Coligaz-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KOLIGAS–ZDOROVYE (COLIGAS–ZDOROVYE)

Composition:

Active substance: simeticone;

1 tablet contains simeticone, equivalent to 125 mg of polydimethylsiloxane;

Excipients: aluminium hydroxide, hydralite; 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, polyvinyl alcohol; tartrazine (E 102).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: yellow, elongated, biconvex film-coated tablets with a groove on one side.

Pharmacotherapeutic group. Drugs used in functional gastrointestinal disorders. Silicones. ATC code A03AX13.

Pharmacological properties.

Pharmacodynamics.

Simethicone, an ingredient of 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 disruption. The gases released thereby may 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 promotes thorough coating of the colonic mucosa with contrast medium, thus preventing rupture of the contrast film even during intestinal distension.

Pharmacokinetics.

Simethicone acts exclusively on the surface of gas bubbles and is not absorbed by the gastrointestinal mucosa. 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 adjunctive 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 (detergents or other cleaning agents).

Contraindications.

Hypersensitivity to simethicone or other components of the medicinal product. Intestinal obstruction. Obstructive gastrointestinal disorders.

Interaction with other medicinal products and other forms of interactions.

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

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

Special precautions for use.

If gastrointestinal disturbances persist for a prolonged period or recur, consult a physician.

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

The excipient tartrazine (E 102) may cause allergic reactions.

Use during pregnancy or breastfeeding.

There are no clinical data on the use of the drug in pregnant women. 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 influence reaction rate while 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 intake of the medicinal product is not affected by food intake.

Symptomatic treatment of gastrointestinal disorders: 1 tablet 3 times daily.

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

As an anti-foaming agent in intoxications with surfactant substances (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 may 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, the drug should be administered in liquid dosage forms.

Overdose.

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

Adverse reactions.

Immune system disorders: allergic manifestations, hypersensitivity reactions, including itching, skin rash, urticaria, facial swelling, tongue swelling, and breathing difficulties.

Gastrointestinal disorders: nausea, constipation.

Reporting of adverse reactions.

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of effectiveness via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

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

Keep out of reach of children.

Packaging. Film-coated tablets, pack sizes: №7 (7×1), №14 (7×2) in a blister pack within a carton.

Availability. Over-the-counter (without prescription).

Manufacturer.

Limited liability company "Pharmaceutical Company "Zdorov'ya".

Manufacturer's address and location of business activity.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.