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Package leaflet: Infromation for the user

Ibuprofen 10% w/w Gel
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:

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 gro up of medicines called nonsteroid antiInflammatory drugs (NSAID’s).
Ibuprofen 10% w/w Gel is used to treat a num ber of painful conditions affecting the j oints 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 t o ibuprofen or any of th e 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 Ibuprofen 10% w/w Gel:
- If you have had an ulcer or some other problem effecting 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 gential 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 further.
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 (including other forms of Ibuprofen), 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 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
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
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
Adults, the elderly and children over 12 years: Squeeze 2 t o 5c m (i.e. 0.8 to 2 inches) of g el
(equivalent to 50 m g to 125 m g ibuprofen) fro m the tube on affected area. Massage until absorbed. Do
not use more frequently than every four hours and no more than 4 times a day in any 24 hour period.
Ibuprofen 10% w/w Gel should o nly 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 ey es with col d water and consult your doc tor. Hands shou ld be washed after appl ying
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 1 0% w/w Gel is not reco mmended for use in children under 1 2
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 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
5. How to store Ibuprofen 10% w/w Gel
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expir y date whic h is stated on the carton and tube after “EXP”. Th e
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.
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 hy droxyethylcellulose (E152 5), 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 supplied in aluminium tubes containing 30g or 40g gel.
Marketing Authorisation Holder: Mercury Pharma Group Ltd, Capital House, 85 King William Street,
London EC4N 7BL, UK
Manufacturer: Farmasierra Manufacturing S.L. Carretera De Irun KM 26 ,200 287 00, SAN Sebastian
De Los Reyes,Madrid, Spain.
This leaflet was last revised on November 2015.

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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.