gic 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
Aceclofenac is both structurally related and metabolised to diclofenac for which a greater amount of clinical and epidemiological data consistently point towards an increased risk of general arterial thrombotic events (for example myocardial infarction or stroke, particularly at high doses or in long treatment). Epidemiological data has also found an increased risk of acute coronary syndrome and myocardial infarction associated with the use of aceclofenac (see section 4.3 and 4.4 for Contraindications and Special warnings and special precautions for use).
Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment
Other adverse reactions reported less commonly include:
Renal: interstitial nephritis.
Neurological and special senses: optic neuritis, 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), confusion, hallucinations, malaise and drowsiness.
Haematological: agranulocytosis, aplastic anaemia .
Dermatological: Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.
If serious adverse reactions occur, Preservex should be withdrawn.
The following is a table of adverse reactions reported during clinical studies and after authorization, grouped by System-Organ Class and estimated frequencies. 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).
MedDRa SOC
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
Blood and lymphatic system disorders
Anaemia
Bone Marrow depression
Granulocytopenia
Thrombocytopenia
Neutropenia
Haemolytic anaemia
Immune system disorders
Anaphylactic reaction (including shock)
Hypersensitivity
Metabolism and nutrition disorders
Hyperkalemia
Psychiatric disorders
Depression
Abnormal dreams
Insomnia
Nervous system disorders
Dizziness
Paraesthesia
Tremor
Somnolence
Headache
Dysgeusia (abnormal taste)
Eye disorders
Visual disturbance
Ear and labyrinth disorders
Vertigo
Tinnitus
Cardiac disorders
Cardiac failure
Palpitations
Vascular disorders
Hypertension
Flushing
Hot flush
Vasculitis
Respiratory, thoracic and mediastinal disorders
Dyspnoea
Bronchospasm
Stridor
Gastrointestinal disorders
Dyspepsia
Abdominal pain
Nausea
Diarrhoea
Flatulence
Gastritis
Constipation
Vomiting
Mouth ulceration
Melaena
Gastrointestinal haemorrhage
Gastrointestinal ulceration
Stomatitis
Int |
