Motelegaz Forte capsules 120mg, No. 20

Symptomatic treatment of flatulence, excess gas and bloating associated with disorders of the gastrointestinal tract, including functional dyspepsia.

Take 1 capsule 3 times daily after meals with a little water. The maximum daily dose is no more than 3 capsules (360 mg).

1 capsule of the drug contains:

active substance: simethicone - 120.00 mg;

excipients: gelatin - 50.60 mg, glycerol - 19.60 mg.

Hypersensitivity to simethicone or other components of the drug, children under 18 years of age.

Trade name: Motelegaz

International non-proprietary name: simethicone.

Dosage form: capsules.

Composition:

1 capsule of the drug contains:

active substance: simethicone - 120.00 mg;

excipients: gelatin - 50.60 mg, glycerol - 19.60 mg.

Description: oval-shaped soft gelatin capsules; contents of capsules: viscous opalescent liquid.

Pharmacotherapeutic group: other drugs for the treatment of functional disorders of the gastrointestinal tract.

ATX code: ј03AX13.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics

Simethicone is a chemically inert polymer of methylsiloxane containing about 5% silicon dioxide.

Simethicone has antifoam and antifoam properties, significantly reduces the surface tension of purified and

model solutions of surfactants. The results of experiments on defoaming showed complete destruction of the foam within 3Ц6 seconds with the addition of a liquid suspension of simethicone at a concentration of 0.1 mg / ml. Below this threshold, complete foam destruction does not occur. As an antifoam agent, simethicone is also effective at a concentration of 0.1 mg / ml. This effect lasts over 24 hours.

The mechanism of action is based on the spread of silicone fluid over the surface of the foam film, as well as on a local change in the surface tension in the contact area. Thus, a rapid drainage of the liquid occurs, which contributes to the rupture of the film, as a result of which the released gas is able to be absorbed or excreted naturally.

Pharmacokinetics

Simethicone is a chemically inert substance that has no physiological activity, it is not absorbed, passes through the digestive tract and is excreted unchanged.

INDICATIONS FOR USE:

Symptomatic treatment of flatulence, excess gas and bloating associated with disorders of the gastrointestinal tract, including functional dyspepsia.

CONTRAINDICATIONS:

Hypersensitivity to simethicone or other components of the drug, children under 18 years of age.

APPLICATION DURING PREGNANCY AND DURING BREASTFEEDING:

There are no clinical data on the effects of simethicone when used during pregnancy.

Simethicone can be used during pregnancy only if the intended benefit of therapy to the mother outweighs the potential risk to the fetus, taking into account the fact that simethicone is physiologically inactive and is not absorbed from the gastrointestinal tract.

There are no data on the excretion of simethicone in breast milk.

DOSAGE AND APPLICATION:

Take 1 capsule 3 times daily after meals with a little water. The maximum daily dose is no more than 3 capsules (360 mg).

SIDE EFFECT:

The frequency of adverse reactions is given in the following gradation: very often (? 1/10); often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); rarely (? 1/10000, <1/1000); very rare (<1/10000), including individual messages of unspecified frequency (frequency cannot be estimated from available data).

According to post-registration application data

Gastrointestinal disorders

Very rare: vomiting

Skin and subcutaneous tissue disorders

Very rare: angioedema, rash

OVERDOSE:

During the analysis of post-registration observation data, no indications of the existence of overdose symptoms were found.

INTERACTION WITH OTHER MEDICINAL PRODUCTS:

There is no data.

SPECIAL INSTRUCTIONS:

If a medicinal product has become unusable or the expiration date has expired, do not throw it into waste water or throw it out into the street! Place the medicine in a bag and put it in the trash can. These measures will help protect the environment!

INFLUENCE ON THE ABILITY TO OPERATE VEHICLES AND OTHER MECHANISMS:

Simethicone does not affect the ability to drive and work with moving machinery.

RELEASE FORM:

Capsules 120 mg.

10 soft capsules in PVC / PVDC / aluminum blister. 1, 2 and 4 blisters in a cardboard box together with instructions for medical use.

STORAGE CONDITIONS:

Store at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

SHELF LIFE:

3 years.

Do not use the drug after the expiration date printed on the package.

HOLIDAY TERMS:

Without recipe.

MANUFACTURER:

The manufacturer of the finished dosage form and issuing quality control:

Catalent France Beinheim SA, France

Legal address: 74 rue Principale, 67930 Beinheim, France / 74 rue Principale, 67930 Beinheim, France

Organization providing primary and secondary packaging:

'Catalent Germany Schorndorf GmbH', Germany / 'Catalent Germany Schorndorf Gmbh', Germany

Legal address : Steinbeisstr. 1 and 2, 73614 Schorndorf, Germany / Steinbeisstr. 1 und 2, 73614 Schorndorf, Germany

Organization accepting claims:

LLC 'Johnson & Johnson', Russia, 121614, Moscow, st. Krylatskaya,

house 17, bldg. 2, tel. (495) 726-55-55.