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

• if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibuleve Pain Relief 5% Gel 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;
• if you have severe joint pain of recent onset that is not related to an injury or period of overuse;
• if you feel ill, have a temperature or any other symptoms that accompany the pain.

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

Because Ibuleve Pain Relief 5% Gel 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 Pain Relief 5% 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 Pain Relief 5% 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 on children under 12 years of age except on the advice of a doctor.
• Do not apply it to broken or irritated skin.
• Do not use under protective waterproof dressings.
• Do not use more than the recommended dose (see Section 3).
• Keep the gel away from the eyes, nose and mouth.

• Interaction between Ibuleve Pain Relief 5% Gel 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 Pain Relief 5% Gel 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.

To use the gel

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

• Use the gel up to three times a day, leaving 4 hours between applications.
• Lightly apply the gel to intact skin over the painful area.
• Squeeze out a 4 to 10 cm length of gel onto the affected area, enough to thinly cover it, then massage gently until absorbed. Do not apply more than 30 cm of gel in any 24 hour period.
• Wash hands after use, unless treating them.
• Carry on using the gel in this way for up to two weeks (or longer if recommended by your doctor), until your condition gets better.
• If your symptoms worsen or continue for more than two weeks, discuss this with your pharmacist or 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 of 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 (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 4g, 30g, 40g, 50g and 100g. Not all pack sizes may be marketed.