Radian B Ibuprofen 5% w / w Gel

1. Name Of The Medicinal Product

Radian B Ibuprofen 5% w/w Gel

Radian B Anti-inflammatory Ibuprofen 5% w/w Gel.

Care Ibuprofen 5% w/w Gel

2. Qualitative And Quantitative Composition

Ibuprofen 5.0%w/w

3. Pharmaceutical Form

Gel for topical application

4. Clinical Particulars

4.1 Therapeutic Indications

Topical analgesic and anti-inflammatory for backache, rheumatic and muscular pain, sprains and sports injuries.

4.2 Posology And Method Of Administration

Strength 5% maximum.

Method of Administration

For topical application to the skin

Dosage

Adults, the elderly and children over 14 years:

Squeeze 5 to 10cm of the gel (containing 50 to 100mg of ibuprofen) from the tube and lightly rub into the affected area until absorbed.

The dose should not be repeated more frequently than every four hours and no more than 4 times in any 24 hour period.

Wash hands after each application. Do not exceed the stated dose. Unless recommended by a doctor advice should be sought about continued treatment if symptoms persist for more than 2 weeks.

Children under 14 years: Do not use on children under 14 years of age except on the advice of a doctor.

4.3 Contraindications

Hypersensitivity to ibuprofen or any of the excipients in the product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other NSAIDs.

Patients suffering from renal failure.

4.4 Special Warnings And Precautions For Use

Apply with gentle massage only. Avoid contact with eyes, mucous membranes and inflamed or broken skin.

Discontinue if rash develops.

Hands should be washed immediately after use.

Not for use with occlusive dressings.

Not to be used during pregnancy.

The label will state:

Do not exceed the stated dose.

Keep out of the reach of children.

For external use only.

You must contact your doctor if your symptoms worsen at any time, or do not improve after 2 weeks.

Do not use if you are allergic to ibuprofen or any of the ingredients, aspirin or any other painkillers.

Consult your doctor before use if:

You are taking aspirin or any other pain relieving medication.

The leaflet will state:

Section 4: Side effects

Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.

Not recommended for children under 14 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concurrent use of aspirin or other NSAIDs may result in an increased incidence of adverse reactions.

4.6 Pregnancy And Lactation

Not to be used during pregnancy. Whilst no teratogenic effects have been demonstrated in animal experiments, Ibuprofen should be avoided during pregnancy. The onset of labour may be delayed and duration of labour increased. Ibuprofen appears in breast milk in very low concentration and is unlikely to affect the breast fed infant adversely.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Skin disorders are most frequently reported.

Skin: application site reactions, rashes, pruritis, and urticaria. Gastro-intestinal: abdominal pain, dyspepsia. Respiratory: bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of a) non-specific allergic reactions 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 multiforms).

Other adverse effects reported very rarely include renal failure.

4.9 Overdose

Overdosage with a topical presentation of ibuprofen gel is unlikely.

Symptoms of ibuprofen overdose include headache, vomiting, drowsiness and hypotension. Correction of severe electrolyte abnormalities should be considered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ibuprofen is a non-steroidal anti-inflammatory drug which has been tested and proved to be effective as an analgesic, anti-pyretic and anti-inflammatory after systemic administration. When administered as a topical preparation ibuprofen has been shown to be an effective topical analgesic and anti-inflammatory for the relief of rheumatic and muscular pain, backache, sprains, strains, lumbago and fibrositis by virtue of precutaneous absorption.

Radian B Ibuprofen Gel or Care Ibuprofen 5% Gel is a clear odourless gel. Following application to the affected area, it initially feels cool to the skin and is free from skin warming effects.

5.2 Pharmacokinetic Properties

The gel product containing ibuprofen diffuses through the skin as a function of time and after 24 hours an application to human skin shows that the dose administered is present in the epidermis and dermis. Percutaneous absorption of this 5% ibuprofen gel is approximately 5% that of oral ibuprofen. Therapeutic concentrations are reached locally but not systemically.

5.3 Preclinical Safety Data

There are no new data published on the active ingredient.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hydroxyethylcellulose

Sodium Hydroxide

Benzyl Alcohol

Isopropyl Alcohol

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months – Aluminium Tube

6.4 Special Precautions For Storage

Store below 25°C. Replace cap tightly after use.

6.5 Nature And Contents Of Container

Aluminium tube with internal epoxy phenolic coating containing 30g, 50g or100g of Ibuprofen Gel.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 002400358

9. Date Of First Authorisation/Renewal Of The Authorisation

14 May 2002

10. Date Of Revision Of The Text

15/04/2011