Ibuprofen Gel 35G

Ibuprofen 10% w/w gel

Nurofen Joint & Back Pain Relief Max Strength 10 % Gel

Boots Max Strength Ibuprofen 10% Gel

Ibuprofen 10% w/w

Excipient(s) with known effects

Each 100mg of gel contains 1mg of Benzyl alcohol

For the full list of excipients, see section 6.1

Gel.

For cutaneous use.

Clear or slightly opalescent, colourless or almost colourless gel with Isopropanol odour.

For the relief of pain and inflammation associated with backache, rheumatic pain, muscular aches, pains or swellings such as sprains, strains and sports injuries.

Posology

Adults, the elderly, and children over 12 years: Squeeze 2 to 5cm (i.e. 0.8 to 2 inches) of gel (50mg to 125 mg ibuprofen) from the tube and lightly rub into the affected area until absorbed. Use up to four times daily with individual doses administered at least 4 hours apart. Patients should not apply more than 500mg ibuprofen (approximately 5g gel) in any 24 hour period.

Wash hands after each application. 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 cutaneous use.

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

Hypersensitivity to aspirin, ibuprofen or related painkillers (including when taken by mouth), especially where associated with a history of asthma, rhinitis or urticaria.

Not to be used on broken or damaged skin.

Apply with gentle massage only.

Discontinue if rash develops.

Hands should be washed immediately after use.

Not for use with occlusive dressings.

Keep away from the eyes and mucous membranes.

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 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, asthma or intolerance to aspirin or ibuprofen taken orally should seek medical advice before using the gel as should patients already taking other painkillers.

The label should include the following warnings:

• Do not apply more of this medicine than the label tells you to.

• Not recommended for children under 12 years.

• Use this medicine only on your skin.

• Not to be used during pregnancy or breastfeeding.

• Do not use if you are allergic to any of the ingredients or have experienced problems with aspirin, ibuprofen or related painkillers (including when taken by mouth).

• If symptoms do not get better after 2 weeks or if they worsen, consult your doctor or pharmacist.

• Keep out of the sight and reach of children.

• Patients with asthma, an active peptic ulcer or history of kidney problems should consult their doctor before use, as should patients already taking aspirin or other painkillers.

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, which is equivalent to 0.01mg/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’.

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.

Where aspirin or other NSAID tablets are taken concurrently, it is important to bear in mind that these may increase the incidence of undesirable effects.

Not to be used during pregnancy or breast-feeding.

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.

Breastfeeding:

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

Fertility:

No data available.

Not relevant

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:-