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PRESERVEX is a brand name for Aceclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Preservex is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Verbatim from this product's MHRA label. Tap a section to expand.
Preservex film-coated tablets are supplied for oral administration. Posology When Preservex was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section
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:
). 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. Paediatric population There are no clinical data on the use of Preservex 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 Preservex are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency. Renal insufficiency There is no evidence that the dosage of Preservex needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see also Precautions).
Hepatic insufficiency There is some evidence that the dose of Preservex 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 To be taken preferably with or after food.
The tablets should be swallowed whole with a sufficient quantity of liquid. 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.
4). Patients with 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.
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.
4). Patients with 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.
Active bleedings or bleeding disorders. Preservex should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
Active bleedings or bleeding disorders. Preservex should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. 6). 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 or recovering from major surgery, and the elderly.
The importance of prostaglandins in maintaining renal blood flow should be taken into account in these patients. 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 Preservex.
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), Preservex 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 Preservex 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. g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with aceclofenac after careful consideration.
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. 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, or haematological […]