Gastrointestinal:
The most commonly-observed adverse events are gastrointestinal in nature. 4). 4) 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 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).
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.
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 If serious adverse reactions occur, Preservex should be withdrawn.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) 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 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 Intestinal perforation Exacerbation of Crohn’s disease and Colitis Ulcerative Haematemesis Pancreatitis Hepatobiliary disorders Hepatic enzyme increased Hepatic injury (including hepatitis ) Jaundice Blood alkaline phosphatase increased Skin and subcutaneous tissue disorders Pruritus Rash Dermatitis Urticaria Angioedema Purpura Severe mucocutaneous skin reaction (including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis Renal and urinary disorders Blood urea increased Blood creatinine increased Renal failure Nephrotic syndrome General disorders and administration site conditions Oedema Fatigue Cramps in legs Investigations Weight increase 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.