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FENOPRON is a brand name for Fenoprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. For the relief of mild/moderate pain.
Verbatim from this product's MHRA label. Tap a section to expand.
4). For oral administration to adults only, and not recommended for administration to children. Dosage: 300-600mg three or four times per day. To be taken preferably with or after food.
Fenopron 300:
Recommended initial dosage is 2 tablets three times per day then adjusted to the needs of the patient. The maximum daily dose should not exceed 3g. If fenoprofen is administered with meals the total amount absorbed is not affected although peak blood levels are delayed and diminished.
The elderly:
There is no difference in the metabolism or pharmacokinetics of fenoprofen in the elderly. The elderly 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.
Gastrointestinal:
The most commonly observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration. Less frequently, gastritis has been observed.
Hypersensitivity:
Hypersensitivity reactions have been reported following treatment with NSAIDs. They 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:
Palpitations, tachycardia, atrial fibrillation, pulmonary oedema, hypertension, cardiac failure, ECG changes and supraventricular tachycardia have been reported in association with NSAID treatment. 4).
Other adverse events reported less commonly include:
Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, papillary necrosis and renal failure. Episodes of dysuria, cystitis and haematuria, oliguria, azotaemia and anuria have occurred.
Hepatic:
Abnormal liver function, hepatitis and jaundice. Increases in alkaline phosphatase, LDH and AST have been observed. 4), depression, confusion, hallucinations, tinnitus, hearing decrease, vertigo, dizziness, nervousness, malaise, fatigue, drowsiness, burning tongue, breast pain, personality change, lymphadenopathy, mastodynia, fever, upper respiratory infection and nasopharyngitis have been reported.
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 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. Clinical trial and epidemiological data suggest that the 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 Fenopron. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Fenopron after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Cardiovascular, Renal and Hepatic Impairment:
The administration of a 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). Discontinuation of therapy is typically followed by recovery to the pre-treatment state. Some patients have developed elevation of serum transaminase, LDH and alkaline phosphatase and it is recommended that fenoprofen be discontinued if any significant liver abnormalities occur.
Hypersensitivity to fenoprofen or to any of the excipients. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Fenoprofen should not be given to patients in whom aspirin, ibuprofen and other non-steroidal anti-inflammatory drugs induce any hypersensitivity reaction such as asthma, rhinitis, angioedema or urticaria, because cross-sensitivity to these drugs occurs in a high proportion of patients.
4). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Haematological:
Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Dermatological:
Photosensitivity, pruritus, rash, urticaria, anaphylaxis, Stevens-Johnson syndrome, angioneurotic oedema, increased sweating, exfoliative dermatitis; toxic epidermal necrolysis and alopecia have been reported.
Borderline elevations of one or more liver function tests may occur in up to 15% of patients. Severe hepatic reactions, including jaundice and cases of fatal hepatitis, have been reported. Patients in whom an abnormal liver test has occurred should be evaluated for evidence of more severe hepatic reactions.
During long-term therapy, liver function tests should be monitored periodically. If fenoprofen is used in the presence of impaired liver function, it must be done under strict observation.
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. Minor upper gastro- intestinal problems, such as dyspepsia, are common, usually developing early in therapy.
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 Fenopron, the treatment should be withdrawn. 8). 8).
Impaired Female fertility:
The use of Fenopron 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 Fenopron should be considered.
8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of reaction occurring in the majority of cases within the first month of treatment. Fenopron should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Genito-urinary:
The most frequent reported problems have been episodes of dysuria, cystitis, haematuria, interstitial nephritis and nephrotic syndrome. This syndrome may be preceded by the appearance of fever, rash, arthralgia, oliguria and uraemia, and may progress to anuria.
Early recognition of the syndrome and withdrawal of the […]