Adverse reactions : תופעות לוואי

4.8     Undesirable effects
The most common adverse events are diarrhoea, muscle cramps, fatigue, nausea, vomiting and insomnia.

Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency. 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) and not known (cannot be estimated from available data).

System Organ Very          Common           Uncommon           Rare               Very Rare            Not Known Class          Common
Infections and             Common cold infestations
Metabolism and             Anorexia nutrition disorders
Psychiatric                Hallucinations**                                                            Libido increased, disorders                  Agitation**                                                                 Hypersexuality Aggressive behaviour**
Abnormal dreams and
Nightmares**
Nervous system             Syncope*         Seizure*           Extrapyramidal Neuroleptic              Pleurothotonus disorders                  Dizziness                           symptoms       malignant                (Pisa syndrome) Insomnia                                           syndrome

Cardiac                                     Bradycardia        Sino-atrial                             Polymorphic disorders                                                      block                                   ventricular Atrioventricular                        tachycardia block                                   including Torsade de Pointes
Electrocardiogram
QT interval prolonged
Gastrointestinal Diarrhoea Vomiting         Gastrointestinal disorders        Nausea Abdominal           haemorrhage disturbance      Gastric and duodenal ulcers
Salivary hypersecretion
Hepato-biliary                                                 Liver disorders                                                      dysfunction including hepatitis***
Skin and                   Rash subcutaneous               Pruritis tissue disorders
Musculoskeletal,           Muscle cramps                                          Rhabdomyolysis**** connective tissue and bone disorders
Renal and                  Urinary urinary disorders          incontinence
System Organ      Very     Common             Uncommon          Rare         Very Rare          Not Known Class             Common
General           Headache Fatigue disorders and              Pain administration site conditions
Investigations                                Minor increase in serum concentration of muscle creatine kinase

Injury and                  Accidents poisoning                   including falls
*          In investigating patients for syncope or seizure the possibility of heart block or long sinusal pauses should be considered (see section 4.4).
**         Reports of hallucinations, abnormal dreams, nightmares, agitation and aggressive behaviour have resolved on dose-reduction or discontinuation of treatment.
***        In cases of unexplained liver dysfunction, withdrawal of Memorit should be considered.
****       Rhabdomyolysis has been reported to occur independently of Neuroleptic Malignant syndrome and in close temporal association with donepezil initiation or dose increase.

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/( 
Additionally, you can report to “Unipharm Ltd”