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DIFFLAM 0.15% ORAL RINSE

Active substance(s): BENZYDAMINE HYDROCHLORIDE / BENZYDAMINE HYDROCHLORIDE

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Package leaflet: Information for the patient
79 mini

Difflam 0.15 % Oral Rinse
Benzydamine hydrochloride
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
Always use this medicine exactly as d
­ escribed in
this leaflet or as your doctor, pharmacist or nurse
have told 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
again.
• 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.
• 
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Difflam Oral Rinse is and what it is
used for
2. What you need to know 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. Contents of the pack and other information.
1. What Difflam Oral Rinse is and what
it is used for
Difflam Oral Rinse contains the active substance
benzydamine hydrochloride and 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. What you need to know before you use
Difflam Oral Rinse
Do not use Difflam Oral Rinse if
• you are allergic to benzydamine hydro
chloride
• 
you are allergic to any of the other ingredients
of Difflam Oral Rinse (see section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
using Difflam Oral Rinse:
• If you have a history of asthma

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• 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.
Other medicines and Difflam Oral Rinse
Tell your doctor or pharmacist if you are
­taking, have recently taken or might take any
other medicines
Pregnancy, breast-feeding and fertility.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
This medicine contains glycerol which may
cause headache, stomach upset and diarrhoea.
This product 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
Important:
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.
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.

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If you use more Difflam Oral Rinse than you
should
If you take too much or you accidentally swallow
large quantities of your medicine, contact immediately your doctor or pharmacist for advice.
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
planned.
If you have any further questions about the use
of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Difflam Oral Rinse can cause
side effects, although not everybody gets them.
Some side effects could be serious. If you
have any of the side effects listed below, seek
immediate medical help:
• Serious allergic reaction (anaphylactic
shock), signs of which may include difficulty
breathing, chest pain or chest tightness,
and/or feeling dizzy/faint, severe itching of
the skin or raised lumps on the skin, swelling
of the face, lips, tongue and/or throat, and
which may be potentially life threatening.
Other side effects include the following, if
they get serious, please tell your doctor:
Uncommon
(affects 1 in 1,000 people):
• Numbness and/or stinging in the mouth
and/or throat.
Very rare
(affects less than 1 in 10,000 people):
• Difficulty breathing and wheezing
• Itching
• Skin rash
Not known (frequency cannot be estimated
from the available data)
• Skin redness or swelling
• Allergic reaction (Hypersensitivity)
If this solution stings your mouth, the next
dose can be diluted with some water to reduce
this effect.
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: 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 Difflam Oral Rinse
Keep out of the sight and reach 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.
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 pharmacist.
6. C
 ontents of the pack and other
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
Takeley
Bishop’s Stortford
CM22 6PU
Manufacturer
3M Health Care Limited
3M House
Morley Street
Loughborough
Leicestershire
LE11 1EP
This leaflet was last revised in October 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

6204 2613 6
56UK1812220-04

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

SPECIFICATION BOX: Leaflet
MANUFACTURER: Meda Pharma GmbH & Co. KG

COLOURS USED:

PRODUCT: Difflam 0.15% Oral Rinse

Black
30% Black

MEDA-NO.: 56UK1812220-05
MFS-NO.:
LAETUS-CODE:
COUNTRY:

United Kingdom UK
English

DRAWING REF.:

PE00256 (V2 11/07/2011)

LANGUAGE:

PACK SIZE:

127 x 191 mm

CORRECTION: 1.

FONT SIZE:

8,0 pt / 8 pt

DATE:

24. 10. 2016

79 mini

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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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