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IBULEVE MAXIMUM STRENGTH GEL

Active substance: IBUPROFEN

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PACKAGE LEAFLET
Information for the user

ibuprofen 10% w/w

Read all of this leaflet carefully before using this product.

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 one week.
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.

1. What Ibuleve Maximum Strength is and
what it is used for
2. Before you use Ibuleve Maximum Strength
3. How to use Ibuleve Maximum Strength
4. Possible side effects
5. How to store Ibuleve Maximum Strength
6. Further information

1. WHAT IBULEVE MAXIMUM STRENGTH
IS AND WHAT IT IS USED FOR

























Ibuleve Maximum Strength is an
anti-inflammatory painkiller applied to,
and absorbed through, the skin.
It is for the treatment of the following conditions
involving the musculoskeletal system:
• backache
• rheumatic or muscular pain
• sprains
• strains
• neuralgia.
It is also for pain relief in common arthritic
conditions.
Ibuleve Maximum Strength is recommended
for use by adults, the elderly and children
over the age of 12 years. Children under the
age of 12 may also use it if recommended by
their doctor.
The active ingredient in this product is
ibuprofen. This is one of a group of medicines
known as non-steroidal anti-inflammatory
drugs (NSAIDs).
Ibuprofen works by:
• relieving pain
• reducing swelling and inflammation.

2. BEFORE YOU USE IBULEVE
MAXIMUM STRENGTH
Do not use Ibuleve Maximum Strength:
• if you are allergic (hypersensitive) to
ibuprofen or any of the other ingredients
of Ibuleve Maximum Strength 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.
Before applying this product for the first time,
make sure it is suitable for you to use:
Because Ibuleve Maximum Strength 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 at risk:
• 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
pharmacist.
Take special care when using this product:
• Use it only on the skin.
• Do not use it on children under 12 years 
old unless advised by a doctor.
• Keep the gel away from the eyes, nose
and mouth.
Using other medicines
• Interaction between Ibuleve Maximum
Strength and blood pressure lowering drugs
and anticoagulants (medicines that stop blood
clotting) 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 without prescription.
Pregnancy and breast-feeding
You should not use Ibuleve Maximum Strength
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.

3. HOW TO USE IBULEVE
MAXIMUM STRENGTH
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, or as
often as advised by your doctor.
• Lightly apply the gel to intact skin over the
painful area.

continued...

KD33/11/1 2xxxxx

In this leaflet:

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibuleve Maximum Strength
can cause side effects, although not everybody
gets them.
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
Maximum Strength that are applied to the skin.
If you experience any of the following, stop
using Ibuleve Maximum Strength 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 light sensitivity;
• 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 MAXIMUM
STRENGTH














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 that
month.
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 MAXIMUM STRENGTH
What Ibuleve Maximum Strength contains:
The active ingredient is ibuprofen (10% w/w).
The other ingredients are industrial methylated
spirit, carbomers, diethylamine and purified water.
What Ibuleve Maximum Strength looks like
and contents of the pack
• The product is a clear or slightly hazy gel
that is non-greasy and 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 revised in October 2011.
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 Maximum Strength, 00173/0176.
This is a service provided by the Royal National
Institute of Blind People (RNIB).

KD33/11/1 2xxxxx

• Apply 2 to 5cm of gel (50 to 125mg
ibuprofen), then massage gently into the
skin over and around the affected area until
absorbed.
• Wash hands after use, unless treating them.
• Carry on using the gel in this way until your
condition gets better.
• If your symptoms worsen or continue for
more than one week, discuss this with
your doctor before continuing treatment.
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.

PACKAGE LEAFLET
Information for the user

ibuprofen 10% w/w

Read all of this leaflet carefully before using this product.

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 one week.
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.

