Motilium film-coated tablets 10 mg blister 30 pcs.

To relieve symptoms of nausea and vomiting.

• active ingredient: domperidone;
• 1 tablet contains domperidone 10 mg;
• Excipients: tablet core: lactose monohydrate; corn starch; microcrystalline cellulose; pregelatinized potato starch; povidone; magnesium stearate; hydrogenated cottonseed oil; sodium lauryl sulfate;
• film coating: hypromellose, sodium lauryl sulfate.

Motilium® is contraindicated:

• patients with established hypersensitivity to the active or auxiliary substances of the drug;
• patients with a prolactin-secreting pituitary tumor (prolactinoma);
• patients with severe or moderate liver and/or kidney dysfunction;
• patients with known prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte imbalances or underlying heart disease such as congestive heart failure;
• patients with liver failure;
• if stimulation of gastric motor function may be dangerous, for example, in case of gastrointestinal bleeding, mechanical obstruction or perforation;
• with simultaneous use of ketoconazole, erythromycin or other potent CYP3A4 inhibitors;
• with concomitant use of drugs that prolong the QT interval (except apomorphine), such as fluconazole, erythromycin, itraconazole, oral ketoconazole, posaconazole, ritonavir, saquinavir, telaprevir, voriconazole, clarithromycin, amiodarone, telithromycin.

Provided that the dosage and duration of treatment recommendations are followed, domperidone is usually well tolerated and adverse events occur infrequently.

Nervous system: infrequently – headache, drowsiness, dizziness, extrapyramidal disorders; very rarely – insomnia, thirst, lethargy, akathisia; frequency unknown – convulsions, restless legs syndrome (exacerbation of restless legs syndrome in patients with Parkinson’s disease).

Gastrointestinal: often – dry mouth; infrequently – diarrhea; rarely – gastrointestinal disorders, including abdominal pain, regurgitation, change in appetite, nausea, heartburn, constipation; very rarely – short-term intestinal spasms.

Skin and subcutaneous tissue disorders: infrequently – rash, itching, urticaria; frequency unknown – angioedema.

Motilium® should be used at the lowest effective dose for the shortest time necessary to relieve symptoms of nausea and vomiting.

Adults and children over 12 years of age with a body weight of at least 35 kg: 1 tablet (10 mg) 3 times a day.

The maximum daily dose is 3 tablets (30 mg per day).

It is recommended to take Motilium® before meals. Absorption of the drug is somewhat delayed if taken after meals. The patient should take the drug according to the recommended dosage regimen. If a dose is missed, the next dose should be taken according to the recommended regimen. Do not double the dose to make up for the missed one. The duration of treatment should not exceed 1 week.

Use during pregnancy or breastfeeding

Motilium® should be prescribed during pregnancy only if, in the opinion of the doctor, the expected positive effect for the woman outweighs the potential risk to the fetus.

It is not known whether it harms the infant, therefore mothers taking Motilium® should refrain from breastfeeding. A decision on whether to discontinue breastfeeding or to discontinue domperidone therapy should be made taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.

Children

The drug should be used to treat children aged 12 years and older with a body weight of at least 35 kg.

Domperidone should be given to children at the lowest effective dose for the shortest period of time.

Ability to influence reaction speed when driving vehicles or other mechanisms

Dizziness and drowsiness have been observed after the use of domperidone. Therefore, patients should be advised to refrain from driving, operating other machinery, or other activities that require concentration and coordination until they have established how Motilium® affects them.

Symptoms: Overdose has been reported mainly in infants and children. Symptoms of overdose may include agitation, impaired consciousness, convulsions, disorientation, drowsiness and extrapyramidal reactions.

Treatment. There is no specific antidote for domperidone, but in case of significant overdose, symptomatic treatment should be given immediately. Gastric lavage within 1 hour after ingestion and administration of activated charcoal are recommended, as well as close observation of the patient and supportive therapy. ECG monitoring should be performed due to the possibility of QT prolongation. Anticholinergic drugs, drugs for the treatment of Parkinson’s disease may be effective in controlling extrapyramidal reactions.

No special storage conditions are required.

Keep out of reach of children.