POM: Prescription only medicine
This information is intended for use by health professionals
AdultsThe recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.
Paediatric populationThere are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children under 18 years of age.
ElderlyThe elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, are at increased risk of 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 are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.
Renal insufficiencyThere is no evidence that the dosage of Aceclofenac needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see Section 4.4).
Hepatic insufficiencyThere is some evidence that the dose of Aceclofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used.
Method of administrationSwallow the tablet whole with a glass of water. Do not crush or chew the tablets. Never change the dose of your medicine without talking to your doctor first. Continue to take your tablets for as long as your doctor recommends.
Elderly:The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2).
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. Renal function should be monitored in these patients (see also section 4.3).
Renal:The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, liver dysfunction, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible on withdrawal of Aceclofenac Tablets. 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.
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 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 NSAIDs in patients with hepatic porphyria may trigger an attack.
Cardiovascular and cerebrovascular effects:Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure 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 congestive heart failure, significant risk factors for cardiovascular events and history of cerebrovascular bleeding. 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). There are insufficient data to exclude such a risk for aceclofenac. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with aceclofenac after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
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. Close medical surveillance is imperative in patients with: • symptoms indicative of gastro-intestinal disorders involving either the upper or lower gastrointestinal tract • with a history suggestive of gastro-intestinal ulceration, bleeding or perforation • with ulcerative colitis or with Crohn's disease • bleeding diathesis or haematological abnormalities. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5). 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. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5). When GI bleeding or ulceration occurs in patients receiving aceclofenac, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).
SLE and mixed connective tissue disease:In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8).
Impaired female fertility:The use of Aceclofenac 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 infertility, withdrawal of Aceclofenac Tablets should be considered.
Hypersensitivity/Dermatological reactions:As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Jonson syndrome, and toxic epidermal necrolysis, have been reporting very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of 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 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.
Haematological:Aceclofenac Tablets may reversibly inhibit platelet aggregation (see anticoagulants under 'Interactions').
Long-term treatment:All patients who are receiving NSAIDs should be monitored as a precautionary measure e.g. renal failure, hepatic function (elevation of liver enzymes may occur) and blood counts.
Pregnancy:There is no information on the use of Aceclofenac during pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation or gastroschisis after use of prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, Aceclofenac should not be given unless clearly necessary. If Aceclofenac is used by a women attempting to conceive, or during the first the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus) and on the possible risk of persistent pulmonary hypertension of the new born, use in the last trimester of pregnancy is contraindicated. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: - Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to: - Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses. - Inhibition of uterine contractions resulting in delayed or prolonged labour with an increased bleeding tendency in both mother and child. Consequently, aceclofenac is contraindicated during the third trimester of pregnancy (see section 4.3)
Lactation:There is no information on the secretion of Aceclofenac to breast milk, there was however no notable transfer of radio labelled (14C) Aceclofenac to the milk of lactating rats. The use of Aceclofenac Tablets should therefore be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the foetus. Fertility; NSAIDs may impair fertility and are not recommended in women trying to conceive. The temporary discontinuation of Aceclofenac should be considered in women having difficulties to conceive or undergoing investigations for infertility.
Gastrointestinal:The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (See section 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: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 an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).Other adverse reactions reported less commonly include:
Renal:Nephrotoxicity in various forms, including interstitial nephritis, nephritic syndrome and renal failure.
Hepatic:abnormal liver function, hepatitis and jaundice.
Neurological and special senses:Visual disturbances, optic neuritis, headaches, paraesthesia, 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) , depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.
Haematological:Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Dermatological:Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.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 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 Intestinal perforation Exacerbation of Crohn's disease and colitis Ulcerative Haematemesis Gastrointestinal haemorrhage Gastric ulcer Pancreatitis|
|Skin and subcutaneous tissue disorders||Pruritus Rash Dermatitis Urticaria||Face oedema Angioedema||Purpura Severe mucocutaneous skin reaction (including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis) Dermatitis bullous|
|Musculoskeletal and connective tissue disorders||Cramps in the leg|
|Renal and urinary disorders||Blood urea increased Blood creatinine increased||Renal insufficiency Nephrotic syndrome Renal failure|
|Hepatobiliar disorders||Hepatic enzyme increased||Hepatitis Jaundice Hepatic injury (including hepatitis) Blood alkaline phosphatase increased|
|General disorders and administration site conditions||Oedema Fatigue Cramps in legs|
a) SymptomsSymptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible. b) Therapeutic measure:Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Given the route of administration and the pharmaceutical form, an overdose with injectable Aceclofenac is unlikely.Specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism. Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. In case of frequent or prolonged convulsions, patients should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition. Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.
Core Tablet:Cellulose microcrystalline Croscarmellose sodiumPovidone K-30 Glyceryl palmitostearate
Tablet coating:Hypromellose 15 cpsMacrogol 400 Titanium dioxide (E171).
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