Trimspha 200

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRIMSPA 200 (TRIMSPA 200)

Composition:

Active substance: trimebutine maleate;

One tablet contains trimebutine maleate 200 mg;

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

Medicinal form. Film-coated tablets.

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

Pharmacotherapeutic group.

Agents used in functional gastrointestinal disorders.

ATC code A03A A05.

Pharmacological properties.

Pharmacodynamics.

Trimethobutine is a synthetic agonist of peripheral μ, δ, and κ opioid receptors. Its mechanism of action involves a direct effect on the smooth muscle of the gastrointestinal tract and regulation of motility disorders without affecting the central nervous system. Unlike other opioids, trimethobutine does not exhibit selectivity for any of the three receptor types, which allows it to either enhance or inhibit peristalsis. The process of motility normalization begins 30 minutes after administration.

Pharmacokinetics.

Absorption.

After oral administration, trimethobutine is almost completely absorbed. Maximum concentration is reached within 30 minutes.

Distribution.

Plasma protein binding is approximately 5%. After oral administration, it crosses the placental barrier in an amount of about 0.05% and enters breast milk in an amount of about 0.04%.

Metabolism.

Trimethobutine is metabolized in the liver.

Elimination.

It is excreted in the urine as metabolites.

Clinical characteristics.

Indications.

Irritable bowel syndrome; functional gastrointestinal disorders accompanied by abdominal pain, spasms, sensation of fullness, bloating, constipation, or diarrhea.

Contraindications.

Hypersensitivity to trimebutine or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use.

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

Trimspa 200 may enhance the sedative effect of medicinal products that depress the central nervous system and/or ethanol.

The preparation contains lactose; therefore, the drug must not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

If you have an intolerance to certain sugars, consult your doctor before taking this medicinal product.

Use during pregnancy or breastfeeding.

Since data on the use of the drug during pregnancy or breastfeeding are lacking, the administration of the drug to women during these periods is contraindicated. Breastfeeding should be discontinued during treatment with this drug.

Ability to affect reaction speed when driving or operating machinery.

If dizziness or drowsiness occurs, refrain from driving or operating machinery.

Method of Administration and Dosage

Tablets should be taken orally with a glass of boiled water.

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

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

The duration of treatment is determined individually by a physician depending on the severity of the disease. Usually, the treatment course lasts 2–6 weeks depending on the severity of the condition.

Children.

Experience with the use of the drug in children is limited; therefore, it should not be prescribed to this patient group.

Overdose.

There are no data regarding cases of trimetazidine overdose. Overdose may lead to an increase in the severity of adverse reactions.

Side effects.

Gastrointestinal disorders: dry mouth, taste disturbances, diarrhea, dyspepsia, stomach pain, nausea, constipation.

Nervous system disorders: drowsiness, fatigue, dizziness, restlessness, headache, sensation of cold/heat, hearing impairment.

Immune system disorders: allergic reactions, including skin rashes.

Reproductive system disorders: menstrual cycle disturbances, breast tenderness.

Renal and urinary disorders: urinary retention.

Shelf life.

2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

6 tablets per strip, 1 or 5 strips per cardboard package.

15 tablets per strip; 1 or 2 strips per cardboard package labeled in Ukrainian.

Prescription category.

Prescription only.

Manufacturer.

Macleods Pharmaceuticals Limited.

Manufacturer's address and place of business.

Phase II, Plot No. 12,15, 21, 23, 24, 25, 26, 27, 28, and 30, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210, India.