COLIKID

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KOLIKIDÒ (COLLICKIDÒ)

Composition:

Active substance: simethicone;

1 tablet contains 125 mg of simethicone;

Excipients: magnesium-aluminum silicate, lactose monohydrate, microcrystalline cellulose, calcium hydrogen phosphate, stearic acid, anhydrous colloidal silicon dioxide, crospovidone, povidone K 29/32, Opadry II 85G 52218 yellow.

Pharmaceutical form. Film-coated tablets.

Main physical and chemical properties: oval, smooth on both sides, film-coated tablets of yellow color.

Pharmacotherapeutic group.

Agents used in functional gastrointestinal disorders. Silicones.

ATC code A03AX13.

Pharmacological Properties

Pharmacodynamics

Simethicone, a component of the drug, is a non-toxic, inert surface-active substance based on silicon and acts as 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 through the intestinal walls or eliminated from the body via 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 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 membranes of the gastrointestinal tract. After oral administration, simethicone is excreted unchanged. Simethicone does not exert any systemic 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 drug or its components.
• 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.

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

Use during pregnancy or breastfeeding.

There are no clinical data on the use of Colicid® in pregnant women. Since the active ingredient is not absorbed through the mucous membrane of the gastrointestinal tract, no effect of the drug on the fetus or accumulation in breast milk is expected.

Colicid® may be used during pregnancy or breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction rate 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.

Colikid® tablets are intended for oral administration to adults and children aged 12 years and older. The drug may be taken independently of food intake.

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

As an adjunct in diagnostic examinations of abdominal organs: 1 tablet three times daily the day before the examination and an additional 1 tablet in the morning on the day of the procedure.

As an anti-foaming agent in intoxications with surfactants (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 used for prolonged periods.

Children.

Colikid® tablets may be administered to children aged 12 years and older.

Children under 12 years of age should receive the drug in liquid dosage forms.

Overdose.

Cases of overdose have not been reported to date. Since simeticone 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 rash, urticaria, facial swelling, tongue swelling, and breathing difficulty.

Gastrointestinal tract: nausea, constipation.

Shelf life.

3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

7 tablets in a blister; 2 blisters in a cardboard package.

15 tablets in a blister; 1, 2, or 4 blisters in a cardboard package.

Availability.

Over-the-counter.

Manufacturer.

LLC "KUSUM PHARM".

Manufacturer's location and address of business activity.

40020, Ukraine, Sumy region, city of Sumy, Sykrabina St., 54.

or

Manufacturer.

LLC "GLEDPHARM LTD".

Manufacturer's location and address of business activity.

40020, Ukraine, Sumy region, city of Sumy, Davydovskoho Hryhoriya St., 54.