Valenta Pharmaceuticals Trimedat Forte 300mg film-coated tablets # 20

Release form

White round biconvex film-coated tablets with an embossed symbol in the form of two drop-shaped elements on one side.

In cross section, the core is white or almost white.

pharmachologic effect

Trimebutin, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis.

Acting on peripheral? -, µ- and?

receptors, including those located directly on smooth muscles throughout the gastrointestinal tract (GIT), it regulates motility without affecting the central nervous system.

Thus, trimebutin restores the normal physiological activity of the intestinal musculature in various gastrointestinal diseases associated with motility disorders.

By normalizing visceral sensitivity, trimebutin provides an analgesic effect in abdominal pain syndrome.

Indications

Symptomatic treatment of pain, cramps and discomfort in the abdominal region, bloating (flatulence), intestinal motor disorders with changes in stool frequency (diarrhea or constipation), dyspepsia, heartburn, belching, nausea, vomiting associated with functional diseases of the gastrointestinal tract and biliary tract (non-erosive form of gastroesophageal reflux disease cholelithiasis dysfunction of the biliary tract irritable bowel syndrome sphincter of Oddi dysfunction, postcholecystectomy syndrome).

Postoperative paralytic intestinal obstruction.

Contraindications

Hypersensitivity to the components that make up the drug.

Pregnancy.

Children under 12 years of age (for this dosage form).

Carefully:

The drug Trimedat forte should be used with caution during breastfeeding, since there is no data on its ability to penetrate into breast milk.

Application during pregnancy and lactation

Experimental studies have not revealed data on the teratogenicity and embryotoxicity of the drug.

However, due to the lack of the necessary clinical data, the use of the drug Trimedat forte during pregnancy is contraindicated.

It is not recommended to prescribe Trimedat forte during lactation, due to the lack of reliable clinical data confirming the safety of the drug during this period.

If necessary, use of the drug during lactation should stop breastfeeding.

special instructions

To prevent recurrence of irritable bowel syndrome after the course of treatment during the period of remission, it is recommended to continue taking it at a dose of 300 mg per day for 12 weeks.

Influence on the ability to drive vehicles and mechanisms:

The drug does not have a sedative effect, does not affect the speed of the psychomotor reaction and can be used in people of various professions, including those requiring increased attention and coordination of movements.

However, given the possible side effects that can affect these abilities (dizziness and others), care should be taken when driving and engaging in other potentially hazardous activities.

Structure

One tablet contains:

active substance: trimebutine maleate - 300 mg

excipients: microcrystalline cellulose, povidone (K 25), hypromellose, magnesium stearate

shell composition: Opadray II 85F18422: partially hydrolyzed polyvinyl alcohol, macrogol-3350, titanium dioxide E 171, talc.

Method of administration and dosage

Inside.

Adults and children over 12 years old take 1 tablet 2 times a day (with a break of 12 hours).

The course of treatment for abdominal pain associated with functional diseases of the digestive tract and biliary tract is 28 days.

Side effects

From the digestive system: dry mouth, unpleasant taste, diarrhea, dyspepsia, nausea, constipation.

From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety.

Allergic reactions: skin rash.

Others: menstrual irregularities, painful enlargement of the mammary glands, urinary retention.

Drug interactions

The drug interaction of the drug Trimedat forte is not described.

Overdose

Overdose cases of Trimedat forte have not been registered to date.

Treatment: drug withdrawal, gastric lavage, activated carbon prescription, symptomatic therapy.

There are no specific antidotes.

Storage conditions

In original packaging at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

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

Active substance

Trimebutin

Name ENG

TRIMEDAT FORTE

Clinical and pharmacological group

A drug that regulates the motor function of the gastrointestinal tract

ATX code

Trimebutine

Dosage

300mg

Structure

One tablet contains: active substance: trimebutine maleate - 300 mg excipients: microcrystalline cellulose, povidone (K 25), hypromellose, magnesium stearate shell composition: Opadray II 85F18422: polyvinyl alcohol, partially hydrolyzed, macrogol-3350, titanium dioxide E 171 , talc.

Indications

Symptomatic treatment of pain, cramps and discomfort in the abdomen, bloating (flatulence), intestinal motor disorders with changes in stool frequency (diarrhea or constipation), dyspepsia, heartburn, belching, nausea, vomiting associated with functional diseases of the gastrointestinal tract and biliary tract (non-erosive form of gastroesophageal reflux disease cholelithiasis biliary dysfunction irritable bowel syndrome sphincter of Oddi dysfunction, postcholecystectomy syndrome) Postoperative paralytic intestinal obstruction.

INN / Active ingredient

Trimebutin

Storage conditions and periods

At a temperature not exceeding 25 degrees, in the original packaging.

Expiration date: 2 years

Contraindications

Hypersensitivity to the components that make up the drug.

Pregnancy.

Children under 12 years of age (for this dosage form).

Carefully:

The drug Trimedat forte should be used with caution during breastfeeding, since there is no data on its ability to penetrate into breast milk.

Specifications

Category

Preparations for the gastrointestinal tract

Scope of the drug

Gastrointestinal tract

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

twenty

Scope of application

Gastroenterology

Minimum age from

12 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Valenta Pharmaceuticals

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antispasmodic

Anatomical and therapeutic characteristics

A03AA05 Trimebutin

Packaging

Cardboard box

The target audience

Children

Expiration date in days

730

Dosage (volume) of the substance in the preparation

trimebutine maleate 300 mg

Package weight, g

25

Mode of application

:

Inside.

Adults and children over 12 years old take 1 tablet 2 times a day (with a break of 12 hours).

The course of treatment for abdominal pain associated with functional diseases of the digestive tract and biliary tract is 28 days.

Dosage form

:

Sustained-release film-coated tablets

Information on technical characteristics, delivery set, country of manufacture