Medicinal Products

DOMPERIDONE TEVA 10 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
Active ingredients: [Dompierre, 933]
laboratory: Teva Sante

Film-coated tablet
box of 40
All forms

Indication

DOMPERIDONE TEVA is indicated for the relief of nausea and vomiting symptoms.

Dosage DOMPERIDONE TEVA 10 mg tablet film-coated box of 40

DOMPERIDONE TEVA is indicated for the relief of nausea and vomiting symptoms.

Against indications

DOMPERIDONE TEVA is contraindicated in the following situations:

· Hypersensitivity known to domperidone or any of the excipients;

· Pituitary prolactin tumor (prolactinoma);

 · when gastric motility stimulation may be harmful, for example in patients with gastrointestinal bleeding, mechanical obstruction or perforation;

· 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 ).

Side effects Domperidone Teva

The job safety of the domperidone has been evaluated in clinical trials and post-marketing experience. Clinical trials (31 double-blind, placebo-controlled trials) included 1275 patients with dyspepsia, gastroesophageal reflux disease (GERD), irritable bowel syndrome, nausea And vomiting or other similar conditions.

All patients were at least 15 years old and received at least one dose of domperidone (domperidone base). The total daily median dose was 30 mg (range 10 to 80 mg). Median exposure duration was 28 days (range 1 to 28 days).

Studies in patients with diabetic gastroparasia, secondary symptoms, chemotherapy or Parkinson's disease have been excluded.

Adverse effects are classified according to their frequency, according to the following convention: very frequent (≥1 / 10), frequent (≥1 / 100 to <1/10), not very frequent (≥1 / 1, 000 to <1/100), rare (≥1 / 10, 000 to <1/1000) and very rare (<1 / 10, 000). When the frequency could not be estimated on the basis of the clinical data, it is indicated as "indefinite".

Body Class System

Undesirable effect

Frà © quence

Frà © Quent

Not very frequent

© Indà ended © e

Immune system disorders

Anaphylactic reaction (including anaphylactic shock)

Psychiatric disorders

Loss of libido

Anxia been © ©

agitation

© nervousness

Nervous system disorders

Drowsiness

CÃ © Phala © es

Extrapyramidal disorders

convulsions

Eye disorders

Oulogyric crisis

Heart conditions

Ventricular arrhythmias

QTc interval prolongation

Torsades de pointes

Sudden death

(see section Warnings and Precautions )

Gastrointestinal disorders

Dry mouth

Diarrha © es

Skin and subcutaneous tissue disorders

Skin rash

itching

Urticaria

Angioedème

Renal and urinary disorders

Urinary retention

Body Class System

Undesirable effect

Frà © quence

Frà © Quent

Not very frequent

© Indà ended © e

Disorders of reproductive organs and breast

Galactorrhà © e

Breast pain

Breast hypersensitivity

© Gyna comastie

Amà © norrhà © e

General disorders and administration site defects.

Astha © nie

investigations

Abnormalities of the tests of the hepatic function, increase of the prolactinemia

Domperidone has been used at higher doses in 45 longer-term clinical trials and in indications such as diabetic gastroparasites. In these studies, the frequency of adverse events (except dry mouth) was considerably higher, particularly the known and related pharmacological effects. s to increase prolactin. In addition to the effects listed above, the following effects have also been observed: akathisia, breast discharge, breast enlargement, breast enlargement, depression, hypersensitivity, disorders of lactation and irregularity of the rules.

Extrapyramidal disorders occur primarily in newborns and infants.

Other disorders of the central nervous system such as convulsions and agitation are mainly reported 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 disclose any suspected adverse effects via the national reporting system: National Agency for Drug and Health Product Safety (ANSM) and network Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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