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Drug Details

Ibuleve Speed Relief Max Strength Gel

• Presentation
  Aqueous-alcoholic, non-greasy, fragrance-free, clear or slightly hazy gel.
• Description
  Ibuprofen 10.0% w/w. For a full list of excipients, see section List of excipients.
• Indications
  

  For fast local relief of backache, rheumatic pain, muscular aches, pains or swellings such as sprains, strains and sports injuries.

• Adult Dosage
  

  Adults, including the elderly, and children over 12 years.

  Lightly apply the gel to the affected areas and gently massage well into the skin, until completely absorbed. The dose is 0.5 to 1.25g gel (quantified on the labelling by appropriate means) up to three times daily with individual doses administered at least 4 hours apart. Patients should not apply more than approximately 4 g of gel (quantified appropriately on the labelling) in any 24 hour period. Wash hands after use unless treating them.

  Unless recommended by a doctor, advice should be sought about continued treatment if symptoms persist for more than 2 weeks.

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

• Special Precautions
  

  Keep away from the eyes and mucous membranes.

  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 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 the gel.

  Patients should seek medical advice if symptoms worsen or persist.

  The label should include the following warnings: “Do not exceed the stated dose. Not recommended for children under 12 years. For external use only. Not to be used during pregnancy or breastfeeding. Do not use if you are allergic to any of the ingredients or have experienced problems with aspirin, ibuprofen or related painkillers (including when taken by mouth). If symptoms persist consult your doctor or pharmacist. Keep out of the reach of children. Patients with asthma, an active peptic ulcer or history of kidney problems should consult their doctor before use, as should patients already taking aspirin or other painkillers.”

• 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 this occurring with a topically administered preparation is extremely remote. Where aspirin or other NSAID tablets are taken concurrently, it is important to bear in mind that these may increase the incidence of undesirable effects.

• 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 reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm, or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).

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

  Gastrointestinal: side effects such as abdominal pain and dyspepsia have been reported.