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IBUPROFEN 5% W/W GEL
Active substance(s): IBUPROFEN
IBUPROFEN 5% GEL
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 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 get
serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor
WHAT IS IN THIS LEAFLET
1. What is Ibuprofen 5% Gel and what it is
2. What you need to know before you use
Ibuprofen 5% Gel
3. How to use Ibuprofen 5% Gel
4. Possible side effects
5. How to store Ibuprofen 5% Gel
6. Contents of the pack and other information
WHAT IS IBUPROFEN 5% GEL
AND WHAT IT IS USED FOR
Ibuprofen 5% Gel 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 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.
WHAT YOU NEED TO KNOW BEFORE
YOU USE IBUPROFEN 5% GEL
DO NOT use Ibuprofen 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 Ibuprofen 5% Gel
• Protect treated areas from direct sunlight to
avoid any sensitivity reaction, e.g. a rash
• If you suffer from bronchial asthma or any
• 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
Adults: Squeeze 4 to 10cm (i.e. 1.6 to 4
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 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.
If any of the above apply to you, only use this
product on advice from your doctor or pharmacist.
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 5% Gel,
unless they are the site of treatment.
IBUPROFEN 5% GEL IS FOR EXTERNAL
Other medicines and Ibuprofen 5% Gel
If the condition does not improve after two
weeks use, or becomes worse at any time,
speak to your doctor or pharmacist.
Can you use Ibuprofen 5% Gel with
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.
• Medicines used to thin the blood (e.g. warfarin)
• Aspirin or other NSAIDs, used for pain and
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.
Children: Ibuprofen 5% Gel is not recommended
for use in children under 12 years.
If the gel is accidently swallowed:
If you accidentally swallow any Ibuprofen 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.
POSSIBLE SIDE EFFECTS
Like all medicines Ibuprofen 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, rash or
itching (especially affecting your whole body)
should be reported to a doctor immediately.
Pregnancy and breast feeding
You should not use Ibuprofen 5% gel if you are
pregnant or breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
Ibuprofen 5% Gel is designed for topical
(on the skin) application only. Never take
the gel by mouth.
Side effects include:
• Itching or reddening of the skin
• A burning feeling
• Sore or weeping spots
• Kidney problems (particularly in people who
have a history of kidney disease)
• Abdominal Pain (pains in your stomach) or
other abnormal stomach symptoms
Always use Ibuprofen 5% Gel exactly as this
leaflet tells you. You should check with your
doctor or pharmacist if you are not sure.
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.
Check the seal is intact before first use (invert
cap to break seal).
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
HOW TO USE IBUPROFEN 5% GEL
Further information overleaf.
Generic Ibuprofen 5% Gel
Mercury Pharma Ltd
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.
HOW TO STORE IBUPROFEN 5% GEL
Keep this medicine out of the sight and reach
Do not use Ibuprofen 5% Gel 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.
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.
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.
CONTENTS OF THE PACK AND
What Ibuprofen 5% Gel contains
The active substance is ibuprofen. The other
ingredients are hydroxyethylcellulose, sodium
hydroxide, benzyl alcohol, isopropyl alcohol and
What Ibuprofen 5% Gel looks like and
contents of the pack
Ibuprofen 5% Gel 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., Capital House,
85 King William Street, London EC4N 7BL, UK.
Mercury Pharmaceuticals Ltd., Capital House,
85 King William Street, London EC4N 7BL, UK.
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.
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.