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IBUGEL FORTE 10%

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET Information for the user

IBUGEL FORTE
ibuprofen 10% w/w

• Ibugel Forte 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.
• Ibugel Forte 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.

• 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.
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 Ibugel Forte 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 Ibugel Forte 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.

2. BEFORE YOU USE IBUGEL FORTE

3. HOW TO USE IBUGEL FORTE

Do not use Ibugel Forte:
• if you are allergic (hypersensitive) to
ibuprofen or any of the other ingredients of
Ibugel Forte 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 Ibugel Forte 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;

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 Ibugel Forte easier and more economical
to use, a red 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 Ibugel Forte 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.
• 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.

In this leaflet:
1. What Ibugel Forte is and what it is used for
2. Before you use Ibugel Forte
3. How to use Ibugel Forte
4. Possible side effects
5. How to store Ibugel Forte
6. Further information

1. WHAT IBUGEL FORTE IS AND WHAT
IT IS USED FOR

continued…

GP15/16/1 201479

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.
This medicine has been prescribed for you.
Do not pass it on to others, 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 or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibugel Forte 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 Ibugel Forte
that are applied to the skin.
If you experience any of the following, stop
using Ibugel Forte 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;

5. HOW TO STORE IBUGEL





Keep out of the sight and reach 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
IBUGEL FORTE
What Ibugel Forte contains:
The active ingredient is ibuprofen (10% w/w).
The other ingredients are industrial methylated
spirit, carbomers, diethylamine and purified water.
What Ibugel Forte 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 100g.
The packs also contain a tube key.
The Marketing Authorisation holder is Dermal
Laboratories, Tatmore Place, Gosmore, Hitchin,
Herts, SG4 7QR, UK.
The Manufacturer is Fleet Laboratories Ltd,
94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
This leaflet was last revised in March 2016.
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:
Ibugel Forte, 00173/0175. This is a service
provided by the Royal National Institute of Blind
People (RNIB).

GP15/16/1 201479

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.
• Squeeze out a 2 to 5 cm length of gel (50 to
125 mg ibuprofen) onto the affected area,
enough to thinly cover it, then massage gently
until absorbed.
• Wash hands after use, unless treating them.
• Carry on using the gel in this way until your
condition gets better (you may find you need to
use it for a few weeks, and your doctor
may want you to continue using it for longer
than this).
• If your symptoms worsen or continue for more
than a few weeks, 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.

• 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.
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 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.

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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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