Usually, the undesirable effects reported were mild and transient. In a small proportion of patients the interruption of treatment due to undesirable effects was necessary. The most commonly observed adverse events are gastrointestinal in nature.
4). 4) have been reported following administration. Less frequently, gastritis has been observed. Should any of these be reported during treatment, Tenoxicam should be stopped immediately and appropriate treatment instituted. Within the system organ classes, adverse reactions are listed under headings of 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) Blood and lymphatic disorders Not known: agranulocytosis, anaemia, aplastic anaemia, haemolytic anaemia, leukopenia, thrombocytopenia, non-thrombocytopenic purpura, eosinophilia.
Decreases in haemoglobin, unrelated to gastro-intestinal bleeding, have occurred. g. insomnia), Rare: depression, nervousness, dream abnormalities, mental confusion, paraesthesia. 4), depression, nervousness, confusional state, hallucinations, dream abnormalities, insomnia, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness, have been reported Eye disorders Not known: visual disturbances (such as visual impairment and vision blurred), swollen eyes, eye irritation, optic neuritis.
No evidence of ocular changes has been revealed by ophthalmoscopy and slit- lamp examination. Ear and labyrinth disorders Uncommon: vertigo Not known: tinnitus Cardiac disorders Uncommon: palpitations Not known: cardiac failure The possibility of precipitating congestive cardiac failure in elderly patients or those with compromised cardiac function should therefore be borne in mind.
g. 4). Although tenoxicam has not shown to increase thrombotic events such as myocardial infarction, there are insufficient data to exclude such a risk with tenoxicam. Respiratory, thoracic and mediastinal disorders Rare: bronchospasm, aggravated asthma, dyspnoea Not known: epistaxis Bronchospasm and aggravated asthma have been reported following treatment with NSAIDs.
Gastrointestinal disorders Very common: stomatitis Common: gastric, epigastric and abdominal pain and discomfort, dyspepsia, nausea, peptic ulcer, sometimes fatal, particularly in the elderly Uncommon: gastrointestinal haemorrhage (including haematemesis and melaena), gastrointestinal ulcers, constipation, diarrhoea, vomiting, mouth ulceration, gastritis, dry mouth Very rare: pancreatitis Not known: Gastrointestinal perforation, exacerbation of colitis and Crohn’s disease, flatulence Hepatobiliary disorders Uncommon: increased hepatic enzymes Not known: hepatitis, jaundice Skin and subcutaneous tissue disorders Uncommon: pruritus, erythema, exanthema, rash, urticaria Rare: vesiculo-bullous reactions.
4) Not known: photosensitivity reaction. Nail disorders and, photosensitivity reaction, alopecia, erythema, purpura and more rarely exfoliative, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme) have been reported rarely following treatment with NSAIDs.
g. renal failure, interstitial nephritis, nephrotic syndrome).
Reproductive system and breast disorders Not known:
Female infertility* *Isolated cases of female infertility have been reported with drugs known to inhibit cyclooxygenase/prostaglandin synthesis including tenoxicam. General disorders and administration site conditions Uncommon: fatigue, oedema Not known: Malaise 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.