The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
IBULEVE PAIN RELIEF 5% W/W GEL
Information for the user
PAIN RELIEF 5% GEL ibuprofen
Read all of this leaflet carefully before using this product.
In this leaflet:
1. What Ibuleve Pain Relief Gel is and what
it is used for
2. Before you use Ibuleve Pain Relief Gel
3. How to use Ibuleve Pain Relief Gel
4. Possible side effects
5. How to store Ibuleve Pain Relief Gel
6. Further information
1. WHAT Ibuleve Pain Relief Gel
IS AND WHAT IT IS USED FOR
• Ibuleve Pain Relief Gel is an anti-inflammatory
painkiller applied to, and absorbed through,
• It is for the treatment of the following conditions
involving the musculoskeletal system:
• muscular backache
• muscular pain
• rheumatic pain
• sports injuries.
• Ibuleve Pain Relief Gel is recommended for
use by adults, the elderly and children over
the age of 12 years.
• The active ingredient in this product is
ibuprofen. This is one of a group of medicines
known as non-steroidal anti-inflammatory
• Ibuprofen works by:
• relieving pain
• reducing swelling and inflammation.
2. BEFORE YOU USE IBULEVE PAIN
Do not use Ibuleve Pain Relief Gel:
• if you are allergic (hypersensitive) to ibuprofen
or any of the other ingredients of Ibuleve Pain
Relief Gel listed in Section 6;
• 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;
• if you are pregnant or breast-feeding;
• on broken, damaged, infected or diseased skin;
• if you have severe joint pain of recent onset that
is not related to an injury or period of overuse;
• if you feel ill, have a temperature or any other
symptoms that accompany the pain.
Before applying this product for the first time,
make sure it is suitable for you to use:
Because Ibuleve Pain Relief Gel is delivered through
the skin, directly over the painful area, there is less
risk of the complications that sometimes occur when
ibuprofen (or a similar anti-inflammatory painkiller) is
taken by mouth. However, in rare cases you may be
• if you have a stomach ulcer
(also called a peptic or gastric ulcer);
• if you have ever had kidney problems;
• if you have ever had asthma;
• if you have ever had a bad reaction to aspirin
or ibuprofen taken by mouth.
If any of the above apply to you, only use
this product on advice from your doctor or
Take special care when using this product:
• Use it only on the skin.
• Do not use on children under 12 years of
age except on the advice of a doctor.
• Do not apply it to broken or irritated skin.
• Do not use under protective waterproof dressings.
• Do not use more than the recommended dose
(see Section 3).
• Keep the gel away from the eyes,
nose and mouth.
Using other medicines
• Interaction between Ibuleve Pain Relief Gel
and blood pressure lowering drugs and
anticoagulants is possible, in theory, although
very unlikely. If you would like more advice
about this, speak to your doctor or pharmacist.
• If you are also taking aspirin or other NSAIDs by
mouth, discuss this beforehand with your doctor
or pharmacist because these may increase the
risk of undesirable effects.
• Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines including other medicines obtained
Pregnancy and breast-feeding
You should not use Ibuleve Pain Relief Gel
if you are pregnant or breast-feeding.
Driving and using machinery
Using this product is not known to affect your
ability to drive or use machinery.
Important information about one of the
ingredients of Ibuleve Pain Relief Gel
The product contains a small amount of propylene
glycol. This ingredient may cause skin irritation
in a small number of people who are intolerant
to it. If your doctor has told you that you have an
This medicine is available without prescription. However, you still need to use it carefully
to get the best results from it. Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve after a few weeks.
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.
3. HOW TO USE Ibuleve Pain Relief Gel
Before using this tube of gel for the first
time, open it as follows:
• Unscrew the cap, turn it upside down
and then use the sharp point of the cap to
pierce the membrane in the neck of the tube.
To use the gel
(for adults, the elderly and children over 12 years old):
• Use the gel up to three times a day, leaving
4 hours between applications.
• Lightly apply the gel to intact skin over the
• Apply 4 to 10 cm gel to thinly cover the affected
area, then massage gently until absorbed.
Do not apply more than 30 cm of gel in any
24 hour period.
• Wash hands after use, unless treating them.
• Carry on using the gel in this way for up to
two weeks (or longer if recommended by
your doctor), until your condition gets better.
• If your symptoms worsen or continue for more
than two weeks, discuss this with your
pharmacist or doctor before continuing
If the gel comes into contact with broken skin
or gets into the eyes, nose or mouth
• The product may cause irritation if it comes
into contact with broken skin or gets into
the eyes, nose or mouth. If this happens,
rinse the affected areas with plenty of
water. If rinsing one eye, take care to avoid
washing product into the other eye. If irritation
persists, tell your doctor or pharmacist.
If the gel is accidentally swallowed
• Symptoms may include headache, vomiting,
drowsiness and low blood pressure.
• If you experience any of these symptoms
contact a doctor or hospital straight away.
If you forget to use this product
Do not worry if you occasionally forget to use this
product, just carry on using it when you remember.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibuleve Pain Relief Gel can
cause side effects, although not everybody
Occasionally, mild skin rashes, itching or irritation
can sometimes occur at the site of application.
If this is unacceptable, or persists, stop using the
product and tell your doctor or pharmacist.
Very rarely, the following side effects can happen
with ibuprofen, although these are extremely
uncommon with products such as Ibuleve Pain
Relief Gel that are applied to the skin.
If you experience any of the following,
stop using Ibuleve Pain Relief Gel
immediately and tell your doctor:
• Allergic reactions (particularly in people
who have a history of asthma or allergic
problems), such as:
• unexplained runny nose and watery
eyes, or, in more serious cases asthma
or aggravated asthma involving breathing
difficulties, wheezing or chest tightness;
• generalised allergic skin reactions
involving itch, swelling, inflammation,
redness and perhaps blistering and
• other more serious generalised allergic
reactions possibly involving unexplained
nausea and vomiting, swollen eyes,
face or tongue, difficulty swallowing,
dizziness or light-headedness.
Unconsciousness could perhaps occur
in the most serious cases.
• Kidney problems
(particularly in people who have a history
of kidney disease), such as:
• decreased urine volume;
• loss of appetite / weight loss;
• swelling to abdomen.
• Problems with the digestive system
(particularly in people who have a history
of stomach ulcers etc), such as:
• stomach pain;
• heartburn / indigestion.
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.
5. HOW TO STORE Ibuleve
Pain Relief Gel
Keep it out of the reach and sight of children.
Always replace the cap tightly after use.
Do not store the product above 25°C.
Do not use after the expiry date shown
on the fold of the tube and the carton.
The expiry date refers to the last day of
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. FURTHER INFORMATION
ABOUT Ibuleve Pain Relief Gel
What Ibuleve Pain Relief Gel contains:
The active ingredient is ibuprofen (5% w/w).
The other ingredients are industrial methylated
spirit, carbomers, propylene glycol, diethylamine
and purified water.
What Ibuleve Pain Relief Gel looks like and
contents of the pack
• The product is a clear, colourless gel that
contains no fragrance.
• The gel is available in tubes containing 30g.
The Marketing Authorisation holder is
Diomed Developments Limited, Tatmore Place,
Gosmore, Hitchin, Herts, SG4 7QR, UK.
The Manufacturer is DDD Limited,
94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
The Distributor is DDD Limited,
94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
This leaflet was last approved in
To listen to or request a copy of this leaflet in
Braille, large print or audio, please call free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following information:
Ibuleve Pain Relief Gel 00173/0408.
This is a service provided by the Royal National
Institute of Blind People (RNIB).
intolerance to propylene glycol, please talk to your
doctor before using this product.
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.