Ibugel Forte 10%

Keep this leaflet. You may need to read it again. If you have any further questions ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 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.

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

• if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibugel Forte 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 Ibugel Forte 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.

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 Ibugel Forte:

• 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 Ibugel Forte 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.
• Keep the gel away from the eyes, nose and mouth.

• Interaction between Ibugel Forte 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 Ibugel Forte if you are pregnant or breast-feeding.

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

• 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.

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.
• Squeeze out a 2 to 5 cm length of gel (50 to 125 mg ibuprofen) onto the affected area, enough to thinly cover it, 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.

• 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.

• 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 get 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 (10% w/w). The other ingredients are industrial methylated spirit, carbomers, diethylamine and purified water.

• The product is a clear or slightly hazy gel that is non-greasy and contains no fragrance.
• The gel is available in tubes containing 100g.

The Marketing Authorisation holder is

The Manufacturer is