FRONT

NUROF€N(^)

5% Gel (Ibuprofen)

Pharmacode Reads This Way

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine is 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What is Nurofen 5% Gel and what it is used for

2.    Before you use Nurofen 5% Gel

3.    How to use Nurofen 5% Gel

4.    Possible side effects

5.    How to store Nurofen 5% Gel

6.    Further information

1. What is Nurofen 5% Gel and what it is used for

Nurofen 5% Gel contains ibuprofen and belongs to a group of medicines called non-steroid anti-inflammatory drugs (NSAID's). These medicines reduce pain and inflammation, and bring down a high temperature.

Nurofen 5% Gel is used to treat a number of painful conditions affecting the joints and muscles, such as backache, rheumatic and muscular pain, sprains, strains and sports injuries.

2. Before you use Nurofen 5% Gel

DO NOT use Nurofen 5% Gel:

•    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 Take special care with Nurofen 5% Gel

•    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.

Nurofen 5% Gel IS FOR EXTERNAL USE ONLY

Taking / Using other medicines

Can you take Nurofen 5% Gel with other medicines?

Please inform 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 Nurofen 5% Gel if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Nurofen 5% Gel

Nurofen 5% Gel is designed for topical (on the skin) application only. Never take the gel by mouth.

Always use Nurofen 5% Gel 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 4 to 10cm (i.e.1.6 to 4 inches) of gel from the tube and lightly 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.

BACK

Nurofen 5% Gel should only be used on healthy, unbroken skin.

Do not use it on or near cuts or grazes or under dressings such as plasters. Also do not use it on the genital area.

Do not let any gel come in contact with your eyes. If it does, rinse your eyes with cold water and consult your doctor. Hands should be washed after applying Nurofen 5% Gel, unless they are the site of treatment.

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

Children: Nurofen 5% Gel is not recommended for use in children under 12 years.

If the gel is accidently swallowed:

If you accidentally swallow any Nurofen 5% Gel, 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.

4. Possible side effects

Like all medicines Nurofen 5% Gel 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 or itching (especially affecting your whole body) should be reported to a doctor immediately.

Side effects include:

•    Itching or reddening of the skin

•    A burning feeling

•    Sore or weeping spots

•    Abdominal pains (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 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.

5. How to store Nurofen 5% Gel

Keep out of the reach and sight of children.

Do not use Nurofen 5% Gel after the expiry date which is stated on the tube. They should be stored in a cool, dry place, below 25°C. Keep the tube tightly closed.

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

Remember:

The medicine is for you.

Never give this medicine to someone else, it could harm them, even if their symptoms seem the same as yours.

6. Further information

What Nurofen 5% Gel contains

The active substance is Ibuprofen. The other ingredients are hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

What Nurofen 5% Gel looks like and contents of the pack Nurofen 5% Gel is supplied in aluminium tubes containing 35g gel.

Marketing Authorisation Holder and Manufacturer Mercury Pharma Group Ltd.,

Capital House, 85 King William Street, London EC4N 7BL, UK.

Distributor:

Reckitt Benckiser Healthcare (UK) Ltd, Hull, HU8 7DS.

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 April 2014.

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Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS, U.K.

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