Lubriol^® (Emulsion) Instructions for Use

Marketing Authorization Holder

PharmVILAR NPO, LLC (Russia)

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Dosage Form

Lubriol®

Emulsion for oral administration 40 mg/ml: 30 ml or 50 ml fl.

Dosage Form, Packaging, and Composition

Emulsion for oral administration from white to yellowish-white, slightly viscous, with a banana odor; separation is allowed, which disappears after shaking.

Excipients: macrogol stearate – 6.56 mg, glyceryl monostearate 40-55 – 4.02 mg, carbomer – 6.35 mg, banana flavor – 4.233 mg, acesulfame potassium – 0.318 mg, sorbitol – 148.159 mg, sodium chloride – 0.708 mg, sodium citrate – 4.445 mg, sodium hydroxide – 0.708 mg, potassium sorbate – 1.42 mg, purified water – up to 1 ml.

30 ml – bottles – cardboard packs complete with a dropper-dispenser.
50 ml – bottles – cardboard packs complete with a dropper-dispenser.
50 ml – bottles – cardboard packs complete with a measuring spoon.
50 ml – bottles – cardboard packs complete with a measuring cap.

Clinical-Pharmacological Group

A drug reducing flatulence

Pharmacotherapeutic Group

Carminative agent

Pharmacological Action

A drug that reduces flatulence. Simeticone is a chemically inert polymer of methylsiloxane containing about 5% silicon dioxide.

It has surfactant properties and the ability to reduce surface tension at the liquid/gas interface, which impedes the formation of gas bubbles and also promotes their coalescence and the destruction of foam in the intestine, as a result of which the released gas is absorbed or eliminated naturally under the influence of intestinal peristalsis.

The use of simeticone in preparation for diagnostic examinations of the abdominal organs prevents the occurrence of image defects caused by gas bubbles.

Pharmacokinetics

Due to physiological and chemical inertness, it is not absorbed in the body; after passing through the gastrointestinal tract, it is excreted unchanged.

Indications

Excessive formation and accumulation of gases in the gastrointestinal tract (flatulence, increased gas formation in the postoperative period); symptoms of excessive gas formation caused by functional dyspepsia; symptoms of intestinal colic in newborns and infants – depending on the dosage form.

Preparation for diagnostic examinations of the abdominal and pelvic organs (ultrasound, radiography, esophagogastroduodenoscopy, etc.), including as an additive to contrast agent suspensions for double-contrast imaging.

Acute poisoning with detergents containing foaming substances (tensides), as a defoaming agent.

ICD codes

Dosage Regimen

Administer orally. Determine the dosage individually based on indication and patient age.

For symptomatic relief of flatulence and functional dyspepsia in adults and children over 14 years: take 2 ml (80 mg) up to four times daily after meals and at bedtime. The maximum single dose is 2 ml (80 mg). The maximum daily dose is 8 ml (320 mg).

For preparation for diagnostic examinations (e.g., ultrasound, radiography): take 2-4 ml (80-160 mg) the evening before the procedure. Take another 2-4 ml (80-160 mg) on the morning of the examination.

When used as an additive to contrast agent suspensions: add 4-8 ml (160-320 mg) per liter of contrast suspension to obtain a double-contrast image.

For acute poisoning with detergents (tensides): administer a single dose of 10-20 ml (400-800 mg) to adults; administer 2.5-10 ml (100-400 mg) to children, depending on age and severity.

For infants and children with intestinal colic: administer 0.5-1 ml (20-40 mg) before or during each feeding, up to four times daily. Use the provided dropper-dispenser for accurate dosing.

For children aged 6 to 14 years: administer 1-2 ml (40-80 mg) up to four times daily after meals.

Shake the bottle vigorously before each use. Use the provided dropper-dispenser, measuring spoon, or measuring cap to ensure accurate measurement of the dose. Do not exceed the recommended maximum daily dose.

Adverse Reactions

Possible angioedema, rash, allergic reactions, vomiting.

Contraindications

Hypersensitivity to simeticone; intestinal obstruction; childhood – depending on the dosage form.

Use in Pregnancy and Lactation

Due to the lack of absorption of the active substance, the risk to the fetus and the penetration of simeticone into breast milk is unlikely. It can be used during pregnancy and breastfeeding according to indications, in recommended doses.

Pediatric Use

It can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the simeticone drug leaflets regarding contraindications for the use of specific simeticone dosage forms in children of different ages.

Special Precautions

If symptoms of excessive gas formation and/or intestinal colic persist for a long time, it is necessary to consult a doctor.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.