Medicinal Products

ALPRAZOLAM MYLAN 0.25 mg

Generic drug of Xanax
Therapeutic Class: Neurology-Psychiatry
active ingredients: Alprazolam
laboratory: Mylan

Tablet breackable
Box of 30
All forms

Indication

· Symptomatic treatment of severe and / or disabling anxiety

· Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal.

Dosage ALPRAZOLAM MYLAN 0.25 mg Breakable tablet Box of 30

Reserved for adults.

The safety and efficacy of alprazolam has not been demonstrated in children and adolescents under 18 years of age; therefore, the use of alprazolam is not recommended.

Oral way.

Dosage 0.25 mg is particularly suitable for the elderly, the renal or hepatic insufficiency.

Dose

In all cases, treatment will be initiated at the lowest effective dose and the maximum dose of 4 mg / day will not be exceeded.

In general, in adults, treatment will be started at the dosage of 0.75 mg to 1 mg per day, divided into 3 doses as follows:

· 0.25 mg in the morning and at noon, and 0.25 to 0.50 mg in the evening.

The dosage will then be individually adapted according to the therapeutic response.

The average dosage is between 1 and 2 mg per day.

In children, the elderly, the renal or hepatic insufficiency: it is recommended to reduce the dosage, by half for example.

duration

The treatment should be as short as possible. The indication will be reviewed regularly especially in the absence of symptoms. The overall duration of treatment should not exceed 8 to 12 weeks for the majority of patients, including the dose reduction period (see Warnings and Precautions section ).

In some cases, it may be necessary to prolong the treatment beyond the recommended periods. This requires accurate and repeated assessments of the patient's condition.

Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal: short treatment of the order of 8 to 10 days.

Against indications

This medicine should never be used in the following situations:

Hypersensitivity to the active substance or any of the other ingredients,

· Severe respiratory failure,

· sleep apnea syndrome,

· Severe hepatic insufficiency, acute or chronic (risk of encephalopathy),

Myasthenia.

Adverse effects Alprazolam Mylan

They are related to the dose ingested, the individual sensitivity of the patient.

Neuropsychiatric side effects ( see Warnings and precautions for use section )

· Anterograde amnesia, which can occur at therapeutic doses, the risk increasing in proportion to the dose,

· Behavior disorders, changes in consciousness, irritability, aggression, agitation,

· Physical and mental dependence, even at therapeutic doses with withdrawal syndrome or rebound at discontinuation of treatment,

· Lightheadedness, headache, ataxia,

Confusion, decreased alertness or drowsiness (particularly in the elderly), insomnia, nightmares, tension,

· Changes in libido.

Cutaneous adverse effects

· Skin rash, itchy or otherwise.

General side effects

· Muscular hypotonia, asthenia.

Ocular adverse effects

· Diplopia.

Hepatic side effects

Very rare cases of increased liver enzymes, jaundice, cytolytic or cholestatic hepatitis.

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. Healthcare 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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