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INSTRUCTIONS FOR MEDICAL ADMINISTRATION

Bobotik

Drops for oral administration 66.66 mg/ml

Trade name: Bobotik

PHARMACOLOGICAL PROPERTIES

Pharmacokinetics

Simethicone is chemically inert, after oral administration it is not absorbed from the gastrointestinal tract and acts only in its lumen. Does not interact with microorganisms and enzymes and does not affect the digestion process. It is excreted unchanged by the intestines.

INDICATIONS FOR USE

symptoms of intestinal colic and infants;

symptoms of excessive formation and accumulation of gases in the gastrointestinal tract (including flatulence, increased gas formation in the postoperative period);

symptoms of excessive gas formation caused by functional dyspepsia;

preparation for diagnostic studies of the abdominal and pelvic organs (ultrasound, radiography, esophagogastroduodenoscopy, etc.), incl. as an additive to suspensions and contrast agents for obtaining images using the double contrast method;

acute poisoning with detergents containing foaming agents (tensides) as defoamers.

METHOD OF APPLICATION AND DOSES

Inside, after eating.

1 ml of the drug contains approximately 27 drops.

Before use, shake until a homogeneous emulsion is obtained.

For accurate dosage of the drug, during instillation, the bottle should be held vertically.

Increased gas formation and accumulation of gases in the gastrointestinal tract:

children from 28 days of life to 3 years, 8 drops (20 mg of simethicone) 4 times a day;

children from 3 to 6 years old, 14 drops (35 mg of simethicone) 4 times a day;

children over 6 years of age and adults: 16 drops (40 mg of simethicone) 4 times a day.

For more convenient administration of the drug, in particular for young children, it can be pre-mixed with a small amount of cold boiled water, baby food or non-carbonated liquid.

After the symptoms disappear, the drug should be discontinued.

Preparation for diagnostic procedures:

X-ray examination of the gastrointestinal tract:

One day before the study, the drug is used 2 times a day (morning and evening):

children from 28 days of life to 3 years, 10 drops (25 mg)

children from 3 to 6 years old, 16 drops (40 mg)

children over 6 years old and adults – 20 drops (60 mg).

Sonographic examination of the gastrointestinal tract

One day before the examination, the drug is used 2 times a day (morning and evening) in the dosages recommended in preparation for the x-ray examination. Three hours before the start of the study, the dose should be repeated.

Acute poisoning from detergents containing foaming agents (tensides) as an antifoam agent:

Children: From 1.5 to 6 ml of the drug (40-160 drops or up to 1/5 of the contents of the bottle)

Adults: From 6 to 12 ml of the drug (from 1/5 to 2/5 of the contents of the bottle)

SPECIAL INSTRUCTIONS

The drug does not contain sugar; it can be used by patients with diabetes and digestive disorders.

The drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions (including delayed ones).

During treatment, it is not recommended to drink carbonated drinks.

Taking this medicine may interfere with the results of some diagnostic tests, such as the guaiac test.

Best before date

3 years.

An opened bottle must be used within 2 months.

Do not use after the expiration date stated on the package.

Manufacturer

Medana Pharma Joint Stock Company

98-200 Sieradz, st. Polish Military Organization 57, Poland

BOBOTIK

Compound:

Active ingredient: simethicone (dimethicone activated with silicon dioxide in the amount of 30% emulsion);

1 ml of emulsion contains simethicone (dimethicone activated by silicon dioxide in the amount of 30% emulsion) 66.66 mg 1 ml contains approximately 27 drops;

Excipients: sodium saccharin, sodium carmellose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, raspberry flavor (96% ethanol, isopropyl alcohol, aromatics), purified water.

Dosage form. Oral drops, emulsion.

Basic physical and chemical properties: thick opaque emulsion of whitish or light cream color with a sweet and sour taste and raspberry smell.

Pharmacological group.

Medicines used for functional gastrointestinal disorders.

ATX code A03A X13.

Pharmacological properties.

Pharmacodynamics.

Simethicone (activated dimethicone) is a combination of methylated linear siloxane polymers stabilized with trimethylsiloxy groups and silica. By reducing the surface tension at the interface, it impedes the formation and promotes the destruction of gas bubbles in the nutrient suspension and mucus of the gastrointestinal tract (GIT). The gases that are released during this process can be absorbed by the intestinal walls or excreted through peristalsis. This prevents the formation of large gas-mucus conglomerates that cause painful bloating. During sonography and radiography, it prevents image defects and promotes better irrigation of the colon mucosa with contrast agents, preventing rupture of the contrast film.

Pharmacokinetics.

