SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Orudis 2.5% gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g gel contains 25 mg ketoprofen.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gel for cutaneous use.
A colourless transparent gel with a scent of lavender.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
For the symptomatic treatment of mild to moderate local pain associated with muscle and/or joints
injuries, e.g. sport injuries.
4.2
Posology and method of administration
Posology
Adults: The gel should be applied on to the painful or inflammed area two to three times daily. The
amount of gel should be adjusted so that it covers the painful area. The total daily dose shall not
exceed 15 grams per day. (7.5 grams correspond to approximately 14 cm gel). The length of treatment
should not exceed one week.
Paediatric population
The safety and efficacy of ketoprofen gel in children have not been established.
Method of administration
For cutaneous use.
The gel should be massaged onto the skin for a few minutes.
4.3
Contraindications
The gel is contraindicated in the following cases:
 history of any photosensitivity reaction
 known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen,
fenofibrate, tiaprofenic acid, asteylsalicylic acid, or to other NSAID
 history of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or UV blocker or parfumes
 sun exposure, even in case of hazy sun, including UV light from solarium, during the treatment
and 2 weeks after its discontinuation
 history of hypersensitivity to one of the excipients
 on pathological skin changes such as eczema or acne; or in infectious skin or open wounds
 third trimester of pregnancy (see section 4.6)
4.4
Special warnings and precautions for use
Precautions: The gel should be used with caution in patients with reduced heart, liver or renal
function: isolated cases of systemic adverse reactions consisting of renal affections have been
reported.
The gel must not be used with occlusive dressings.
The gel must not come into contact with mucous membranes or the eyes.
Treatment should be discontinued immediately upon development of any skin reaction including
cutaneous reactions after co-application of octocrylene containing 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 (see section 4.3).
Hands should be washed thoroughly after each application of the product.
The recommended length of treatment should not be exceeded due to the risk of developing contact
dermatitis and photosensitivity reactions increases over time.
Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a
higher risk of allergy to aspirin and/or NSAIDs than the rest of the population.
Paediatric population: The safety and efficacy of ketoprofen gel in children have not been
established.
4.5
Interaction with other medicinal products and other forms of interaction
Interactions are unlikely as serum concentrations following cutaneous administration are low.
4.6
Fertility, pregnancy and lactation
In absence of clinical experience with the cutaneous form and by reference with the systemic forms:
Pregnancy
During the first and second trimester:
As the safety of ketoprofen in pregnant women has not been evaluated, the use of ketoprofen during
the first and second trimester of pregnancy should be avoided.
During the third trimester:
During the third trimester of pregnancy, all prostaglandin synthetase inhibitors including ketoprofen
may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy, prolonged
bleeding time in both mother and child, may occur. Therefore, ketoprofen is contra-indicated during
the last trimester of pregnancy.
Breastfeeding
No data is available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in
nursing mothers.
4.7
Effects on ability to drive and use machines
None known.
4.8
Undesirable effects
Localised skin reactions have been reported which may secondarily spread outside the application site
and may in isolated cases be severe and generalized. Isolated cases of systemic adverse reactions,
such as renal affection, have been reported.
The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10);
uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known
(cannot be estimated from the available data).
Immune system disorders
- Not known: Anaphylactic shock, angioedema, hypersensitivity reactions.
Skin and subcutaneous tissue disorders
- Uncommon: Local skin reactions such as erythema, ,eczema, pruritis and burning sensations.
- Rare: Dermatological: photosensitisation and urticaria. Cases of more severe reactions such as
bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.
Renal and urinary disorders
- Very rare: Cases of aggravation of previous renal insufficiency.
4.9
Overdose
Overdose is unlikely to be caused by cutaneous administration. If accidentally ingested, the gel may
cause systemic adverse effects depending on the amount ingested. However, if they occur, treatment
should be symptomatic and supportive in accordance with overdosage of oral NSAIDs.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: Musculo-skeletal system, ATC code: M02 AA10.
Ketoprofen gel contains ketoprofen, a phenyl propionic acid derivative of a non-steroid nature with
analgesic and anti-inflammatory properties.
The exact mechanism of action for the anti-inflammatory effects is not known. Ketoprofen inhibits
the prostaglandin synthesis and the thrombocyte aggregation.
5.2
Pharmacokinetic properties
Plasma and tissue levels of ketoprofen have been measured in 24 patients undergoing knee surgery.
After repeated percutaneous administration of ketoprofen gel the plasma levels were about 60 fold less
(9 - 39 ng/g) than those obtained after a single oral dose of ketoprofen (490 - 3300 ng/g). Tissue
levels in the actual area were within the same concentration range, for the gel as for the oral treatment,
though the gel had a considerably higher interindividual variability.
Bioavailability of ketoprofen after cutaneous administration has been estimated to approximately 5%
of the level obtained after an orally administered dose based on urinary excretion data.
The protein binding in plasma is approximately 99%. Ketoprofen is excreted through the kidneys
mainly as glucuronide conjugate.
5.3
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already
included in other sections of the SmPC.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Ethanol, carbomer, triethanolamine, lavender oil, purified water.
6.2
Incompatibilities
Not applicable
6.3
2 years
Shelf-life
6.4
Special precautions for storage
Store below 25°C.
6.5
Nature and contents of container
Aluminium tube internally coated with polycondensed epoxyphenol varnish.
Orudis 2.5% gel is supplied in tubes of 30 g or 60 g. One box contains 1 tube of 30 g or 60 g, or 2
tubes of 60 g.
Not all pack sizes may be marketed.
6.6
Special precautions for disposal and other handling
The tube should be closed after use.
7
MARKETING AUTHORISATION HOLDER
To be completed nationally
8
MARKETING AUTHORISATION NUMBER(S)
To be completed nationally
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1995-10-18 / 2010-10-18
10
DATE OF REVISION OF THE TEXT
2013-01-10