Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Hypersensitivity reactions to NSAIDs have been reported and these may consist of: (a) non-specific allergic reactions and anaphylaxis
(b) respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea
(c) various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 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). There is insufficient data to exclude such a risk for flurbiprofen 8.75 mg lozenges.a

The following list of adverse effects relates to those experienced with flurbiprofen at OTC doses for short-term use.
(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), not known (cannot be estimated from the available data))

Blood and lymphatic system disorders:
Not known: anaemia, thrombocytopenia.
Immune System disorders:
Rare: anaphylactic reaction

Psychiatric disorders:
Uncommon: insomnia
Cardiovascular and cerebrovascular disorders
Not known: Oedema, hypertension and cardiac failure

Nervous System disorders:
Common: dizziness, headache, parasthesia
Uncommon: somnolence

Respiratory, thoracic and mediastinal disorders:
Common: throat irritation
Uncommon: exacerbation of asthma and bronchospasm, dyspnoea, wheezing, oropharyngeal blistering, pharyngeal hypoaesthesia.

Gastrointestinal disorders:
Common: diarrhoea, mouth ulceration, nausea, oral pain, paraesthesia oral, oropharyngeal pain, oral discomfort (warm or burning feeling or tingling of the mouth).
Uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting 
Hepatobiliary disorders:
Not known: hepatitis

Skin and subcutaneous tissue disorders:
Uncommon: various skin rashes, pruritus.
Not known: severe forms of skin reaction such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

General disorders and administration site conditions:
Uncommon: pyrexia, pain

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=AdversEffec tMedic@moh.health.gov.il) or by email (adr@MOH.HEALTH.GOV.IL)