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Antiflat Lannaher (Tablets, Suspension) Instructions for Use

ATC Code

A03AX (Other drugs for functional gastrointestinal disorders)

Active Substance

Simeticone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug reducing flatulence

Pharmacotherapeutic Group

Carminative agent

Pharmacological Action

A means of reducing 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 suspensions of contrast agents for imaging by the double-contrast method. Acute poisoning with detergents containing foaming substances (tensides), as an antifoaming agent.

ICD codes

ICD-10 code Indication
K30 Functional dyspepsia (digestive disorder)
R10.4 Other and unspecified abdominal pain (colic)
R14 Flatulence and related conditions (including abdominal bloating, belching)
T55 Toxic effect of soaps and detergents
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
ICD-11 code Indication
DD90.0 Globus sensation
DD90.1 Functional dysphagia
DD90.3 Functional dyspepsia
DD90.Z Functional disorders of esophagus or gastroduodenal system, unspecified
DD93.1 Infantile colic
MD81.4 Other and unspecified abdominal pain
ME08 Flatulence and related conditions
NE61 Toxic effect of poisonous substances, chiefly nonmedicinal, not elsewhere classified
QB9A Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally. Adjust the dosage individually based on the clinical indication, patient age, and the specific pharmaceutical form used.

For symptomatic relief of flatulence in adults and children over 6 years: take 40-80 mg (1-2 tablets or 1-2 ml of suspension) after meals and at bedtime. The total daily dose should not exceed 320 mg.

For preparation for diagnostic procedures (e.g., radiography, ultrasonography): take 80-160 mg (2-4 tablets or 2-4 ml of suspension) the evening before the examination. Repeat the same dose on the morning of the procedure.

When used as an additive to contrast agent suspensions, add 40-80 mg (1-2 ml of suspension) per 500 ml of contrast medium to achieve a double-contrast effect.

For the management of acute poisoning by detergents containing tensides, administer a single dose of 40-160 mg (1-4 ml of suspension) to adults; the dosage for children is determined by the physician based on the severity of poisoning.

For infant colic and flatulence in newborns and infants: administer 20 mg (0.5 ml of suspension) before each feeding, up to 4 times per day. Use only the oral suspension form for this age group. Do not use tablets in children under 6 years.

Shake the suspension well before each use. For accurate dosing of the suspension, use the measuring dropper or cup provided. Take tablets with a small amount of water.

If symptoms persist after 3-4 days of therapy, consult a physician to re-evaluate the diagnosis and treatment strategy.

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 are 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

VALEA NT, LLC (Russia)

Manufactured By

Lannacher Heilmittel, GmbH (Austria)

Dosage Form

Bottle OTC Icon Antiflat Lannaher Chewable tablets 42 mg: 30 or 50 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets round, biconvex, white in color, with a characteristic odor.

1 tab.
Simeticone 42 mg

Excipients: glyceryl monostearate, bitter fennel fruit essential oil, dextrose, sucrose.

10 pcs. – Al/PVC blisters (3) – cardboard packs.
10 pcs. – Al/PVC blisters (5) – cardboard packs.

Marketing Authorization Holder

VALEA NT, LLC (Russia)

Manufactured By

G.L. Pharma, GmbH (Austria)

Dosage Form

Bottle OTC Icon Antiflat Lannaher Oral suspension 41.2 mg/ml: 50 ml or 100 ml bottle

Dosage Form, Packaging, and Composition

Oral suspension almost white in color, with a characteristic banana odor.

1 ml
Simeticone 41.2 mg

50 ml – brown glass bottles (1) – cardboard packs.
100 ml – brown glass bottles (1) – cardboard packs.

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