Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Gastrointestinal
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, exacerbation of colitis and Crohn's disease (see section 4.4), indigestion, heartburn, rectal bleeding have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Hypersensitivity
Hypersensitivity reactions have been reported following treatment with NSAIDs.
These may consist of (a) non‐specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Cardiovascular and cerebrovascular
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggests that use of some NSAID's (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction of stroke) (see section4.4).
Other adverse reactions reported less commonly include:
Endocrine disorders:
Oedema, pyrexia
Musculoskeletal connective tissue and bone disorders:
Weakness/malaise

Respiratory, thoracic and mediastinal disorders:
Dyspnoea
Neurological and special senses:
Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing auto‐immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4), depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue, tremor, insomnia, and drowsiness.
Dermatological:
Bullous reactions including Stevens‐Johnson syndrome, and Toxic Epidermal Necrolysis (very rare). Photosensitivity.
Haematological:
Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Hepatic:
Abnormal liver function, hepatitis and jaundice.
Renal:
Bilirubinuria, urinary frequency, dysuria, nephrotoxicity in various forms including interstitial nephritis, nephrotic syndrome and renal failure.

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
http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=Adve rsEffectMedic@moh.gov.il