SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

IBULEVE/IBULEVE SPORTS GEL

(In the case of GSL presentations : IBULEVE SPEED RELIEF GEL/IBUDERM)

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Ibuprofen    5.0% w/w

Excipient:

Propylene glycol    2.0% w/w

For a full list of excipients see Section 6.1.

3    PHARMACEUTICAL FORM

Non-greasy, fragrance-free, clear aqueous-alcoholic GEL

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Administered topically for fast local relief    of    pain    and    inflammation in

musculoskeletal conditions including backache, rheumatic and muscular pain, sprains, strains, lumbago and fibrositis, and neuralgia. lbuleve is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.

(In the case of GSL presentations: For fast local relief of rheumatic pain, muscular aches, pains or swellings, such as strains, sprains and sports injuries).

4.2    Posology and method of administration

P presentations

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. Wash hands after use unless treating them. Do not use excessively.

Treatment 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 the gel is not normally recommended for children under 12 years, unless instructed by their doctor.

GSL presentations

Adults, including the elderly, and children over 12 years.

Apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed. The dose is 1.0 to 2.5 g gel (quantified by appropriate means), applied up to three times daily, with individual doses administered at least 4 hours apart. Patients should not apply more than approximately 7.5 g of gel (quantified appropriately on the labelling) in any 24 hour period. Wash hands after use unless treating them. Not to be used under occlusive dressings.

Unless recommended by a doctor, advice should be sought about continued treatment if symptoms persist for more than 2 weeks.

Do not use in children under 12 years of age except on the advice of a 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.

4.4 Special warnings and special precautions for use

Keep away from the eyes and mucous membranes.

Oral NSAID's, 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, patients with asthma, an active peptic ulcer or a history of kidney problems, should seek medical advice before using the gel, as should patients already taking other painkillers.

Patients should seek medical advice if symptoms worsen or persist.

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

Keep out of the reach and sight of children.

For external use only.

The label will state: Do not exceed the stated dose. Not recommended for children under 12 years. 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.

4.5 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. Where aspirin or other NSAID tablets are taken concurrently, it is important to bear in mind that these may increase the incidence of undesirable effects.

4.6 Pregnancy and lactation

Not to be used during pregnancy or lactation. Although no teratogemc effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed, and the duration of labour increased. lbuprofen appears in breast milk in veiy 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

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.

4.9 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

ATC code: M02A A13, Antiinflammatory preparations, non-steroids for topical use.

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.

5.2 Pharmacokinetic properties

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.

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

5.3 Preclinical safety data

No special information

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

IMS

Carbomer Propylene Glycol Diethylamine Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

30 g, 40 g, 50 g and 100 g collapsible aluminium containers:- 3 years from the date of manufacture.

4 g collapsible aluminium containers:- 18 months from the date of manufacture.

30 g, 40 g, 50 g and 100 g laminate copolymer tubes:- 4 years from the date of manufacture.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

1) Membrane sealed, epoxy resin coated, collapsible aluminium TUBE, fitted with a SCREW CAP (containing 4 g, 30 g, 40 g, 50 g or 100 g of product)

2) Membrane-sealed laminate TUBE, made of a HDPE/aluminium/Ethylene Acrylic Acid (EAA) copolymer, fitted with a CAP (containing 30 g, 40 g, 50 g or 100 g of product)

3) Laminate TUBE made of a HDPE/aluminium/Ethylene Acrylic Acid (EAA) copolymer, fitted with an air-return-free 'Precitube' pump head and CAP (containing 30 g, 40 g, 50 g or 100 g of product).

(In the case of GSL presentations, the three containers as listed, containing up to 50 g of product).

6.6 Special precautions for disposal

No special requirements.

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 0173/0060

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/04/1991 / 08/02/2005

10    DATE OF REVISION OF THE TEXT

08/10/2010