Simeotic® 40 mg

Package Insert for Simeotic® capsules 40 mg

Marketing Authorization Number: LP-006132

International Nonproprietary Name: Simethicone

Brand Name: Simeotic^®

Dosage Form: capsules

Composition per one capsule:

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

Description

Spherical or nearly spherical, soft gelatin capsules, yellow to orange in color, with a seam and smooth surface.
The capsule contents are a colorless, viscous, opalescent liquid.
Pharmacotherapeutic group: Antiflatulent.

ATC Code: A03AX13

Pharmacological properties

Pharmacodynamics

Simeotic^® is a drug that reduces the amount of gas in the intestines. The active substance, simethicone, has surface activity and the ability to reduce surface tension at the gas/liquid interface. This leads to the coalescence of gas bubbles and the breakdown of foam, allowing the released gas to be either absorbed or eliminated naturally through intestinal peristalsis. The use of Simeotic^® for preparation for diagnostic examinations prevents the occurrence of image defects caused by gas bubbles.

Pharmacokinetics

Simethicone is chemically inert. After oral administration, it is not absorbed from the gastrointestinal tract (GIT) and acts only within its lumen. It does not affect enzymes or microorganisms present in the GIT. It is excreted unchanged.

Indications for use

• Excessive formation and accumulation of gas in the GIT (flatulence, Roemheld syndrome, aerophagia, postoperative gas buildup);
• Preparation for diagnostic examinations of the abdominal and pelvic organs (ultrasound, X-ray, etc.);
• Symptoms of excess gas caused by functional dyspepsia;
• Acute poisoning by detergents containing foaming agents (as an antifoaming agent).

Contraindications

• Hypersensitivity to the components of the drug;
• Intestinal obstruction;
• Children under 6 years of age.

Use in Pregnancy and Lactation

Simeotic^® can be used during pregnancy and breastfeeding.

Dosage and administration

For complaints related to excess gas:

Adults and children over 6 years: 2 capsules of 40 mg or 1 capsule of 80 mg 3-5 times daily, optionally with a small amount of liquid, after each meal and at bedtime.

The duration of treatment depends on the presence of symptoms of increased gas formation. If necessary, Simeotic^® can be used for a long period.

Preparation for diagnostic examinations: 2 capsules of 40 mg or 1 capsule of 80 mg 3 times daily the day before the examination; 2 capsules of 40 mg or 1 capsule of 80 mg in the morning on the day of the examination, without water.

As an antifoaming agent for poisoning by detergents containing foaming substances: a single dose for adults is 10-20 capsules of 40 mg or 5-10 capsules of 80 mg; for children over 6 years, 3-10 capsules of 40 mg or 2-5 capsules of 80 mg in one dose; dosing depends on the severity of intoxication.

If there is no improvement after treatment, or symptoms worsen, or new symptoms appear, consult a doctor.

Use the drug only according to the indications, dosage, and administration method described in the instructions.

Adverse reactions

Allergic reactions are possible. If you experience any adverse effects listed in the instructions, if they worsen, or if you notice any other adverse effects not listed, inform your doctor.

Overdose

Overdose with Simeotic^® is unlikely due to its chemical and physiological inertness.

Drug interactions

No clinically significant interaction of Simeotic^® with other medicinal products has been established.

Special instructions

In individuals with hypersensitivity to the components of the drug, immediate-type hypersensitivity reactions, as well as delayed-type hypersensitivity reactions, may occur. If any allergic reactions occur, discontinue the drug immediately and consult a doctor.

If excessive gas persists for a long time, it is necessary to consult a doctor for a medical examination.

Effect on ability to drive and operate machinery

The drug does not affect the ability to perform potentially hazardous activities requiring increased concentration and rapid psychomotor reactions (including driving vehicles, operating machinery).

Pharmaceutical form

Capsules, 40 mg, 80 mg.

25 capsules (40 mg dosage) or 15 capsules (80 mg dosage) in a blister pack made of polyvinyl chloride film and printed lacquered aluminum foil.

1 or 2 blister packs of 25 capsules (40 mg) or 2 blister packs of 15 capsules (80 mg), along with the package insert, are placed in a cardboard carton.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.

2 years. Do not use after the expiration date.

Regulatory status

Over-the-counter

Marketing Authorization Holder / Organization for Claims:

JSC "AVVA RUS", Russia 121614, Moscow, Krylatskie Kholmy St., 30, building 9.

Tel./Fax: +7 (495) 956-75-54. avva.com.ru

Manufacturing address:

UP "Minskintercaps", Republic of Belarus, 220075, Minsk, Inzhenernaya St., 26.

Tel. +375 (17) 276-01-59