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AFTASOL 5% W/W OROMUCOSAL PASTE

Active substance(s): AMLEXANOX

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Aftasol 5% w/w Oromucosal Paste
amlexanox
Read all of this leaflet carefully before you start
using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
dentist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- 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 dentist.
- Aftasol 5% Oromucosal Paste will be known as
Aftasol throughout this leaflet.
In this leaflet:
1. What Aftasol is and what it is used for
2. Before you use Aftasol
3. How to use Aftasol
4. Possible side effects
5. How to store Aftasol
6. Further information
1. WHAT AFTASOL IS AND WHAT IT IS USED FOR
Aftasol contains the active ingredient amlexanox,
which belongs to a group of medicines called
anti-allergic and anti-inflammatory agents.
Aftasol is used for the treatment of minor mouth
ulcers (minor aphthous ulcers) in adults. It works by
speeding up the healing and relieving the pain of
minor mouth ulcers.
2. BEFORE YOU USE AFTASOL
Do not use Aftasol if:
• You are allergic (hypersensitive) to amlexanox or any
of the other ingredients of Aftasol. A full list of
ingredients is provided in Section 6 “Further Information”
• You are under 18 years of age
• You are over 65 years of age.
Take special care with Aftasol
Talk to your doctor or dentist before using Aftasol if:
• You are being treated for kidney (renal) conditions

• You are being treated for liver (hepatic) conditions.

Taking or using other medicines
Please tell your doctor or dentist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
Aftasol should not be used if you are pregnant or
breast-feeding.
Ask your doctor or dentist for advice before taking any
medicine.
Driving and using machines
Aftasol is unlikely to affect your ability to drive and use
machines.
3. HOW TO USE AFTASOL
Always use Aftasol exactly as your doctor has told
you. You should check with your doctor or dentist if
you are not sure.
Adults
The usual dose is 0.5 cm of paste for each mouth ulcer.
Aftasol should be applied as soon as possible after
first noticing the symptoms of a mouth ulcer.
Treatment with Aftasol must be started no later than
48 hours after the first symptoms develop.
The paste should be applied four times daily after
meals and cleaning your teeth. Suggested times are
after breakfast, lunch, dinner and at bedtime.
The Elderly and Children
Do not use Aftasol if you are over 65 years of age or
under 18 years of age.
How to apply Aftasol:
• Before using Aftasol you should wash your hands
• Dry the ulcer by gently patting with a soft clean cloth
• Squeeze 0.5 cm (a pea sized amount) of paste onto
a wet finger tip
• Dab the paste onto the ulcer – do not rub it into the
ulcer as this will cause irritation
• Repeat with a further 0.5 cm of paste for each
further ulcer, up to a maximum of 3 ulcers
• After applying Aftasol you should wash your hands.
IMPORTANT
• Do not treat more than three ulcers at a time unless
your doctor or dentist has advised you differently.

• If Aftasol comes into contact with your eyes, bathe

your eyes with water several times.
How long to use Aftasol for
You should use Aftasol until the ulcer has healed, for
up to a maximum of 7 days.
Consult your doctor or dentist if your mouth ulcer
does not heal or if you are still in pain 7 days after you
started treatment with Aftasol.
If you use more Aftasol than you should
If you swallow excessive amounts of Aftasol, contact
your doctor or go to the nearest hospital casualty
department. Take the Aftasol tube and pack with you.
Symptoms of overdose include feeling and being sick
and diarrhoea.
If you forget to use Aftasol
Apply the paste as soon as you remember and then
continue with your next dose as normal.
Do not use a double dose to make up for a forgotten
dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Aftasol can cause side effects,
although not everybody gets them.
Immediately contact your doctor if you
experience rapid swelling of the face or throat.
You may be having a serious allergic reaction.
This is a very rare side effect (likely to affect
less than 1 in 10,000 people).
Most people find using Aftasol causes no problems,
however the following side effects have been reported:
Common side effects (likely to affect less than 1 in
10 people and more than 1 in 100)
• Temporary pain, stinging or burning sensation at
the site of application.
Uncommon side effects (likely to affect less than 1
in 100 people and more than 1 in 1,000)
• Reddening and tenderness of the mouth lining
(oral mucositis)
• Dry lips
• Bumps on the lips
• Feeling unwell or sick (nausea)
• Diarrhoea
• Skin inflammation (contact dermatitis).

If any of the side effects get serious, or if you
noticeany side effects not listed in this leaflet, please
tell your doctor, dentist or pharmacist.
5. HOW TO STORE AFTASOL
• Keep out of the reach and sight of children.
• Do not use Aftasol after the expiry date, which is
stated on the carton after EXP. The expiry date
refers to the last day of that month.
• This medicine does not require any special storage
conditions.
• 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 Aftasol contains
Each 1g of Aftasol contains 50mg of the active
ingredient amlexanox.
The other ingredients are liquid paraffin, gelatin,
pectin, carmellose sodium, glyceryl monostearate
40-55, soft white paraffin, benzyl alcohol.
What Aftasol looks like and contents of the pack
Aftasol is a granular, beige-coloured, paste. Aftasol
comes in plastic tubes containing either 3 or 5 grams
of paste, with a screw cap. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd
Skyway House, Parsonage Road, Takeley, Bishop’s
Stortford, CM22 6PU, United Kingdom
Manufacturer
Contract Pharmaceuticals Ltd
7600 Danbro Crescent, Mississauga,
Ontario, L5N 6L6, Canada
This leaflet was last approved in 11/2011.
If this leaflet is difficult to see or read or you
would like it in a different format, please contact:
Meda Pharmaceuticals
Skyway House
Parsonage Road, Takeley
Bishop's Stortford, CM22 6PU United Kingdom

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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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