sanofi-aventis

Orugesic 2.5%w/w Gel.

Ketoprofen 2.5% w/w.

For excipients, see 6.1.

Cutaneous Gel.

A clear, colourless or practically colourless, transparent gel.

In the topical management of soft tissue trauma and for the relief of pain and inflammation associated with extra-articular rheumatism and osteoarthritis in joints.

Orugesic Gel is for cutaneous use.

Recommended Dosage:

Adults: Application by gentle massage 2 to 4 times daily. Treatment should not extend beyond 6 weeks.

Elderly: There are not specific dosage recommendations for the elderly. The lowest dose compatible with adequate safe clinical controls should be employed in the elderly, who are more prone to adverse events.

Children: Not recommended for children under 12 years of age.

Contact with the eyes or mucosa should be avoided.

• Patients with a history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to ketoprofen, aspirin or non-steroidal anti-inflammatory drugs

• Hypersensitivity to any of the excipients of Orugesic Gel

• Use on pathological skin changes such as eczema or acne; or in infectious skin or open wounds

• Patients with active peptic ulceration

• Use with occlusive dressings

• Simultaneous use to the same site with any other topical cream

• Use in children under 12 years of age

• Third trimester of pregnancy.

1. Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration. The total dose of product should not exceed 15g daily.

2. If there is no improvement, or the condition is aggravated, the doctor should be consulted.

3. Although systemic effects should be low, the gel should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulceration or inflammatory bowel disease, intracranial haemorrhage or bleeding diathesis. Isolated cases of systemic adverse reactions consisting of renal affection, have been reported.

4. Elderly Patients – NSAIDS should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. See also Section 4.2.

5. The gel must not be used with occlusive dressings.

6. The gel must not come into contact with mucous membranes of the eyes.

7. The treatment should be interrupted if a rash appears.

8. Direct sunlight, including solarium, should be avoided during treatment and for 2 weeks following treatment.

9. The tube should be closed after use.

10. Hand washing is recommended after application.

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.

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 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.

Ketoprofen is not recommended in nursing mothers.

None known.

Localised skin reactions have been reported which may secondarily spread outside the application site. Erythema, pruritus and photosensitivity reactions have been reported.

Uncommon (1/100 – 1/1000)

Skin: Erythema, itch, pruritus, eczema.

Rare (<1/1000)

Skin: Photosensitivity reactions, bullous eruptions, urticaria.

Very rare (<1/10000):

Cases of aggravation of previous renal insufficiency have been reported.

Overdose 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 this occurs, treatment should be supportive and symptomatic in accordance with the overdosage of oral antiphlogistics.

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

A non-steroidal anti-inflammatory drug of the phenylpropionic acid group readily absorbed from the gastrointestinal tract, strongly protein bound and excreted mainly in the urine after glucuronidation.

Applied locally as a gel, ketoprofen is absorbed very slowly and there is no accumulation in the body. The bioavailability of the gel relative to oral forms of ketoprofen is around 5%. The low systemic bioavailability suggests that systemic effects are unlikely.

Not relevant.

Carbomer 980

Triethanolamine

Lavender oil

Ethanol 96% v/v

Purified water

Not applicable.

3 years.

Do not store above 25^oC. Keep away from naked flames.

Aluminium tube internally lacquered with polycondensed epoxyphenol varnish, with the tip sealed by the same material. The cap is a moulded white polypropylene screw cap.

The tube is supplied in an outer cardboard carton.

Pack sizes:

10g, 15g, 20g – sample packs

40g, 45g, 50g, 60g, 75g, 100g, 150g.

Not all pack sizes are marketed.

No special requirements.

sanofi-aventis Ireland Ltd.,

Citywest Business Campus

Dublin 24.

PA 540/118/1

12^th October 1994 / 12^th October 2004

July 2009.