Oruvail 2.5% Gel
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oruvail 2.5% Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoprofen 2.5% w/w
3 PHARMACEUTICAL FORM
Gel
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ketoprofen is a non-steroidal anti-inflammatory drug. It has anti-inflammatory and analgesic actions.
Relief of acute painful musculoskeletal conditions caused by trauma, such as sports injuries, sprains, strains and contusions.
Pain of non serious arthritis.
4.2 Posology and method of administration
Adults: To be applied two to four times daily to the skin in the painful or
inflamed region for up to 7 days. Apply gently but massage well to ensure gel penetration. The usual recommended dose is 15g per day (7.5 grams correspond to approximately 14cm of gel).
Elderly: There are no specific dosage recommendations for the elderly.
Children: Not recommended as safety in children has not been established.
4.3
Contraindications
Oruvail Gel must not be used in patients with:
• history of photosensitivity reactions
• known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other Non-Steroidal Anti-Inflammatory agents (NSAIDs)
• history of skin allergy reactions to ketoprofen, tiaprofenic acid, fenofibrate, UV blockers or perfumes
• sun exposure, even hazy sun, including UV light from solarium, during treatment and for 2 weeks after its discontinuation (see Section 4.4 Special warnings and precautions for use).
• history of hypersensitivity to any of the excipients
• third trimester of pregnancy (see section 4.6)
• pathological skin changes such as eczema or acne; or in infected skin or open wounds.
• Oruvail gel should not be applied to mucous membranes, anal or genital areas, eyes or used with occlusive dressings.
4.4 Special warnings and precautions for use
• Hands should be washed thoroughly after each application of the Gel.
• 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 areas by wearing clothing during all the application of the Gel and two weeks following its discontinuation to avoid the risk of photosensitisation.
• The gel must not come into contact with mucous membrane or the eyes
• The recommended length of treatment should not be exceeded (see section 4.2) due to the risk of developing contact dermatitis and photosensitivity reactions which 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
• The safety and efficacy of ketoprofen gel in children have not been established
• Although systemic effects are minimal, 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.
• Should a skin rash occur after gel application, treatment must be stopped.
• Do not apply Oruvail Gel beneath occlusive dressing.
• Areas of skin treated with Oruvail Gel should not be exposed to direct sunlight, or solarium ultraviolet light, either during treatment or for two weeks following treatment discontinuation, in order to avoid phototoxicity reactions and photoallergy.
• Keep the gel away from naked flames. Do not incinerate.
4.5 Interaction with other medicinal products and other forms of interaction
Interactions are unlikely as serum concentrations following topical administration are low.
Serious interactions have been recorded after the use of high dose methotrexate with non-steroidal anti-inflammatory agents, including ketoprofen, when administered by the systemic route.
4.6 Pregnancy and lactation
Pregnancy
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 the first and second trimester of pregnancy.
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. Non-steroidal anti-inflammatory drugs may also delay labour. Therefore, ketoprofen is contraindicated during the last trimester of pregnancy.
Lactation
Trace amounts of ketoprofen are excreted in breast milk; therefore Oruvail Gel should not be used during breast feeding.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
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 generalised have occurred rarely.
Renal and urinary disorders
Very rare: Cases of aggravation of previous renal insufficiency Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
Overdosage is unlikely 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 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Ketoprofen is a non-steroidal anti-inflammatory drug. It has antiinflammatory and analgesic actions.
5.2 Pharmacokinetic properties
Plasma and tissue levels of ketoprofen have been measured in 24 patients undergoing knee surgery. After repeated percutaneous administration of Oruvail 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 at the area of application were within the same concentration range for the gel as for the oral; treatment, although the gel was associated with a considerably higher inter-individual variability.
The bioavailability of ketoprofen after topical administration has been estimated to be 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
No additional pre-clinical data of relevance to the prescriber.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Carboxypolymethylene Triethanolamine Lavender Oil Ethanol Purified water
6.2 Incompatibilities
The gel should not be diluted.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Cardboard carton containing aluminium tube internally coated with polycondensed epoxyethanol varnish with the tip sealed with the same material. Tubes contain 5, 7.5, 10, 15, 25, 30, 50, 60, 100 or 150g of gel.
6.6 Special precautions for disposal
Wash your hands following application. Keep the gel away from naked flames. Do not incinerate.
The tube should be closed after use.
7 MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Or trading as:
Sanofi-aventis or Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 04425/0627
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/02/2009
04/07/2014