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Patient Information Leaflet

Difflam 0.15 % Oral Rinse
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 it carefully to get the best results.
• Keep this leaflet.You may need to read it
• Ask your doctor, dentist or pharmacist if
you need more information or advice.
• You must contact a doctor if your
symptoms worsen or do not improve.

Taking other medicines
Tell your doctor, dentist or pharmacist before
using Difflam Oral Rinse if you are taking any
other medicines, even medicines obtained
without a prescription.

In this leaflet:
1. What Difflam Oral Rinse is for
2. Before you use Difflam Oral Rinse
3. How to use Difflam Oral Rinse
4. Possible side effects
5. How to store Difflam Oral Rinse
6. Further information.

This medicine contains glycerol which may
cause headache, stomach upset and

1. What Difflam Oral Rinse is for
Difflam Oral Rinse belongs to a group of
medicines called non-steroidal
anti-inflammatory drugs or NSAIDS.
Difflam Oral Rinse works by stopping pain
and swelling (inflammation). It is used to treat
many painful conditions of the mouth or
throat including:
• Mouth ulcers
• Sore throat
• Discomfort associated with dentures
or dental work.

2. Before you use Difflam Oral Rinse
Do not use Difflam Oral Rinse if
• you are allergic to benzydamine
• you are allergic to any of the other
ingredients of Difflam Oral Rinse
(see section 6).
Take special care:
• If you have a history of asthma
• If you are allergic to acetylsalicylic acid or
other non-steroidal anti-inflammatory
(NSAID) drugs
If any of these apply to you, talk to your
doctor, dentist or pharmacist.

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Pregnancy and breastfeeding
If you are pregnant, trying to become pregnant
or breast-feeding ask your doctor, dentist
or pharmacist for advice before using Difflam
Oral Rinse.

This medicine contains only a small amount
of ethanol (alcohol). Each 15 ml of solution
contains 1.5 ml of ethanol.

3. How to use Difflam Oral Rinse
Always use Difflam Oral Rinse exactly as your
pharmacist has told you. You should check
with your doctor, dentist or pharmacist if you
are not sure.
If you get Difflam Oral Rinse in your eyes
Do not use Difflam Oral Rinse in or near your
eyes. If any Oral Rinse gets in your eyes,
wash them immediately with cold water.
How much Difflam Oral Rinse to use
Adults, adolescents and elderly: The
usual dose is 15 ml of solution to be used
every 1½ to 3 hours. Use the measuring
cup provided to measure the dose.
Children: This medicine is not suitable for
children aged 12 years or under.
How to use the Oral Rinse

The solution should be rinsed around the mouth
or used as a gargle for 20 to 30 seconds and
then spat out.
This solution should not be swallowed.

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This solution should not be used for more than
7 days unless your doctor or dentist tells you to.
If your symptoms worsen or do not improve
Contact your doctor or dentist if your
symptoms worsen or they do not improve.
If you use more Difflam Oral Rinse than
you should
It should not cause you any problems if you
accidentally take too much or you swallow
some of your medicine. If you have any
concerns, contact your doctor or pharmacist.
If you forget to use Difflam Oral Rinse
Do not take a double dose to make up for a
missed dose. Simply take the next dose as
If you have any further questions about
the use of this medicine, ask your doctor or

4. Possible side effects
Like all medicines Difflam Oral Rinse can
cause side effects, although not everybody
gets them.
You may experience the following:
• Severe allergic reaction (anaphylaxis)
• Itching
• Skin rash
• Skin redness or swelling
• Difficulty breathing and wheezing
Numbness or stinging in the mouth or throat.
If this solution stings your mouth, the next dose
can be diluted with some water to reduce this
Some people may react after using the product
with a severe allergic reaction experiencing
symptoms as described above (a so called
anaphylactic reaction) which may be potentially
life-threatening. In this case you should seek
immediate medical assistance.
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:
By reporting side effects you can help provide
more information on the safety of this medicine.

Store in an upright position. Do not store
above 30 °C. Do not store in the refrigerator
or freezer. If you store the product without
the original carton, make sure it is kept out of
direct sunlight.
Medicines should not be disposed of via
wastewater or household waste. Return
any medicine you no longer need to your

6. Further information
What Difflam Oral Rinse contains
The active substance is benzydamine
hydrochloride. Each 15 ml contains 22.5 mg
benzydamine hydrochloride.
The other ingredients are ethanol, glycerol,
saccharin sodium, mouthwash flavour 52
503/T, polysorbate 20, methyl hydroxybenzoate, Quinoline Yellow (E104) and Patent Blue V
(E131), purified water.
For advice on what to do if you are allergic
to any of these ingredients see section 2.
What Difflam Oral Rinse looks like
It comes in a 300 ml bottle with a metal screw cap
and a 30 ml graduated, plastic measuring cup.
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Bishop‘s Stortford
CM22 6PU
3M Health Care Limited
3M House
Morley Street
LE11 1EP
This leaflet was last revised in March 2016.

If this leaflet is difficult to see or
read or you would like it in a different
format, please contact Meda
Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop‘s
Stortford, CM22 6PU

5. How to store Difflam Oral Rinse
Keep out of the reach and sight of children.
Do not use Difflam Oral Rinse after the expiry
date on the bottle. The expiry date refers to
the last day of that month.

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6204 2495 8

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Studio Oberländer GmbH · Rubensstr.  33 · 60596 Frankfurt a. M. · Germany
Phone: +49 69 631520-85  ·  Fax: -87  ·  E-Mail:

MANUFACTURER: Meda Pharma GmbH & Co. KG


PRODUCT: Difflam 0.15% Oral Rinse


30% Black

MEDA-NO.: 56UK1812220-04
6204 2495 8


United Kingdom UK




127 x 191 mm



8,0 pt / 8,5 pt


15. 03. 2016


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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.