BOBOTIK

Active material: Simethicone
When ATH: A03AX13
CCF: Preparation, umenshayuschyy flatulence
ICD-10 codes (testimony): R14, Z51.4
When CSF: 11.09
Manufacturer: MEDANA PHARMA Joint Stock Company (Poland)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Drops for intake Thick opaque liquid from white to white with a cream shade with a fruity odor; allowed separation into a liquid layer and precipitate, which after shaking to form a uniform emulsion.

1 ml
Simethicone emulsion 30%222.2 mg
simethicone66.66 mg

Excipients: sodium saccharin, metilparagidroksiʙenzoat, propilparagidroksibenzoat, carmellose sodium, citric acid monohydrate, raspberry flavor, Purified water.

30 ml – dark glass bottles with cork-screw plastic dropper and cap (1) – packs cardboard.

 

Pharmacological action

Preparation, umenshayuschyy flatulence. Simethicone (activated dimethicone) It is a combination of methylated linear siloxane polymers, trimetilsiloksilovymi stabilized with silicon dioxide groups. By reducing the surface tension at the interface, hinders the formation and contributes to the destruction of the gas bubbles in the contents of the bowel and gastrointestinal mucus. The released gases can thus be absorbed by the intestinal wall or displayed through peristalsis. This prevents the formation of large gas-mucous conglomerates, causing painful bloating.

When sono- and radiography prevents image defects; promotes better irrigation of the colonic mucosa contrast agents, preventing rupture contrast film.

The chemical inertness does not affect the microorganisms and enzymes, present in the gastrointestinal tract. It does not reduce food intake, response and does not alter the volume of gastric juice.

 

Pharmacokinetics

Simethicone after ingestion is not absorbed from the gastrointestinal tract and excreted through the intestines in unchanged form.

 

Testimony

- Increased gas formation and accumulation of gases in the digestive tract (gripes, filling feeling of abdominal, flatulence / incl. Postoperative /, syndrome Remgelda, aerofagija);

- Preparation for diagnostic examinations of the abdomen and pelvis (radiography, Sonography, gastroscopy and duodenoscopy – for the prevention of the formation of foam).

 

Dosage regimen

The drug is prescribed inside, after meal.

Before use, the vial should be shaken until a homogeneous emulsion.

For exact dosage of the drug during instillation of the vial should be held vertically.

At enhanced gas formation and accumulation of gas in the digestive tract Children from 28 day of life to 2 years appoint 8 drops (20 mg simethicone) 4 times / day; Children from 2 to 6 years – by 14 drops (35 mg simethicone) 4 times / day; older children 6 years and adults – by 16 drops (40 mg simethicone) 4 times / day.

For more convenient dosing, In particular small children, it can be premixed with a small amount of cold boiled water, baby food or non-carbonated liquids.

After the disappearance of the symptoms of the drug should be discontinued.

At preparing for diagnostic procedures (X-ray study of the digestive tract) for 1 the day before the study drug taking 2 times / day (in the morning and in the evening): Children 28 day of life to 2 years – 10 drops (25 mg), Children 2 to 6 years – 16 drops (40 mg), older children 6 years and adults – 20 drops (50 mg)

To sonographic studies GIT for 1 the day before the study drug taking 2 times / day (in the morning and in the evening) at dosages, recommended in preparation for radiographic examinations. For 3 hours prior to the study the dose should be repeated.

 

Side effect

Maybe allergic reactions.

 

Contraindications

- Bowel obstruction;

- Obstructive diseases of the digestive tract;

- Newborn to 28 days of life;

- Hypersensitivity to simethicone and / or other components of the drug.

 

Pregnancy and lactation

In pregnancy, the use of the drug is possible only in cases, when the intended benefits to the mother outweighs the potential risk to the fetus.

There are no data on the safety of the drug in breast-feeding women. During breastfeeding the baby medication should be used only when necessary.

 

Cautions

The product does not contain sugar, It can be applied by patients with diabetes and digestive disorders.

During treatment is not recommended intake of carbonated drinks.

The drug can distort the results of certain diagnostic tests, eg, test using guaiac.

Effects on ability to drive vehicles and management mechanisms

The drug has no effect on driving vehicles and maintenance of mechanical devices.

 

Overdose

Reports of overdose are missing.

Simethicone is not absorbed from the gastrointestinal tract, and an overdose is not a threat to life and health.

 

Drug Interactions

Simethicone can cause malabsorption of oral anticoagulants.

 

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

 

Conditions and terms

The drug should be stored in the dark, reach of children, at a temperature from 15 ° C to 25 ° C. Shelf life – 2 year.

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