Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class and frequency.
The frequency using the following convention: very common (> 1/10); common (>1/100 to < 1/10); uncommon (>1/1000 to < 1/100); rare (>1/10000 to < 1/1000); very rare (< 1/10000), including isolated reports; not known: frequency cannot be estimated from the 

available data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Frequency                     System                              Symptoms Blood and lymphatic system Platelet disorders, stem cell disorders.
disorders
Rare
>1/10000 - < 1/1000 Immune system disorders           Allergies (excluding angioedema).
Psychiatric disorders          Depression NOS, confusion, hallucinations.
Nervous system disorders       Tremor NOS, headache NOS.
Eye disorders                  Abnormal vision.
Cardiac disorders              Oedema.

Gastrointestinal disorders     Haemorrhage NOS, abdominal pain NOS, diarrhea NOS, nausea, vomiting.

Hepatobiliary disorders        Hepatic function abnormal, hepatic failure, hepatic necrosis, jaundice.

Pruritus, rash, sweating, purpura,
Skin and subcutaneous tissue angioedema, urticaria. Very rare cases of disorders serious skin reactions have been reported.

General disorders and          Dizziness (excluding vertigo), malaise, administration site conditions pyrexia, sedation, drug interaction NOS.

Injury, poisoning and          Overdose and poisoning procedural complications

Hepatobiliary disorders        hepatotoxicity
Very Rare         General disorders and          hypersensitivity reaction (requiring (< 10 000)        administration site conditions discontinuation of treatment) Blood and lymphatic system Thrombocytopenia, leukopenia, neutropenia disorders                  hemolytic anemia, agranulocytosis

Anaphylaxis, Cutaneous hypersensitivity reactions including, among others, skin
Immune system disorders        rashes and angioedema.
Very rare cases of serious skin reactions have been reported.

Respiratory, thoracic and      Bronchospasm*
Mediastinal disorders


Metabolism and nutrition
Hypoglycemia disorders

Renal and urinary               Sterile pyuria (cloudy urine) disorders                       and renal side effects

Not known: Some cases of edema of the larynx, anaphylactic shock, anaemia, bronchospasm*, liver alteration and hepatitis, renal alteration (severe renal impairment, nephrite interstitial, haematuria, anuresis), gastrointestinal effects and vertigo have been reported.
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.


Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorization 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