FENBID BIPHASIC

Posology Adults: 1 capsule twice daily. The dose may be increased to two capsules twice daily if necessary. The first should be taken in the morning and the second 8-12 hours later. The capsules should be taken with or after food. Fenbid is not recommended for children under 12 years of age.

Patients should be instructed not to chew or suck the capsules as this destroys the sustained release properties. Providing this is ensured, the contents of a capsule may be sprinkled onto a spoonful of soft food, yoghurt, or similar substance, for patients who experience difficulty in swallowing the capsule.

Elderly Patients:

It would appear that advanced age has minimal influence on the pharmacokinetics of ibuprofen.

However the following should be considered:

Ibuprofen has been reported to be associated with cognitive dysfunction 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. 4).

Method of Administration:

For oral administration. To be taken preferably with or after food. The capsules should be swallowed whole with a liberal quantity of water.

Gastrointestinal disorders:

The most commonly observed adverse events are gastrointestinal in nature. 4). 4 – Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity:

Hypersensitivity reactions have been reported following treatment with NSAIDs. These 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, angioedema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Skin and subcutaneous tissue disorders:

Frequency very rare: Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis).

Frequency not known:

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Acute generalised exanthematous pustulosis (AGEP). 4). Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Not known:

Kounis syndrome.

Other adverse reactions reported less commonly include:

Renal and Urinary disorders: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic Syndrome and renal failure.

5) If given to patients receiving anticoagulant therapy, prothrombin time should be monitored at least for the first few days of combined treatment. 2, and GI and cardiovascular risks below).

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. Renal disorders Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.

Cardiovascular, Renal and Hepatic Impairment:

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.

3 – Contraindications).

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 studies suggest that use of ibuprofen, particularly at a high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

g. < 1200mg/daily) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II- III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided..

1. g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. • Severe heart failure (NYHA Class IV), hepatic, failure and renal failure. 4). 6) • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.