Publisher: PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Progit 50 mg must not be used in patients in whom increased gastrointestinal motility could be harmful, e.g. in patients with gastrointestinal haemorrhage, mechanical obstruction or perforation.
Itopride potentiates acetylcholine action and can induce side anticholinergic effects.
Data about long-term administration of itopride is not available.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
No interaction was detected when itopride was administered concomitantly with warfarin, diazepam, diclofenac, ticlopidine, nifedipine and nicardipine.
Drug-drug interactions that arise due to cytochrome P450 metabolism are not assumed because itopride is metabolised mainly by flavine monooxygenase.
Itopride has gastrokinetic effect that could influence the absorption of concomitantly orally administered medicines. Particular attention should be paid to medicines with a narrow therapeutic index, medicines with prolonged-release of the active substance and enteric-coated drug formulations.
Anticholinergic agents may reduce the action of itopride.
Substances as cimetidine, ranitidine, teprenone and cetrexate do not affect prokinetic activity of itopride.
Safety of itopride in pregnancy was not verified. Therefore itopride can be used in pregnant women or women in that pregnancy cannot be excluded only if therapeutic benefits outweigh possible risks considerably.
Data about excretion in mother milk is known only in animals. Because of lack of experience with use of itopride during breast-feeding itopride it is not recommended for breast-feeding women.
Although no effects on ability to drive and use machines have been found, impairment of alertness cannot be ruled out since dizziness may occur very rarely.
Adverse reactions have been ranked according to MedDRA terminology under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Uncommon: Leucopenia*.
Not known: Thrombocytopenia.
* Careful observation should be made through haematological examination. The treatment should be discontinued when any abnormality is observed.
Not known: Anaphylactoid reaction.
Uncommon: Hyperprolactinaemia**.
Not known: Gynecomastia.
** If e.g. galactorrhea or gynecomastia appeals the treatment must be interrupted or terminated.
Uncommon: Irritability.
Uncommon: Headache, sleep disorders, dizziness.
Not known: Tremor.
Uncommon: Diarrhoea, constipation, abdominal pain, hypersalivation.
Not known: Nausea.
Not known: Jaundice.
Rare: Rash, erythema, pruritus.
Uncommon: Chest or back pain.
Uncommon: BUN (blood urea nitrogen) and creatinine increased.
Uncommon: Fatigue.
Not known: AST increased, ALT increased, gamma-GTP increased, alkaline phosphatase increased, bilirubin increased.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Not applicable.
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