Medicinal Products

DOMPERIDONE SANDOZ 20 mg

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

Divisible 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 SANDOZ 20 mg Film-coated tablet scored box of 40

It is recommended to take DOMPERIDONE SANDOZ 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):

½ to 1 20 mg tablet, 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 oral suspension.

Always follow the dosage given by your doctor, if in doubt consult your doctor or pharmacist.

Against indications

DOMPERIDONE SANDOZ is contraindicated in the following cases:

· Known hypersensitivity to domperidone or any of the excipients,

· Pituitary prolactin tumor (prolactinoma).

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

Side effects Domperidone Sandoz

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: QTc interval prolongation (unknown frequency). Very rare: ventricular arrhythmia.

· 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.

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