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IBUPROFEN 10% W/W GEL

Active substance(s): IBUPROFEN

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Package leaflet: Infromation for the user

Ibuprofen 10% w/w Gel
(Ibuprofen) 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. 2. 3. 4. 5. 6. What Ibuprofen 10% w/w Gel is and what it is used for What you need to know before you use Ibuprofen 10% w/w Gel How to use Ibuprofen 10% w/w Gel Possible side effects How to store Ibuprofen 10% w/w Gel Contents of the pack and other information

1. What Ibuprofen 10% w/w Gel is and what it is used for Ibuprofen 10% w/w Gel contains ibuprofen and belongs to a group of medicines called nonsteroid antiInflammatory drugs (NSAIDs). Ibuprofen 10% w/w Gel is used to treat a number of painful conditions affecting the joints and muscles such as back pain, sprains, strains and other sport injuries.

2. What you need to know before you use Ibuprofen 10% w/w Gel DO NOT use Ibuprofen 10% w/w Gel: - If you are allergic to ibuprofen or any of the other ingredients ofthis 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 Ibuprofen 10% w/w 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 disease. If any of the above apply to you, only use this product on advice from your doctor or pharmacist.

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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. Ibuprofen 10% w/w Gel is FOR APPLICATION TO THE SKIN ONLY Other medicines and Ibuprofen 10% w/w Gel: Speak to your doctor or pharmacist before using Ibuprofen 10% w/w 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 Ibuprofen 10% w/w Gel if you are pregnant or breast-feeding. If you are pregnant or breat 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 Ibuprofen 10% w/w Gel should not affect the ability to drive or use machines. 3. How to use Ibuprofen 10% w/w Gel Ibuprofen 10% w/w Gel is designed for topical (on the skin) application only. Never take the gel by mouth. Always use Ibuprofen 10% w/w Gel exactly as described in 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 50 mg to 125 mg ibuprofen) from the tube on affected area. Massage until absorbed. Do not use more frequently that every four hours and no more that 4 times in any 24 hour period. Ibuprofen 10% w/w 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 Ibuprofen 10% w/w gel, unless they are the site of treatment. Do not use the gel 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: Ibuprofen 10% w/w Gel is not recommended for use in children under 12 years. If you accidentally swallow any Ibuprofen 10% w/w Gel, rinse out your mouth thoroughly.In case of an upset stomach, speak to your doctor or pharmacist. If you forget to use your Ibuprofen 10% w/w 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 Ibuprofen 10% w/w 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 Free phone 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 Ibuprofen 10% w/w 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 25C. Keep the tube in the outer carton in order to protect from light. 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. Contents of the pack and other information What Ibuprofen 10% w/w Gel contains The active substance is ibuprofen. The other ingredients are hydroxyethylcellulose (E1525), sodium hydroxide (E524), benzyl alcohol (E1519), isopropyl alcohol, purified water.

What Ibuprofen 10% w/w Gel looks like and contents of the pack Ibuprofen 10% w/w Gel is a transparent gel supplied in aluminium tubes containing 30g or 40g gel. Marketing Authorisation Holder and Manufacturer: Mercury pharma Group Ltd., 1, Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK Manufacturer: Farmasierra Manufacturing S.L. Carretera De Irun KM 26,200 28700, SAN Sebastian De Los Reyes,Madrid, Spain. This leaflet was last revised on January 2013.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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