Simeticone

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SIMETICONE

Composition:

Active substance: 1 tablet contains simethicone 125 mg;

Excipients: aluminium hydroxide; lactose monohydrate; microcrystalline cellulose; calcium hydrogen phosphate; stearic acid; colloidal anhydrous silicon dioxide; crospovidone; povidone; dry mixture "Opadry II white" containing titanium dioxide (E 171), talc, polyethylene glycol (macrogol), polyvinyl alcohol; tartrazine (E 102).

Pharmaceutical form. Coated tablets.

Main physicochemical properties: coated tablets, yellow in color, elongated shape with a biconvex surface, with a score line.

Pharmacotherapeutic group.

Agents used in functional gastrointestinal disorders. Silicones.

ATC code A03AX13.

Pharmacological properties.

Pharmacodynamics.

Simethicone, included in the medicinal product, is a non-toxic, inert surfactant based on silicon, an antifoaming agent. It alters the surface tension of gas bubbles formed in the intestine, causing their destruction. The gases released in this process can either be absorbed by the intestinal walls or eliminated from the body through intestinal peristalsis. Administration of the drug prior to diagnostic examinations of abdominal organs prevents image artifacts caused by gas bubbles; it facilitates thorough coating of the colonic mucosa with contrast agent, thus preventing disruption of the contrast film even during intestinal distension.

Pharmacokinetics.

Simethicone acts exclusively on the surface of gas bubbles and is not absorbed by the mucous membrane of the gastrointestinal tract; after oral administration, it is excreted unchanged. Simethicone does not exert central effects.

Clinical characteristics.

Indications.

− Symptomatic treatment of gastrointestinal disorders associated with gas formation, such as meteorism, including in the postoperative period.

− As an auxiliary agent during diagnostic examinations of abdominal organs (X-ray, ultrasound) and in preparation for gastro-duodenoscopy.

− As an anti-foaming agent in intoxications with surface-active substances (laundry detergents or other cleaning agents).

Contraindications.

− Hypersensitivity to the components of the medicinal product.

− Intestinal obstruction.

− Obstructive gastrointestinal disorders.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of simethicone and laxatives containing mineral oil (paraffin) is not recommended, as mixing these substances leads to reduced effectiveness of simethicone.

Levothyroxine may bind to simethicone. Intestinal absorption of levothyroxine may be impaired when administered simultaneously with simethicone.

Special precautions for use.

If gastrointestinal symptoms (complaints) recur, persist for more than 14 days, or worsen, a physician should be consulted.

If a patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Tartrazine (E 102) may cause allergic reactions.

Use during pregnancy or breastfeeding.

There are no clinical data on the use of the drug during pregnancy. Since the active ingredient is not absorbed through the gastrointestinal mucosa, no effect of the drug on the fetus or accumulation in breast milk is expected.

The use of this drug during pregnancy or breastfeeding is possible only when the expected benefit to the woman outweighs the potential risk to the fetus or infant.

Ability to affect reaction speed when driving or operating machinery.

Since simethicone is an inert substance that is not absorbed, its effect on the ability to drive or operate machinery is practically negligible.

Dosage and Administration

Administer orally to adults and children aged 12 years and older. The administration of the drug is independent of food intake.

Symptomatic treatment of gastrointestinal tract complaints: 1 tablet 3 times daily.

As an adjunctive agent prior to diagnostic examinations of abdominal organs: 1 tablet 3 times daily the day before the examination and an additional 1 tablet on the morning of the examination day.

As an antifoaming agent in intoxications with surfactants (laundry detergents or other cleaning agents): dosage depends on the severity of intoxication. The minimum recommended dose is 3 tablets.

The duration of treatment is determined individually. If necessary, the drug can be taken for a prolonged period.

Children. The medicinal product is indicated for children aged 12 years and older.

For children under 12 years of age, simethicone should be administered in liquid dosage forms.

Overdose.

Cases of overdose have not been reported to date. Since simethicone is chemically and physiologically inert, intoxication is practically impossible. In case of administration of doses higher than recommended, medical advice should be sought.

Side effects.

Immune system: allergic reactions, hypersensitivity reactions such as itching, skin rashes, urticaria, facial swelling, tongue swelling, and breathing difficulties.

Gastrointestinal tract: nausea, constipation.

Shelf life.

2 years from the date of manufacture of the drug in bulk packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

Tablets No. 14 (7×2) in blisters in a box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

Limited Liability Company "Pharmaceutical Company "Vertex".

Manufacturer's address and place of business.

33, Astronomichna Street, building V-1, Kharkiv, Kharkiv region, 61085, Ukraine.