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IBUGEL GEL

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET Information for the user

IBUGEL
ibuprofen 5% 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 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.

1. WHAT IBUGEL IS AND WHAT IT IS
USED FOR

• Ibugel 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 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 IBUGEL

Do not use Ibugel:
• if you are allergic (hypersensitive) to
ibuprofen or any of the other ingredients of
Ibugel 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 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.
• Do not apply it to broken or irritated skin.
• Keep the gel away from the eyes, nose and
mouth.
Using other medicines
• Interaction between Ibugel 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 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 Ibugel
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
intolerance to propylene glycol, please talk
to your doctor before using this product.

3. HOW TO USE IBUGEL

Before using this tube of gel for the first time,
open it as follows:
• U
 nscrew 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 easier and more economical
to use, a blue 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 when the tube is
nearly empty.
continued…

GP8/15/1 201345

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

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 only enough gel to thinly cover the
affected area, 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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ibugel 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 that are
applied to the skin.
If you experience any of the following, stop
using Ibugel immediately and tell your doctor:
• Allergic reactions (particularly in people who
have a history of asthma or allergic problems),
such as:

• u
 nexplained 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.
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.

5. HOW TO STORE IBUGEL





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
IBUGEL

What Ibugel contains:
The active ingredient is ibuprofen (5% w/w).
The other ingredients are industrial methylated
spirit, carbomers, propylene glycol, diethylamine
and purified water.
What Ibugel 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 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 2015.
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, 00173/0050. This is a service provided by
the Royal National Institute of Blind People (RNIB).

GP8/15/1 201345

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.

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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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