Koligaz-zdorovya
UkraineTable of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KOLIGAS-ZDOROV'YA (COLIGAS-ZDOROVYE)
Composition:
Active substance: simeticone;
1 ml (27 drops) of the preparation contains 40 mg of simeticone, calculated as polydimethylsiloxane;
Excipients: sodium benzoate (E 211); benzoic acid (E 210); sodium saccharin; polyethylene glycol stearate; glycerol monostearate; purified water; banana flavoring containing: mixture of natural and nature-identical flavoring substances, maltodextrin, dextrin (E 1400), glyceryl triacetate (E 1518).
Pharmaceutical form. Oral drops, emulsion.
Main physicochemical properties: homogeneous emulsion, white or almost white in color, with a fruity odor. Slight layering of the emulsion may occur, which disappears upon shaking.
Pharmacotherapeutic group.
Agents used in functional gastrointestinal disorders. Other agents used in functional gastrointestinal disorders. Silicones. ATC code A03AX13.
Pharmacological properties.
Pharmacodynamics.
ColiGas-Zdorovia contains as the active substance simethicone – a stable surface-active polydimethylsiloxane. It changes the surface tension of gas bubbles present in the food bolus and the mucus of the gastrointestinal tract, resulting in the breakdown of the bubbles. The released gases can then be absorbed through the intestinal walls or eliminated via intestinal peristalsis.
Simethicone exerts a purely physical action, does not participate in chemical reactions, and is inert from a pharmacological and physiological standpoint.
Pharmacokinetics.
Simethicone is not absorbed following oral administration and is excreted unchanged through the gastrointestinal tract.
Clinical characteristics.
Indications.
- For symptomatic treatment of gastrointestinal complaints associated with gas formation, such as flatulence and infant colic.
- As an auxiliary agent in diagnostic examinations of the abdominal cavity, such as X-ray imaging, ultrasound diagnostics, and preparation for gastro-duodenoscopy.
- As an anti-foaming agent in intoxications with surface-active substances (laundry detergents or cleaning agents).
Contraindications.
Hypersensitivity to the active substance or to any of the excipients, complete intestinal obstruction.
Interaction with other medicinal products and other forms of interaction.
Currently unknown.
Special precautions for use.
When gastrointestinal symptoms first appear and/or persist, a clinical examination should be performed.
The medicinal product should be used with caution in patients with obstructive gastrointestinal disorders.
The drops do not contain sugar but contain artificial substances that impart a sweet taste; therefore, the preparation can be administered to patients with diabetes mellitus.
Use during pregnancy or breastfeeding.
No adverse effects during pregnancy or breastfeeding are expected, due to the negligible systemic effect of simethicone. The medicinal product can be used during pregnancy and breastfeeding.
Fertility.
Non-clinical data do not indicate any specific risk to humans regarding effects on fertility.
Ability to affect reaction speed when driving or operating machinery.
ColiGaz-Zdorovya has no effect or has a negligible effect on the ability to drive or operate machinery.
Method of administration and dosage.
Dosage.
27 drops correspond to 1 mL of the emulsion.
For symptomatic treatment of gastrointestinal complaints associated with gas formation
- e.g., in meteorism, in infant colic:
| Age |
Dosage in drops |
Frequency of administration |
||
| Children under 1 year |
27 drops (1 ml) added to a bottle of infant feeding at each feeding, or administered with a small spoon before or after breastfeeding |
|||
| Children aged 1–6 years |
27 drops (1 ml) |
3–5 times daily |
||
| Children aged 6–14 years |
27–54 drops (1–2 ml) |
3–5 times daily |
||
| Children from 14 years and adults |
54 drops (2 ml) |
3–5 times daily |
||
As an adjunct in diagnostic examinations of the abdominal cavity
- radiological examination, ultrasound diagnostics:
| The day before the study |
In the morning on the day of the study |
| 2 ml three times a day (54 drops three times a day) |
2 ml (54 drops) |
- as an additive to contrast media suspensions:
| 4–8 ml (108–216 drops) per 1 liter of contrast agent suspension for double-contrast imaging |
- for preparation for gastroscopy:
| Before endoscopy, apply 4–8 mL (108–216 drops) If necessary during the procedure, several milliliters of the emulsion can be administered through the endoscope's instrument channel to eliminate gas bubbles |
As an antidote in poisoning with surfactants
Depending on the severity of poisoning:
| Age |
Dosage |
| Children |
2.5–10 ml (from 67 drops to 1/3 of the bottle content) |
| Adults |
10–20 ml (from 1/3 to 2/3 of the bottle content) |
Method of administration.
The medicinal product should be taken during or after a meal, and if necessary, before bedtime.
The preparation may also be used in the postoperative period.
Shake before use; when dosing drops, hold the bottle vertically with the opening facing downward.
The duration of treatment depends on the presence of symptoms and is determined individually by the physician.
If necessary, the preparation may be used for a prolonged period (see section "Special instructions").
Children.
The medicinal product may be used in pediatric practice.
Overdose.
Cases of overdose have not been reported to date. Since simethicone is chemically and physiologically inert, intoxication is practically impossible. Even large amounts of the ingested preparation are tolerated without symptoms. In case of using doses higher than recommended, consult a physician.
Side effects.
Hypersensitivity reactions have been reported, including urticaria, rash, erythema, pruritus, allergic dermatitis, and other skin reactions to medicinal products containing simethicone. Frequency cannot be estimated from available data (frequency unknown).
Reporting suspected adverse reactions.
Reporting suspected adverse reactions after medicinal product authorization is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.
Shelf life.
3 years. The shelf life of the product after opening the bottle is 28 days.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach and sight of children.
Packaging.
30 ml in a bottle closed with a dropper stopper and cap, in a carton.
Supply category.
Over-the-counter (without prescription).
Manufacturer.
Limited Liability Company "Pharmaceutical Company "Zdorovya".
Manufacturer's address and place of business.
22 Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.