Reckitt Benckiser Ireland Limited

Nurofen 5% w/w Gel

5% w/w Ibuprofen

For excipients, see 6.1

Gel

A clear, colourless and smooth gel.

For local symptomatic relief of pain and inflammation in the trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism

Strength 5% maximum

Method of administration:

For topical application to the skin

Dosage:

Adults, the elderly and children over 14 years: Unscrew and invert cap to pierce seal. Apply a thin layer of gel from the tube to the affected area and massage gently until absorbed. Repeat as necessary up to three times a day.

Wash hands after each application. Do not exceed the stated dose.

Review treatment after 2 weeks, especially if the symptoms worsen or persist.

Children under 14 years: Do not use on children under 14 years of age except on the advice of a doctor.

Hypersensitivity to any of the constituents. Hypersensitivity e.g. (bronchospasm, asthma, rhinitis or urticaria) to aspirin, or other non-steroidal anti-inflammatory drugs.

Not to be used on broken skin.

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.

Do not exceed the 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 before use if:

-You are taking aspirin or any other pain relieving medication

-You are pregnant

Not recommended for children under 14 years.

Oral NSAIDs can sometimes be associated with renal impairment, aggravation of peptic ulcers, and can induce bronchial reactions in susceptible patients.

Although systemic absorption of topically applied ibuprofen is less than for oral dosage forms, these complications can occur in rare cases.

Concurrent aspirin or other NSAIDs may result in an increased incidence of adverse reactions.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelets aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding the extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional use (see section 5.1)

Whilst no teratogenic effects have been demonstrated in animal experiments, Ibuprofen should be avoided during pregnancy. The onset of labour may be delayed and duration of labour increased. Ibuprofen appears in breast milk in very low concentration and is unlikely to affect the breast fed infant adversely.

None known

Skin disorders are most frequently reported.

Skin: application site reactions, rashes, pruritis, urticaria.

Gastro-intestinal: abdominal pain, dyspepsia.

Respiratory: bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

Overdose with a topical presentation of Nurofen 5% Gel is unlikely. Symptoms of ibuprofen overdose include headache, vomiting, drowsiness and hypotension. Correction of severe electrolyte abnormalities should be considered.

Ibuprofen is a non-steroidal anti-inflammatory drug which has been tested and proved to be effective as an analgesic, anti-pyretic and anti-inflammatory after systemic administration. When administered as a topical preparation, ibuprofen has been shown to be an effective topical analgesic and anti-inflammatory for the relief of mild to moderate arthritic pain, muscular pain, backache, sprains, strains, lumbago and fibrositis by virtue of percutaneous absorption.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelets aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

The gel product containing ibuprofen diffuses through the skin as a function of time and after 24 hours an application to human skin shows that the dose administered is present in the epidermis and dermis. Percutaneous absorption of this ibuprofen gel is approximately 5% that of oral ibuprofen. Therapeutic concentrations are reached locally; but not systemically.

Animal irritancy (including phototoxicity) and absorption studies have been carried out. There is no new data published on the active ingredient per se.

Hyetellose/hydroxyethylcellulose

Sodium Hydroxide (E524)

Benzyl Alcohol

Isopropyl Alcohol

Purified Water

None known

3 years

Store below 25°C

Aluminium tube with internal epoxy phenolic coating containing 30 g of Nurofen 5% Gel.

No special requirements

Reckitt Benckiser Ireland Ltd.,

7 Riverwalk,

Citywest Business Campus,

Dublin 24

PA 979/32/3

Date of first authorisation: 31^st March 2000

Date of last renewal: 31^st March 2005

April 2009