SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

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 or lactation.

Oral NSAIDs, including ibuprofen, can sometimes be associated with renal impairment, aggravation of active peptic ulcers, and can induce allergic bronchial reactions in susceptible asthmatic patients. Although the systemic absorption of topically applied ibuprofen is less than for oral dosage forms, these complications can occur in rare cases. For these reasons, patients with a history of kidney problems, an active peptic ulcer, asthma or intolerance to aspirin or ibuprofen should seek medical advice before using Radian B Ibuprofen 5% w/w Gel.

Avoid excessive sunlight exposure on the treated area as this may possibly lead to photosensitisation.

The label will state:

Do not exceed the stated dose.

Keep out of the reach and sight 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    Fertility, pregnancy and lactation

Not to be used during pregnancy or lactation. 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, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Other adverse effects reported very rarely include renal failure.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9    Overdose

Overdosage with a topical presentation of ibuprofen gel is unlikely; however, it may be encountered following excessive use or accidental ingestion.

In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms

Most patients who have ingested or been exposed to clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

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.

6.1    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 or 100g of Ibuprofen Gel

6.6    Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD75QH

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 00240/0358

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/05/2002

10 DATE OF REVISION OF THE TEXT

31/07/2014