Medicinal Products

ANAUSIN METOCLOPRAMIDE 15 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Metoclopramide
laboratory: Meda Pharma

Sustained release tablet
Box of 30
All forms

Indication

ANAUSIN METOCLOPRAMIDE 15 mg prolonged-release tablets are indicated for adults in:
the prevention of delayed nausea and vomiting induced by antimitotics,
the prevention of nausea and vomiting induced by radiotherapy,
- the symptomatic treatment of nausea and vomiting, including nausea and vomiting induced by a migraine attack. In migraine attacks, metoclopramide can be used in combination with oral analgesics to improve their absorption.

Dosage ANAUSIN METOCLOPRAMIDE 15 mg prolonged release tablet Box of 30

RESERVED FOR THE ADULT.

Oral way.

The recommended dose is 15 mg taken once or twice daily.

The maximum recommended daily dose is 30 mg or 0.5 mg / kg.

The maximum recommended duration of treatment is 5 days.

Administration mode :

A minimum interval of 12 hours between 2 administrations must be respected, even in case of vomiting or rejection of the dose (see Warnings and Precautions ).

Special populations

Elderly

In elderly patients, a dose reduction should be considered, taking into account renal and hepatic function and the overall fragility of health status.

Renal failure

In patients with end-stage renal impairment (creatinine clearance <15 ml / min), the daily dose should be reduced by 75%.

In patients with moderate to severe renal impairment (creatinine clearance between 15 and 60 ml / min), the dose should be decreased by 50% (see section 5.2 ).

Hepatic insufficiency

In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2 ).

Other dosage forms / dosages may be more suitable for use in this population.

Against indications

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

· When stimulation of gastrointestinal motility is dangerous: gastrointestinal haemorrhage, mechanical obstruction or digestive perforation.

· In carriers, known or suspected, of pheochromocytoma, because of the risk of episodes of severe hypertension.

· Previous history of tardive dyskinesia with neuroleptics or metoclopramide.

· Epilepsy (increased frequency and intensity of seizures).

· Parkinson disease.

· In combination with levodopa or dopaminergic agonists (see section 4.5, Interactions with other medicinal products and other forms of interaction ).

· Known history of methemoglobinemia with metoclopramide or NADH deficiency cytochrome-b5 reductase.

· In children under one year of age due to increased risk of extrapyramidal disorders (see Warnings and Precautions )

Adverse effects Anausin Metoclopramide

Side effects are listed by organ system. Adverse events were ranked in order of frequency using the following convention: very common (³ 1/10); frequent (³ 1/100 to <1/10); uncommon (1/ 1/1000 to <1/100); rare (1/10000 to <1/1000); very rare (<1 / 10, 000), not known (can not be estimated based on available data).

Body System

Frequency

Side effects

Blood and lymphatic system disorders

Not known frequency

Methemoglobinemia, possibly due to deficiency of NADH cytochrome-b5 reductase, especially in newborns (see Warnings and precautions for use )

Sulfhaemoglobinemia, mainly when concomitant administration of high doses of sulphate-releasing drugs

Heart conditions

Rare

Bradycardia, especially with intravenous

Not known frequency

Cardiac arrest, occurring shortly after administration by injection, and may be followed by bradycardia (see Warnings and Precautions for Use section ); atrioventricular block, sinus pause especially with the intravenous route; prolongation of the QT interval on the electrocardiogram; Torsades de Pointes

Endocrine disorders *

Rare

In morrhea, H y perprolactin é m ie

Rare

G alactorrhea

Not known frequency

G y neco m astie

Gastrointestinal disorders

Frequent

Diarrhea

General disorders and administration site conditions

Frequent

Asthenia

Immune system disorders

Rare

hypersensitivity

Not known frequency

Anaphylactic reaction (including anaphylactic shock) especially with intravenous injection

Nervous system disorders

Very common

Drowsiness

Frequent

Extrapyramidal disorders (especially in children and young adults and / or when the recommended dose is exceeded, including after a single dose) (see section Warnings and precautions for use ), insonial pa rk syndrome, akathisia

Rare

Dystonia, dyskinesia, disorders of consciousness

Rare

Convulsion especially in epileptic patients

Not known frequency

Persistent dyskinesia that may be persistent during or after prolonged milking, especially in the elderly (see Warnings and Precautions ), Neuroleptic Malignant Syndrome (see Warnings and Precautions section). employment )

Psychiatric disorders

Frequent

Depression

Rare

Hallucination

Rare

Confusional state

Vascular disorders

Frequent

Hypotension, especially with the intravenous route

Not known frequency

Shock, syncope after use of the injectable form. Hypertensive crisis in patients with pheochromocytoma (see Contraindications section )

* Endocrine disorders during prolonged treatment in relation to hyperprolactinemia (amenorrhea, galactorrhea, gynecomastia).

The following effects, sometimes associated, occur more frequently when using high doses:
- Extrapyramidal symptoms: acute dystonia and dyskinesia, Parkinson's syndrome, akathisia, including after a single dose of the drug, especially in children and young adults (see Warnings and Precautions section ).
- Drowsiness, disturbances of consciousness, confusion, hallucination.

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 must report any suspected adverse reactions 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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