FENBID 10% w/w Gel Ref.[6923] Active ingredients: Ibuprofen

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.

Consult your doctor or pharmacist before use if:

• You are taking aspirin or any other pain relieving medication.
• You are pregnant.

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.

This medicine contains 1.25 mg benzyl alcohol in each 125mg dose which is equivalent to 0.01mg/mg. Benzyl alcohol may cause allergic reactions.

Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote. Concurrent aspirin or other NSAIDS may result in an increased incidence of adverse reactions.

Not to be used during pregnancy or lactation.

Pregnancy

Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed and the duration of labour increased.

Lactation

Ibuprofen appears in breast milk in very low concentrations but is unlikely to affect breast fed infants adversely.

None known.

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:

Hypersensitivity: Hypersensitivity 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 © assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Gastro-intestinal: Side effects such as abdominal pain and dyspepsia have been reported.

Renal: Renal impairment can occur in patients with a history of kidney problems.

Photosensitivity reactions: frequency unknown.

Reporting of side effects

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None known.