Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Psychoses
Benzodiazepines should not be used alone for the treatment of psychotic illness.
Benzodiazepines alone are not suitable for the treatment of severe depression and should not be used alone for the treatment of anxiety associated with severe depression (suicide may be precipitated in such patients). Appropriate precautions must be taken when using benzodiazepines in severely depressed and suicidal patients.
Pre-existing depression may be unmasked.

Psychiatric and paradoxical reactions can occur during benzodiazepine treatment, particularly in the elderly. These reactions include restlessness, agitation, irritability, rages, nightmares, increased insomnia, hallucinations, psychoses, inappropriate behaviour, delirium and other adverse behavioural effects. Should this occur, use of the medicinal product should be discontinued.

Dependence
Chronic use of benzodiazepines may lead to the development of physical and psychological dependence. Experience shows that benzodiazepines are prescribed too often and for excessive lengths of time, which can lead to the development of dependence**.
The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse. Dependence without an increase in dose and "low-dose" dependence can occur**.

Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, insomnia, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: derealisation, depersonalisation, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Withdrawal symptoms may occur several days after discontinuation of treatment.

Risks of concurrent use with opioids
Concurrent use of Bondormin and opioids can result in sedation, respiratory depression, coma and death. Due to these risks, the use of sedative drugs (benzodiazepines or related drugs such as Bondormin) at the same time as opioids should only be prescribed to patients for whom no other treatment options exist. If it is nevertheless considered necessary to prescribe Bondormin concurrently with opioids, the lowest effective dose should be used and the duration of treatment should be kept as short as possible (also see section 4.2).
Patients should be closely monitored for signs and symptoms of respiratory depression and sedation.
In this context, it is strongly recommended to inform patients and their caregivers about possible symptoms (see section 4.5).


Use with alcohol
Concurrent use of brotizolam and alcohol can result in sedation, drowsiness and impaired concentration (see section 4.5).

Tolerance
Some loss of efficacy to the hypnotic effect may develop after repeated use for a few weeks.
Rebound anxiety and tension
Withdrawal of brotizolam treatment can lead to the development of a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form. The syndrome may be accompanied by mood changes, sleep disturbances and restlessness. Since the risk of withdrawal phenomena / rebound phenomena is greater after sudden dose reduction or abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually.

Duration of treatment
The duration of treatment should be as short as possible (see section 4.2). Extension beyond the recommended maximum treatment period should not take place without re-evaluation of the patient’s status. The duration of treatment should be agreed with the patient before treatment is started, and the need for continued treatment should be evaluated at short intervals**. Patients should be instructed not to pass benzodiazepines on to other people under any circumstances**.

It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased.

Moreover, it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued.

Abrupt withdrawal of benzodiazepines can lead to the occurrence of paraesthesias, perceptual disturbances and depersonalisation, which may last for a week or more. Convulsions have been reported in a small number of cases.

Amnesia
In common with other benzodiazepines, brotizolam may induce anterograde amnesia. The condition occurs most often several hours after taking the product.

Specific patient groups
Benzodiazepines have a muscle relaxant effect, which increases the risk of falls. Brotizolam should therefore be used with caution in the elderly.
Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy.
Benzodiazepines should be used with extreme caution in patients with a history of alcoholism, medication dependence or drug abuse.

Bondormin contains lactose
Bondormin tablets contain 82.75 mg lactose monohydrate per tablet. Patients with the rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Bondormin.

Effects on Driving

4.7   Effects on ability to drive and use machines

Even when used in accordance with the prescribing instructions, this product may affect reactions and thus impair the ability to drive and operate machinery. Concurrent use of alcohol and/or medicinal products with CNS depressant activity will potentiate this impairment.

No studies on the effects of Bondormin on the ability to drive and use machines have been performed.
However, patients should be advised that they may experience undesirable effects (see section 4.8) such as sedation, amnesia and impaired psychomotor skills during treatment with Bondormin.
Psychomotor impairment may increase the risk of falls and road traffic accidents.

Caution should therefore be recommended when driving a vehicle or using machines. If the patient does not get enough sleep, the likelihood of impaired alertness may be increased. If patients experience any of the above-mentioned undesirable effects, they should avoid potentially hazardous tasks such as driving a vehicle or using machines.