PATIENT INFORMATION LEAFLET

IBUPROFEN PAIN RELIEF GEL MAXIMUM STRENGTH 10% W/W

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

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 recommended for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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.

WHAT IS IN THIS LEAFLET

1.    What is Ibuprofen Pain Relief Gel Maximum Strength 10% w/w and what it is used for

2.    What you need to know before you use Ibuprofen Pain Relief Gel Maximum Strength 10% w/w

3.    How to use Ibuprofen Pain Relief Gel Maximum Strength 10% w/w

4.    Possible side effects

5.    How to store Ibuprofen Pain Relief Gel Maximum Strength 10% w/w

6.    Contents of the pack and other information

n WHAT IS IBUPROFEN PAIN RELIEF GEL MAXIMUM STRENGTH 10% W/W AND WHAT 11 IT IS USED FOR

Ibuprofen Pain Relief Gel Maximum Strength 10% w/w contains ibuprofen and belongs to a group of medicines called non-steroid anti-inflammatory drugs (NSAIDs). These medicines reduce pain and |inflammation, and bring down a high temperature.

Ibuprofen Pain Relief Gel Maximum Strength 10% w/w is used to treat a number of painful conditions affecting the joints and muscles such as back pain, sprains, strains and other sports injuries. It is also used for the relief of pain caused by non-serious arthritic conditions and nerve pain (neuralgia).

KJ WHAT YOU NEED TO KNOW BEFORE YOU USE IBUPROFEN PAIN RELIEF GEL MAXIMUM El STRENGTH 10% W/W

DO NOT use Ibuprofen Pain Relief Gel Maximum Strength 10% w/w:

•    If you are allergic to ibuprofen, aspirin or similar medicines (e.g NSAIDs) or any of the other ingredients in this gel (listed at the end of this leaflet).

» If you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives)

•    On broken, damaged, infected or diseased skin.

^ake special care with Ibuprofen Pain Relief Gel Maximum Strength 10% w/w

•    Protect treated areas from direct sunlight to avoid any sensitivity reaction, e.g. a rash

,• If you have had an ulcer or some other problem affecting your stomach or intestines in the past |» If you have asthma or wheezing attacks (or if you have had asthma in the past)

•    If you have any kidney problems

,• If you develop a rash after using the gel stop using it any further |» If you suffer from bronchial asthma or any allergic disease

If any of the above apply to you, only use this product on advice from your doctor or pharmacist. ilBUPROFEN PAIN RELIEF GEL MAXIMUM STRENGTH 10% W/W IS FOR APPLICATION TO THE SKIN ONLY.

Other medicines and Ibuprofen Pain Relief Gel Maximum Strength 10% Gel

ban you use Ibuprofen Pain Relief Gel Maximum Strength 10% w/w with other medicines?

Tell your doctor or pharmacist if you are taking, or have recently taken any other medicine, even those not prescribed by a doctor.

[The effect of this medicine may affect or be affected by taking the following medicines at the same time:

•    Medicines to lower your blood pressure (e.g. atenolol)

•    Medicines used to thin the blood (e.g. warfarin)

!• Aspirin or other NSAIDs, used for pain and inflammation

Please tell your doctor or pharmacist if you are taking any of the above, or have recently taken any other medicine - even those not prescribed.

Pregnancy and breast feeding

You should not use Ibuprofen Pain Relief Gel Maximum Strength 10% w/w if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Ibuprofen Pain Relief Gel Maximum Strength 10% w/w should not affect the ability to drive or use machines. El HOW TO USE IBUPROFEN PAIN RELIEF GEL MAXIMUM STRENGTH 10% W/W

Ibuprofen Pain Relief Gel Maximum Strength 10% w/w is designed for topical (on the skin) Application only. Never take the gel by mouth. _ _ _ _ Further information overleaf

Always use Ibuprofen Pain Relief Gel Maximum Strength 10% w/w exactly as this leaflet tells you. You should] check with your doctor or pharmacist if you are not sure. Check the seal is intact before first use (invert cap to break seal).

Adults: Squeeze 2 to 5cm (i.e. 0.8 to 2 inches) of gel from the tube and rub into the affected area until absorbed. This dose should not be repeated more frequently than every four hours and no more than four times a day in any 24 hour period. The amount of gel squeezed would be equivalent to 50 to 125mg of ibuprofen. Ibuprofen Pain Relief Gel Maximum Strength 10% w/w should only be used on healthy, unbroken skin.

Do not use it on or near cuts or grazes or under dressings such as plasters. Do not let any gel come in bontact with your eyes. If it does, rinse your eyes with cold water and consult your doctor. Hands should be washed after applying Ibuprofen Pain Relief Gel Maximum Strength 10% w/w, unless they are the site of treatment. Do not use the gel on the genital area.

Ilf the condition does not improve after two weeks use, or becomes worse at any time, speak to your doctor or pharmacist.

Children: Ibuprofen Pain Relief Gel Maximum Strength 10% w/w is not recommended for use in children under 14 years.

If the gel is accidentally swallowed

Jf you accidentally swallow any Ibuprofen Pain Relief Gel Maximum Strength 10% w/w, rinse out your mouth thoroughly and contact your doctor, or nearest hospital, as soon as possible. If swallowed, the gel may cause an upset stomach.

If you forget to use your Ibuprofen Pain Relief Gel Maximum Strength 10% w/w:

|lf you miss a dose, just carry on with the next dose as normal. Do not apply a double dose.

FI POSSIBLE SIDE EFFECTS

Like all medicines Ibuprofen Pain Relief Gel Maximum Strength 10% w/w can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare.

Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

bther side effects include:

» Itching or reddening of the skin    • A burning feeling    • Sore or weeping spots

• Abdominal Pain (pains in your stomach) or other abnormal stomach symptoms |» Kidney problems (particularly in people who have a history of kidney disease).

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.

[Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

H HOW TO STORE IBUPROFEN PAIN RELIEF GEL MAXIMUM STRENGTH 10% W/W

Keep this medicine out of the sight and reach of children.

Do not use Ibuprofen Pain Relief Gel Maximum Strength 10% w/w after the expiry date which is stated on the tube. The expiry date refers to the last day of that month.

They should be stored in a cool, dry place, below 25°C. Keep the tube tightly closed. Store in original packaging in order to protect from light.

1/ledicines 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.

Remember: This medicine is for you. Never give this medicine to someone else, it could harm them, even if their symptoms seem the same as yours.

fSl CONTENTS OF THE PACK AND OTHER INFORMATION

What Ibuprofen Pain Relief Gel Maximum Strength 10% w/w contains

The active substance is ibuprofen. The other ingredients are hydroxyethylcellulose, sodium hydroxide, benzyll alcohol, isopropyl alcohol and purified water.

What Ibuprofen Pain Relief Gel Maximum Strength 10% w/w looks like and contents of the pack

Ibuprofen Pain Relief Gel Maximum Strength 10% w/w is supplied in aluminium tubes containing 30g or 50g of gel. Not all pack sizes may be marketed.

Marketing Authorisation Holder: Mercury Pharma Group Ltd., No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK.

Manufacturer Mercury Pharmaceuticals Ltd., No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK. Alternate Manufacturer: Farmasierra Manufacturing S.L. Carretera De Irun KM 26,200 28700, SAN Sebastian De Los Reyes, Madrid, Spain.

This leaflet was last revised in November 2012. _ _ _ _ _ ooooo/o_    _4003163

Colour Swatches | Black

Additional Swatches

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