Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Within the system organ classes, adverse reactions are listed under the frequency (number of patients expected to experience the reaction), using the following categories: 
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)

The following undesirable effects were observed whereas the frequency of undesirable effects is not known:

The most common adverse reactions associated with oral administration are nausea, abdominal pain, dyspepsia, flatulence, constipation and diarrhea. The reported adverse reactions are usually mild and transitory.

In the following table, adverse reactions have been grouped on the basis of "Internationally agreed Order of Importance" System Organ Class (SOC) MedDRA Classification. In each SOC, undesirable effects were classified according to their occurrence frequency. In each frequency class the undesirable effects are reported according to a decreasing order of severity.


System          Very   Common                   Uncommon          Rare            Very rare    Unknown* Organ           Common from >1/100              from > 1/1,000 to from >          <1/10,000 Class           >1/10  to <1/10                 <1/100            1/10,000 to <1/1,000
Immune                                                                                         Allergic reaction** system disorders
Metabolism                                                                                     Diabetes inadequate and nutrition                                                                                  control disorders
Psychiatric                                                                                    Insomnia disorders

Nervous                     Headache                                                         Dizziness system                      Somnolence disorders
Eye                                                                                          Visual disorders                                                                                    disturbances Cardiac                                                                                      Cardiac disorders                                                                                    arrhythmias e.g.
tachycardia
Vascular                                       Flushing disorders
Respiratory,                                                                                Asthma/ asthma thoracic and                                                                                aggravated mediastinal disorders
Gastrointestinal            Diarrhea                                                         Vomiting disorders                   Constipation
Nausea
Flatulence
Abdominal pain
Dyspepsia
Skin and                                       Erythema subcutaneous                                   Pruritus                                      Angioedema, tissue                                         Rash                                          Urticaria disorders
Hepatobiliary                                                                               Hepatic enzyme disorders                                                                                   increased and jaundice***
General                     Tiredness                                                        Oedema/peripheral disorders and                                                                                oedema administration site conditions
Investigations                                                                               Hepatic enzyme elevation, blood glucose increased,
blood pressure increased,
international normalized ratio fluctuation
*which frequency cannot be estimated by the available data
**Predisposed patients might develop severe allergic reactions to glucosamine ***Cases of hepatic enzymes increase and jaundice have been reported, but causality with Arthryl has not been established
Cases of hypercholesterolaemia have been reported, but a causal link has not been demonstrated.

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/