Simeticone
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SIMETICONE
Composition:
Active substance: 1 ml (27 drops) of the preparation contains simethicone 40 mg;
Excipients: sodium benzoate (E 211), benzoic acid (E 210), sodium saccharin, polyethylene glycol stearate, glycerol monostearate, flavour "Banana", purified water.
Pharmaceutical form. Oral drops.
Main physicochemical properties: homogeneous emulsion of white or almost white colour with a fruity odour. Separation of the emulsion may occur, which is eliminated upon shaking.
Pharmacotherapeutic group. Agents used in functional gastrointestinal disorders. Other agents used in functional gastrointestinal disorders. Silicones. ATC code A03A X13.
Pharmacological Properties.
Pharmacodynamics.
The active ingredient of the medicinal product is simethicone — a stable surface-active polydimethylsiloxane. It alters the surface tension of gas bubbles present in the intestinal contents and gastrointestinal mucus, causing the bubbles to break down. The released gases can then be absorbed by the intestinal walls or eliminated through intestinal peristalsis.
Simethicone exerts a purely physical effect, does not participate in chemical reactions, and is inert from both pharmacological and physiological standpoints.
Pharmacokinetics.
Simethicone is not absorbed following oral administration and is excreted unchanged through the gastrointestinal tract.
Clinical characteristics.
Indications.
- For symptomatic treatment of gastrointestinal disorders associated with gas formation, such as meteorism 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 antifoaming agent in intoxications with surface-active substances (e.g. 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.
Clinical evaluation should be performed upon the first occurrence and/or persistent complaints of abdominal discomfort.
The medicinal product should be used with caution in patients with obstructive gastrointestinal disorders.
The drops are sugar-free and 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 are expected during pregnancy or breastfeeding, as the systemic impact of simethicone is negligible. The medicinal product can be used during pregnancy and breastfeeding.
Fertility.
Non-clinical data do not indicate any harmful effect on human fertility.
Ability to influence reaction speed when driving or operating machinery.
The medicinal product 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 disorders associated with gas formation
- For meteorism and infant colic:
| Age |
Dosage in drops |
Frequency of administration |
||
| Children under 1 year |
27 drops (1 ml) to be added to the bottle with infant feed 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
- X-ray examination, ultrasound diagnostics:
| One day before the procedure |
On the morning of the procedure day |
| 2 mL three times a day (54 drops three times a day) |
2 mL (54 drops) |
- As an additive to contrast medium suspensions:
| 4–8 ml (108–216 drops) per 1 liter of contrast agent suspension for double-contrast imaging |
- For preparation for gastroscopy:
| Before endoscopy, administer 4–8 ml (108–216 drops). If necessary during the procedure, several millilitres of the emulsion can be administered through the endoscope's instrument channel to eliminate gas bubbles. |
As an antidote in poisoning with surfactants:
| Age |
Dosage (depending on severity of poisoning) |
| 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.
Take the medicinal product during or after meals, and if necessary, before bedtime.
The medicinal product can also be used in the postoperative period.
Shake well 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 drug may be used for a prolonged period (see section "Special instructions").
Children.
The medicinal product can 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 drug are well tolerated without symptoms. In case of using doses higher than recommended, consult a physician.
Side effects.
In individual cases, hypersensitivity skin reactions including pruritus, rash, and urticaria have been observed during the use of the medicinal product.
Reporting of suspected adverse reactions.
If any adverse reaction occurs, including those not listed in this instruction, consult your doctor. It is very important to report suspected adverse reactions after the medicinal product has been registered. This allows continuous monitoring of the benefit-risk balance of the medicinal product.
Shelf life. 2 years from the date of manufacture of the product in inbulk packaging.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
The shelf life of the product after opening the bottle is 28 days.
Keep out of reach of children.
Packaging. 30 ml in a bottle closed with a dropper stopper and cap, in a box.
Supply classification. Over-the-counter (without prescription).
Manufacturer. Limited liability company "Pharmaceutical Company "Vertex".
Manufacturer's address.
33, Astronomichna Street, lit. "V-1", Kharkiv, Kharkiv region, 61085, Ukraine.