Motiligas

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MOTILIGAS (MOTILIGAS)

Composition:

Active substance: simethicone;

1 soft capsule contains 120 mg of simethicone;

Excipients: gelatin, glycerin, purified water.

Pharmaceutical form. Soft capsules.

Main physicochemical properties: oval capsules with naturally transparent shell and oily opalescent contents.

Pharmacotherapeutic group. Agents used in functional intestinal disorders. Other agents used in functional gastrointestinal disorders. Silicones.

ATC code A03AX13.

Pharmacological properties.

Pharmacodynamics. Simethicone is a physiologically inert substance and therefore pharmacologically inactive. It acts by altering the surface tension of gas bubbles, causing their coalescence.

Pharmacokinetics. Simethicone is not absorbed from the gastrointestinal tract following oral administration and is excreted from the body unchanged.

Clinical characteristics.

Indications. Symptomatic treatment of bloating (meteorism).

Contraindications. Hypersensitivity to the active substance or to any of the excipients. Complete intestinal obstruction. Obstructive gastrointestinal disorders.

Interaction with other medicinal products and other forms of interaction. Levothyroxine may bind to simethicone. Intestinal absorption of levothyroxine may be impaired when administered concomitantly with simethicone. Studies on interaction with other medicinal products have not been conducted.

Special precautions for use

If symptoms persist or worsen, and also in case of prolonged constipation, the patient should consult a physician.

Use during pregnancy or breastfeeding.

There are no data on the use of simethicone during pregnancy and lactation.

Although simethicone is not absorbed in the gastrointestinal tract and is physiologically inert, the medicinal product should be prescribed during pregnancy or breastfeeding only when, in the opinion of the physician, the expected potential benefit to the mother outweighs the potential risk to fetal/infant development.

Simethicone is not excreted in breast milk.

Fertility. Data on reproductive toxicity of the drug obtained from animal studies are insufficient.

Ability to affect reaction speed when driving or operating machinery. Does not affect the ability to drive or operate machinery.

Dosage and Administration.

Adults: The recommended dose is no more than 4 capsules per day.

The duration of treatment should not exceed 10 days.

Administration method

For oral use.

Take one capsule after each main meal, swallowing with a glass of water.

Children. Motiligas is not recommended for use in children due to lack of appropriate information.

Overdose. No cases of overdose have been reported. In case of administration of doses higher than recommended, consult a physician. Keep out of reach of children.

Adverse Reactions

The frequency of adverse reactions is defined as follows: very common — ≥1/10; common — from ≥1/100 to <1/10; uncommon — from ≥1/1,000 to <1/100; rare — from ≥1/10,000 to <1/1,000; very rare — <1/10,000; frequency not known — cannot be estimated based on available data.

Gastrointestinal disorders: frequency not known — nausea, vomiting, constipation.

Immune system disorders: frequency not known — hypersensitivity reactions such as skin rash, itching, facial or tongue swelling, difficulty breathing.

Skin and subcutaneous tissue disorders: frequency not known — rash, angioneurotic edema.

If any adverse reactions occur, treatment should be discontinued and medical advice should be sought.

Reporting of Adverse Reactions

Reporting adverse reactions following marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. No special storage conditions required. Keep out of reach and sight of children.

Packaging. 10 soft capsules in a blister; 2 or 4 blisters per cardboard pack.

Supply category. Over-the-counter (without prescription).

Manufacturer: Catalent France Beine.

Manufacturer’s location and address of its place of business: 74 Rue Principale, Beine, 67930, France.

Marketing Authorization Holder: McNeil Products Limited, England.

Address of Marketing Authorization Holder: 50-100 Holmers Farm Way, High Wycombe, HP12 4EG, England.

Representative of the Marketing Authorization Holder: LLC "Johnson & Johnson Ukraine".

Address of the representative in Ukraine: 32/2 Ostrizkykh Knyaziv St., Kyiv, 01010, Ukraine.

+38 (044) 498 0888
+38 (044) 498 7392