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sanofi-aventis

sanofi-aventis
Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: IEmedinfo@sanofi-aventis.com


Summary of Product Characteristics last updated on medicines.ie: 31/07/2009
SPC Orugesic Gel

Table of Contents

  • 1. NAME OF THE MEDICINAL PRODUCT
  • 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
  • 3. PHARMACEUTICAL FORM
  • 4. CLINICAL PARTICULARS
  • 4.1 Therapeutic indications
  • 4.2 Posology and method of administration
  • 4.3 Contraindications
  • 4.4 Special warnings and precautions for use
  • 4.5 Interaction with other medicinal products and other forms of interaction
  • 4.6 Pregnancy and lactation
  • 4.7 Effects on ability to drive and use machines
  • 4.8 Undesirable effects
  • 4.9 Overdose
  • 5. PHARMACOLOGICAL PROPERTIES
  • 5.1 Pharmacodynamic properties
  • 5.2 Pharmacokinetic properties
  • 5.3 Preclinical safety data
  • 6. PHARMACEUTICAL PARTICULARS
  • 6.1 List of excipient(s)
  • 6.2 Incompatibilities
  • 6.3 Shelf life
  • 6.4 Special precautions for storage
  • 6.5 Nature and contents of container
  • 6.6 Special precautions for disposal and other handling
  • 7. MARKETING AUTHORISATION HOLDER
  • 8. MARKETING AUTHORISATION NUMBER(S)
  • 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
  • 10. DATE OF REVISION OF THE TEXT


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1. NAME OF THE MEDICINAL PRODUCT

Orugesic 2.5%w/w Gel.


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ketoprofen 2.5% w/w.

For excipients, see 6.1.


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3. PHARMACEUTICAL FORM

Cutaneous Gel.

A clear, colourless or practically colourless, transparent gel.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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.


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4.2 Posology and method of administration

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.


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4.3 Contraindications

• 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.


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4.4 Special warnings and precautions for use

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.


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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.


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4.6 Pregnancy and lactation

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.


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4.7 Effects on ability to drive and use machines

None known.


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4.8 Undesirable effects

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.


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4.9 Overdose

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.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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


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5.2 Pharmacokinetic properties

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.


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5.3 Preclinical safety data

Not relevant.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Carbomer 980

Triethanolamine

Lavender oil

Ethanol 96% v/v

Purified water


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years.


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6.4 Special precautions for storage

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


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6.5 Nature and contents of container

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.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

sanofi-aventis Ireland Ltd.,

Citywest Business Campus

Dublin 24.


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8. MARKETING AUTHORISATION NUMBER(S)

PA 540/118/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12th October 1994 / 12th October 2004


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10. DATE OF REVISION OF THE TEXT

July 2009.



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Active Ingredients

 
   Ketoprofen

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