FENBID 5% w/w Gel Ref.[27889] Active ingredients: Ibuprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Mercury Pharma Group Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

4.1. Therapeutic indications

Pharmacy Only Indications:

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

General Sales List Indications:

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.

Posology

Adults, the elderly and children over 12 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 USE MORE GEL THAN THE LABEL TELLS YOU TO.

Review treatment after 2 weeks, especially if the symptoms worsen or persist.

Paediatric population

Do not use on children under 12 years of age except on the advice of a doctor.

Method of Administration

For topical application to the skin.

4.9. Overdose

Overdosage with a topical presentation of ibuprofen gel is unlikely.

Symptoms

Symptoms of severe ibuprofen overdosage (eg following accidental oral ingestion) include headache, vomiting, drowsiness and hypotension.

Management

Correction of severe electrolyte abnormalities should be considered.

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 with Polypropylene cap containing 15g (trial size/starter pack) and 30/35/50/100g of Fenbid Gel/Phorpain Gel. The 100g pack size is restricted to “Pharmacy” only. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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