Medicinal Products

PERIDYS 10 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
Active ingredients: [Dompierre, 933]
laboratory: Pierre Fabre Medicament

Film-coated tablet
box of 40
All forms

Indication

PERIDYS 10 mg, film-coated tablet is indicated for the relief of nausea and vomiting-like symptoms.

Dosage PERIDYS 10 mg tablet film-coated box of 40

PERIDYS 10 mg, film-coated tablet is indicated for the relief of nausea and vomiting-like symptoms.

Against indications

The domperidone is contraindicated in the following situations:

· Hypersensitivity to the active substance or to any of the excipients listed under Composition ;

· Pituitary prolactin tumor (prolactinoma);

· In patients with moderate or severe hepatic impairment (see section Pharmacokinetic properties );

· In patients with known prolongation of cardiac conduction intervals, including the QTc interval, patients with significant electrolyte disturbances or underlying heart disease such as congestive heart failure (see section 4.4). Warnings and Precautions );

· Concomitant administration with medicinal products that prolong the QT interval (see section 4.5 Interactions with other medicinal products and other forms of interaction ).

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

 · When gastric motility stimulation may be harmful: gastrointestinal bleeding, mechanical obstruction or digestive perforation.

Peridys side effects

Adverse effects are classified according to their frequency, according to the following convention: very frequent (> 1/10), frequent (> 1/100, 1/1000, 1/10000, <1/1000), very rare (<1/10000), undefined frequency (can not be estimated from the available data)

 · Immune system disorders:

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

 · Endocrine disorders:

Rare: increased prolactin levels 1 .

· Psychiatric conditions:

Very rare: agitation 3, nervousness.

 · Nervous system disorders:

Very rare: extrapyramidal effects 2, convulsions 3, somnolence 3, cephalad.

 · Heart conditions:

Uncertain: ventricular arrhythmias, QTc prolongation, torsade de pointes, 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: hives, pruritus, rash.

 · Disorders of the reproductive organs and breast:

Rare: galactorrhea, gynecomasty, ameliorated.

· Investigations:

Very rare: test for abnormal hepatic function.

1 Since the pituitary gland is located below the hemi-encephalic barrier, domperidone may cause an increase in prolactin levels. In rare cases, this hyperprolactinemia can lead to neuroendocrine inducible effects such as galactorrhea, gynecomasty, and ameliority.

2 Extrapyramidal effects are very rare in newborns and infants, and exceptional in adults. These untoward effects spontaneously and completely subside at the end of treatment.

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

Declaration of suspected untoward effects

The declaration of suspected adverse effects after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals should report any suspected adverse effects via the national reporting system: National Agency for Drug and Health Product Safety (Ansm) and Ree Bucket of the Regional Pharmacovigilance Centers. Website: www.ansm.sante.fr.

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