Medicinal Products

DOMPERIDONE GNR 10 mg

Generic drug of Motilium
Therapeutic class: Gastro-Entero-Hepatology
Active ingredients: Domperidone
laboratory: Sandoz

Coated tablet
Box of 40
All forms

Indication

Adults :
Relief of symptoms such as nausea and vomiting, sensations of epigastric distension, discomfort in the upper abdomen or gastric regurgitation.

Dosage DOMPERIDONE GNR 10 mg Film-coated tablet Box of 40

It is recommended to take the oral forms of domperidone before meals. If the medicine is taken after meals, its absorption is somewhat delayed.
The initial duration of treatment is four weeks. Patients should be re-examined after four weeks and the need for continued treatment will be assessed.
Adults and adolescents (over 12 years and over 35 kg) :
1 to 2 tablets at 10 mg, three or four times a day, the maximum daily dose being 80 mg.
The compressed form is not suitable for children weighing less than 35 kg.
Children will be treated preferentially with a form of oral suspension at 1 mg / ml.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in the following cases:
- Known hypersensitivity to domperidone or to any of the excipients.
- Pituitary tumor with prolactin (prolactinoma).
- This medication should not be used when stimulation of gastric motility may be harmful: gastrointestinal bleeding, mechanical obstruction or digestive perforation.
- The tablets contain lactose and may be unsuitable in patients with lactose intolerance, galactosemia or glucose or galactose malabsorption.
- Use in case of hepatic disorders: since domperidone is highly metabolized in the liver, this drug should not be used in patients with liver disorders.
NOT RECOMMENDED :
Pregnancy: There is little post marketing data on the use of domperidone in pregnant women. A study in rats showed a toxic effect on reproduction in case of high dose, toxic for the mother. The potential risk in humans is unknown. Therefore, this drug should be used during pregnancy only when the expected therapeutic benefit justifies it.
- Use during lactation: the total amount of domperidone excreted in human milk is estimated to be less than 7 μg per day at the maximum recommended dosage. Toxicity to newborns is unknown. It is therefore recommended that mothers taking this medication not breastfeed their children.

Side effects Domperidone Gnr

- Immune system disorders : very rare; allergic reaction.
- Endocrine system disorders : rare; increased levels of prolactin.
- Nervous system disorders : very rare; extrapyramidal side effects.
- Gastrointestinal disorders : rare; gastrointestinal disorders, including very rare and transient intestinal cramps.
- Skin and subcutaneous tissue disorders : very rare, urticaria.
- Reproductive and mammary disorders : rare; galactorrhea, gynecomastia, amenorrhea.
Because the pituitary gland is below the blood-brain barrier, domperidone can cause an increase in prolactin levels. In rare cases, this hyperprolactinemia can lead to neuroendocrine side effects such as galactorrhea, gynecomastia and amenorrhea.
Extrapyramidal side effects are very rare in newborns and infants, and exceptional in adults. These side effects regress spontaneously and completely when the treatment is stopped.

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