Each 100 g contains:
Ibuprofen ………………………........................................................…………. 5 g
Excipients: Isopropyl alcohol, 2,2 Dimethyl-4hydroxymethyl-1,3 dioxolan, Poloxamer 407, Middle chain triglycerides, lavender oil, neroli oil and purified water.





Topical analgesic and anti-inflammatory for backache, rheumatic and muscular pain, sprains and sports injuries.





Dosage:
Adults, the Elderly and Children over 14 years:
Squeeze 5 to 10 cm of the gel (containing 50 to 100 mg of ibuprofen) 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.
Unless recommended by a doctor, advice should be sought about continued treatment if symptoms persist for more than 2 weeks.
Children under 14 years: Do not use on children under 14 years of age except on the advice of a doctor.
Administration:
For topical application to the skin.





Hypersensitivity to ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other NSAIDs.
Patients suffering from renal failure.




Cardiovascular Risk:
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
NSAIDs are contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk:
NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events.
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.
Not to be used during pregnancy or lactation.
Do not exceed the stated dose.
Keep out of the reach of children.
For external use only.
You must contact your doctor if your symptoms worsen at any time, or do not improve after 2 weeks.
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.
Some people may have side-effects when taking this medicine. If you have any unwanted side-effects, you should seek advice from your doctor, pharmacist or other healthcare professional.
Not recommended for children under 14 years.





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





Pregnancy:
Not to be used during pregnancy. Whilst no teratogenic effects have been demonstrated in animal experiments, Ibutop should be avoided during pregnancy. The onset of labour may be delayed and duration of labour increased.
Lactation:
Ibuprofen appears in breast milk in very low concentration and is unlikely to affect the breastfed infant adversely.





None known.





Skin disorders are most frequently reported.
Skin: Application site reactions, rashes, pruritus, and urticaria.
Gastrointestinal: Abdominal pain, dyspepsia.
Respiratory: Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.
Hypersensitivity reactions: These have been reported following treatment with ibuprofen. These may consist of:
a) non-specific allergic reactions and anaphylaxis,
b) respiratory tract reactivity comprising of asthma, aggravated asthma, bronchospasm or dyspnoea, or
c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforms).
Other adverse effects reported very rarely include renal failure.
Ibutop gel may cause Steven-Johnson Syndrome.





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





Pharmacodynamic properties:
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 rheumatic and muscular pain, backache, sprains, strains, lumbago and fibrositis by virtue of precutaneous absorption.
Ibutop Gel is a clear odourless gel. Following application to the affected area, it initially feels cool to the skin and is free from skin-warming effects.
Pharmacokinetic properties:
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 5% ibuprofen gel is approximately 5% that of oral ibuprofen. Therapeutic concentrations are reached locally but not systemically.





Store at a temperature not exceeding 30°C.





Ibutop Gel: Box containing collapsible aluminum tube containing 20 g gel with threaded tip and plastic (HDPE) screw cap.