PACKAGE LEAFLET

Information for the user

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ibuprofen 5% w/w

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 Ibuleve Mousse is and what it is used for

2.    Before you use Ibuleve Mousse

3.    How to use Ibuleve Mousse

4.    Possible side effects

5.    How to store Ibuleve Mousse

6.    Further information

1.    WHAT IBULEVE MOUSSE IS AND WHAT IT IS USED FOR

•    Ibuleve Mousse is an anti-inflammatory painkiller applied to, and absorbed through, the skin.

•    It is for the treatment of the following conditions involving the musculoskeletal system:

•    backache

•    rheumatic or muscular pain

•    sprains

•    strains

•    neuralgia.

•    It is also for pain relief in common arthritic conditions.

•    Ibuleve Mousse is recommended for use by adults, the elderly and children over the age of 12 years. Children under the age of 12 may also use it if recommended by their doctor.

•    The active ingredient in this product is ibuprofen. This is one of a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

•    Ibuprofen works by:

•    relieving pain

•    reducing swelling and inflammation.

2.    BEFORE YOU USE IBULEVE MOUSSE

Do not use Ibuleve Mousse:

•    if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibuleve Mousse 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 Mousse 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:

•    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 mousse away from the eyes, nose and mouth.

Using other medicines

•    Interaction between Ibuleve Mousse and blood pressure lowering drugs and anticoagulants 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 Ibuleve Mousse 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 Ibuleve Mousse 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.

3. HOW TO USE IBULEVE MOUSSE

Do not spray near flames, burning cigarettes, electric heaters or similar ignition sources. Shake the container well before use For adults, the elderly and children over 12 years old:

•    Use the mousse up to three to four times a day, or as often as advised by your doctor.

•    Hold the can upright, then press the nozzle to dispense the mousse into the palm of your hand.

•    Gently massage the mousse 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 1 to 2g (1 to 2 golf-ball sized quantities of mousse dispensed into the palm of your hand) should be enough.

•    Wash hands after use, unless treating them.

•    Carry on using the mousse 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 mousse 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 mousse 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 have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ibuleve Mousse can cause side effects, although not everybody gets them. Occasionally, the temporary cooling effect of the mousse may pale the skin temporarily. Mild skin rashes, itching or irritation can sometimes occur at the site of application. If this is unacceptable, or persists, stop using the product and tell your doctor or pharmacist.

Very rarely, the following side effects can happen with ibuprofen, although these are extremely uncommon with products such as Ibuleve Mousse that are applied to the skin.

If you experience any of the following, stop using Ibuleve Mousse 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 lightheadedness. 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.

5.    HOW TO STORE IBULEVE MOUSSE

•    Keep it out of the reach and sight of children.

•    Always replace the cap after use.

•    Do not store the product above 25°C.

•    Protect from sunlight and do not expose pressurised container to temperatures higher than 50°C.

•    Do not use after the expiry date shown on the base of the can and on the carton. The expiry date refers to the last day of that month.

•    Do not pierce or burn, even when empty.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION ABOUT IBULEVE MOUSSE

What Ibuleve Mousse contains:

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

The other ingredients are propylene glycol, carbomer, phenoxyethanol, diethylamine and purified water. The ozone-friendly aerosol propellant is butane 40.

What Ibuleve Mousse looks like and contents of the pack

•    The product is a white, cutaneous foam that is non-sticky, non-greasy and contains no fragrance.

•    The mousse is available in pressurised spray cans containing 75g.

The Marketing Authorisation holder is Diomed Developments Limited, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK.

The Manufacturer is Pharmasol Ltd, Andover, Hants, SP10 5AZ, UK.

The Distributor is DDD Limited,

94 Rickmansworth Road, Watford, Herts,

WD18 7JJ, UK.

This leaflet was last approved in October 2007. To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Ibuleve Mousse, 00173/0168.

This is a service provided by the Royal National Institute of Blind People (RNIB).