1. WHAT IBULEVE MAXIMUM STRENGTH
IS AND WHAT IT IS USED FOR


























Ibuleve Maximum Strength is an
anti-inflammatory painkiller applied to,
and absorbed through, the skin.
It is for the treatment of the following
conditions involving the musculoskeletal
system:
• backache
• rheumatic or muscular pain
• sprains
• strains
• neuralgia.
It is also for pain relief in common arthritic
conditions.
Ibuleve Maximum Strength is recommended
for use by adults, the elderly and children
over the age of 12 years. Children under the
age of 12 may also use it if recommended by
their doctor.
The active ingredient in this product is
ibuprofen. This is one of a group of
medicines known as non-steroidal
anti-inflammatory drugs (NSAIDs).
Ibuprofen works by:
• relieving pain
• reducing swelling and inflammation.

2. BEFORE YOU USE IBULEVE
MAXIMUM STRENGTH
Do not use Ibuleve Maximum Strength:
• if you are allergic (hypersensitive) to
ibuprofen or any of the other ingredients of
Ibuleve Maximum Strength 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.
Before applying this product for the first time,
make sure it is suitable for you to use:
Because Ibuleve Maximum Strength 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 at risk:
• 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
pharmacist.
Take special care when using this product:
• Use it only on the skin.
• Do not use it on children under 12 years old
unless advised by a doctor.
• Keep the gel away from the eyes, nose
and mouth.
Using other medicines
• Interaction between Ibuleve Maximum
Strength and blood pressure lowering drugs
and anticoagulants (medicines that stop blood
clotting) 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
without prescription.
Pregnancy and breast-feeding
You should not use Ibuleve Maximum Strength 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.

3. HOW TO USE IBULEVE
MAXIMUM STRENGTH
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.
The tube squeezer key:
To make Ibuleve Maximum Strength easier and
more economical to use, a yellow tube squeezer
key has been provided. Once fitted to the tube,
simply turning the key will dispense the gel more
easily for patients who experience difficulties in
squeezing tubes. For economy, the key will also
help expel the last few grams of Ibuleve Maximum
Strength when the tube is nearly empty.
To fit the tube squeezer key:
• Ensure that the tube nozzle has been pierced
using the point of the cap.
continued...

2xxxxx

1. What Ibuleve Maximum Strength is and
what it is used for
2. Before you use Ibuleve Maximum Strength
3. How to use Ibuleve Maximum Strength
4. Possible side effects
5. How to store Ibuleve Maximum Strength
6. Further information

KD37/11/1

In this leaflet:

To use the gel (for adults, the elderly and children
over 12 years old):
• Use the gel up to three times a day, or as often
as advised by your doctor.
• Lightly apply the gel to intact skin over the
painful area.
• Apply 2 to 5cm of gel (50 to 125mg
ibuprofen), then massage gently into the
skin over and around the affected area until
absorbed.
• Wash hands after use, unless treating them.
• Carry on using the gel in this way until your
condition gets better.
• If your symptoms worsen or continue for
more than one week, discuss this with
your doctor before continuing treatment.
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 Maximum Strength can
cause side effects, although not everybody gets
them.
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
Maximum Strength that are applied to the skin.
If you experience any of the following, stop
using Ibuleve Maximum Strength 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 light sensitivity;
• 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
MAXIMUM STRENGTH














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 that
month.
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 MAXIMUM STRENGTH
What Ibuleve Maximum Strength contains:
The active ingredient is ibuprofen (10% w/w).
The other ingredients are industrial methylated
spirit, carbomers, diethylamine and purified water.
What Ibuleve Maximum Strength looks like
and contents of the pack
• The product is a clear or slightly hazy gel
that is non-greasy and contains no fragrance.
• The gel is available in tubes containing 50g.
• The packs also contain a tube key.
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 revised in October 2011.
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 Maximum Strength 00173/0176.
This is a service provided by the Royal National
Institute of Blind People (RNIB).

2xxxxx

Slide the slit of the key over the folded end
of the tube.
Carefully turn the key to roll up the tube until
the required amount of gel has been expelled.
Always replace the cap after use, leaving
the key in place on the end of the tube.

KD37/11/1








Expand view ⇕

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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