Dermal Laboratories Limited

IBUGEL™ 5% w/w Gel

Each gram of gel contains 50 mg ibuprofen (5.0% w/w).

Excipients: also contains propylene glycol 2.0% w/w.

For a full list of excipients, see section List of excipients.

Non-greasy, fragrance-free, clear, aqueous-alcoholic gel.

For the topical treatment of rheumatic and muscular pain, sprains, strains, backache and neuralgia. Ibugel is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.

Apply the gel to the affected areas, up to three times daily, or as directed by the physician. On each occasion apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed. Do not use excessively.

Treatment should be reviewed after 14 days and should not normally continue for more than a few weeks, unless recommended to do so by a doctor.

The same dosage and dosage schedule applies to all age groups, although Ibugel is not normally recommended for use on children under the age of 12 years, unless instructed by their doctor.

Not to be used in cases of sensitivity to any of the ingredients. Not to be used on broken skin. Not to be used in asthmatic patients known to be hypersensitive to aspirin or other non-steroidal anti-inflammatory agents.

Seek medical advice if symptoms worsen or persist. 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, waterproof protective dressings should not be used over the treated areas, and patients with an active peptic ulcer, a history of kidney problems or asthma should seek medical advice before using Ibugel.

The excipient propylene glycol may on rare occasions cause skin irritation in sensitive people.

Keep away from the eyes and mucous membranes. This product should not be used with occlusive dressings.

Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may 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.

Experimental data suggest that oral ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. 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 (see section 5.1).

Not to be used during pregnancy or lactation.

None known.

Occasionally mild skin rashes, itching or irritation may occur at the site of application.

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 reactions and anaphylaxis, (b) respiratory tract reactivity comprising 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 multiforme).

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

Gastrointestinal: side effects such as abdominal pain and dyspepsia have been reported.

Not applicable. Any overdose with a topical presentation of ibuprofen is extremely unlikely.

Ibugel is a topical preparation which has anti-inflammatory and analgesic properties. It contains the active ingredient, ibuprofen, which exerts its effects directly in inflamed tissues underlying the site of application, mainly by inhibiting prostaglandin biosynthesis.

Because it is formulated in an aqueous/alcoholic gel, Ibugel also exerts a soothing and cooling effect when applied to the affected area.

Experimental data suggest that oral ibuprofen may inhibit the effect of low dose aspirin on platelet 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 dosing (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.

Specially formulated for external application, the active ingredient penetrates through the skin rapidly and extensively, achieving high, therapeutically relevant local concentrations in underlying soft tissues, joints and 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.

Furthermore, there do not appear to be any appreciable differences between the oral and topical routes of administration regarding metabolism or excretion.

Published information on subchronic toxicity studies confirms that topically applied ibuprofen is well tolerated both locally and by the gastro-intestinal tract. Any local erythema is only mild and no signs of mucosal lesions or ulcerogenic effects have been determined in the gastro-intestinal tract.

In the course of assessing mucosal tolerance, topical ibuprofen has been found to cause acute, but reversible, irritant reactions in the eyes and mucous membranes.

Industrial Methylated Spirit; Carbomer; Propylene Glycol; Diethylamine; Purified Water.

None known.

36 months.

Do not store above 25°C.

100 g collapsible aluminium tube, fitted with a screw cap.

No special requirements.

Dermal Laboratories Limited

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK

PA 278/20/1.

19 September 2010.

February 2011.