Metofarc – emulsion for oral administration

INSTRUCTIONS FOR MEDICAL USE

METOFARC

Trade name of the drug: METOFARC

Active substance (INN): Simethicone

Pharmaceutical form: oral emulsion

Contents:

1 ml contains:

Active ingredient: Simethicone – 66.66 mg.

Excipients: sodium saccharinate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium carmellose, citric acid monohydrate, raspberry flavoring, purified water.

Description: Thick, opaque liquid of whitish or light-cream color with fruity odor.

Pharmacotherapeutic group: medicine against flatulence.

ATX code: 03AX13.

Pharmacological properties

A drug which reduces flatulence. By reducing the surface tension at the interface, it hinders the formation and promotes the destruction of gas bubbles in the intestinal contents and gastrointestinal mucus. The released gases can be absorbed by the intestinal walls or excreted through peristalsis. This prevents the formation of large gas-mucous conglomerates causing painful abdominal bloating.

During sono- and radiography it prevents image defects; promotes better irrigation of colon mucosa by contrast agents, preventing rupture of contrast film.

Due to chemical inertness does not affect microorganisms and enzymes present in the gastrointestinal tract. It does not reduce absorption of food, does not change the reaction and volume of gastric juice.

Pharmacokinetics

Simethicone after oral administration is not absorbed from the gastrointestinal tract and is excreted unchanged in the intestine.

Indications for use

  • Increased gas formation and accumulation of gases in intestinal tract (colic, feeling of fullness in abdomen, flatulence (including in post-operative period), Remgeld syndrome, aerophagia);
  • Preparation for diagnostic studies of the abdominal cavity and pelvis (X-ray, sonography, gastroscopy and duodenoscopy – to prevent foaming).

Dosage and administration method

The drug is prescribed orally, after meals.

Shake bottle until homogeneous emulsion is obtained before use.

For an accurate dosage of the drug at the time of injection of the bottle should be kept upright.

If gastric mucus is increased and there is accumulation of gastric gases: children from 28 days of life to 2 years old are prescribed 8 drops (20 mg simethicone) 4 times per day; children from 2 to 6 years old – 14 drops (35 mg simethicone) 4 times per day; children over 6 years old and adults – 16 drops (40 mg simethicone) 4 times per day.

For more convenient administration, particularly in small children, the drug can be premixed with a small amount of cold boiled water, baby food or non-carbonated liquid.

Once the symptoms disappear the drug should be discontinued.

In preparation for diagnostic procedures (gastrointestinal X-ray examination) 1 day before the examination the preparation is taken twice a day (in the morning and in the evening): for children aged 28 days to 2 years – 10 drops (25 mg simethicone), for children aged 2 to 6 years – 16 drops (40 mg simethicone), for children over 6 years and adults – 20 drops (50 mg simethicone).

For gastrointestinal sonographic examination: 1 day before the examination the drug is prescribed 2 times/day (in the morning and in the evening) in the dosages recommended in preparation for the radiographic examination. The dose should be repeated 3 hours before the study.

Side effects

Allergic reactions may develop.

Contraindications

  • intestinal obstruction;
  • obstructive diseases of the gastrointestinal tract;
  • Infants up to 28 days of life;
  • Hypersensitivity to simethicone and/or other drug components.

Administration during pregnancy and lactation

During pregnancy, the drug may be used only in cases when the anticipated benefits to the mother exceed the potential risk to the fetus.

There are no data on safety of the drug administration in nursing women. During breast feeding the drug should be used only in case of necessity.

Administration in children

The drug is contraindicated in neonates younger than 28 days of life.

Drug interactions

Simethicone may cause impairment of absorption of oral anticoagulants.

Special indications

The drug does not contain sugar, patients with diabetes mellitus and digestive disorders can use it.

It is not recommended to take carbonated drinks during the treatment.

Administration of the drug may distort the results of some diagnostic tests, such as the test with guaiac resin.

Influence on driving and operating machinery

The drug has no effect on driving vehicles and operating machinery.

Overdose

No reports of overdose are available.

Simethicone is not absorbed from digestive tract and overdose is not dangerous to life and health.

Form of production

Oral emulsion 66.66 mg/ml in 30 ml, 50 ml, 100 ml (vials with or without measuring spoon or cup).

Storage conditions

Store in a dry, dark place at temperatures between 15°C and 25°C. Keep out of the reach of children!

Shelf life

3 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies

Released without a prescription.

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