Medication Guide App

DIFFLAM ORAL RINSE

Active substance: BENZYDAMINE HYDROCHLORIDE

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3.
Difflam™ Oral Rinse
(benzydamine hydrochloride)
PATIENT INFORMATION LEAFLET
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 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.

In
1.
2.
3.
4.
5.
6.
1.

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

WHAT DIFFLAM ORAL RINSE IS FOR

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.

BEFORE YOU USE DIFFLAM ORAL RINSE

Do not use Difflam Oral Rinse if



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.

this leaflet:
What Difflam Oral Rinse is for
Before you use Difflam Oral Rinse
How to use Difflam Oral Rinse
Possible side effects
How to store Difflam Oral Rinse
Further information

Difflam Oral Rinse belongs to a group of medicines called non-steroidal anti-inflammatory drugs or
NSAIDS.

2.

HOW TO USE DIFFLAM ORAL RINSE

Important:

you are allergic to benzydamine hydrochloride
you are allergic to any of the other ingredients of Difflam Oral Rinse (see section 6).

If either of these applies to you, talk to your doctor, dentist or pharmacist.

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.

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.

Important information about some of the ingredients of Difflam Oral Rinse

This product contains only a small amount of ethanol (alcohol). Each 15ml of solution contains 1.5ml of
ethanol.
This product also contains methyl parahydroxybenzoate (E218) which may cause allergic reactions
(possibly delayed).




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

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 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 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.
You may experience the following:

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 effect.
Page 1 of 2

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 pharmacist.

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 (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.
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.

6.

FURTHER INFORMATION

What Difflam Oral Rinse contains

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

What Difflam Oral Rinse looks like

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.

Manufacturer

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: 12.05.14
Difflam™ is a trademark of Meda AB.
To request a copy of this leaflet in large print or audio, please call 01302 365000 and ask for the
Regulatory Department.
Page 2 of 2

3.
Difflam™ Oral Rinse
(benzydamine hydrochloride)
PATIENT INFORMATION LEAFLET
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 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.

In
1.
2.
3.
4.
5.
6.
1.

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

WHAT DIFFLAM ORAL RINSE IS FOR

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.

BEFORE YOU USE DIFFLAM ORAL RINSE

Do not use Difflam Oral Rinse if



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.

this leaflet:
What Difflam Oral Rinse is for
Before you use Difflam Oral Rinse
How to use Difflam Oral Rinse
Possible side effects
How to store Difflam Oral Rinse
Further information

Difflam Oral Rinse belongs to a group of medicines called non-steroidal anti-inflammatory drugs or
NSAIDS.

2.

HOW TO USE DIFFLAM ORAL RINSE

Important:

you are allergic to benzydamine hydrochloride
you are allergic to any of the other ingredients of Difflam Oral Rinse (see section 6).

If either of these applies to you, talk to your doctor, dentist or pharmacist.

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.

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.

Important information about some of the ingredients of Difflam Oral Rinse

This product contains only a small amount of ethanol (alcohol). Each 15ml of solution contains 1.5ml of
ethanol.
This product also contains methyl parahydroxybenzoate (E218) which may cause allergic reactions
(possibly delayed).




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

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 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 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.
You may experience the following:

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 effect.
Page 1 of 2

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 pharmacist.

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 (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.
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.

6.

FURTHER INFORMATION

What Difflam Oral Rinse contains

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

What Difflam Oral Rinse looks like

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.

Manufacturer

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: 12.05.14
Difflam™ is a trademark of Meda AB.
To request a copy of this leaflet in large print or audio, please call 01302 365000 and ask for the
Regulatory Department.
Page 2 of 2

Expand view ⇕

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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