In the adult

Treatment symptomatic of the crisis, dizzy.

Prevention and treatment of motion sickness

Crisis and dizziness

1 to 3 tablets daily, to be taken before meals

Swallow without chewing with a little water or other non-alcoholic beverage

Transport sickness

The first dose should be taken 1 hour before the trip: 1 to 4 tablets per day

Pediatric population: no data for children and adolescents

ATC code R06AE05 (antihistamines for systemic use)

Meclozine is a derivative of piperazine.

Dizziness, nausea and vomiting are not diseases but are symptoms of a dysfunction of the body or a bad functioning of the body. Treatment of the cause depends on the underlying disease and may or may not require treatment.

The mechanism of action, anti-emetic, in case of motion sickness and in cases of vertigo of meclozine, is not completely elucidated but probably related to its anticholinergic central activity and its action, depressive on the Central nervous system.

AGYRAX may cause drowsiness. It is important to take this into account in vehicle drivers and machine users, where the association with alcohol or other sedative medicines is otherwise discouraged (see section Interactions with other medicinal products And other forms of interactions).

Hypersensitivity to méclozine, to a component of the product or to a derivative thereof, of piperazine

· Patients with hepatic impairment (see section "Pharmacokinetic properties")
· Related to anticholinergic effect

O Risk of glaucoma by closure of the angle

O Risk of urinary retention due to urethroprostatic disorders

Warnings, special

This drug is contraindicated in patients with galactose intolerance, Lapp lactase deficiency or glucose and galactose malabsorption syndrome (rare hereditary diseases).

Precautions for use

Because of its anticholinergic properties, AGYRAX should be used with caution in patients with
· Pyloric stenosis

· A decrease in gastrointestinal motility

· Myasthenia gravis

· A dementia.

The product should be used with caution in the subject who is more sensitive to the anticholinergic effects of meclozine, so it is preferable to start treatment at the lowest dose recommended. Br>

The product should be used with caution in patients with epilepsy

Treatment with AGYRAX should be stopped 4 days before allergic tests to avoid influencing the test results

The absorption of alcoholic beverages is discouraged during treatment.

ATROPINIC MEDICINAL PRODUCTS

It is necessary to take into account the fact that atropine substances can add up to their undesirable effects and lead more easily to urinary retention, acute glaucoma, constipation, dry mouth etc.

The various atropinic drugs are represented by antidepressants, imipraminic, most antihypertensive H1 antihistamines, antiparkinsonian anticholinergic, antispasmodic, atropinic, disopyramide, neuroleptic, phenothiazinic as well as clozapine.

MEDICINAL PRODUCTS, SEDATIVES

It must be taken into account that many drugs or substances can add up to their depressant effects of the central nervous system and contribute to diminish vigilance. These include morphine derivatives (analgesics, antitussives and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics, other than benzodiazepines (eg, meprobamate), hypnotics, antidepressants, sedatives (Amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), antihistamines H1, sedatives, central antihypertensives, baclofen and thalidomide
(See also Warnings and Precautions for Use)

+ Alcohol

Increase by alcohol of the sedative effect of these substances. The alteration of vigilance can make driving dangerous and the use of machinery. Avoid drinking alcoholic beverages and medicines containing alcohol

Symptoms

As with other antihistamine treatments, the symptoms observed in overdose are due to central nervous system effects: drowsiness, coma or excitation, seizures, convulsions and post-stroke depression
< Br>

Anti-cholinergic overdose effects can also be observed such as dilated pupils, sudden redness, face, dry mouth, excitement, hallucination, crisis, tonic-clonic. Other effects were also observed: ataxia, tremors, psychoses, hyperthermia, hypotension, hypertension, tachycardia and arrhythmia. Extrapyramidal syndromes have been reported.

The symptoms observed in cases of significant overdose include: edema, cerebral, deep coma, depression, respiratory distress, cardiorespiratory collapse or even death

Support

There is no specific antidote, monitoring of vital functions and, if necessary, symptomatic treatment should be established in specialized settings. >
Pregnancy

Considering the available data, the use of meclozine hydrochloride is possible during pregnancy whatever the term.

In case of treatment at the end of pregnancy, take into account the atropinic and sedative properties of this molecule for the monitoring of the newborn

Breastfeeding

The passage of meclozine hydrochloride in breast milk is not known. Considering the possibilities of sedation or excitation, paradoxical of the newborn, this medicine is not advised in case of breast-feeding

The undesirable effects of AGYRAX are mainly related to its action on the central nervous system, its anticholinergic effects and the hypersensitivity reactions it can cause. They are listed below by class of organ. The most undesirable effects considered to be most frequent are somnolence or sedation. The dryness of the mouth is a frequent and undesirable effect. Blurred vision, nausea and vomiting rarely occur

Cardiac disorders: palpitations, tachycardia

Ear and labyrinth disorders, tinnitus, dizziness

Eye disorders: diplopia, blurred vision

Gastrointestinal disorders: abdominal pain, constipation, diarrhea, dry mouth, nausea, vomiting

General disorders: fatigue, weakness

Immune system disorders: shock, anaphylactic.

Investigations: weight gain

Metabolism and nutrition disorders: anorexia, increased appetite

Nervous system disorders, dizziness, headache, paresthesia, sedation, somnolence, movement disorders (including Parkinson's syndrome)
Psychiatric disorders, anxiety, euphoric mood, excitability, hallucinations, insomnia, psychotic disorders, memory disorders, disorientation, confusion and paranoia
Renal and urinary disorders, dysuria, polyuria, urinary retention

Respiratory, thoracic and mediastinal disorders: dry throat, dryness, nose

Vascular disorders, hypotension

Skin and tissue disorders, subcutaneous: rash, urticaria.

Reporting of suspected adverse reactions

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

Prevention and treatment of motion sickness