KETOPROFEN

4). 4). Ketoprofen capsules should always be taken with food to reduce the occurrence of gastrointestinal disturbance. Adults: 50-100mg twice daily. The dosage can be altered depending on the patient weight and on the severity of symptoms.

Dysmenorrhoea: 50mg up to 3 times a day. Three to 4 days treatment is normally required from the onset of menstruation or symptoms of dysmenorrhoea.

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 for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Children:

Dosage has not been established.

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). 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.

Warnings Masking of symptoms of underlying infections Ketoprofen 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 Ketoprofen 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. 5). 2, and GI and cardiovascular risks below).

Ketoprofen should be used with caution:

At the start of treatment, close supervision is necessary of the volume of urine passed and of renal function in patients with cardiac insufficiency, cirrhosis and nephrosis, in patients on diuretics, in patients with chronic renal insufficiency and in particular, in elderly patients intrauterine device: a possible reduction of the device’s effectiveness.

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. 5). When GI bleeding or ulceration occurs in patients receiving ketoprofen, the treatment should be withdrawn.

2). 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.

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. 8). At the start of treatment, renal function must be carefully monitored in patients with heart impairment, heart failure, liver dysfunction, 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 decomposition. 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.

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). If visual disturbances, such as 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.

The use of NSAIDs may impair female fertility and is not recommended in women attempting […]

1 Known allergy to aspirin and to other substances with similar effect (non- steroidal anti-inflammatory agents): who have a history of hypersensitivity reactions such as bronchospasm, asthmatic attacks, rhinitis, urticaria or other allergic-type reactions to ketoprofen.

8). Active peptic ulcers or any history of gastrointestinal bleeding, ulceration or perforation. Severe hepatocellular insufficiency. Severe renal insufficiency. Children aged less than 15 years. Severe heart failure. Haemorrhagic diathesis.

Ketoprofen is also contraindicated in the third trimester of pregnancy.