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DIFFLAM ORAL RINSE

Active substance(s): BENZYDAMINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Difflam™ 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 described 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.

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.

Important information about some of the ingredients of Difflam Oral Rinse

This medicine contains glycerol which may cause headache, stomach upset and diarrhoea.
This product contains only a small amount of ethanol (alcohol). Each 15ml of solution contains
1.5ml 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 15ml 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

WHAT DIFFLAM ORAL RINSE IS AND WHAT IT IS USED FOR

This solution should not be swallowed.

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 hydrochloride
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
• If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory (NSAID)
drugs

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 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 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.

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.

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4.

POSSIBLE SIDE EFFECTS

6.

Some side effects could be serious. If you have any of the side effects listed
below, seek immediate medical help:


CONTENTS OF THE PACK AND OTHER INFORMATION

What Difflam Oral Rinse contains

Like all medicines Difflam Oral Rinse can cause side effects, although not everybody gets them.

The active substance is benzydamine hydrochloride.
Each 15ml contains 22.5mg benzydamine hydrochloride.

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.

The other ingredients are ethanol, glycerol, saccharin sodium, mouthwash flavour 52 503/T,
polysorbate 20, methyl parahydroxybenzoate (E218), Quinoline Yellow (E104),
Patent Blue V (E131) and purified water.
For advice on what to do if you are allergic to any of these ingredients see section 2.

Other side effects include the following, if they get serious, please tell your
doctor:
Uncommon (affects 1 in 1,000 people):

What Difflam Oral Rinse looks like

Very rare (affects less than 1 in 10,000 people):

Manufacturer







Numbness and/or stinging in the mouth and/or throat
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 or search for MHRA Yellow Card in the Google Play or
Apple App Store.
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 (Exp) stated on the carton and the bottle.
The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze. Store in an upright position.
Store in the original package. If you store the product without the original carton, make sure it
is kept out of direct sunlight.

Difflam Oral Rinse is a clear, green coloured gargle solution.
It comes in a 300ml bottle with a metal screw cap and a 20ml graduated, plastic measuring
cup.
Manufactured by: 3M Health Care Limited, Loughborough, Leicestershire, LE11 1EP, UK.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0585

P

Leaflet issue and revision date: 08.11.17
Difflam™ is a trademark of Meda AB.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call +44 (0) 1302 365000 (Regulatory)
Please be ready to give the following
information:
Product name: Difflam Oral Rinse
Reference No: 21828/0585

If your doctor decides to stop the treatment, return any leftover medicine to the pharmacist.
Only keep it if your doctor tells you to.
If your medicine appears to be discoloured or shows any other signs of deterioration, please
return to your pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household waste. Return any medicine
you no longer need to your pharmacist.
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