What you need to know before you take it

e Ibuleve dermatitis, erythema multiforme, Stevens3. How to use Ibuleve Johnson syndrome, toxic epidermal necrolysis, 4. Possible side effects drug reaction with eosinophilia and systemic 5. How to store Ibuleve symptoms (DRESS), acute generalized

How to take it

IBULEVE

• on broken, damaged, infected or diseased skin. Before using this tube of gel for the first time, Before applying this product for the first time, open it as follows: make sure it is suitable for you to use:
• Unscrew the cap, turn it upside down Because Ibuleve is delivered through the skin, and then use the sharp point of the cap to directly over the painful area, there is less risk of the pierce the membrane in the neck of the tube. complications that sometimes occur when ibuprofen This pack contains a tube squeezer key: (or a similar anti-inflammatory painkiller) is taken by To make Ibuleve easier and more economical to mouth. However, in rare cases you may be at risk: use, a tube squeezer key has been provided.
• if you have a stomach ulcer (also called a Once fitted to the tube, simply turning the key peptic or gastric ulcer); will dispense the gel more easily for patients
• if you have ever had kidney problems; who experience difficulties in squeezing tubes.
• if you have ever had asthma; For economy, the key will also help expel the last
• if you have ever had a bad reaction to aspirin few grams of Ibuleve when the tube is nearly empty. or ibuprofen taken by mouth. To fit the tube squeezer key: If any of the above apply to you, only use
• Ensure that the tube nozzle has been pierced this product on advice from your doctor or using the point of the cap. pharmacist.
• Slide the slit of the key over the folded end Warnings and precautions of the tube. Do not 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.

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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

4. POSSIBLE SIDE EFFECTS Like all medicines, Ibuleve Gel 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). Ibuleve gel may cause the following side effects:

• Occasionally,  mild skin rashes, itching or irritation can sometimes occur at the site of application.
• Skin becomes sensitive to light If this is unacceptable, or persists, stop using the product and tell your doctor or pharmacist. If you experience any of the following side effects, stop using Ibuleve Gel immediately and tell your doctor:
• Serious skin reactions such as:
• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).
• Allergic reactions (particularly in people who have a history of asthma or allergic problems), such as:

Possible side effects

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.

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• Carefully turn the key to roll up the tube until the required amount of gel has been expelled.
• Always replace the cap after use, leaving the key in place on the end of the tube.

How to store it

IBULEVE

• Keep it out of the sight and reach of children.
• Always replace the cap tightly after use.
• Do not store the product above 25°C.
• Do not use after the expiry date shown on the fold of the tube and the carton. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Ibuleve contains: The active ingredient is ibuprofen (5% w/w). The other ingredients are industrial methylated spirit, carbomers, propylene glycol (E1520), diethylamine and purified water. What Ibuleve looks like and contents of the pack

• The product is a clear, colourless gel that contains no fragrance.
• The gel is available in tubes containing 50g.
• This pack contains a tube squeezer key. The Marketing Authorisation holder is Diomed Developments Limited, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. The Manufacturer is Laleham Health & Beauty Ltd, Fairfield, Bradshaw Lane, Greenhalgh, Kirkham, Preston, Lancashire, PR4 3JA, UK. This leaflet was last revised in September 2025. To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only). Please be ready to give the following information: Ibuleve 00173/0413. This is a service provided by the Royal National Institute of Blind People (RNIB).

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To use the gel (for adults, the elderly and children over 12 years old):

• Use the gel up to three times a day, or as often as advised by your doctor.
• Lightly apply the gel to intact skin over the painful area.
• Apply only enough gel to thinly cover the affected area, then massage gently until absorbed.
• Wash hands after use, unless treating them.
• Carry on using the gel in this way until your condition gets better (you may find you need to use it for a few weeks, and your doctor may want you to continue using it for longer than this).
• If your symptoms worsen or continue for more than a few weeks, discuss this with your doctor before continuing treatment. If the gel comes into contact with broken skin or gets into the eyes, nose or mouth
• The product may cause irritation if it comes into contact with broken skin or gets into the eyes, nose or mouth. If this happens, rinse the affected areas with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, tell your doctor or pharmacist. If the gel is accidentally swallowed
• Symptoms may include headache, vomiting, drowsiness and low blood pressure.
• If you experience any of these symptoms contact a doctor or hospital straight away. If you forget to use this product Do not worry if you occasionally forget to use this product, just carry on using it when you remember. If you have any further questions on the use of this product, ask your doctor or pharmacist.

• unexplained runny nose and watery eyes, or, in more serious cases asthma or aggravated asthma involving breathing difficulties, wheezing or chest tightness;
• generalised allergic skin reactions involving itch, swelling, inflammation, redness and perhaps blistering and light sensitivity;
• other more serious generalised allergic reactions possibly involving unexplained nausea and vomiting, swollen eyes, face or tongue, difficulty swallowing, dizziness or light-headedness. Unconsciousness could perhaps occur in the most serious cases.
• Kidney problems (particularly in people who have a history of kidney disease), such as:
• decreased urine volume;
• loss of appetite / weight loss;
• swelling to abdomen.
• Problems with the digestive system (particularly in people who have a history of stomach ulcers etc), such as:
• stomach pain;
• heartburn / indigestion. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report

Contents of the pack and other information

exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. 1. WHAT IBULEVE IS AND WHAT Stop using Ibuleve Gel and seek medical IT IS USED FOR attention immediately if you notice any of the

• Ibuleve is an anti-inflammatory painkiller symptoms related to these serious skin reactions described in section 4. applied to, and absorbed through, the skin.
• Do not use it on children under 12 years old
• It is for the treatment of the following conditions unless advised by a doctor. involving the musculoskeletal system:
• Do not apply it to broken or irritated skin.
• backache
• Keep the gel away from the eyes, nose
• rheumatic or muscular pain and mouth.
• sprains Using other medicines
• strains
• Interaction between Ibuleve and blood pressure
• neuralgia. lowering drugs and anticoagulants (medicines that
• It is also for pain relief in common arthritic stop blood clotting) is possible, in theory, although conditions. very unlikely. If you would like more advice about
• Ibuleve is recommended for use by adults, this, speak to your doctor or pharmacist. the elderly and children over the age of • If you are also taking aspirin or other NSAIDs by 12 years. Children under the age of 12 may mouth, discuss this beforehand with your doctor also use it if recommended by their doctor. or pharmacist because these may increase the
• The active ingredient in this product is risk of undesirable effects. ibuprofen. This is one of a group of medicines
• Please tell your doctor or pharmacist if you known as non-steroidal anti-inflammatory are taking or have recently taken any other drugs (NSAIDs). medicines including other medicines obtained
• Ibuprofen works by: without prescription.
• relieving pain Pregnancy and breast-feeding
• reducing swelling and inflammation. You should not use Ibuleve if you are pregnant 2. WHAT YOU NEED TO KNOW BEFORE or breast-feeding. YOU USE IBULEVE Driving and using machinery Do not use Ibuleve: Using this product is not known to affect your ability
• if you are allergic (hypersensitive) to ibuprofen to drive or use machinery. or any of the other ingredients of Ibuleve Ibuleve Gel contains propylene glycol (E1520) listed in Section 6; Propylene glycol may cause skin irritation. This
• if you are asthmatic, or suffer from rhinitis medicine contains 20mg propylene glycol in each (allergic runny nose) or urticaria (hives) and gram. If your doctor has told you that you have an have ever had a bad reaction to aspirin, intolerance to propylene glycol, please talk to your ibuprofen or other NSAIDs in the past; doctor before using this product.
• if you are pregnant or breast-feeding;