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
Class       Common
Infections and
Common cold infestations
Metabolism and nutrition                      Anorexia disorders
Hallucinations**
Agitation**
Aggressive
Psychiatric behaviour** disorders
Abnormal dreams and
Nightmares**
Syncope*                                                 Neuroleptic Nervous system                                                       Extrapyramidal Dizziness          Seizure*                              malignant disorders                                                            symptoms Insomnia                                                 syndrome
Sino-atrial
Cardiac                                                              block Bradycardia disorders                                                            Atrioventricular block
Gastrointestinal haemorrhage
Vomiting           Gastric and
Gastrointestinal   Diarrhoea
Abdominal          duodenal disorders          Nausea disturbance        ulcers
Salivary hypersecretion
Liver
Hepato-biliary                                                       dysfunction disorders                                                            including hepatitis***
Skin and
Rash subcutaneous
Pruritis tissue disorders
Musculoskeletal,
connective
Muscle cramps                                            Rhabdomyolysis**** tissue and bone disorders
Renal and
Urinary urinary incontinence disorders
General disorders and
Fatigue administration     Headache
Pain site conditions
System Organ        Very
Common          Uncommon             Rare             Very Rare
Class         Common
Minor increase in serum
Investigations                                  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 Asenta 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 also report to www.perrigo-pharma.co.il.