Ibuleve Gel/Ibuleve Sports Gel

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

1. What Ibuleve is and what it is used for
2. What you need to know before you use Ibuleve
3. How to use Ibuleve
4. Possible side effects
5. How to store Ibuleve
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibuleve listed in Section 6;
• if you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives) and have ever had a bad reaction to aspirin, ibuprofen or other NSAIDs in the past;
• if you are pregnant or breast-feeding;
• on broken, damaged, infected or diseased skin.

Before applying this product for the first time, make sure it is suitable for you to use:

Because Ibuleve is delivered through the skin, directly over the painful area, there is less risk of the complications that sometimes occur when ibuprofen (or a similar anti-inflammatory painkiller) is taken by mouth. However, in rare cases you may be at risk:

• if you have a stomach ulcer (also called a peptic or gastric ulcer);
• if you have ever had kidney problems;
• if you have ever had asthma;
• if you have ever had a bad reaction to aspirin or ibuprofen taken by mouth.

If any of the above apply to you, only use this product on advice from your doctor or pharmacist.

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.

Take special care when using Ibuleve Gel:

• Use it only on the skin.
• Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Ibuleve Gel and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
• Do not use it on children under 12 years old unless advised by a doctor.
• Do not apply it to broken or irritated skin.
• Keep the gel away from the eyes, nose and mouth.

• Interaction between Ibuleve and blood pressure lowering drugs and anticoagulants (medicines that stop blood clotting) is possible, in theory, although very unlikely. If you would like more advice about this, speak to your doctor or pharmacist.
• If you are also taking aspirin or other NSAIDs by mouth, discuss this beforehand with your doctor or pharmacist because these may increase the risk of undesirable effects.
• Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including other medicines obtained without prescription.

You should not use Ibuleve if you are pregnant or breast-feeding.

Using this product is not known to affect your ability to drive or use machinery.

Propylene glycol may cause skin irritation. This medicine contains 20mg propylene glycol in each gram. If your doctor has told you that you have an intolerance to propylene glycol, please talk to your doctor before using this product.

• Unscrew the cap, turn it upside down and then use the sharp point of the cap to pierce the membrane in the neck of the tube.

The 50g and 100g packs also contain a tube key.

To make Ibuleve easier and more economical to use, a tube squeezer key has been provided. Once fitted to the tube, simply turning the key will dispense the gel more easily for patients who experience difficulties in squeezing tubes. For economy, the key will also help expel the last few grams of Ibuleve when the tube is nearly empty.

• Ensure that the tube nozzle has been pierced using the point of the cap.
• Slide the slit of the key over the folded end of the tube.
• 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.

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.

• 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.

• Symptoms may include headache, vomiting, drowsiness and low blood pressure.
• If you experience any of these symptoms contact a doctor or hospital straight away.

Do not worry if you occasionally forget to use this product, just carry on using it when you remember.

• 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:
  • 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.

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 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.

The active ingredient is ibuprofen (5% w/w).

The other ingredients are industrial methylated spirit, carbomers, propylene glycol (E1520), diethylamine and purified water.

• The product is a clear, colourless gel that contains no fragrance.
• The gel is available in tubes containing 30g, 50g and 100g.
• The 50g and 100g packs also contain a tube key.