Bosfen 400

POSOLOGY, METHOD OF ADMINITRATION

Method of administration

Bosfen 400 is used for oral administration. The capsule should be swallowed with a glass of water preferably during a meal.

Posology

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms  (see WARNING AND PRECAUTIONS FOR USE)

Adults:

The usual dose for pain relief is 3-4 tablets/day in divided small doses; however, some patients  can be maintained dose on 1- 2 tablets daily to be effective. If necessary, the dose can be increased to a maximum of 6 tablets daily (equivalent to 2400 mg ibuprofen). Rheumatoid arthritis patients often have to take higher doses of ibuprofen than people with osteoarthritis.

The recommended dose to reduce fever is 1 tablet/time, can be repeated every 6 - 8 hours if needed, do not exceed 3 tablets/day (equivalent to 1200 mg / day).

Children:

Children >12 years (or >30 kg): The usual dose for pain relief or fever reduction is 20-30 mg/kg/day, in divided small doses. Up to 40 mg/kg/day may be used for juvenile rheumatoid arthritis if needed.

Children ≤12 years: other preparations should be used to match the dose.

Elderly:

The elderly are at a higher risk of serious consequences from the side effects of ibuprofen. If the use of an NSAID is absolutely necessary, using the lowest effective dose for the shortest duration. Patients should be regularly monitored for gastrointestinal bleeding during treatment. If hepatic or renal impairment is present, the dose should be re-evaluated on a case-by-case basis.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.

• Patients who have shown hypersensitivity reactions (asthma, rhinitis, or urticaria) in response to ibuprofen, aspirin, or other NSAIDs.
• Patients with a history of gastrointestinal bleeding or perforation due to NSAID use.
• Patients with active peptic ulcer or with a history of recurrent peptic ulcer or gastrointestinal bleeding.
• Patients with severe heart failure (NYHA class IV), severe renal failure, or hepatic failure
• Patients in the third trimester of pregnancy

WARNING AND PRECAUTIONS FOR USE

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

The use of ibuprofen with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the increased risk of ulceration or bleeding.

Elderly

The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal. Therefore, caution should be exercised when using ibuprofen in the elderly

Gastrointestinal bleeding, ulceration, or perforation

GI bleeding, ulceration or perforation has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRI) or anti-platelet agents such as aspirin.

Caution and closely monitored in patients ulcerative colitis or Crohn's disease because their condition may be exacerbated.

If ulceration or bleeding occurs, treatment with BOSFEN 400 should be discontinued immediately.

The risk of cardiovascular thrombosis

Systemic nonsteroidal anti-inflammatory drugs (NSAIDs), other than aspirin, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses.

Physicians should periodically evaluate the occurrence of cardiovascular events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and see a doctor immediately when these symptoms appear.

Respiratory disorders and hypersensitivity reactions

Caution is required if ibuprofen is administered to patients suffering from or with a previous history of bronchial asthma, chronic rhinitis or allergic diseases since NSAIDs have been reported to precipitate bronchospasm, urticaria or angioedema in such patients.

Heart failure, liver failure and kidney failure

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 and the elderly. For these patients, use the lowest effective dose, for the shortest possible duration and monitor renal function especially in long-term treated patients.

Systemic Lupus Erythematosus (SLE) and mixed connective tissue disorder

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders, the risk of aseptic meningitis may be increased with ibuprofen use.

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. In most case,, the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Impaired female fertility

The use of ibuprofen may impair 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 BOSFEN 400 should be considered.

SHELF LIFE

36 months from the manufacturing date. Do not use after the expiry use