Babalu^® (Drops) Instructions for Use

Marketing Authorization Holder

Avva Pharmaceuticals, Ltd. (Cyprus)

Manufactured By

Avva Rus, JSC (Russia)

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Dosage Forms

	Babalu®	Oral drops 40 mg/1 ml: 30 ml bottle
		Oral drops 100 mg/1 ml: 30 ml bottle

Dosage Form, Packaging, and Composition

Oral drops in the form of a white or almost white emulsion, homogeneous after shaking, with a characteristic odor.

* Simeticone is a mixture of polydimethylsiloxane (dimethicone) and silicon dioxide in a ratio of 95:5.

Excipients: macrogol stearyl ether 20 – 14 mg, macrogol stearyl ether 2 – 11 mg, carbomer – 3 mg, banana flavor – 2 mg, potassium sorbate – 1.42 mg, sucralose – 0.1 mg, purified water – up to 1 ml.

30 ml – dark glass bottles with a dosing device (dropper cap) (1) complete with a measuring cup – cardboard packs.

Oral drops in the form of a white or almost white emulsion, homogeneous after shaking, with a characteristic odor.

* Simeticone is a mixture of polydimethylsiloxane (dimethicone) and silicon dioxide in a ratio of 95:5.

Excipients: macrogol stearyl ether 20 – 14 mg, macrogol stearyl ether 2 – 11 mg, carbomer – 3 mg, banana flavor – 2 mg, potassium sorbate – 1.42 mg, sucralose – 0.1 mg, purified water – up to 1 ml.

30 ml – dark glass bottles with a dosing device (dropper cap) (1) complete with a measuring cup – cardboard packs.

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 an antifoaming agent.

ICD codes

Dosage Regimen

Administer orally, using the provided dropper or measuring cup. Shake the bottle vigorously before each use to ensure a homogeneous emulsion.

For the 40 mg/ml formulation: Administer 20 drops (1 ml) containing 40 mg simeticone. For the 100 mg/ml formulation: Administer 20 drops (1 ml) containing 100 mg simeticone.

For newborns and infants with colic: Use the 40 mg/ml formulation. Administer 8 drops (0.4 ml) before each feeding, up to four times daily. Drops can be mixed with a small amount of cool, boiled water or infant formula.

For children aged 1 to 6 years: Use the 40 mg/ml formulation. Administer 14-16 drops (0.7-0.8 ml) three to five times daily.

For children over 6 years and adults: Use the 40 mg/ml or 100 mg/ml formulation. Administer 20-30 drops (1-1.5 ml) of the 40 mg/ml formulation three to five times daily. Alternatively, administer 8-10 drops (0.4-0.5 ml) of the 100 mg/ml formulation three to five times daily.

For preparation for diagnostic procedures: Take the dose on the eve of the examination and again on the morning of the procedure, as directed by a physician.

For acute poisoning with detergents: A single dose of 50-100 drops (2.5-5 ml) of the 40 mg/ml formulation or 20-40 drops (1-2 ml) of the 100 mg/ml formulation is administered, depending on the severity of intoxication.

The maximum single dose for adults is 2 ml (40 drops) of the 40 mg/ml formulation or 1 ml (20 drops) of the 100 mg/ml formulation. The maximum daily dose for adults should not exceed 8 ml (160 drops) of the 40 mg/ml formulation or 4 ml (80 drops) of the 100 mg/ml formulation.

Take doses after meals and/or at bedtime. The duration of treatment depends on symptom resolution. Consult a physician if symptoms persist beyond one week of continuous use.

Adverse Reactions

Possible angioedema, rash, allergic reactions, vomiting.

Contraindications

Hypersensitivity to simeticone; intestinal obstruction; pediatric age – 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 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.