Simenal (Drops) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Dosage Form

Simenal

Oral drops 100 mg/1 ml: 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, or 50 ml bottle

Dosage Form, Packaging, and Composition

Oral drops as a viscous milky-white liquid with a characteristic banana odor.

Excipients: banana flavor 03836 – 2 mg, glyceryl monostearate 40-55 – 3.78 mg, acesulfame potassium – 0.3 mg, carbomer (carbopol 971P) – 3 mg, macrogol stearate 40 – 6.17 mg, sodium hydroxide – 0.45 mg, sodium chloride – 0.67 mg, sodium citrate – 4.19 mg, liquid non-crystallizing sorbitol – 199.17 mg, sorbic acid – 1.06 mg, purified water – up to 1 ml.

5 ml – polyethylene bottles with dropper caps (1) – cardboard boxes.
10 ml – polyethylene bottles with dropper caps (1) – cardboard boxes.
15 ml – polyethylene bottles with dropper caps (1) – cardboard boxes.
20 ml – polyethylene bottles with dropper caps (1) – cardboard boxes.
25 ml – polyethylene bottles with dropper caps (1) – cardboard boxes.
30 ml – polyethylene bottles with dropper caps (1) – cardboard boxes.
35 ml – polyethylene bottles with dropper caps (1) – cardboard boxes.
40 ml – polyethylene bottles with dropper caps (1) – cardboard boxes.
45 ml – polyethylene bottles with dropper caps (1) – cardboard boxes.
50 ml – polyethylene bottles with dropper caps (1) – cardboard boxes.

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 obtaining an image by double contrast method.

Acute poisoning by detergents containing foaming substances (tensides), as an antifoaming agent.

ICD codes

Dosage Regimen

Administer orally. Shake the bottle vigorously before each use.

For infant colic and flatulence: administer 10 drops (equivalent to 40 mg simeticone) per dose. Give this dose up to four times daily, typically before each feeding.

For preparation for diagnostic examinations: take 2 ml (equivalent to 200 mg simeticone) the evening before the procedure. Take another 2 ml dose on the morning of the examination.

For use as an additive to contrast agent suspensions: add 4-8 drops per 1 liter of contrast suspension to facilitate double-contrast imaging.

For acute poisoning by detergents: the dosage for adults is 50-100 mg simeticone. For children, administer 25-50 mg simeticone as an emergency antifoaming measure.

For symptomatic relief of flatulence in adults and children over 6 years: take 20-40 drops (80-160 mg simeticone) per dose. This dose can be repeated up to four times daily, following meals and at bedtime.

Measure doses using the provided dropper. Drops can be administered directly into the mouth or mixed with a small amount of cool, non-carbonated water or infant formula immediately before administration.

Do not exceed the recommended daily dosage. The duration of use depends on the indication; for persistent symptoms, consult a physician.

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 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.