Keep out of reach of children.
Read all of this leaflet carefully before you start taking this medicine.
The drug is for prescription only.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Domperidone .................................... 10 mg
Excipients q.s …………………………….. 1 tablet
Film coated tablet.
Product description: A white to off-white, round, film-coated tablet, plain on both sides, intact edges.
Domperidone has no or negligible influence on the ability to drive or use machines.
Pregnancy
Modom’S is contraindicated in pregnant women.
Breast-feeding
Domperidone is excreted in human milk and breast-fed infants receive less than 0.1% of the maternal weight-adjusted dose. Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the women. Caution should be exercised in case of QTc prolongation risk factor in breast-fed infants.
The effect of domperidone is inhibited by anticholinergic agents, opioid analgesics and antimuscarinic drugs.
Increased risk of occurrence of QT-interval prolongation, due to pharmacodynamic and/or pharmacokinetic interactions.
Concomitant use of the following substances is contraindicated:
QTc-prolonging medicinal products:
- anti-arrhythmics class IA (e.g., disopyramide, hydroquinidine, quinidine)
- anti-arrhythmics class III (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol)
- certain antipsychotics (e.g., haloperidol, pimozide, sertindole)
- certain antidepressants (e.g., citalopram, escitalopram)
- certain antibiotics (e.g., erythromycin, levofloxacin, moxifloxacin, spiramycin)
- certain antifungal agents (e.g., pentamidine)
- certain antimalarial agents (in particular halofantrine, lumefantrine)
- certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride)
- certain antihistaminics (e.g., mequitazine, mizolastine)
- certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine)
- certain other medicines (e.g., bepridil, diphemanil, methadone)
(see Contraindications)
Potent CYP3A4 inhibitors (regardless of their QT prolonging effects), i.e:
- protease inhibitors
- systemic azole antifungals
- some macrolides (erythromycin, clarithromycin and telithromycin)
(see Contraindications).
Concomitant use of the following substances is not recommended:
Moderate CYP3A4 inhibitors i.e. diltiazem, verapamil and some macrolides.
(See Contraindications)
Concomitant use of the following substances requires caution in use:
Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT-interval prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated as it is a potent CYP3A4 inhibitor).
The above list of substances is representative and not exhaustive.
Loss of libido, rash, and other allergic reactions. Galactorrhoea, menstrual disorders, dysmenorrhea, enlarged breast or breast tenderness due to elevated serum prolactin may be seen in patients with high doses of prolonged use.
Cardiac disorders:
Not known: ventricular arrhythmias, QTc prolongation, Torsade de pointes, sudden cardiac death (See Special warnings and precautions for use).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 Center or Regional center for Drug Information and Adverse Drug Reactions Monitoring.
Please inform your doctor of all undesirable effects upon drug administration.
Domperidone should be administered to Parkinsonian patients not more than 12 weeks. The possible nervous central adverse effects may happen. Domperidone should only be used in Parkinsonian patients when other safer antiemetic measures have failed. Domperidone should be administered with caution in patients with liver and kidney impairment.
Renal impairment:
The elimination half-life of domperidone is prolonged in severe renal impairment. For repeated administration, the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced.
Cardiovascular effects:
Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking domperidone. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors (see Undesirable effects).
Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see Undesirable effects). A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors.
Domperidone should be used at the lowest effective dose in adults and children.
Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patients with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia (see Contraindications). Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrhythmic risk.
Treatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patient should consult their physician.
Patients should be advised to promptly report any cardiac symptoms.
Related to lactose excipient:
Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Modom’S is indicated for the relief of the symptoms of nausea and vomiting.
Domperidone is contraindicated in the following situations:
In patients with vomiting after surgery. In patients with gastro-intestinal haemorrhage, mechanical obstruction. Children younger than 1 year of age. Frequent and long-term administration of domperidone.
In patients with moderate or severe hepatic impairment (see Pharmacokinetics).
In patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure.
Co-administration with QT-prolonging drugs (see Interactions).
Co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects) (see Interactions).
Modom’S should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
It is recommended to take oral domperidone tablets before meals. If taken after meals, absorption of the drug is somewhat delayed.
Patients should try to take each dose at scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose.
Usually, the maximum treatment duration should not exceed one week.
Adults and adolescents (12 years of age and older and weighing 35 kg or more):
One 10mg tablet up to three times per day with maximum dose of 30 mg per day.
Neonates, infants, children (less than 12 years of age) and adolescents weighing less than 35 kg.
Due to the need for accurate dosing, domperidone tablets are unsuitable for use in children and adolescents weighing less than 35 kg.
Hepatic impairment:
Modom’S is contraindicated in moderate or severe hepatic impairment (see Contraindications). Dose modification in mild hepatic impairment is however not needed.
Renal impairment:
Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Modom’S should be reduced to once or twice daily depending on the severity of the impairment.
Or as directed by a physician.
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