Adverse reactions : תופעות לוואי

4.8 Undesirable effects
 a) General description
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Oedema, hypertension, and cardiac failure have been reported in association with NSAID treatment. Very rare cases of bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis have been reported.

The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, Page 5 of 8
exacerbation of colitis and Crohn’s disease (see section 4.4 - Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed.
 b) Table of adverse reactions

The following listing of undesirable effects is based on data from controlled clinical trials (approximately 7,800 patients) and from post marketing surveillance with reporting rates classified 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 (<1/10,000), including isolated cases.

Blood disorders                              Rare                 Anemia* Eosinophilia*
Very rare            Thrombocytopenia
Pancytopenia
Purpura
Immune system disorders                      Rare                 Hypersensitivity* Very rare            Anaphylaxis
Metabolism and nutrition disorders           Rare                 Hyperkalemia* Psychiatric disorders                        Rare                 Anxiety* Nervousness*
Nightmare*
Nervous system disorders                     Uncommon             Dizziness* Very rare            Headache
Somnolence
Encephalopathy (Reye’s syndrome)
Eye disorders                                Rare                 Vision blurred* Very rare            Visual disturbance
Ear and labyrinth disorders                  Very rare            Vertigo Cardiac disorders                            Rare                 Tachycardia* Vascular disorders                           Uncommon             Hypertension* Rare                 Haemorrhage*
Blood pressure fluctuation*
Hot flushes*
Respiratory disorders                        Uncommon             Dyspnoea* Very rare            Asthma
Bronchospasm
Gastrointestinal disorders                   Common               Diarrhoea* Nausea*
Vomiting*
Uncommon             Constipation*
Flatulence*
Gastrointestinal bleeding
Duodenal ulcer and perforation
Gastric ulcer and perforation
Very rare            Gastritis*
Abdominal pain
Dyspepsia
Stomatitis
Melaena

Common               Hepatic enzymes increased*
Hepato-biliary disorders                     Very rare            Hepatitis (see section 4.4.”Special warnings and                            Fulminant hepatitis (including fatal special precautions for use”)                                     cases) Jaundice
Cholestasis
Skin and subcutaneous tissue disorders       Uncommon             Pruritus* Rash*
Sweating increased*
Rare                 Erythema*
Dermatitis*


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Very rare           Urticaria
Angioneurotic oedema
Face oedema
Erythema multiforme
Stevens Johnson syndrome
Toxic epidermal necrolysis
Unknown             Fixed drug eruption (see Section 4.4)
Renal and urinary disorders                Rare                Dysuria* Haematuria*

Very rare           Urinary retention*
Renal failure
Oliguria
Interstitial nephritis
General disorders                          Uncommon            Oedema* Rare                Malaise*
Asthenia*
Very rare           Hypothermia
*frequency based on clinical trial

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/