Medicinal Products

DOMPERIDONE EG 10 mg

Generic drug of Motilyo
Therapeutic class: Gastro-Entero-Hepatology
Active ingredients: Domperidone
laboratory: EG Labo

Orodispersible tablet
box of 30
All forms

Indication

Adults and adolescents (from 12 years and 35 kg)

DOMPERIDONE EG is indicated for the relief of symptoms such as nausea and vomiting.

Dosage DOMPERIDONE EG 10 mg orodispersible tablet box of 30

Adults and adolescents (from 12 years and 35 kg)

DOMPERIDONE EG is indicated for the relief of symptoms such as nausea and vomiting.

Against indications

Domperidone is contraindicated in the following situations:

· Known hypersensitivity to domperidone or any of the excipients;

· Pituitary prolactin tumor (prolactinoma);

· In patients with moderate or severe hepatic impairment (see section 5.2 ).

· In patients with known prolongation of cardiac conduction intervals, including QTc interval, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure (see Warnings and Precautions section). of employment ),

· Concomitant administration with drugs that prolong the QT interval (see section 4.5 ).

· Concomitant administration with strong CYP3A4 inhibitors (regardless of their effects of QT prolongation) (see section 4.5 ).

This medication should not be used when stimulation of gastric motility may be harmful: gastrointestinal bleeding, mechanical obstruction or digestive perforation.

Side effects Domperidone Eg

Adverse reactions are ranked in order of decreasing frequency, with the following conventions: very common (≥ 1/10), common (≥ 1/100, <1/10), infrequent (≥ 1/1000, <1 / 100), rare (≥ 1/10 000, 1/1 000), very rare (<1 / 10, 000), unknown (can not be estimated from the available data).

System, organ, class (MedDRA classification)

Rare (≥1 / 10, 000, <1 / 1, 000),

Very rare (<1 / 10, 000),

unknown (can not be estimated from available data)

Immune system disorders

allergic reaction including: anaphylaxis, anaphylactic shock, anaphylactic reaction, urticaria, angioedema

Endocrine system disorders

increased levels of prolactin 1

Nervous system disorders

extrapyramidal side effects 2, convulsion 3, somnolence 3, headache

Restless legs syndrome *

Gastrointestinal disorders

gastrointestinal disorders, including very rare and transient intestinal cramps

diarrhea

Skin and subcutaneous tissue disorders

pruritus, rash.

Reproductive and mammary disorders

galactorrhea, gynecomastia, amenorrhea.

Cardiac disorders

ventricular arrhythmias

Ventricular arrhythmias, prolongation of the QTc interval, torsade de pointes, sudden death (see Warnings and precautions for use section )

Psychiatric disorders

Stirring 3, nervousness

investigations

Anomaly of liver tests

* exacerbation of restless legs syndrome in patients with Parkinson's disease

1 Since the pituitary gland is below the blood-brain barrier, domperidone may cause an increase in prolactin levels. In rare cases, this hyperprolactinemia can lead to neuroendocrine side effects such as galactorrhea, gynecomastia and amenorrhea.

2 Extrapyramidal side effects are very rare in newborns and infants, and exceptional in adults. These side effects regress spontaneously and completely as soon as treatment is stopped.

3 Other central nervous system effects such as convulsions, restlessness and drowsiness are very rare and occur mainly in infants and children.

Due to the presence of sulfur dioxide (E220), there is a rare risk of severe hypersensitivity reactions and respiratory discomfort.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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