Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Most of the undesirable effects observed to date are related to the medicinal product's pharmacological activity. They occur predominantly at the start of therapy and usually decrease with continued administration.

The risk of dependence (in the form of e.g. a rebound effect, altered mood, anxiety and restlessness) increases with the duration of Bondormin treatment, which should not exceed two weeks.

The following definitions of frequencies are used:

Very common (≥ 1/10)
Common (≥ 1/100 up to < 1/10)
Uncommon (≥ 1/1.000 up to < 1/100)
Rare (≥ 1/10.000 up to < 1/1.000)
Very rare (< 1/10.000)
Not known (frequency cannot be estimated from the available data)
Psychiatric disorders             Uncommon           Nightmares, depression, altered mood, anxiety, drug dependence, altered affect, emotional disorder,
behavioural changes, agitation, changes in libido
Rare               Confusion, restlessness
Nervous system disorders          Common             Light-headedness, headache Uncommon           Dizziness, sedation, ataxia, anterograde amnesia,
dementia*, mental impairment*, impairment of psychomotor skills*
Rare               Reduced alertness
Eye disorders                     Uncommon           Diplopia
Gastrointestinal disorders        Common             Gastrointestinal disturbances Uncommon           Dry mouth
Hepatobiliary disorders           Uncommon           Liver disorders, jaundice Skin and subcutaneous tissue      Uncommon           Skin reactions disorders
Musculoskeletal and             Uncommon             Muscle weakness connective tissue disorders
General disorders and           Uncommon             Withdrawal and rebound phenomena, administration site conditions                       paradoxical reactions, irritability, drowsiness Investigations                  Uncommon             Changes in liver function tests Injury, poisoning and           Uncommon             Road traffic accidents*, falls* procedural complications
*) Class effect of benzodiazepines

Brotizolam has a muscle relaxant effect and should therefore be used with caution in the elderly because of the risk of falls.

Abuse of benzodiazepine has been reported.

Withdrawal symptoms
Withdrawal and rebound phenomena may indicate development of dependence.
Once physical dependence has developed, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms such as headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
In severe cases, derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and touch, hallucinations or epileptic seizures may occur (see section 4.4).

Psychological and paradoxical reactions
Reactions such as restlessness, agitation, irritability, aggressiveness, delusion, rages, vivid nightmares, hallucinations, psychoses and behavioural changes are known to occur when using benzodiazepines and benzodiazepine-like agents. They are more likely to occur in children and the elderly (see section 4.4). Should this occur, use of the medicinal product should be discontinued.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events, including all cases of dependence and abuse**, should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/