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Ibuprofen 10% Gel

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NUROF€N

Maximum Strength 10% Gel Ibuprofen


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Pharmacode Reads This Way


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 has 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.

-    You must talk to a doctor if you do not feel better or if you feel worse after 14 days


What is in this leaflet:

1.    What Nurofen Maximum Strength 10% Gel is and what it is used for

2.    What you need to know before you use Nurofen Maximum Strength 10% Gel

3.    How to use Nurofen Maximum Strength 10% Gel

4.    Possible side effects

5.    How to store Nurofen Maximum Strength 10% Gel

6.    Contents of the pack and other information


1. What Nurofen Maximum Strength 10% Gel is and what it is used for.


Nurofen Maximum Strength 10% Gel contains ibuprofen and belongs to a group of medicines called non-steroid anti-inflammatory drugs (NSAIDs).

Nurofen Maximum Strength 10% Gel is used to treat a number of painful conditions affecting the joints and muscles such as back pain, rheumatic and muscular pain, sprains, strains and sports injuries


2. What you need to know before you use Nurofen Maximum Strength 10% Gel.


DO NOT use Nurofen Maximum Strength 10% Gel:

•    If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), aspirin or similar medicines (e.g. NSAIDs)

•    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.

■ On broken, damaged, infected or diseased skin.

Take special care with Nurofen Maximum Strength 10% Gel:

•    If you have had an ulcer or some other problem affecting your stomach, or intestines in the past

•    If you have any kidney problems

•    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.

•    When applying the gel to the skin, be careful to avoid the eyes, lips and mouth, and any damaged skin

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

•    Do not use on the genital area.

•    Do not apply a dressing to the same area after using the gel

•    If you develop a rash after using the gel stop using it any further.

Nurofen Maximum Strength 10% Gel is FOR APPLICATION TO THE SKIN ONLY Other medicines and Nurofen Maximum Strength 10% Gel:

Speak to your doctor or pharmacist before using Nurofen Maximum Strength 10% gel if you are using or have recently taken or might use any other medicines, including medicines obtained without a prescription.

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.

Pregnancy and breast feeding

You should not use Nurofen Maximum Strength 10% Gel if you are pregnant or breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

Nurofen Maximum Strength 10% Gel should not affect the ability to drive or use machines.


BACK


3. How to use Nurofen Maximum Strength 10% Gel


Nurofen Maximum Strength 10% Gel is designed for topical (on the skin) application only. Never take the gel by mouth.

Always use Nurofen Maximum Strength 10% 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). If the seal is not intact, do not use the gel.

Adults, the elderly and children over 12 years: Squeeze 2 to 5cm (i.e. 0.8 to 2 inches) of gel (equivalent to 50mg to 125mg ibuprofen) from the tube on affected area. Massage until absorbed. Do not use more frequently than every four hours and no more than 4 times in any 24 hour period.

Nurofen Maximum Strength 10% 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. 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 Maximum Strength 10% Gel, unless they are the site of treatment. Do not use on the genital area.

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

Children under 12 years: Nurofen Maximum Strength 10% Gel is not recommended for use in children under 12 years.

If you accidentally swallow any Nurofen Maximum Strength 10 % Gel, rinse your mouth thoroughly. In the case of an upset stomach, speak to your doctor or pharmacist for advice. If you forget to use Nurofen Maximum Strength 10% Gel:

If you miss a dose, just carry on with the next dose as normal. Do not apply a double dose to make up for a forgotten dose.


4. Possible side effects


Like all medicines Nurofen Maximum Strength 10% 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, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Other 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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.


5. How to store Nurofen Maximum Strength 10% Gel


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

Do not use this medicine after the expiry date which is stated on the carton and tube after "EXP". The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the tube in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.


6. Contents of the pack and other information.


What Nurofen Maximum Strength 10% Gel contains

The active substance is ibuprofen. The other ingredients are hydroxyethylcellulose (E1525), sodium hydroxide (E524), benzyl alcohol (E1519), isopropyl alcohol, purified water.

What Nurofen Maximum Strength 10% Gel looks like and contents of the pack

Nurofen Maximum Strength 10% Gel is a transparent gel supplied in aluminium tube containing 30g and 40g gel. Not all pack sizes may be marketed.

Marketing Authorisation Holder & Manufacturer:

Mercury Pharma Group Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK. Manufacturer : Farmasierra Manufacturing S.L. Carretera De Irun KM 26,200 28700, SAN Sebastian De Los Reyes, Madrid, Spain.

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


This leaflet was last revised in April 2014.


81612Q7 17247/3


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