Kuplaton oral drops 300 mg/ml bottle 30 ml

Instructions Kuplaton oral drops 300 mg/ml bottle 30 ml

Composition

active ingredient: 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.

Dosage form

Oral drops.

Main physicochemical properties: white or yellowish emulsion.

Pharmacotherapeutic group

Drugs used in functional gastrointestinal disorders. ATX code A0ZA X13.

Pharmacological properties

Pharmacodynamics.

Dimethicone is a surface-active polysiloxane. It reduces the surface tension of gas bubbles, causing them to collapse and promoting gas release.

When taken orally, dimethicone reduces flatulence caused by various factors, relieves bloating and abdominal pain.

Pharmacokinetics.

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

Indication

Symptomatic treatment of gastrointestinal complaints associated with gas formation, for example, flatulence, colic in infants.

As an aid in diagnostic examinations of the abdominal organs (radiography, ultrasound, gastroduodenoscopy).

Increased gas formation after surgical interventions.

As an antifoam for detergent intoxication.

Contraindication

Hypersensitivity to dimethicone or to any of the excipients of the drug. Intestinal obstruction, obstructive diseases of the gastrointestinal tract.

Interaction with other medicinal products and other types of interactions

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

Application features

No special precautions are required.

Use during pregnancy or breastfeeding

Controlled studies on this subject in animals and with the participation of humans have not been conducted. Dimethicone is not absorbed from the digestive tract, does not penetrate the placental barrier and does not enter breast milk.

Ability to influence reaction speed when driving vehicles or other mechanisms

Dimethicone does not affect the reaction rate when driving or using other mechanisms.

Method of administration and doses

Shake before use!

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

Symptomatic treatment.

Adults and children over 10 years of age: 5 drops 4 times a day for flatulence, mixed with a small amount of liquid.

Children aged 6 to 10 years: 4 drops 4 times a day, 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 baby food bottle or with meals.

Infants: To treat colic, mix 4 drops with a small amount of liquid before each feeding.

To prepare for an X-ray or ultrasound examination.

Adults: 12 drops after meals 3 times a day before the test and 12 drops in the morning on the day of the test.

To prepare for gastroduodenoscopy.

Adults and children over 10 years of age: 12 drops 4 times a day for 2–3 days before the examination.

With increased gas formation in the postoperative period.

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

Poisoning by detergents.

In case of poisoning with detergents, the dosage depends on the severity of the intoxication. The minimum recommended dose of Kuplaton is 1 ml.

The duration of treatment depends on the presence of complaints and is determined by the doctor individually. If necessary, the drug can be taken for a long time.

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, side effects are unlikely. However, rare (≥ 1/10,000 to <1/1,000) adverse reactions such as nausea, stomach pain, bloating, sleep disturbances, weakness, rash have been observed with the use of the drug. Allergic reactions, including itching, flushing, urticaria, are possible.

Expiration date

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 in a cardboard box.

Leave category. Without a prescription.

Vacation category

Without a prescription.

Producer

Orion Corporation.

Address

Orionintie 1, 02200 Espoo, Finland.