Colikid
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KOLIKIDÒ (COLLICKIDÒ)
Composition:
Active substance: 1 ml of suspension contains simethicone emulsion equivalent to 40 mg of simethicone;
Excipients: polysorbate 80, carbomer, sodium saccharin, glycerin, sodium benzoate (E 211), raspberry flavor, sodium hydroxide, purified water.
Pharmaceutical form. Oral suspension.
Main physicochemical properties: white-colored suspension with characteristic odor.
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 gases released in this process 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 artifacts in imaging caused by gas bubbles; it promotes thorough coating of the colonic mucosa with contrast medium, thus preventing rupture 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 mucous membranes of the gastrointestinal tract. Simethicone is not absorbed by the gastrointestinal mucosa and, following oral administration, is excreted unchanged. Simethicone has no central effects.
Clinical characteristics.
Indications.
- Symptomatic treatment of gastrointestinal disorders associated with gas formation (e.g., meteorism, including postoperative period, infant colic).
- As an auxiliary agent during diagnostic examinations of abdominal organs (X-ray, ultrasound) and prior to gastro-duodenoscopy.
- As an anti-foaming agent in intoxications with surface-active substances (detergents or other cleaning agents).
Contraindications.
− Hypersensitivity to the medicinal product and its components.
- Intestinal obstruction.
- Obstructive diseases of the gastrointestinal tract.
Interaction with other medicinal products and other types of interactions.
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 taken 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 medicinal product should be used with caution in patients with obstructive gastrointestinal disorders.
Use during pregnancy or breastfeeding
There are no clinical data on the use of Colikid® in pregnant women. Since the active ingredient is not absorbed through the mucous membrane of the gastrointestinal tract, any effect of the drug on the fetus or accumulation in breast milk is not expected.
Colikid® 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 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.
Method of administration and dosage.
To ensure accurate dosing, the package contains a dosing syringe.
For gastrointestinal disorders associated with gas formation
| Age |
Dosage |
Frequency of administration |
| Children under 1 year of age |
0.5–1 ml |
Kolikid® should be added to the bottle with infant food at each feeding or administered with a dosing syringe before or after breastfeeding |
| Children 1–6 years of age |
1 ml |
The medicine should be taken during or after meals every 4–6 hours |
| Children 6–14 years of age |
1–2 ml |
|
| Children from 14 years of age and adults |
2 ml |
|
For preparation for diagnostic examinations of the abdominal cavity
Radiological examinations, ultrasound diagnostics
| Age |
Dosage and frequency of administration |
|
| Day before the procedure |
Morning on the day of the procedure |
|
| Children |
1 mL three times daily |
1 mL as a single dose |
| Adults |
2 mL three times daily |
2 mL as a single dose |
For preparation for gastro-duodenoscopy
| Age |
Dosage and frequency of administration |
|
| Prior to endoscopy |
During endoscopy |
|
| Adults |
4–8 mL as a single dose |
If necessary, administer several milliliters of the suspension through the endoscope channel to eliminate gas bubbles interfering with the examination |
As a defoaming agent in intoxications with surfactant substances (depending on the severity of poisoning)
| Age |
Dosage |
| Children |
From 2.5 to 10 ml |
| Adults |
From 10 to 20 ml |
Colicid can also be used in the postoperative period.
Method of administration of the oral suspension
- Shake the contents of the bottle well before opening.
- Insert the dosing syringe adapter into the neck of the bottle upon first use (Fig. 1).
- Insert the dosing syringe into the adapter (Fig. 2), turn the bottle upside down (Fig. 3), and draw the suspension into the syringe by pulling the plunger to the mark corresponding to the required dose in milliliters (mL) (Fig. 4).
- Turn the bottle upright and remove the dosing syringe from the adapter (Fig. 5).
- Administer the contents of the syringe into the oral cavity (Fig. 6).
- Close the bottle with the plastic cap, leaving the adapter in place.
- Rinse the dosing syringe with water and dry it.
For children under 1 year of age, the suspension may be added to a bottle containing infant feed.
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Take the medication during or after meals, and if necessary, before bedtime.
The duration of treatment depends on the presence of symptoms and is determined individually by a physician.
If necessary, Colikid® can be used for a prolonged period.
In case of recurrence of gastrointestinal disturbances and/or if such disturbances are persistent, a clinical examination should be performed.
Children.
The medication can be used in children from birth.
Overdose.
There have been no reported cases of overdose to date. Since simethicone is chemically and physiologically inert, intoxication is practically impossible. In case of administration of higher doses than recommended, consult a physician.
Side effects.
Immune system: allergic reactions, hypersensitivity reactions, including itching, skin rash, urticaria, facial swelling, tongue swelling, and difficulty breathing.
Gastrointestinal disorders: 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.
After first opening of the bottle, store the medication for no more than 6 months.
Packaging.
30 mL of suspension in a glass bottle. Each bottle is packed in a cardboard box together with a 5 mL dosing syringe and a syringe adapter.
Supply category.
Over-the-counter.
Manufacturer.
LLC "KUSUM PHARM".
Manufacturer's name and address of place of business.
54 Skryabina Street, Sumy, Sumy Region, 40020, Ukraine.