COLIGAZ-ZDOROVYA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT COLIGAS-ZDOROVIYA

Composition:

Active substance: simethicone;

1 capsule contains 125 mg of simethicone;

Excipients: capsule shell contains: gelatin, glycerin, methylparaben (E 218), propylparaben (E 216), patent blue V (E 131), quinoline yellow (E 104).

Medicinal form. Soft capsules.

Main physicochemical characteristics: nearly round, soft gelatin capsules with a seam and smooth surface, from light green to dark green in color, a bluish tint is acceptable. The capsule contents is a viscous, colorless liquid; slight opalescence is permissible.

Pharmacotherapeutic group. Agents used for functional gastrointestinal disorders. Silicones. ATC code A03AX13.

Pharmacological properties.

Pharmacodynamics. Simethicone, a component 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 breakdown. 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 imaging of abdominal organs prevents image artifacts caused by gas bubbles; it promotes thorough coating of the colonic mucosa with contrast medium, thereby preventing disruption of the contrast film even in cases of intestinal distension.

Pharmacokinetics. Simethicone acts exclusively on the surface of gas bubbles and is not absorbed by the mucosa of the gastrointestinal tract. After oral administration, it is excreted unchanged. Simethicone does not exert any central effects.

Clinical characteristics.

Indications.

• Symptomatic treatment of gastrointestinal disturbances associated with gas formation, such as meteorism, including in the postoperative period.
• As an adjunctive agent during diagnostic examinations of abdominal organs (radiography, ultrasound) and in preparation for gastro-duodenoscopy.
• As an anti-foaming agent in intoxications with surface-active substances (detergent powders or other cleaning agents).

Contraindications.

• Hypersensitivity to simethicone or 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.

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

Special precautions for use.

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

Due to the presence of methylparaben (E 218) and propylparaben (E 216), the medicinal product may cause allergic reactions (possibly delayed).

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, effects of the drug on the fetus or accumulation in breast milk are not expected.

The use of the 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 simeticone is an inert substance that is not absorbed, its influence on driving or operating machinery is practically excluded.

Dosage and Administration

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

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

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

As an antifoaming agent in intoxications with surface-active substances (detergents or other cleaning agents): dosage depends on the severity of intoxication. The minimum recommended dose is 3 capsules.

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, prescribe Kolihaz-Zdorovya, oral drops.

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.

Adverse reactions.

Immune system side effects: allergic manifestations, hypersensitivity reactions, including itching, skin rash, urticaria, facial swelling, tongue swelling, and difficulty breathing.

Gastrointestinal side effects: nausea, constipation.

Reporting of adverse reactions. Reporting of adverse reactions after drug registration is important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy 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. Soft capsules No. 10 (10×1), No. 20 (10×2), No. 30 (10×3) in blisters, packed in a box.

Availability classification. Over-the-counter.

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

Manufacturer's address and place of business.
Ukraine, 08301, Kyiv region, Boryspil, Shevchenka St., bld. 100, lit. B-II (corpus 4).