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Drug Details

Fenbid 5% Gel

• Drug Class Description
  Non-steroidal anti-inflammatory drugs (topical NSAIDs).
• Generic Name
  Ibuprofen
• Presentation
  Gel for topical application.
• Description
  5% w/w Ibuprofen Ph.Eur.
• 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.

• Adult Dosage
  

  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.

• Child Dosage
  

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

• Contra Indications
  

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

  Not to be used on broken or damaged skin.

• Special Precautions
  

  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 stated dose

  Keep out of reach of children

  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 or pharmacist 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 or asthma should seek medical advice before using Ibuprofen gel as should patients already taking other painkillers.

  Patients should seek medical advice if symptoms worsen or persist.

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

• Interactions
  

  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.

• Adverse Drug Reactions
  

  Very rarely, susceptible patients may experience the following side effects with ibuprofen, but these are extremely uncommon when ibuprofen is administered topically. If they occur, treatment should be discontinued:-

  Hypersensitivity: 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, brochospasm 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).

  Gastro-intestinal: Side effects such as abdominal pain and dyspepsia have been reported.

  Renal: Renal impairment can occur in patients with a history of kidney problems.