
150 ml – bottles (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).
200 ml – bottles (1) – cardboard packs (1) (complete with a measuring spoon or measuring cup, or measuring syringe, or dosing pipette).

Simeticone [Iris, LLC (Russia)]
Oral drops 40 mg/ml: 30 ml bottle
Oral drops 100 mg/ml: bottle 30 ml

Marketing Authorization Holder

Iris, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Forms

	Simeticone	Oral drops 40 mg/ml: 30 ml bottle
		Oral drops 100 mg/ml: bottle 30 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

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

30 ml – bottles (1) – cardboard packs (1) (complete with a measuring cup).

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

	1 ml (20 drops)
Simeticone*	100 mg

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

30 ml – bottles (1) – cardboard packs (1) (complete with a measuring cup).

Simeticone [Production Of Medicaments, LLC (Russia)]
Capsules 40 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Production Of Medicaments, LLC (Russia)

Dosage Form

Simeticone

Capsules 40 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 3, with a purple body and cap, opaque; capsule contents – white or almost white spherical pellets.

	1 caps.
Simeticone*	40 mg

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

Excipients: microcrystalline cellulose – 24 mg, silicon dioxide (aerosil) – 1.6 mg, mannitol – 12 mg, sodium hydrogen phosphate – 2.4 mg.

Composition of the hard gelatin capsule titanium dioxide (E171) – 1%, dye azorubine (E122) – 0.1395%, dye iron oxide black (E172) – 0.7846%, gelatin – 100%.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.

Simeticone [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Oral drops 66.66 mg/1 ml: 30 ml bottle