Motilium, 10 mg 30 pcs.

Gastrointestinal motility disorders, Nausea, Vomiting, Meteorism, Hiccups, Intestinal infections, Abdominal bloating, Reflux esophagitis, Heartburn For relief of symptoms of nausea and vomiting.

Active ingredient

Domperidone

Composition

Active ingredient:

Domperidone 10 mg;

Excipients:

lactose monohydrate 54.2 mg,

corn starch 20 mg,

microcrystalline cellulose 10 mg,

pregelatinized starch 3 mg,

How to take, the dosage

Oral. It is recommended to take MOTILIUM® tablets 15 – 30 min before a meal. In case of taking the preparation after a meal absorption of domperidone may decrease.

Adults and children over 12 years of age with body weight of 35 kg or more.

1 tablet (10 mg) 3 times a day, maximum daily dose is 3 tablets (30 mg).

Children under 12 years of age and with body weight of 35 kg or more.

1 tablet (10 mg) 3 times a day, the maximum daily dose is 3 tablets (30 mg).

In pediatric practice, MOTILIUM® suspension should be mainly used.

Continuous administration of MOTILIUM® without physician’s consultation should not exceed 7 days in duration. If necessary the physician may prolong the course of treatment.

Use in patients with renal insufficiency.

Since the half-life of domperidone in severe renal insufficiency (with serum creatinine level over 6 mg/10 ml, i.e. over 0.6 mmol/l) increases, the frequency of administration.

Interaction

Interaction with the following drugs may increase the risk of QT interval prolongation.

Contraindicated combinations: drugs that increase the QT interval: Class IA antiarrhythmic drugs (e.g., disopyramide, hydroquinidine, quinidine), Class III antiarrhythmic drugs (e.g., amiodarone, dofetidil, dronedarone, ibutilide, sotalol), antipsychotic drugs (e.g., haloperidol pimozide, sertindole), antidepressants (e.g., citalopram, escitalopram), antibiotics (erythromycin, levofloxacin, moxifloxacin, spiramycin), antifungal drugs (e.g., pentamidine), antimalarials (e.g, halofantrine, lumefantrine), gastrointestinal drugs (e.g., cisapride, dolasetron, prucalopride), antihistamines (e.g., mechitazine, misolastin), anticancer drugs (e.g., toremifene, vandetanib, vincamine) other drugs (e.g., bepridil, difemanyl methyl sulfate, methadone), powerful CYP3A4 inhibitors (protease inhibitors, azole antifungals, some antibiotics from macrolide group (erythromycin, clarithromycin, telithromycin).

Unrecommended combinations: moderate CYP3A4 inhibitors (diltiazem, verapamil, some antibiotics from the macrolide group).

Combinations that should be used with caution: drugs that cause bradycardia and hypokalemia, as well as azithromycin and roxithromycin.

Cimetidine, sodium bicarbonate, other antacids and antisecretory drugs reduce the bioavailability of domperidone.

Increase the plasma concentration of domperidone: azole antifungal agents, antibiotics of macrolide group, HIV protease inhibitors, nefazodone.

Compatible with antipsychotic drugs (neuroleptics), dopaminergic receptor agonists (bromocriptine, levodopa).

Simultaneous use with paracetamol and digoxin has no effect on the blood concentration of these drugs.

Special Instructions

Domperidone is not recommended for prevention of nausea and vomiting after anesthesia. During long-term therapy with the drug, patients should be under regular medical supervision.

Domperidone may cause prolongation of the QT interval on ECG. During the post-marketing studies in patients receiving domperidone, in rare cases prolongation of the QT interval and the occurrence of ventricular tachycardia by “pirouette” type were noted. These adverse reactions were noted mainly in patients with risk factors, with significant electrolyte disturbances or concomitantly taking drugs that increase the QT interval.

During some studies it was shown that domperidone use may increase the risk of ventricular arrhythmia or sudden coronary death (especially in patients older than 60 years or when using a single dose of more than 30 mg, as well as in patients concomitantly taking drugs that increase the QT interval or CYP3A4 inhibitors).

The use of domperidone and other drugs that may cause prolongation of the QT interval, in patients with significant electrolyte disturbances (hypo- and hyperkalemia, hypomagnesemia) or in patients with heart diseases, such as chronic heart failure. It has been shown that the presence of electrolyte disturbances (hypo- and hyperkalemia, hypomagnesemia) and bradycardia may increase the risk of arrhythmia. Domperidone should be discontinued in case of any symptoms that may be associated with arrhythmia. In this case, consult a physician.

