Itoprid PMCS 50 mg
Itopride hydrochloride 50 mg in one coated tablet
Prokinetics (ATC code: A03FA07)
The drug is intended for the treatment of gastrointestinal symptoms of functional non-ulcer dyspepsia such as feelings of bloating, gastric fullness, discomfort due to pain in the epigastrium, anorexia, heartburn, nausea and vomiting. The medicinal product is intended for adults.
Itopride acts as a dopamine D2-receptor antagonist and acetylcholinesterase inhibitor. It activates gastrointestinal motility – increases oesophageal peristalsis, stimulates gastric motility, accelerates gastric emptying and improves gastroduodenal coordination. It also acts as an antiemetic.
Posology and method of administration
The usual dose for adults is 1 tablet three times daily before meals. Tablets should be swallowed whole with a sufficient amount of fluid.
Hypersensitivity to itopride or any of the excipients of this drug. Itopride must not be administered to patients for whom increased gastrointestinal motility could be harmful, e.g. patients with gastrointestinal bleeding, mechanical obstruction or perforation.
Interactions at the cytochrome P-450 level are not expected. Anticholinergic agents reduce the effect of itoprid. Itoprid may influence the absorption of concomitantly administered oral substances, attention must be paid especially to drugs with a narrow therapeutic index, medicinal products with prolonged release of the active substance, and pharmaceutical forms with a gastro-resistant coating.
Itoprid is usually very well tolerated; adverse reactions are rare and include diarrhoea, constipation, abdominal pain, headache, sleep disorders, dizziness, fatigue, increased prolactin levels, etc.
Special warnings and precautions for use
Due to limited experience, itopride is not intended for use in children, pregnant and lactating women. Patients with impaired hepatic and renal function should be monitored and in the event of adverse effects it is necessary to take appropriate measures such as reducing the dose or discontinuing therapy. Itoprid increases the effect of acetylcholine and may cause adverse cholinergic reactions.
For more detailed product information, see the Summary of Product Characteristics.
Contents of container
10, 20, 30, 40, 90, 100 or 120 coated tablets
Package available in the Czech Republic
40 or 100 coated tablets