Medicinal Products

DOMPERIDONE GERDA 10 mg

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

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.


ANSM alert of the 10/03/2014:

The PRAC concludes that the balance of benefits and risks remains favorable in children and adults subject to restricting the indication to the symptomatic treatment of nausea and vomiting.

ANSM alert of 01/09/14:

The benefit-risk ratio of domperidone for the relief of nausea and vomiting-like symptoms remains positive in adults, adolescents and children.

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

It is recommended to take this medicine 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.

ANSM alert of 20/02/2014:

Pending the recommendations of the PRAC expected for March 2014, the ANSM recommends:

- reconsider the usefulness of any new prescription

- strictly observe the indications and take into account the cardiac risk (including QT prolongation), especially in patients with risk factors,
- to limit the prescription to the shortest duration of treatment (usually 7 days maximum) and to the lowest possible dose, without exceeding 30 mg / day in the adult. The risk may be higher in patients over 60 years of age or those treated with daily doses greater than 30 mg.


ANSM alert of the 10/03/2014:
Regarding the dosage, the PRAC recommends:
For oral forms:
Children or adolescents under 35 kg: 0.25 mg / kg taken up to 3 times daily.


ANSM alert of 01/09/14:

  • Domperidone should be used at the lowest effective dose for as short a time as possible. The maximum duration of treatment should generally not exceed one week.
  • The new recommended dosages are:
    - For adults and adolescents from 12 years and 35 kg: 10 mg up to 3 times a day, the maximum daily dose being 30 mg.
    - For newborns, infants, children (under 12 years) and adolescents under 35 kg: 0.25 mg / kg up to 3 times daily, the maximum daily dose being 0.75 mg / kg .

Against indications

This medicine is contraindicated in the following cases:

· Known hypersensitivity to domperidone or 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.

ANSM alert of 01/09/14:

Medications that contain domperidone are now contraindicated in patients with moderate or severe hepatic impairment, for conditions that prolong or could affect cardiac conduction, in the case of underlying cardiac conditions such as congestive heart failure, concomitant use of QT prolonging drugs, or strong cytochrome P450 3A4 inhibitors.

Adverse effects Domperidone Gerda

Adverse reactions are classified according to their frequency according to the following convention: very common (> 1/10), common (> 1/100, 1/1000, 1/10000, <1/1000), very rare (<1 / 10000), including isolated cases.

· Immune system disorders: Very rare: allergic reactions including anaphylaxis, anaphylactic shock, anaphylactic reaction and Quincke's edema.

· Endocrine system disorders: Rare: increased prolactin levels.

· Psychiatric disorders: Very rare: agitation, nervousness.

· Nervous system disorders: Very rare: extrapyramidal effects, convulsions, drowsiness, headache.

· Cardiac disorders: Unknown frequency: prolongation of QTc interval, ventricular arrhythmias, sudden death (see Warnings and Precautions section ).

· Gastrointestinal disorders: Rare: gastrointestinal disorders, including very rare and transient intestinal cramps. Very rare: diarrhea.

· Skin and subcutaneous tissue disorders: Very rare: urticaria, pruritus, rash.

· Reproductive and mammary disorders: Rare: galactorrhea, gynecomastia, amenorrhea.

· Investigations: Very rare: test for abnormal liver function.

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 adverse effects such as galactorrhea, gynecomastia and amenorrhea.

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

Central nervous system disorders such as convulsions, restlessness and drowsiness are also very rare and reported mainly in infants and children.

ANSM alert of 01/09/14:

This re-evaluation confirms a slight increase in the risk of serious cardiac adverse events related to the use of domperidone. This risk has been particularly observed in patients over 60 years of age, in patients treated with a daily dose of more than 30 mg, or when concomitant medications that prolong QT interval or cytochrome inhibitors P450 3A4.

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