Koligaz-zdorovya

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KOLIGAS-ZDOROVYA (COLIGAS-ZDOROVYE)

Composition:

Active ingredient: simethicone;

1 tablet contains simethicone, calculated as polydimethylsiloxane – 125 mg;

Excipients: glucose; calcium hydrogen phosphate; microcrystalline cellulose; colloidal anhydrous silicon dioxide; stearic acid; citric acid monohydrate (E 330); mannitol (E 421); quinoline yellow (E 104); Ponceau 4R (E 124); "Red orange" flavor containing ethanol, triacetin (E 1518), orange essential oil, natural orange extract, natural aromatic compounds (aldehydes and esters), butylated hydroxyanisole (E 320).

Pharmaceutical form. Chewable tablets.

Main physicochemical properties: tablets from light orange to orange in color, with specks, oval-shaped, biconvex surface, with a score line on one side, orange flavored.

Pharmacotherapeutic group.

Agents 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 and acts as an antifoaming agent. It alters the surface tension of gas bubbles formed in the intestine, causing their disruption. The released gases may either be absorbed by the intestinal walls or eliminated from the body through intestinal peristalsis. Administration of simethicone 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 the rupture of the contrast film even during intestinal distension.

Pharmacokinetics.

Simethicone acts exclusively on the surface of gas bubbles and is not absorbed through the mucosa of the gastrointestinal tract. After oral administration, simethicone 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 in 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 to any of the excipients.

− Intestinal obstruction.

− Obstructive gastrointestinal disorders.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use

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

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

Due to the presence of glucose in the formulation, the product may be harmful to teeth.

The dye Ponceau 4R contained in the tablets may cause allergic reactions.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

Use during pregnancy or breastfeeding

There are no clinical data on the use of this medicinal product in pregnant women. Since the active ingredient is not absorbed through the gastrointestinal mucosa, no effect of the medicinal product on the fetus or accumulation in breast milk is expected.

Use of this medicinal product 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.

Method of Administration and Dosage

Chewable tablets are intended for oral administration to adults and children aged 12 years and older. The drug may be taken independently of meals.

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

As an adjunct in preparation for diagnostic examinations of abdominal organs: 1 tablet three 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 surface-active 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 should be determined individually. If necessary, the drug may be taken for a prolonged period.

Children. Chewable tablets are 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 simethicone is chemically and physiologically inert, intoxication is practically impossible. In the event of ingestion of doses higher than recommended, medical advice should be sought.

Side effects.

Immune system disorders: allergic manifestations, hypersensitivity reactions, including itching, skin rash, urticaria.

Reporting of side effects

Reporting of adverse reactions following marketing authorization of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy of the medicinal product 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 and sight of children.

Packaging. Tablets, 7 (7×1), 14 (7×2) in a blister pack in a box.

Supply category. Over-the-counter (without prescription).

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and place of business.

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