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CUPROFEN GEL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Cuprofen Gel

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QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen BP 5.0g

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PHARMACEUTICAL FORM
Gel containing 5.0%w/w ibuprofen

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4.1

CLINICAL PARTICULARS
Therapeutic indications Symptomatic relief of: rheumatic pain; pain due to non-serious arthritic conditions; and muscular aches, pains and swellings such as strains, sprains and sports injuries.

4.2

Posology and method of administration Route of administration: Cutaneous Adults, including the elderly, and children over 12 years: The recommended dose of ibuprofen is 50-125mg 3-4 times daily. 2.5 - 6.25cm of gel is equivalent to 50-125mg ibuprofen. Apply the gel to the affected areas 3-4 times daily. Approximately 2.5 6.25cm (1 - 2.5 inches) of gel should be expressed from the tube and rubbed gently into the skin. Do not give to children under 12 years of age except on the advice of a doctor. The dose should not be repeated more frequently than every 4 hours and no more than 4 times in any 24 hour period.

4.3

Contraindications Hypersensitivity to ibuprofen or any of the other constituents. Hypersensitivity to aspirin or any other non-steroidal anti-inflammatory drugs including patients predisposed to asthma, rhinitis or urticaria.

4.4

Special warnings and precautions for use Apply with gentle massage, and avoid contact with the eyes, mucous membranes and inflamed or broken skin. Discontinue use if a rash develops. Not to be used under an occlusive dressing. Wash hands immediately after use. The label will state: Do not exceed the stated dose. Keep out of the reach of children. For external use only. If symptoms persist consult your doctor or pharmacist. Do not use if allergic to ibuprofen or any other ingredients, aspirin or any other painkillers. Consult your doctor before use if: You are taking aspirin or any other pain relieving medication. You are pregnant. Not recommended in children under 12 years.

4.5

Interaction with other medicinal products and other forms of interaction If used concurrently with aspirin or other NSAIDs there may be an increased incidence of adverse reactions.

4.6

Pregnancy and lactation Pregnancy: Whilst no teratogenic effects have been observed in animal experiments, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed and the duration of labour increased. Lactation: Ibuprofen appears in breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.

4.7

Effects on ability to drive and use machines No effects are known.

4.8

Undesirable effects Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising of asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angiodema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme). Gastrointestinal effects such as abdominal pain and dyspepsia may occur. Very rare: renal failure. Overdose Overdosage with topical ibuprofen is unlikely to occur. Symptoms of ibuprofen overdose include headache, vomiting, drowsiness and hypotension. When treating symptoms, correction of severe electrolyte abnormalities should be considered.

4.9

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties The active constituent is a phenyl propionic acid derivative possessing analgesic, anti-inflammatory and anti-pyretic properties.

5.2

Pharmacokinetic properties Percutaneous absorption amounts to about 5% of that which occurs after oral dosing with ibuprofen.

5.3

Preclinical safety data There is no relevant information additional to that contained elsewhere in this SPC.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients Solketal Poloxamer 407 Miglyol 812 Purified Water Isopropyl Alcohol Lavender Oil Neroli Oil

6.2

Incompatibilities None known.

6.3

Shelf life 36 months unopened.

6.4

Special precautions for storage Store below 25C.

6.5

Nature and contents of container Aluminium tubes, with tamper-evident diaphragm and safety caps, containing 30g. 50g, or 100g of gel. Tube interior surfaces coated with protected varnish.

6.6

Special precautions for disposal Not applicable.

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MARKETING AUTHORISATION HOLDER
SSL International Plc. Venus 1 old Park Lane Trafford park Manchester M41 7HA

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MARKETING AUTHORISATION NUMBER(S)
PL 17905/0019

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15th August 2006

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DATE OF REVISION OF THE TEXT
15/08/2006

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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