In concomitant use, domperidone enhances the effect of neuroleptics. In concomitant use of the drug with dopaminergic receptor agonists (bromocriptine, levodopa) domperidone inhibits undesirable peripheral effects of the latter, such as digestive disorders, nausea and vomiting, without affecting their central effects. The drug is recommended to take the minimum effective dose.

If the drug is out of date or expired – do not throw it in the sewage and on the street! Place the medication in a bag and put it in a trash container. These measures will help protect the environment!

Synopsis

Round biconvex film-coated tablets, white to pale cream color, with the inscription “JANSSEN” on one side of the tablet and M/10 on the other. On the cross section the core of the tablet is white.

Contraindications

– hypersensitivity to domperidone or any other component of the drug;
– lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
– prolactinoma;
– Simultaneous use of oral forms of ketoconazole, erythromycin or other QT interval prolonging drugs or potent CYP34A isoenzyme inhibitors, such as fluconazole, voriconazole, clarithromycin, amiodarone, telithromycin, etc. (see Chapter 3.3). (see.
– marked electrolyte disorders or heart diseases, such as chronic heart failure;
– bleeding from the gastrointestinal tract, mechanical intestinal obstruction, gastric or intestinal perforation;
– hepatic insufficiency of medium and severe degree of severity;
– body weight less than 35 kg;
– children under 12 years of age with body weight less than 35 kg;
– pregnancy;
– breast-feeding period.

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Side effects

According to clinical trials

Adverse reactions observed in ≥ 1% of patients taking MOTILIUMÒ: depression, anxiety, decreased or absent libido, headache, somnolence, akathisia, diarrhea, rash, itching, breast enlargement/gynecomastia, breast pain and sensitivity, galactorrhea, menstrual disorders and amenorrhea, lactation disorders, asthenia.

Adverse reactions observed in < 1% of patients taking MOTILIUMÒ: hypersensitivity, urticaria, mammary gland swelling, mammary gland discharge.

The following adverse effects were classified as follows: very frequently (≥10%), frequently (≥1% but < 10%), infrequently (≥0.1% but < 1%), rarely (≥0.01% but < 0.1%), and very rarely (< 0.01%), including individual cases.

According to spontaneous reports of adverse events.

Immune system disorders. Very rare: anaphylactic reactions, including anaphylactic shock. Psychiatric disorders. Very rarely: increased excitability, nervousness, irritability.

Nervous system disorders. Very rarely: somnolence, headache, dizziness, extrapyramidal disorders and seizures.

Cardiovascular system disorders. Frequency is unknown: ventricular arrhythmia*, ventricular tachycardia by type “pirouette”, sudden coronary death*.

Skin and subcutaneous tissue disorders. Very rarely: urticaria, angioedema.

Renal and urinary tract disorders. Very rarely: urinary retention.

Laboratory and instrumental data. Very rarely: abnormal laboratory parameters of liver function, hyperprolactinemia.

Adverse reactions detected during post-registration clinical studies

Immune system disorders. Frequency unknown: anaphylactic reactions, including anaphylactic shock. Mental disorders. Infrequent: increased excitability, nervousness.

Nervous system disorders. Often: dizziness. Rare: seizures. Frequency unknown: extrapyramidal disorders.

Cardiovascular system disorders. Frequency unknown: ventricular arrhythmia*, pirouette-type ventricular tachycardia, sudden coronary death*.

Gastrointestinal disorders. Frequency unknown: dry mouth.

Skin and subcutaneous tissue disorders. Frequency unknown: angioedema.

Renal and urinary tract disorders. Infrequent: urinary retention.

Laboratory and instrumental data. Infrequent: abnormal laboratory indexes of liver function. Rare: hyperprolactinemia.

* In some epidemiological studies it has been shown that domperidone use may be associated with an increased risk of serious ventricular arrhythmias or sudden death.

The risk of these phenomena is more likely in patients over 60 years of age and in patients taking the drug in a daily dose greater than 30 mg.

It is recommended to use domperidone in the lowest effective dose in adults and children.

Overdose

Symptoms of overdose are most common in infants and children. Signs of overdose are agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions.

Treatment of overdose: Symptomatic, no specific antidote. Gastric lavage, intake of activated charcoal, in case of extrapyramidal reactions – anticholinergic, antiparkinsonian agents. Due to the possible increase in the QT interval, electrocardiogram (ECG) should be monitored.

Pregnancy use

MOTILIUM® is contraindicated in pregnancy and during breastfeeding.

Similarities

Motilium, Passazhix, Motilac, Domperidon-Teva, Motonium, Domperidon, Motilium Express, Motogastric