Ketoprofen 2.5% w/w Gel

Ketoprofen 25 mg/g

For excipients, see 6.1

Gel

Homogenous transparent gel with an odour of lavender and alcohol

Symptomatic relief of pain in such conditions as soft tissue injuries, including sport injuries, sprains, strains, musculo-tendonitis, swelling, backache and rheumatic pain.

For cutaneous use.

Penetration of the gel by gentle and prolonged massage on the painful or inflamed surface for up to seven days.

Two to four daily applications of approximately 2 to 4g gel, representing approximately 5 to 10cm. The usual maximum dose is 15g per day.

Children (under 15 years): Not recommended, as safety in children has not been established.

• Known allergy to Ketoprofen, to substances of similar activity to aspirin

• Known allergy to excipients

• History of any phosensitivity reactions

• Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs (including when taken by mouth)

• History of skin allergy to ketoprofen, tiaprofenic acid, fenobrate or UV blocker or perfumes

• Sun exposure, even in the case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation

• Dermatosis, eczema, infected skin lesion, wounds.

• Not to be applied on mucous membranes nor on the eyes.

For topical use only. The appearance of cutaneous eruption following application of the gel requires interruption of treatment.

Hands should be washed thoroughly before use and immediately after each application of product (unless they are being treated).

Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application of octocrylene products

It is recommended to protect treated areas by wearing clothing during all the application of the product and two weeks following its discontinuation to avoid the risk of photosensitisation.

Not for use with occlusive dressing. Topical application of large amounts may result in systemic effects including hypersensitivity and asthma (renal disease has also been reported).

The label will state:

Do not exceed the stated dose.

For external use only.

Keep out of the reach and sight of children.

If symptoms persist consult your doctor or pharmacist.

Do not use if you are allergic to ketoprofen or any of the ingredients, aspirin or any other pain killers.

Do not expose treated areas to sunlight (even hazy) including UV from solarium during the treatment and the 2 weeks after its discontinuation.

Consult your doctor before use if:

You are taking aspirin or any other pain-relieving medication.

You are pregnant or breast feeding.

Interactions are unlikely, as serum concentrations following topical application are low. However concurrent aspirin or other NSAIDs may result in increased incidence of adverse reaction.

No embryopathic effects have been demonstrated in animals and there is epidemiological evidence of the safety of ketoprofen in human pregnancy. Nevertheless, it is recommended that ketoprofen should be avoided during pregnancy. Non-steroidal anti-inflammatory drugs may also delay labour. Trace amounts of ketoprofen are excreted in breast milk following oral administration, therefore the gel should not be used during breast feeding.

Not applicable.

• Local skin reactions such as erythematous, pruritis and burning sensations.

• Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.

• Hypersensivity reactions.

• Dermatological : phosensitisation

Overdosage is unlikely to be caused by topical administration. If accidentally ingested, the gel may cause systemic adverse effects depending on the amount ingested. However, if they occur, treatment should be supportive and symptomatic.

Ketoprofen is a non-steroidal anti-inflammatory of the propionics group, derivative of aryl-carboxylic acid.

It has anti-inflammatory and analgesic properties.

Applied locally in the form of a gel, ketoprofen is absorbed very gradually and is not accumulated in the body. The systemic passage of the gel compared to that of the oral formulations of ketoprofen is around 5 per cent, which enables a local effect to be obtained without systemic incidence.

The main acute side effect seen during the safety studies after oral, sc and ip routes is the ulcerogenic potential. The target organs for chronic toxicity are the gastro-intestinal tract, the kidney and, to a lesser degree the liver. Due to low systemic passage of ketoprofen from the gel such safety data are not relevant for local administration. Studies on the local tolerance have shown that ketoprofen is well tolerated.

Carbomer

Triethanolamine

Lavender essential oil

Ethanol 95%

Purified water

None stated.

30 months

Do not store above 25ºC.

Varnished aluminium tube – polyethylene screw cap.

50g or 100g.

None stated.

Pinewood Laboratories Limited,

Trading as: Pinewood Healthcare

Ballymacarbry,

Clonmel,

Co. Tipperary,

Ireland.

PL 04917/0069

Date of first authorisation: 31/12/2008

07/01/2011