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LARAFEN CR, KETOPROFEN CONTROLLED RELEASE is a brand name for Ketoprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Larafen* CR is an analgesic, anti-inflammatory and antipyretic; recommended for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and other musculoskeletal conditions including bursitis, capsulitis, synovitis, tendinitis, fibrositis and low back pain. It is also useful to relieve the pain…
Verbatim from this product's MHRA label. Tap a section to expand.
4). 4).
Adults:
One 200mg Larafen CR Capsule to be taken orally once daily with a little food. The maximum daily dose is 200mg. 4).
Patients with impaired renal function and the elderly:
It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose. Individual adjustment may be considered, only after good individual tolerance has been ascertained (see section 5).
Elderly:
The elderly are at increased risk of serious adverse reactions from NSAIDs. If a NSAID is considered necessary, it is generally advisable in the elderly to begin ketoprofen therapy at the lower end of the dose range and to maintain such patients on the lowest effective dosage.
The patient should be monitored for GI bleeding during NSAID therapy. 3 and 5).
Children:
The safety and effectiveness of ketoprofen capsules have not been established. There are no recommendations for the use of Larafen CR in children.
Method of administration:
Oral. Larafen CR capsules should always be prescribed "To be taken with or after food" to minimise gastric intolerance
Classification of expected 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), not known (cannot be estimated from the available data). 4).
Hepatobiliary disorders:
Rare: hepatitis, transaminase increased, elevated serum bilirubin due to hepatitis disorders Not known: abnormal liver function, hepatic damage, jaundice Skin and subcutaneous tissue disorders: Uncommon: rash, pruritus, Not known: photosensitivity reactions, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome, toxic epidermal necrolysis acute generalised exanthematous pustulosis, exfoliative and bullous dermatoses (including epidermal necrolysis, erythema multiforme), purpura Renal and urinary disorders: Not known: renal failure acute, tubulointerstitial nephritis, nephritic syndrome, renal function tests abnormal, nephrotoxicity in various forms, including interstitial nephritis.
4). Should any severe adverse event occur, treatment should be stopped immediately. 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.
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5). 2, and GI and cardiovascular risks below). Masking of symptoms of underlying infections Larafen CR capsules can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection.
This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Larafen CR capsules are administered for fever or pain relief in relation to infection, monitoring of infection is advised.
In non- hospital settings, the patient should consult a doctor if symptoms persist or worsen.
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. 3). 3), and in the elderly. These patients should commence treatment on the lowest dose available.
g. 5). 3). g. 8). 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. As with other drugs in the same therapeutic category, patients should be advised to take ketoprofen with food, to minimise gastric intolerance.
2). When GI bleeding or ulceration occurs in patients receiving Ketoprofen, the treatment should be withdrawn.
Dermatological:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome and toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDs. 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.
1. • Active peptic ulcer, or any history of gastrointestinal bleeding, ulceration or perforation. • Haemorrhagic diathesis. • Patients who have previously shown hypersensitivity reactions such as bronchospasm, asthma attacks, rhinitis, angioedema, urticaria or other allergic-type reactions to ketoprofen, ibuprofen, aspirin or any other non-steroidal anti- inflammatory drugs.
8). 4). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ketoprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Cardiovascular, Renal and Hepatic impairment:
The administration of an NSAID may cause a dose dependent reduction in renal blood flow caused by prostaglandin inhibition and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, heart failure, liver dysfunction, cirrhosis, nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly.
3). 3). NSAIDs have been reported to cause nephrotoxicity in various forms and this can lead to interstitial nephritis, nephrotic syndrome and renal failure. Renal function must be carefully monitored. Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti- inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil fumarate and with risk factors for renal dysfunction.
If tenofovir disoproxil fumarate is co-administered with an NSAID, renal function should be monitored adequately. 5). Caution should be exercised when treating such patients and they must be monitored when receiving ketoprofen. In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy.
Rare cases of jaundice and hepatitis have been described with ketoprofen.
Cardiovascular and cerebrovascular effects Precautions:
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 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 ketoprofen. As with all NSAIDs, careful consideration should be given when treating patients with existing uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or […]