Simethicone after oral administration is not absorbed from the gastrointestinal tract and is excreted unchanged in the feces. Due to chemical inertness, it does not affect microorganisms and enzymes present in the gastrointestinal tract. Does not reduce the absorption of food, does not change the reaction and volume of gastric juice.

Clinical characteristics.

Indications.

Symptomatic treatment of disorders of the digestive tract associated with the accumulation of gases, for example, with flatulence, with colic in newborns.
Preparation for diagnostic examinations of the abdominal and pelvic organs (x-ray examinations, ultrasound diagnostics and gastrofibroscopy).
As a defoamer for acute poisoning with surfactants (washing powders or other detergents).

Contraindications.

Hypersensitivity to simethicone and/or other components of the drug;
complete intestinal obstruction.

Interaction with other drugs and other types of interactions.

Possible malabsorption of oral anticoagulants.

Levothyroxine may bind to simethicone. Therefore, the absorption of levothyroxine may be impaired when simethicone is used simultaneously in infants with thyroid diseases.

Features of application.

The drug should be used with caution in patients with obstructive diseases of the gastrointestinal tract.

Bobotik does not contain sugar, so it can be used by patients with diabetes.

It is not recommended to drink carbonated drinks while using Bobotik.

Taking this medicine may interfere with the results of some diagnostic tests, such as the guaiac test.

If complaints reappear or if there are long-term complaints from the gastrointestinal tract, you should consult a doctor.

The drug contains parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions, including delayed reactions.

Use during pregnancy or breastfeeding.

There is still no evidence that simethicone has a teratogenic or embryotoxic effect. The drug can be used during pregnancy and breastfeeding as prescribed by a doctor.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Does not affect.

Method of administration and dose.

Use the drug orally after consulting a doctor.

Before use, shake until a homogeneous emulsion is obtained.

To accurately measure the dose of the drug, the bottle should be held vertically during instillation.

Take the drug during or after meals, and if necessary, before bedtime.

For disorders of the digestive tract caused by increased accumulation of gases, for example, with flatulence, with colic in newborns

The drug is usually used after meals 3-5 times a day (including before bedtime):

for children under 1 year of age, add 16 drops to a bottle of baby food at each feeding or with a small spoon, give before or after breastfeeding;
children aged 1 to 6 years - 16 drops 3-5 times a day;
children aged 6 to 14 years - 16-32 drops 3-5 times a day;
children over 14 years of age and adults - 32 drops 3-5 times a day.

To make it more convenient for small children to use the drug, it can be mixed in advance with a small amount of boiled chilled water, baby food or non-carbonated liquid.

The duration of treatment depends on the presence of complaints and is decided individually.

Preparation for diagnostic procedures:

X-ray examinations, ultrasound diagnostics.

One day before the study, prescribe to adults 32 drops 3 times a day and 32 drops at a time in the morning before the test. In addition to the contrast agent suspension for adults, add 64-128 drops of Bobotik (2.4-4.8 ml) per 1 liter of contrast mixture to obtain a double-contrast image.

Gastroduodenoscopy

Before endoscopy, use 64-128 drops (2.4-4.8 ml) of Bobotik.

During endoscopy, it is possible, if necessary, to inject a few milliliters of emulsion through the endoscope channel to eliminate gas bubbles that cause interference during the examination.

As an antidote for poisoning with surfactants.

In case of poisoning with detergents, children use from 1.5 to 6 ml of the drug, and adults - from 6 to 12 ml of the drug.

Bobotik can also be used in the postoperative period.

If disorders of the digestive tract reoccur and/or if they are of a long-term nature, a clinical examination should be carried out.

Children.

The drug can be used in pediatric practice.

Overdose.

The drug is chemically inert and is not absorbed from the gastrointestinal tract.

There is still no information about an overdose of Bobotik.

If unusual reactions occur, you should consult your doctor regarding further use of the drug.

Adverse reactions.

When taking the drug in recommended doses, no side effects were identified.

Allergic reactions are possible (skin rash, itching, urticaria).

Best before date. 3 years.

Shelf life after opening the bottle is 2 months.

Do not use after the expiration date stated on the package.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Package.

30 ml in dark glass bottles with a polyethylene dropper stopper and a polyethylene screw cap.

One bottle in a cardboard box.

Vacation category. Over the counter.

Manufacturer.

MEDANA PHARMA Joint Stock Company /

MEDANA PHARMA Spolka Akcyjna.

The location of the manufacturer and its address of place of business.

St. Polish Military Organization 57, 98-200 Sieradz, Poland /

57, Polskiej Organizacji Wojskowej Str., 98-200 Sieradz, Poland.