Trimspa 200 film-coated tablets 200 mg strip No. 30

Instructions Trimspa 200 film-coated tablets 200 mg strip No. 30

Composition

active ingredient: trimebutine maleate;

1 tablet contains trimebutin maleate 200 mg;

excipients: microcrystalline cellulose, lactose monohydrate, tartaric acid, corn starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, hypromellose, diethyl phthalate, titanium dioxide (E 171), talc.

Dosage form

Film-coated tablets.

Main physicochemical properties: round, biconvex, white tablets, film-coated, smooth on both sides.

Pharmacotherapeutic group

Drugs used for functional disorders of the gastrointestinal tract.

ATX code A03A A05.

Pharmacological properties

Pharmacodynamics

Trimebutin is a synthetic agonist of peripheral opioid receptors m, d and k. The mechanism of action is a direct effect on the smooth muscles of the digestive tract and the regulation of motility disorders without affecting the central nervous system. Unlike other opioids, trimebutin is not characterized by selectivity for any of the three types of receptors, due to which it can both enhance and inhibit peristalsis. The process of normalization of motility begins 30 minutes after the use of the drug.

Pharmacokinetics

Absorption

After oral administration, trimebutin is almost completely absorbed. The maximum concentration is reached after 30 minutes.

Distribution

Plasma protein binding is about 5%. After oral administration, about 0.05% crosses the placental barrier, and about 0.04% enters breast milk.

Metabolism

Trimebutin is metabolized in the liver.

Breeding

It is excreted in the urine in the form of metabolites.

Indication

Irritable bowel syndrome; functional disorders of the digestive tract accompanied by abdominal pain, cramps, a feeling of fullness, flatulence, constipation or diarrhea.

Contraindication

Hypersensitivity to trimebutin or to other components of the drug.

Interaction with other medicinal products and other types of interactions

Concomitant use of zotepine may prolong the anticholinergic effect. Trimebutin prolongs the effect of d-tubocurarine.

Application features

The drug Trimspa 200 may cause drowsiness, so the drug should be used with caution in patients with central nervous system depression.

Trimspa 200 may enhance the sedative effect of central nervous system depressants and/or ethanol.

The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Ability to influence reaction speed when driving vehicles or other mechanisms

If you experience dizziness or drowsiness, you should refrain from driving or operating other machinery.

Use during pregnancy or breastfeeding

Since there are no data on the use of the drug during pregnancy or breastfeeding, it is contraindicated to prescribe the drug to women during this period. Breastfeeding should be discontinued during treatment with the drug.

Method of administration and doses

Take the tablets orally, with a glass of boiled water.

For adults, the single dose is 200 mg (1 tablet); daily dose is 600 mg (3 tablets).

At the beginning of treatment for irritable bowel syndrome, the maximum daily dose for adults, if necessary, may be 600 mg (3 tablets), divided into 3 doses (i.e. 1 tablet 3 times a day).

The duration of the course of therapy is determined by the doctor individually depending on the severity of the disease. Usually the course of treatment is 2-6 weeks depending on the severity of the disease.

Children

Experience with the drug in children is limited, so it should not be prescribed to this category of patients.

Overdose

There are no data on cases of overdose with trimebutin. It is possible that adverse reactions may be exacerbated.

Adverse reactions

On the part of the digestive tract: dry mouth, taste disturbance, diarrhea, dyspepsia, stomach pain, nausea, constipation.

Nervous system: drowsiness, fatigue, dizziness, anxiety, headache, feeling of cold/heat, hearing impairment.

Immune system disorders: allergic reactions, including skin rashes.

Reproductive disorders: menstrual irregularities, painful breast enlargement.

Renal and urinary disorders: urinary retention.

Expiration date

2 years.

Storage conditions

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging

15 tablets in a strip; 2 strips in a cardboard box with labeling in Ukrainian.

Vacation category

According to the recipe.

Producer

McLeods Pharmaceuticals Limited.

Location of the manufacturer and its business address

Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210 (Phase II), India.