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Package leaflet: information for the user

Difflam 3 mg Lozenges, orange-honey flavour
Benzydamine Hydrochloride

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without
prescription. However, you still need to use
Difflam Lozenges carefully to get the best
results from it.
• Keep this leaflet. You may need to read
it again.
• Ask your pharmacist if you need more
information or advice.
• You must contact your doctor if your
symptoms worsen or do not improve after
7 days.
• 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
What is in this leaflet:
1. What Difflam Lozenges is and what
it is used for
2. What you need to know before you
take Difflam Lozenges
3. How to take Difflam Lozenges
4. Possible side effects
5. How to store Difflam Lozenges
6. Contents of the pack and other

1. hat Difflam Lozenges is
and what it is used for
Difflam contains benzydamine, which helps to
relieves pain and irritation of the mouth and

2. efore you take Difflam Lozenges
Do not take Difflam Lozenges:
• If you have had an allergic (hypersensitivity)
reaction to benzydamine or to any of the other
• If you are allergic to salicylic acid or to other
anti-inflammatory painkillers called NSAIDs
(e.g ibuprofen).

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Warning and precautions
Talk to your doctor before
taking this medicine:
• If you have a history of Asthma.
• If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicine.
• If after using the lozenges the pain in your
mouth or throat gets worse or does not
improve within 7 days appear fever or other
symptoms, you should speak to your doctor or

Other medicines and Difflam Lozenges
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Difflam Lozenges are not expected to affect other
medicines, however if you are not sure, please ask
your doctor or pharmacist about other medicines
obtained without a prescription.

Difflam Lozenges with food and drink
Food and drink have no influence.

Pregnancy and breast-feeding
You should tell your doctor or pharmacist if you
are pregnant, planning to become pregnant or are
He/She will then decide whether you should take
Difflam Lozenges.
Driving and using machines
Difflam Lozenges does not affect your ability to
drive or use machines.
Important information about some of
the ingredients of Difflam Lozenges
Difflam Lozenges contain isomalt (which is a type
of sugar). If you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
Difflam Lozenges also contains a colour called
sunset yellow (E 110) which may cause allergic
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3. ow to take Difflam Lozenges

5. ow to store Difflam Lozenges

Always take Difflam Lozenges as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is:
Adults and children over 6 years old: one lozenge
3 times a day. Do not take more than 3 lozenges
per day.
Children from 6 to 11 years old: this medicinal
product should be administered under an adult
Children under the age of 6 years old should not
be given Difflam Lozenges.
Let one lozenge dissolve slowly in your mouth up
to three times a day.
Do not swallow. Do not chew.
If after using the lozenges your throat gets worse
or does not feel better, speak to your pharmacist
or doctor.

Keep this medicine out of the sight and reach of

If you take more Difflam Lozenges than
you should
If you accidentally take too many lozenges, you
should contact your pharmacist, doctor or nearest
hospital casualty department immediately. Always
take the labelled medicine package with you,
whether there are any lozenges left or not.

4. ossible side effects
Like all medicines, Difflam Lozenges may cause
side-effects, although not everybody gets them.
Allergic reactions are rare, but can be serious.
Tell your doctor immediately if you get
any sudden swelling in the mouth/ throat,
difficulty breathing, rash or itching especially
if affecting the whole body.
Occasionally, some people feel a burning
sensation and dryness of the mouth. If this
happens to you, try sipping a glass of water to
reduce the effect. Rarely, people taking medicines
with benzydamine may experience sensitivity to

Reporting of side effects
If you get any the side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
(www.mhra.go.uk/yellowcard) By reporting side
effects you can help provide more information on
the safety of this medicine.

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Do not use Difflam Lozenges after the expiry date,
which is stated on the label after EXP.
The expiry date refers to the last day of that
Do not store above 30°C.
Store in the original package in order to protect
from moisture.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the

6. ontents of the pack
and other information
What Difflam Lozenges contains:
Each lozenge contains 3 mg benzydamine
hydrochloride (equivalent to 2.68 mg
benzydamine). The other ingredients are isomalt
(E 953), acesulfame potassium, citric acid
monohydrate, orange flavour, honey flavour,
levomenthol, quinoline yellow (E 104), sunset
yellow (E 110).

What Difflam Lozenges looks like
and contents of the pack
Difflam Lozenges are orange-yellow, square
shaped lozenges with a central cavity, wrapped
in food paper. Pack sizes of 20 lozenges and 30
Not all pack sizes may be marketed
Marketing Authorisation Holder
and Manufacturer
The Marketing Authorisation Holder is
Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop’s Stortford,
CM22 6PU
The Manufacturers are
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22
60131 – Ancona, Italy
Site Diététique et Pharmacie
Zone Industrielle de la Coudette
32290 Aignan, France
This leaflet was last revised in December 2013

2014-01-27 08:36

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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.