Ibuprofen 5% gel,

1. Name Of The Medicinal Product

Ibuprofen 5% gel,

Fenbid gel,

Phorpain Gel

Flexigel,

Boots Ibuprofen Gel, Ibuprofen Pain Relief Gel

Nurofen 5% gel,

Morrison's Ibuprofen pain relief 5% w/w gel

Ibucalm Ibuprofen Pain Relief Gel 5 % w/w

Ibuprofen Pain relief gel 5% w/w

Bell's Healthcare Ibuprofen 5% gel

2. Qualitative And Quantitative Composition

5% w/w ibuprofen Ph. Eur.

3. Pharmaceutical Form

Gel for topical application

4. Clinical Particulars

4.1 Therapeutic Indications

Pharmacy only indication:

Topical analgesic and anti-inflammatory for backache, pain of non-serious arthritic conditions, muscular pain, sprains, strains, sports injuries and neuralgia.

General Sales List indication:

Topical analgesic and anti-inflammatory for backache, rheumatic and muscular pain, sprains, strains 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 50 to 125mg (4 to 10cm) of the gel 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. Review treatment after 2 weeks, especially if the symptoms worsen or persist.

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

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.

The label will state:

Do not exceed the stated dose

Keep out of reach of chilrden

For external use only

If symptoms persist consult your doctor or pharmacist

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.

-you are pregnant.

Not recommended for children under 14 years.

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 an active peptic ulcer, a history of kidney problems, asthma or intolerance to aspirin or ibuprofen taken orally should seek medical advice before using Ibuprofen gel.

Patients should be advised against excessive exposure to sunlight of area treated in order to avoid possibility of photosensitivity.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote. Concurrent aspirin or other NSAIDS may result in an increased incidence of adverse reactions.

4.6 Pregnancy And 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

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, aggrevated asthma, brochospasm 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 erythrema muliforme).

Gastro-intestinal:abdominal pain, dyspepsia.

4.9 Overdose

In children ingestion of more than 400 mg/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 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 maintainance 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 antiinflammatory for the relief of rheumatic and muscular pain, backache, pain of non-serious arthritic conditions, sprains, strains, lumbago and fibrositis by virtue of percutaneous absorption.

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 Fenbid gel is approximately 5% that of oral ibuprofen. Therapeutic concentrations are reached locally; but not systemically.

5.3 Preclinical Safety Data

There is no new data published on the active ingredient.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethylhydroxycellulose EP

Sodium Hydroxide EP

Benzyl alcohol EP

Isopropyl alcohol BP

Purified water EP

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Aluminium tube with internal epoxy phenolic coating containing 15g (trial size/starter pack) and 30/35/50/100g of Fenbid Gel. The 100g pack size is restricted to “Pharmacy” only.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Goldshield Group Limited

(trading as Goldshield Pharmaceuticals)

NLA Tower

12-16 Addiscombe Road

Croydon CR0 0XT

8. Marketing Authorisation Number(S)

PL 10972/0045

9. Date Of First Authorisation/Renewal Of The Authorisation

26 April 1996

10. Date Of Revision Of The Text

06/09/2010