Ibugel

Read all of this leaflet carefully before using this product.

Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve after a few weeks.

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.

In this leaflet:

1. What Ibugel is and what it is used for
2. Before you use Ibugel
3. How to use Ibugel
4. Possible side effects
5. How to store Ibugel
6. Further information

Do not use Ibugel:

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

Take special care when using this product:

• Use it only on the skin.
• 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.

Using other medicines

• Interaction between Ibugel 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.

Pregnancy and breast-feeding

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

Driving and using machinery

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

Important information about one of the ingredients of Ibugel

The product contains a small amount of propylene glycol. This ingredient may cause skin irritation in a small number of people who are intolerant to it.

If your doctor has told you that you have an intolerance to propylene glycol, please talk to your doctor before using this product.

Before using this tube of gel for the first time, open it as follows:

• 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 tube squeezer key:

To make Ibugel easier and more economical to use, a blue 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 Ibugel when the tube is nearly empty.

To fit the tube squeezer key:

• 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.

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 experience any of the following, stop using Ibugel immediately and tell your doctor:

• 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.

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 side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

What Ibugel contains:

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

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

What Ibugel 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 100g.

The packs also contain a tube key.

The Marketing Authorisation holder is

The Manufacturer is