Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of the safety profile

In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Ebixa did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity. The most frequently occurring adverse reactions with a higher incidence in the Ebixa group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).


Tabulated list of adverse reactions
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with Ebixa and since its introduction in the market.


Adverse reactions are ranked according to system organ class, using the following convention: 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), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.



SYSTEM ORGAN CLASS                         FREQUENCY           ADVERSE REACTION 
Infections and infestations                Uncommon            Fungal infections 
Immune system disorders                    Common              Drug hypersensitivity 
Psychiatric disorders                      Common              Somnolence 
Uncommon            Confusion

Uncommon            Hallucinations1
Not known           Psychotic reactions2

Nervous system disorders                   Common              Dizziness 
Common              Balance disorders

Uncommon            Gait abnormal
Very rare           Seizures

Cardiac disorders                          Uncommon            Cardiac failure 
Vascular disorders                         Common              Hypertension 
Uncommon            Venous thrombosis/thromboembolism

Respiratory, thoracic and mediastinal      Common              Dyspnoea disorders

Gastrointestinal disorders                 Common              Constipation 
Uncommon            Vomiting

Not known           Pancreatitis2
Hepatobiliary disorders                    Common              Elevated liver function test 
Not known           Hepatitis

General disorders and administration       Common              Headache site conditions

Uncommon            Fatigue

1
Hallucinations have mainly been observed in patients with severe Alzheimer’s disease.
2
Isolated cases reported in post-marketing experience.
Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. In post-marketing experience these reactions have been reported in patients treated with Ebixa.

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/