Itoprid PMCS 50 mg

Basic information

Composition

Itopride hydrochloride 50 mg in one coated tablet

Pharmacotherapeutic group

Prokinetics (ATC code: A03FA07)

Therapeutic indications

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.

Pharmacological properties

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.

Pharmaceutical form

Film-coated tablets

More information

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.

Contraindications

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

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.

Undesirable effects

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.

Availability

The medicinal product is available on prescription only and is covered by health insurance.

Contents of container

10, 20, 30, 40, 90, 100 or 120 coated tablets

Package available in the Czech Republic

40, 100 or 120 coated tablets

SPC and PIL

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

13 August 2020

Product images