PRODUCT SUMMARY

1. NAME OF THE MEDICINAL PRODUCT Ibuleve Mousse

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ibuprofen 5.0% w/w

3. PHARMACEUTICAL FORM

Non-greasy, fragrance-free, white aqueous cutaneous foam

4. CLINICAL PARTICULARS

4.1. Therapeutic Indications

For fast local relief of pain and inflammation in musculoskeletal conditions including backache, rheumatic and muscular pain, sprains, strains, lumbago and fibrositis, and neuralgia. Ibuleve Mousse is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.

4.2. Posology and method of administration

Shake container before use. Hold container upright, then press nozzle to dispense the mousse into the palm of your hand. Gently massage the mousse into and around the affected areas until absorbed. The exact amount to be applied will vary, depending on the extent and severity of the condition, but it should normally be sufficient to apply 1 to 2 g (1 to 2 golf-ball sized quantities of mousse dispensed into the palm of the hand). This amount may be repeated up to 3 to 4 times daily unless otherwise directed by the doctor.

Treatment should not normally continue for more than a few weeks, unless recommended by a doctor.

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

4.3 Contraindications

Not to be used if allergic to any of the ingredients, or in cases of 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, or where there is infection or other skin disease.

4.4. Special warnings and special precautions for use

This product is flammable. Do not spray near flames, burning cigarettes, electric heaters or similar objects.

Keep away from the eyes and mucous membranes.

Oral NSAID's, including ibuprofen, can sometimes be associated with renal impairment or aggravation of active peptic ulcers, and they can induce allergic bronchial reactions in susceptible asthmatic patients. Although systemic absorption of topically applied ibuprofen is much less than for oral dosage forms, these complications can still occur in rare cases. For these reasons, patients with asthma, an active peptic ulcer or a history of kidney problems, should seek medical advice before using the mousse, as should patients already taking other painkillers.

Patients should seek medical advice if symptoms worsen or persist.

Keep out of the reach and sight of children.

For external use only.

Wash hands after use unless treating them.

Do not use excessively.

The label will include statements to the following effect:

Do not exceed the stated dose. Not recommended for children under 12 years without medical advice. For external use only. Not to be used during pregnancy or breast feeding. 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 persist consult your doctor or pharmacist. Keep out of the reach and sight of children. Patients with asthma, an active peptic ulcer or a history of kidney problems should consult their doctor before use, as should patients already taking aspirin or other painkillers.#

Interaction with other medicinal products and other forms of interaction

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 undesirable effects.

4.6. Pregnancy and lactation

Not to be used during pregnancy or lactation. 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.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

The cooling effect of the mousse may result in a temporary paling of the skin.

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.

Overdose

Any overdose with a topical presentation of ibuprofen is extremely 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.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

The mousse is for topical application. Ibuprofen is a phenylpropionic acid derivative with analgesic and anti-inflammatory properties. It exerts its effects directly in inflamed tissues underlying the site of application, mainly by inhibiting prostaglandin biosynthesis.

Because it is formulated in an aqueous mousse, the preparation also exerts a soothing and cooling effect when applied to the affected area.

5.2. Pharmacokinetic properties

Ibuleve Mousse has been designed for external application. The formulation delivers the active ingredient through the skin rapidly and extensively, 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 or susceptible individuals who are hypersensitive to ibuprofen.

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

5.3. Pre-clinical safety data

No relevant information additional to that contained elsewhere in the SPC.

6. PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients

Propylene Glycol

Carbomer Phenoxyethanol Diethylamine Butane 40 Purified Water

(The ozone-friendly aerosol propellent is a blend of C₂ - H₅ hydrocarbons consisting primarily of propane, iso-butane and n-butane).

6.2.    Incompatibilities

None known

6.3.    Shelf life

48 months

6.4.    Special precautions for storage

Do not store above 25°C. Keep upright and away from direct heat or sunlight. Do not expose pressurised container to temperatures higher than 50^oC. Do not pierce or burn container, even when empty.

6.5.    Nature and content of container

Aluminium pressurised container incorporating a spray valve and cap containing 75 g and 125 g of product. Supplied as original packs (OP).

6.6.    Instructions for use, handling and disposal

Not applicable.

ADMINISTRATIVE DATA

7. MARKETING AUTHORISATION HOLDER

Diomed Developments Limited

T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK

8. MARKETING AUTHORISATION NUMBER(S)

PL 0173/0168

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

11 March 1998 / 11 March 2003

10 DATE OF REVISION OF THE TEXT

16/10/2007