Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ibuprofen may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
IBUGEL
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Ibugel contains: The active ingredient is ibuprofen (5% w/w). The other ingredients are industrial methylated spirit, carbomers, propylene glycol (E 1520), diethylamine and purified water. What Ibugel looks like and contents of the pack
To fit the tube squeezer key:
Prints: Pantone 293
Flat size: 160mm x 315mm
continued… Prints: Pantone 293
Flat size: 160mm x 315mm
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibugel can cause side effects, although not everybody gets them. All side effects listed are of unknown frequency (frequency cannot be estimated from the available data). Ibugel may cause the following side effects:
The active substance in Ibugel is ibuprofen.
Medicines with the same active substance, strength and form include: Anadin Ultra, Brufen Retard, Ibugel Forte 10%. In total there are 11 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Ibugel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the topical treatment of rheumatic and muscular pain, sprains, strains, backache and neuralgia. Ibugel is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.
Apply the gel to the affected areas, up to three times daily, or as directed by the physician. On each occasion apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed. Do not use excessively.
Hands should be washed immediately after use (unless treating them).
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 Ibugel is not normally recommended for use on children under the age of 12 years, unless instructed by their doctor.
Not to be used in cases of sensitivity to any of the ingredients, particularly if asthmatic or suffer from allergic disease, and have previously shown hypersensitivity to aspirin, ibuprofen or related painkillers
Not to be used on broken skin.
Do not use during pregnancy or lactation.
Seek medical advice if symptoms worsen or persist.
Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with the use of ibuprofen (see section 4.8). Most of these reactions occur within the first month.
If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).
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 Ibugel.
Propylene glycol may cause skin irritation.
Keep away from the eyes and mucous membranes.
For external use only.
The label will include statements to the following effect:
If symptoms persist, consult your doctor or pharmacist.
Do not use if sensitive to any of the ingredients, particularly if asthmatic, suffer from rhinitis or urticaria and have previously shown hypersensitivity to aspirin, ibuprofen or related painkillers.
Consult your doctor before use if you are taking aspirin or other painkillers.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
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.
Do not use during pregnancy or lactation.
Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed, and the duration of labour increased. Ibuprofen appears in breast milk in very low concentrations, but is unlikely to affect breast fed infants adversely.
None known
Adverse drug reactions are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse reaction
Skin and subcutaneous tissue disorders
Very rare
Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis)
Not known
Photosensitivity reactions
Skin rash
Pruritus
Skin irritation
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
Acute generalised exanthematous pustulosis (AGEP)
Immune System Disorders
Not known
Hypersensitivity 1
Renal and urinary disorders
Not known
Renal impairment 2
Gastrointestinal disorders
Not known
Abdominal pain
Dyspepsia
1 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).
2 Renal: renal impairment can occur in patients with a history of kidney problems.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable. Any overdose with a topical presentation of ibuprofen is extremely unlikely.
Ask anything about Ibugel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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