IBULEVE Gel Ref.[50235] Active ingredients: Ibuprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Hertfordshire, SG4 7QR, UK

4.1. Therapeutic indications

Administered topically for fast local relief of pain and inflammation in musculoskeletal conditions including backache, rheumatic and muscular pain, sprains, strains, lumbago and fibrositis, and neuralgia. Ibuleve is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.

4.2. Posology and method of administration

Apply 1.0 to 2.5 g gel (quantified by appropriate means) to the affected areas, up to three times daily, or as directed by the physician. Individual doses should be administered at least 4 hours apart. On each occasion apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed. The maximum daily dose is approximately 7.5 g of gel (quantified appropriately on the labelling) in any 24 hour period. Wash hands after use unless treating them. Do not use excessively.

Treatment should not normally continue for more than a few weeks, unless recommended to do so by a doctor.

The same dosage and dosage schedule applies to all age groups, although the gel is not normally recommended for children under 12 years, unless instructed by their doctor.

4.9. Overdose

Any overdose with a topical presentation of ibuprofen is extremely unlikely.

Symptoms of severe ibuprofen overdosage (e.g. following accidental oral ingestion) include headache, vomiting, drowsiness and hypotension. Correction of severe electrolyte abnormalities should be considered.

6.3. Shelf life

30 g, 40 g, 50 g and 100 g collapsible aluminium containers: 3 years from the date of manufacture.

4 g collapsible aluminium containers: 18 months from the date of manufacture.

30 g, 40 g, 50 g and 100 g laminate copolymer tubes: 4 years from the date of manufacture.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

  1. Membrane sealed, epoxy resin coated, collapsible aluminium TUBE, fitted with a SCREW CAP (containing 4 g, 30 g, 40 g, 50 g or 100 g of product).
  2. Membrane-sealed laminate TUBE, made of a HDPE/aluminium/Ethylene Acrylic Acid (EAA) copolymer, fitted with a CAP (containing 30 g, 40 g, 50 g or 100 g of product).
  3. Laminate TUBE made of a HDPE/aluminium/Ethylene Acrylic Acid (EAA) copolymer, fitted with an air-return-free ‘Precitube’ pump head and CAP (containing 30 g, 40 g, 50 g or 100 g of product).

6.6. Special precautions for disposal and other handling

Not applicable.

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