Oruvail Gel 2.5%

1. Name Of The Medicinal Product

Oruvail Gel 2.5%

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

Patients with a known hypersensitivity to ketoprofen or any of the excipients, aspirin or other non-steroidal anti-inflammatory agents; patients suffering from or with a history of bronchial asthma or allergic disease. Oruvail gel should be avoided in patients with exudative dermatoses, eczema, sores and infected skin lesions or broken skin. 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

Although systemic effects are minimal, the gel should be used with caution in patients with severe renal impairment. Should a skin rash occur after gel application, treatment must be stopped. Do not apply Oruvail gel beneath occlusive dressings. Areas of skin treated with Oruvail gel should not be exposed directly sunlight, or solarium ultraviolet light, either during treatment or for two weeks following treatment discontinuation. 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

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, 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

Adverse reactions: Skin reactions, including photosensitivity reactions, pruritus, localised erythema. These are usually mild and resolve after cessation of the gel. Cases of more severe reactions such as bullous or phylcytenar eczema which may spread or become generalised have occurred rarely.

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

Carbopol

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 epoxyphenol varnish with the tip sealed with the same material containing either 30 or 100g of gel.

6.6 Special Precautions For Disposal And Other Handling

Wash your hands following application

Keep gel away from naked flames.

Do not incinerate.

The tube should be closed after use.

7. Marketing Authorisation Holder

sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

8. Marketing Authorisation Number(S)

PL 04425/0627

9. Date Of First Authorisation/Renewal Of The Authorisation

29 July 2010

10. Date Of Revision Of The Text

7^Th January 2011

LEGAL CLASSIFICATION

POM for pack sizes larger than 30g