Oruvail

Oruvail 2.5% Gel

Ketoprofen 2.5% w/w

Gel

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.

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 (NSAID)

• 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.

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.

Serious skin reactions, such as Stevens-Johnson Syndrome (SJS), have been reported in association with the use of NSAIDs, including ketoprofen gel. Patients should be informed about the signs and symptoms of serious skin manifestations. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

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.

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.

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.

None known.

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.

- Not known: Stevens-Johnson syndrome.

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 or search for MHRA yellow card in the Google Play or Apple App store.

Overdose 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.

Ketoprofen is a non-steroidal anti-inflammatory drug. It has anti-inflammatory and analgesic actions.

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.

No additional pre-clinical data of relevance to the prescriber.

Carbopol

Triethanolamine

Lavender Oil

Ethanol

Purified water

The gel should not be diluted.

36 months.

Do not store above 25°C

Cardboard carton containing aluminium tube internally coated with polycondensed epoxyphenol varnish with the tip sealed with the same material containing either 5, 7.5, 10, 15, 25, 30, 50, 60, 100 or 150g of gel.

Wash your hands following application

Keep gel away from naked flames.

Do not incinerate.

The tube should be closed after use.

Aventis Pharma Limited

410 Thames Valley Park Drive

Reading

Berkshire

RG6 1PT

UK

Trading as:

Sanofi

410 Thames Valley Park Drive

Reading

Berkshire

RG6 1PT

UK

PL 04425/0627

Date of First Authorisation: 29 July 2010

18 March 2020

LEGAL CLASSIFICATION

POM for pack sizes larger than 30g