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ACECLOFENAC is a brand name for Aceclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Aceclofenac 100 mg Film-coated Tablets is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Adults The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening. Children There are no clinical data on the use of Aceclofenac 100 mg Tablets in children and therefore it is not recommended for use in children.
Elderly The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration.
The patient should be monitored regularly for GI bleeding during NSAID therapy. The pharmacokinetics of Aceclofenac 100 mg Tablets are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.
4). Patients with liver impairment There is some evidence that the dose of Aceclofenac 100 mg Tablets should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used. Method of administration Aceclofenac 100 mg Film-coated Tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid.
To be taken preferably with or after food. When Aceclofenac 100 mg Tablets was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected
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 (myocardial infarction or stroke, particularly at high doses and in long treatment).
4). 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. Hepatic: abnormal liver function, hepatitis and jaundice. 4), confusion, hallucinations, and drowsiness.
Haematological:
Agranulocytosis, aplastic anaemia.
2, and GI and cardiovascular risks below). 5). 2).
Respiratory disorders:
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.
Cardiovascular, Renal and Hepatic Impairment:
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.
3).
Renal:
Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored regularly.
Effects on renal function are usually reversible on withdrawal of Aceclofenac 100 mg Tablets.
Hepatic:
If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Aceclofenac 100 mg Tablets should be discontinued. Close medical surveillance is necessary in patients suffering from mild to moderate impairment of hepatic function.
Hepatitis may occur without prodromal symptoms. Use of Aceclofenac 100 mg Tablets in patients with hepatic porphyria may trigger an attack. g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with aceclofenac after careful consideration.
1 Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
Patients with active bleeding or bleeding diathesis. 4). Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Aceclofenac 100 mg Tablets should not be prescribed during pregnancy, especially during the last trimester of pregnancy, in women attempting to conceive and lactation unless there are compelling reasons for doing so. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Aceclofenac in United Kingdom.
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Dermatological:
Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity. If serious adverse reactions occur, Aceclofenac 100 mg film-coated Tablets should be withdrawn. Within the system organ classes, undesirable effects are listed under headings of frequency, 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).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System organ class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare/ isolated reports (<1/10,000) Blood and lymphatic Anaemia Bone Marrow system disorders 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 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 authorization of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal products. uk/yellowcard.
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild congestive heart failure (NYHA-I) as fluid retention and oedema have been reported in association with NSAID therapy. As the cardiovascular risks of aceclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically. Aceclofenac should also be administered with caution and under close medical surveillance to patients with a history of cerebrovascular bleeding Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
8). 3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
5). When GI bleeding or ulceration occurs in patients receiving aceclofenac, the treatment should be withdrawn. 8). 8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment.
Aceclofenac 100 mg Film-coated Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Exceptionally, varicella can trigger serious cutaneous and soft tissues infections complications.
To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of aceclofenac in case of varicella.
Impaired female fertility:
The use of Aceclofenac 100 mg Tablets may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of […]