Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The frequencies of the adverse reactions in Table 1 were calculated based on three randomised, double-blind, placebo-controlled studies in patients with alcohol dependence.

The most common adverse reactions were nausea, dizziness, insomnia, and headache. The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration.

Confusional state and, rarely, hallucinations and dissociation were reported in the clinical studies. The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration (a few hours to a few days). Most of these adverse reactions resolved during continued treatment and did not recur upon repeated administration. While these events were generally short-lasting, they could represent alcoholic psychosis, alcohol withdrawal syndrome, or comorbid psychiatric disease.

Tabulated list of adverse reactions
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Table 1 Frequencies of adverse reactions
System Organ Class                   Frequency     Adverse Reaction
Metabolism and nutrition disorders   Common        Decreased appetite Very common   Insomnia
Common        Sleep disorder
Confusional state
Restlessness
Libido decreased (including loss of
Psychiatric disorders libido)
Uncommon      Hallucination (including hallucination auditory,
hallucination tactile, hallucination visual, and somatic hallucination)
Dissociation
Very Common   Dizziness
Headache
Common        Somnolence
Nervous system disorders                           Tremor
Disturbance in attention
Paraesthesia
Hypoaesthesia
Not known     Visual impairment (mostly
Eye disorders                                      transient)

Common        Tachycardia
Cardiac disorders
Palpitations
Very Common   Nausea
Common        Vomiting
Gastrointestinal disorders
Dry mouth
Diarrhoea
Common        Hyperhidrosis
Not known     Angioedema

Skin and subcutaneous tissue                       Urticaria disorders                                          Pruritus
Rash
Erythema
Musculoskeletal and connective       Common        Muscle spasms tissue disorders                     Not known     Myalgia
Reproductive system and breast        Not known               Priapism disorder

Common                  Fatigue

General disorders and                                         Asthenia administration site conditions                                Malaise Feeling abnormal
Investigations                        Common                  Weight decreased 

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 should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/