FENBID FORTE

Posology Adults, the elderly and children over 12 years:

Squeeze 50 to 125mg (2 to 5cm) of the gel from the tube and lightly rub into the affected area until absorbed. The dose should not be repeated more frequently than every four hours and no more than 4 times in any 24 hour period. Wash hands after each application.

Do not exceed the stated dose. Review treatment after 2 weeks, especially if the symptoms worsen or persist.

Paediatric population:

Do not use on children 12 years of age, except on the advice of a doctor. Method of administration For topical application to the skin.

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Uncommon (≥1/1,000 to <1/100) Not known (Frequency cannot be estimated from the available data) Very rarely, susceptible patients may experience the following side effects with ibuprofen, but these are extremely uncommon when ibuprofen is administered topically.

If they occur, treatment should be discontinued:- System Order Class Frequency Adverse effects Immune system disorders Uncommon Hypersentivity1 Gastrointestinal disorders Uncommon Abdominal pain Dyspepsia Renal and urinary disorders Uncommon Renal impairment2 Very rare Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) Skin and subcutaneous tissue disorders Not known Photosensitivity reactions, Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP) 1Hypersensitivity reactions have been reported following treatment with ibuprofen.

These may consist of (a) non-specific allergic reaction and anaphylaxis (b) respiratory tract reactivity comprising of asthma, aggravated asthma, brochospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).

2Renal impairment can occur in patients with a history of kidney problems. 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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Apply with gentle massage only. Avoid contact with eyes, mucous membranes and inflamed or broken skin. Discontinue if rash develops. Hands should be washed immediately after use. Not for use with occlusive dressings.

The label will state:

Do not exceed stated dose Keep out of reach of children For external use only If symptoms persist consult your doctor or pharmacist. Do not use if you are allergic to Ibuprofen or any of the ingredients, aspirin, or any other painkillers.

8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate). Not recommended for children under 12 years.

Oral NSAIDs, including ibuprofen, can sometimes be associated with renal impairment, aggravation of active peptic ulcers, and can induce allergic bronchial reactions in susceptible asthmatic patients. Although the systemic absorption of topically applied ibuprofen is less than for oral dosage forms, these complications can occur in rare cases.

For these reasons, patients with an active peptic ulcer, a history of kidney problems or asthma should seek medical advice before using Ibuprofen gel as should patients already taking other painkillers. Patients should seek medical advice if symptoms worsen or persist.

Patients should be advised against excessive exposure to sunlight of area treated in order to avoid possibility of photosensitivity. Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard.

Washing clothing and bedding may reduce product build-up but not totally remove it. 01mg/mg. Benzyl alcohol may cause allergic reactions and mild local irritation. This medicine contains less than 1 mmol sodium (23 mg) per 125mg, that is to say essentially ‘sodium-free’.

1. Hypersensitivity to aspirin, or other non-steroidal anti- inflammatory drugs. Patients with asthma, rhinitis or urticaria. Not to be used on broken or damaged skin. Third trimester of pregnancy.