Ketoprofen 2.5% W/W Gel
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ketoprofen 2.5% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoprofen 25 mg/g For excipients, see 6.1
3 PHARMACEUTICAL FORM
Gel
Homogenous transparent gel with an odour of lavender and alcohol
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief of pain in such conditions as soft tissue injuries, including sport injuries, sprains, strains, musculo-tendonitis, swelling, backache and rheumatic pain.
4.2 Posology and method of administration
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.
4.3 Contraindications
• 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.
4.4 Special warnings and precautions for use
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.
4.5 Interaction with other medicinal products and other forms of interaction
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.
4.6 Pregnancy and lactation
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.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
• 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
4.9 Overdose
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.
5.1 Pharmacodynamic properties
Ketoprofen is a non-steroidal anti-inflammatory of the propionics group, derivative of aryl-carboxylic acid.
It has anti-inflammatory and analgesic properties.
5.2 Pharmacokinetic 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.
5.3 Preclinical safety data
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 gastrointestinal 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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Carbomer
Triethanolamine Lavender essential oil Ethanol 95%
Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf life
30 months
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Varnished aluminium tube - polyethylene screw cap. 50g or 100g.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Pinewood Laboratories Limited,
Trading as: Pinewood Healthcare Ballymacarbry,
Clonmel,
Co. Tipperary,
Ireland.
8 MARKETING AUTHORISATION NUMBER(S)
PL 04917/0069
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31/12/2008
10 DATE OF REVISION OF THE TEXT
07/01/2011