KUPLATON

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KUPLATON (CUPLATON)

Composition:

Active substance: dimethicone;

1 ml (1 ml = 35 drops) contains 300 mg of dimethicone;

Excipients: colloidal anhydrous silicon dioxide, sorbic acid, sodium saccharin, purified water, glycerol monostearate, polyoxyethylene 100 stearate.

Pharmaceutical form. Oral drops.

Main physicochemical properties: white or yellowish emulsion.

Pharmacotherapeutic group. Drugs used in functional gastrointestinal disorders. ATC code A03AX13.

Pharmacological properties.

Pharmacodynamics.

Simethicone is a surface-active polysiloxane. It reduces the surface tension of gas bubbles, causing their rupture, and facilitates the elimination of gas.

When taken orally, simethicone reduces flatulence caused by various factors and alleviates abdominal bloating and pain.

Pharmacokinetics.

Simethicone is not absorbed from the gastrointestinal tract. It is excreted unchanged in the feces.

Clinical characteristics.

Indications.

Symptomatic treatment of gastrointestinal complaints associated with gas formation, e.g. flatulence, infant colic.

As an adjunct in diagnostic examinations of abdominal organs (X-ray, ultrasound, gastroscopy).

Excessive gas formation following surgical procedures.

As an antifoaming agent in intoxication with detergents.

Contraindications.

Hypersensitivity to dimethicone or to any of the excipients of the medicinal product. Intestinal obstruction, obstructive gastrointestinal disorders.

Interaction with other medicinal products and other forms of interaction.

Antacids containing aluminium hydroxide and magnesium carbonate may adsorb silicones and thus reduce the effectiveness of dimethicone. Dimethicone may increase the absorption of warfarin and digoxin.

Special precautions for use.

No special precautions are required.

Use during pregnancy or breastfeeding.

Controlled studies in this regard have not been conducted in animals or humans. Dimethicone is not absorbed from the gastrointestinal tract and does not penetrate the placental barrier or into breast milk.

Ability to influence reaction rate when driving or operating machinery.

Dimethicone does not affect the reaction rate when driving or operating machinery.

Method of Administration and Dosage

Shake well before use!

1 ml (35 drops) contains 300 mg of dimethicone.

Symptomatic treatment.

Adults and children aged 10 years and older: 5 drops 4 times daily for meteorism, mixed with a small amount of liquid.

Children aged 6 to 10 years: 4 drops 4 times daily, mixed with a small amount of liquid.

Infants and children under 6 years of age: 1 to 3 drops 4 times daily, mixed with a small amount of liquid in a bottle with infant formula or during meals.

Infants: for the treatment of colic, 4 drops mixed with a small amount of liquid before each feeding.

Preparation for radiological or ultrasound examination.

Adults: 12 drops after meals 3 times daily the day before the examination, and 12 drops in the morning on the day of the examination.

Preparation for gastro-duodenoscopy.

Adults and children aged 10 years and older: 12 drops 4 times daily for 2–3 days prior to the procedure.

Excessive gas formation in the postoperative period.

Adults: 12 drops every 4–6 hours; if necessary, the dose may be increased.

Household detergent poisoning.

In cases of detergent poisoning, dosage depends on the severity of intoxication. The minimum recommended dose of the drug Cuplaton is 1 ml.

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.

Children.

The drug is used in pediatric practice.

Overdose.

No cases of overdose have been reported.

Side effects.

Since the active substance, dimethicone, is not absorbed from the gastrointestinal tract and is excreted unchanged, adverse effects are unlikely. However, rare (≥ 1/10,000 to <1/1,000) side effects have been observed during use of the medicinal product, such as nausea, stomach pain, sensation of bloating, sleep disturbances, weakness, rash. Allergic reactions, including itching, hyperemia, and urticaria, may also occur.

Shelf life. 2 years.

Use within 3 months after opening the bottle.

Storage conditions. Store at a temperature not exceeding 25 °C in a place protected from light.

Keep out of reach of children.

Packaging.

30 ml of drops in a bottle; 1 bottle per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer. Orion Corporation/Orion Corporation.

Manufacturer's address.

Orionintie 1, 02200 Espoo, Finland/Orionintie 1, 02200 Espoo, Finland.