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TILOKET CR is a brand name for Ketoprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tiloket CR Capsules are indicated for: • Rheumatoid arthritis • Osteoarthritis • Ankylosing spondylitis • Acute articular and periarticular disorders (bursitis, capsulitis, synovitis, tendonitis) • Cervical spondylitis • Low back pain (strain, lumbago, sciatica, fibrositis) • Painful musculoskeletal conditions •…
Verbatim from this product's MHRA label. Tap a section to expand.
4). The maximum daily dose is 200mg. 4) Adults: 100 - 200 mg daily depending on patient weight and on severity of symptoms, to be taken preferably with food.
Older people:
As for adult dosage as there is no evidence that the pharmacokinetics of ketoprofen are altered in the elderly. The elderly are at risk of 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 gastrointestinal bleeding during NSAID therapy.
Paediatric population:
The safety and efficacy of Tiloket Capsules in children has not yet been established. No data are available. Method of Administration For oral administration
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) Not known: visual disturbances, optic neuritis Ear and labyrinth disorders Rare: tinnitus Cardiac disorders Not known: cardiac failure have been reported in association with NSAID treatment.
Vascular disorders Not known: hypertension, vasodilatation Respiratory, thoracic and mediastinal disorders Rare: respiratory tract reactivity comprising of asthma Not known: aggravated asthma, or dyspnoea, bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs), rhinitis Gastrointestinal disorders Common: dyspepsia, nausea, abdominal pain, vomiting Uncommon: constipation, diarrhoea, flatulence, gastritis Rare stomatitis, peptic ulcer Not known: exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage and perforation Hepatobiliary disorders Rare: hepatitis, transaminases increased, elevated serum bilirubin due to hepatitis disorders Abnormal liver function and jaundice Skin and subcutaneous disorders Uncommon: rash, pruritis Not known: rashes of various types photosensitivity reaction, alopecia, urticaria, purpura, angioedema less commonly bullous dermatoses (including toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome and exfoliative dermatitis) Should any severe adverse event occur, treatment should be stopped immediately.
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). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Warnings Masking of symptoms of underlying infections Tiloket 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 Tiloket is 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. 5). 2, and GI and cardiovascular risks below).
5). 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). 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 Tiloket, the treatment should be withdrawn.
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. 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, liver dysfunction, cirrhosis, those taking diuretics and the elderly.
1. 4). 6). • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ketoprofen in United Kingdom.
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It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
3). NSAIDs have been reported to cause nephrotoxicity in various forms: interstitial nephritis, nephrotic syndrome and renal failure. Renal function must be carefully monitored. Cardiovascular and cerebrovascular effects 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.
Precautions:
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ketoprofen after careful consideration as fluid retention and oedema have been reported in association with NSAID therapy.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). At the start of treatment, renal function must be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly.
In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decompensation. If visual disturbances, such a blurred vision, occur treatment should be discontinued.
As with other NSAIDs, in the presence of an infectious disease, it should be noted that the anti-inflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever. 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. Respiratory disorders Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the […]