Medicinal Products

DOMPERIDONE ALMUS 10 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
Active ingredients: Domperidone
laboratory: Almus France

Coated tablet
box of 20
All forms

Indication

DOMPERIDONE ALMUS is indicated for the relief of symptoms such as nausea and vomiting.

Dosage DOMPERIDONE ALMUS 10 mg film-coated tablet box of 20

DOMPERIDONE ALMUS is indicated for the relief of symptoms such as nausea and vomiting.

Against indications

DOMPERIDONE ALMUS is contraindicated in the following situations:

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

· Pituitary prolactin tumor (prolactinoma).

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

· In patients with moderate or severe hepatic insufficiency (see section Pharmacokinetic properties ).

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

• Concomitant administration with drugs 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. Interactions with other medicinal products and other forms of interaction ).

Adverse effects Domperidone Almus

The safety of domperidone has been evaluated in clinical trials and post marketing experience. Clinical trials (31 double-blind, placebo-controlled studies) 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 of age and received at least one dose of domperidone (domperidone base). The median total daily dose was 30 mg (range 10 to 80 mg). The median duration of exposure was 28 days (range 1 to 28 days).

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

Adverse reactions are classified according to their frequency according to the following convention: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1000 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 clinical data, it is indicated as "undetermined".

Class Organ System

Undesirable effect

Frequency

Frequent

Rare

indeterminate

Immune system disorders

Anaphylactic reaction (including anaphylactic shock)

Psychiatric disorders

Loss of libido

Anxiety

agitation

Nervousness

Nervous system disorders

Drowsiness

headaches

Extrapyramidal disorders

convulsions

Restless legs syndrome *

Eye disorders

Oulogyric crisis

Heart conditions

Ventricular arrhythmias QTc interval prolongation

Torsades de pointes

Sudden death

(see section Warnings and precautions for use )

Gastrointestinal disorders

Dry mouth

diarrhea

Skin and subcutaneous tissue disorders

Skin rash

itching

Urticaria

angioedema

Renal and urinary disorders

Urinary retention

Disorders of reproductive organs and breast

galactorrhoea

Breast pain

Breast hypersensitivity

gynecomastia

Amenorrhea

General disorders and administration site conditions

Asthenia

investigations

Abnormal liver function tests

Increased prolactinemia

* Exacerbation of restless legs syndrome in patients with Parkinson's disease

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

Extrapyramidal disorders occur mainly in newborns and infants.

Other disorders of the central nervous system such as convulsions and agitation are mainly reported in infants and children.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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