TRANXENE Capsule

recommended to treat anxiety when it is accompanied by unpleasant symptoms, or to prevent and/or treat symptoms related to alcohol withdrawal.

Dosage

This medicine is reserved for use in adults and children over the age of 6 years. The dosage is strictly individual and it is not possible to define a standard dosage.

Oral route. Swallow the capsule with a glass of water.

Treatment duration

must be as brief as possible and must not exceed 8-12 weeks.

- known allergy to this active substance or to one of the ingredients of the medicinal product,

- severe respiratory insufficiency,

- sleep apnoea syndrome (pauses in breathing during sleep)

- severe hepatic insufficiency,

- myasthenia (disease characterized by an excessive tendency to muscle fatigue)

These are related to the dose taken and the individual sensitivity of each patient.

Neurological and psychiatric undesirable effects:

- memory disorders (forgetfulness), which may occur at therapeutic doses, the risk increasing proportionally with the dose,

- behavioral disorders, changes to consciousness, irritability, aggressiveness, agitation,

- physical and psychological dependence, even at therapeutic doses, with weaning or rebound phenomenon at treatment discontinuation,

- sensations of drunkenness, headaches, difficulty in coordinating movements,

- confusion, impaired alertness or drowsiness (particularly in the elderly), insomnia, nightmares, tension,

- changes to libido,

Cutaneous undesirable effects: Skin rashes, with or without itching,.

Systemic undesirable effects: muscle weakness, fatigue.

Ocular undesirable effects: double vision.

In order to prevent possible interactions between several medicines, you must systematically inform your doctor or pharmacist if you are taking any other medicines.

Pregnancy

This medicinal product should only be used during pregnancy if your doctor so decides. If you discover that you are pregnant, consult your doctor so that he may decide whether it is necessary to pursue treatment.

Breast-feeding

This medicinal product passes into breast milk: consequently, breast-feeding is inadvisable.

If a loss of efficacy is observed after repeated use of the medicine, do not increase the dose.

Risk if DEPENDENCE: this treatment may cause a state of physical or psychological dependence, particularly after prolonged use.

Various factors seem to favour the onset of dependence:

- duration of treatment, dose, history of other dependencies, drug-related or not, including alcoholism.

Dependence may occur even if these factors are not present.

ABRUPT discontinuation of this treatment may provoke the onset of warning syndrome. This is characterized by the appearance, within a few hours of days, of sighs such as severe anxiety, insomnia, muscle pains; other symptoms may also be observed, such as agitation, irritability, headaches, numbness or tingling in the extremities, abnormal sensitivity to noise, light or physical contact etc.