GSL: General Sales List
This information is intended for use by health professionals
Ibuprofen 5% gel,
Ibuprofen Pain relief gel 5% w/w
5% w/w Ibuprofen Ph.Eur.
Excipient(s) with known effect
Each 100mg of gel contains 1mg of Benzyl alcohol
For the full list of excipients, see section 6.1
Gel for topical application.
Clear or slightly opalescent, colourless or almost colourless gel with Isopropanol odour.
Pharmacy Only Indications:
Topical analgesic and anti-inflammatory for backache, pain of non-serious arthritic conditions, muscular pain, sprains, strains, sports injuries and neuralgia.
General Sales List Indications:
Topical analgesic and anti-inflammatory for backache, rheumatic and muscular pain, sprains, strains and sports injuries.
Strength 5% maximum
Adults, the elderly and children over 12 years: Squeeze 50 to 125mg (4 to 10cm) 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 USE MORE GEL THAN THE LABEL TELLS YOU TO.
Review treatment after 2 weeks, especially if the symptoms worsen or persist.
Paediatric population: Do not use on children under 12 years of age except on the advice of a doctor.
Method of Administration
For topical application to the skin.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
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 USE MORE GEL THAN THE LABEL TELLS YOU TO.
Keep out of the sight and 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.
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 breast-feeding.
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.
Ibuprofen appears in breast milk in very low concentrations but is unlikely to affect breast fed infants adversely.
No data available
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
Immune system disorders
Renal and urinary disorders
Skin and subcutaneous tissue disorders
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdosage with a topical presentation of ibuprofen gel is unlikely.
Symptoms of severe ibuprofen overdosage (eg following accidental oral ingestion) include headache, vomiting, drowsiness and hypotension.
Correction of severe electrolyte abnormalities should be considered.
Pharmacotherapeutic group: Anti-inflammatory preparations, non-steroids for topical use.
ATC code: M02A A13
The gel is for topical application. It contains the active ingredient, ibuprofen, a phenylpropionic acid derivative which exerts its anti-inflammatory and analgesic effects directly in inflamed tissues underlying the site of application, mainly by inhibiting prostaglandin biosynthesis. Because it is formulated in an aqueous/ alcoholic gel, the preparation also exerts a soothing and cooling effect when applied to the affected area.
Absorption and Distribution
Specially formulated for external application, the active ingredient penetrates through the skin rapidly and extensively (approximately 22% of a finite dose within 48 hours), achieving high, therapeutically relevant local concentrations in underlying soft tissues, joints and the synovial fluid, whilst producing plasma levels that are unlikely to be sufficient to cause any systemic side-effects, other than in rare individuals who are hypersensitive to ibuprofen.
Biotransformation and Elimination
Furthermore, there do not appear to be any appreciable differences between the oral and topical routes of administration regarding metabolism or excretion.
There is no new data published on the active ingredient.
Ethylhydroxycellulose EPSodium Hydroxide EP Benzyl alcohol EP Isopropyl alcohol EP Purified water EP
Store below 25° C.
Aluminium tube with internal epoxy phenolic coating with Polypropylene cap containing 15g (trial size/starter pack) and 30/35/50/100g of Fenbid Gel/Phorpain Gel. The 100g pack size is restricted to "Pharmacy" only. Not all pack sizes may be marketed.
No special requirements for disposal.
Mercury Pharma Group Ltd.,
85 King William Street,
London EC4N 7BL, UK
26 April 1996
Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK
+44 (0)208 588 9131
08700 70 30 33
+44 (0)208 588 9273