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, < 1/10), uncommon (> 1/1,000, < 1/100), rare (> 1/10,000, < 1/1,000); very rare (< 1/10000) and not known (cannot be estimated from available data).

System Organ        Very   Common                   Uncommon           Rare               Very Rare Class               Common
Infections and             Common cold infestations
Metabolism and                   Anorexia nutrition disorders
Psychiatric                      Hallucinations** disorders                        Agitation**

Aggressive behaviour**

Abnormal dreams and
Nightmares**
Nervous system                   Syncope*           Seizure*           Extrapyramidal Neuroleptic malignant disorders                                                              symptoms       syndrome Dizziness

Insomnia
Cardiac                                             Bradycardia        Sino-atrial disorders                                                              block 
Atrioventricular block
Gastrointestinal Diarrhoea Vomiting                 Gastrointestinal disorders                                           haemorrhage
Nausea    Abdominal

Israel, Aricept 5 & 10 mg   25 May2016                       2016-0015647 disturbance        Gastric and duodenal ulcers
Hepato-biliary                                                        Liver disorders                                                             dysfunction including hepatitis***
Skin and                         Rash subcutaneous tissue disorders                 Pruritis
Musculoskeletal,                 Muscle cramps                                       Rhabdomyolysis**** connective tissue and bone disorders
Renal and                        Urinary urinary disorders                incontinence
General             Headache Fatigue disorders and administration                   Pain site conditions
Investigations                                      Minor increase in serum concentration of muscle creatine kinase
Injury and                     Accident poisoning
*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 ARICEPT 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
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?for mType=AdversEffectMedic@moh.health.gov.il ) or by email
(adr@MOH.HEALTH.GOV.IL ).