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IGLU GEL

Active substance(s): AMINOACRIDINE HYDROCHLORIDE / LIDOCAINE HYDROCHLORIDE

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PACKAGE LEAFLET Information for the user

gel
mouth ulcer treatment
lidocaine hydrochloride 0.66% w/w,
aminoacridine hydrochloride 0.05% w/w

Please read all of this leaflet carefully before using this product.
Keep this leaflet. You may need to read it again. Ask your doctor, dentist or pharmacist
if you need more information or advice. You must contact a doctor or dentist if your symptoms
worsen or do not improve. If any of the side effects gets serious, or if you notice any side effect
not listed in this leaflet, please tell your doctor, dentist or pharmacist.

1. WHAT IGLÜ GEL IS AND WHAT
IT IS USED FOR
• Iglü Gel is a treatment for fast, effective
relief of pain from common mouth ulcers,
sore gums and denture rubbing.
• The product, which at first looks like a
pale yellow paste, forms a smooth, flexible
and adhesive protective gel coating when
it becomes wet on contact with saliva
inside the mouth.
• Iglü Gel is suitable for use by adults,
the elderly and children over 7 years
of age.
• The product works in three ways:
• by forming a gel coating to protect the
sensitive and delicate area of the mouth
lining as it heals, and
• by the actions of its two active
ingredients, lidocaine hydrochloride
and aminoacridine hydrochloride,
which work by:
• stopping pain (lidocaine
hydrochloride is a local anaesthetic),
and
• preventing infection (aminoacridine
hydrochloride is an antiseptic).

2. BEFORE YOU USE IGLÜ GEL
Do not use Iglü Gel if you are allergic
(hypersensitive) to lidocaine hydrochloride,
aminoacridine hydrochloride or any of the
other ingredients of Iglü Gel listed in Section 6.

Using other medicines
Iglü Gel is not known to affect, or to be
affected by, any other medicines.
Pregnancy and breast-feeding
It is unclear whether this product is safe for
use during pregnancy and breast-feeding.
The potential risks are unknown. If in doubt,
ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machinery
Using this product is not known to affect
your ability to drive or use machinery.

3. HOW TO USE IGLÜ GEL
Only use Iglü Gel for localised application
inside the mouth for the conditions it is
recommended for.
For adults, the elderly and children
over 7 years of age:
• Wash your hands before and after use.
• If you are treating several ulcers, repeat
steps 1 to 3 below for each one:
1. Use a clean tissue to gently remove
excess moisture/saliva from the
ulcer area.
2. Squeeze a small quantity of Iglü onto
a clean, dry finger tip or cotton bud,
and then apply it directly to the ulcer
using a single, gentle wiping action
(avoid dabbing).
3. At first, the product may seem quite
pasty and sticky, but after contact with
saliva, the product will form a flexible
and adhesive gel coating over and
around the ulcer area.

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

Take special care when using this product:
• Apply it sparingly.
• Keep the product away from your eyes.

ED4/15/1

In this leaflet:

continued...

4. POSSIBLE SIDE EFFECTS
Like all medicines, Iglü Gel can cause side
effects, although not everybody gets them.
On rare occasions, hypersensitivity reactions
to lidocaine hydrochloride and aminoacridine
hydrochloride can occur, involving wheezing
or shortness of breath. Seek urgent medical
attention if you experience these symptoms.
If you experience any other symptoms not
mentioned in this leaflet, stop using the product
and tell your doctor, dentist or pharmacist.
Overdose can also lead to other side effects
(see section above: If you use too much
Iglü Gel).
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.

5. HOW TO STORE IGLÜ GEL
• Keep out of the reach and sight of children.
• Do not use Iglü Gel after the expiry date
shown on the fold of the tube and on the
carton. The expiry date refers to the last
day of that month.
• Do not store above 25°C.
• Always replace the cap tightly after use.
• Moisture coming into contact with the
nozzle of the tube may cause the gel
to thicken and block the opening. If this
happens, carefully clear it using a clean pin.
• 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
What Iglü Gel contains:
The active ingredients are
lidocaine hydrochloride (0.66% w/w) and
aminoacridine hydrochloride (0.05% w/w).
The other ingredients are carbomer,
hydroxypropylcellulose, white soft paraffin,
liquid paraffin and peppermint oil.
What Iglü Gel looks like and contents
of the pack
• Although classified as a gel, when squeezed
from the tube the product looks like a thick,
pale yellow paste. It forms a flexible and
adhesive gel coating when it becomes wet
on contact with saliva inside the mouth.
• The product has a peppermint odour and
is available in plastic tubes containing 8g.
The Marketing Authorisation holder is:
Diomed Developments Ltd, Tatmore Place,
Gosmore, Hitchin, Hertfordshire, SG4 7QR, UK.
The Manufacturer is: Aeropak, Viking Road,
Great Yarmouth, Norfolk, NR31 0NU, UK.
The Distributor is: DDD Ltd,
94 Rickmansworth Road, Watford,
Hertfordshire, WD18 7JJ, UK.
This Patient Information Leaflet was last
revised in June 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: Iglü Gel, 00173/0186.
This is a service provided by the Royal
National Institute of Blind People (RNIB).

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If the gel accidentally gets into the eyes
it may cause irritation. If it gets into the eyes,
rinse immediately with plenty of water and
continue rinsing for 10 to 15 minutes, holding the
eyelids well apart. If rinsing one eye, take care
to avoid washing product into the other eye.
If irritation persists, contact a doctor.
If you use too much Iglü Gel overdosage
of the active ingredients is unlikely to occur
because of the low concentrations used and
the small pack size. Overdose may make
swallowing difficult due to the loss of feeling.
This may increase the risk of food or drink
going down the wrong way. Generalised
numbness of the mouth may also lead to
biting the inside of your mouth when eating.
Excessive overdose may also lead to
generalised side effects. If you experience
any of the following, seek urgent medical
attention; nervousness, drowsiness,
breathing problems or low blood pressure.
If you occasionally forget to use Iglü Gel
do not worry, just carry on using it when
you remember.
If you have any further questions on the use of this
product, ask your doctor, dentist or pharmacist.

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.

ED4/15/1

• Re-apply the gel, following steps 1 to 3 above,
as necessary for each ulcer. The aim is to
keep the ulcer area(s) protected with a coating
of gel. As a guide, each application should
normally last for an hour or more, although,
on occasions, eating or drinking may make
it necessary to re-apply the gel. In some
cases, Iglü may remain in place for several
hours, as it has strong adhesive properties.
• Do not apply excessive amounts of the gel,
and avoid applying gel to the back of the
tongue and throat area.
• If you are treating sores caused by rubbing
from false teeth/dentures etc, avoid using
Iglü at the same time (e.g. use the gel at
night or when not wearing dentures).

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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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