Ibuspray

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

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.

In this leaflet:

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

Do not use Ibuspray:

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

Warnings and precautions

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 this product:

• This product is flammable. Do not spray it near flames or ignition sources.
• Use it only on the skin.
• Do not use it on children under 12 years old unless advised by a doctor.
• Keep the spray away from the eyes, nose and mouth.

Using other medicines

• Interaction between Ibuspray 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 Ibuspray 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.

For adults, the elderly and children over 12 years old:

• Use the spray up to three to four times a day, or as often as advised by your doctor.
• Holding the bottle upright or upside-down, approximately 4 to 6 inches away from the skin, spray over the affected area.
• Every 2 to 3 sprays, gently massage the spray into the skin over and around the painful area.
• The exact amount that you need to apply will vary, depending on the extent and severity of your condition, but normally 5 to 10 sprays (1 to 2 ml) should be enough.
• Wash hands after use, unless treating them.
• Carry on using the spray 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 spray 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 spray 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 side effects, stop using Ibuspray 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 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.

What Ibuspray contains:

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

The other ingredients are industrial methylated spirit, macrogol 300, macrogol cetostearyl ether (cetomacrogol 1000) and purified water.

What Ibuspray looks like and contents of the pack

• The product is a clear, colourless spray that contains no fragrance.
• The product is available in a pump spray bottle containing 100 ml.

The Marketing Authorisation holder is

The Manufacturer is