Skip to Content

DIFFLAM 0.15% SORE THROAT RINSE

Active substance(s): BENZYDAMINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the patient
209 mini

Difflam 0.15 % Sore Throat 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 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 Sore Throat Rinse is and what
it is used for
2. What you need to know before you use
Difflam Sore Throat Rinse
3. How to use Difflam Sore Throat Rinse
4. Possible side effects
5. How to store Difflam Sore Throat Rinse
6. Contents of the pack and other information.
1. What Difflam Sore Throat Rinse is and
what it is used for
Difflam Sore Throat Rinse contains the active
substance benzydamine hydrochloride and
belongs to a group of medicines called nonsteroidal anti-inflammatory drugs or NSAIDS.
Difflam Sore Throat Rinse works by stopping
pain and swelling (inflammation). It is used
to treat many painful conditions of the throat
including:
• Sore throat.
2. What you need to know before you use
Difflam Sore Throat Rinse
Do not use Difflam Sore Throat Rinse if
• you are allergic to benzydamine hydro­
chloride
• 
you are allergic to any of the other ingredients
of Difflam Sore Throat Rinse (see section 6).
If either of these applies to you, talk to your
doctor, dentist or pharmacist.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before
using Difflam Sore Throat Rinse:

0715_GI_Difflam Sore Throat Rinse_56UK1812210-02.indd 1

• 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, talk to your doctor, dentist
or pharmacist.
Other medicines and Difflam Sore Throat 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 Sore Throat Rinse
Important:
Always use Difflam Sore Throat 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 Sore Throat Rinse in your
eyes
Do not use Difflam Sore Throat Rinse in or near
your eyes. If any Sore Throat Rinse gets in
your eyes, wash them immediately with
cold water.
How much Difflam Sore Throat 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 Sore Throat Rinse

The solution should be rinsed around the mouth
or used as a gargle for 20 to 30 seconds and
then spat out.
If your symptoms worsen or do not improve
contact your doctor or dentist.

23.05.16 13:24

If you use more Difflam Sore Throat 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 Sore Throat 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 Sore Throat 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:
• severe allergic reaction (anaphylaxis) seen
as swelling of throat and mouth, difficulty
in swallowing or speaking, alterations in
heart rate, severe asthma, collapse and
unconsciousness
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
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 Sore Throat Rinse
Keep out of the sight and reach of children.
Do not use Difflam Sore Throat 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 Sore Throat 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 Sore Throat Rinse looks like
Difflam Sore Throat Rinse is a clear, green
coloured gargle solution. It comes in a 200 ml
bottle with a 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 May 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 2497 4
56UK1812210-02

0715_GI_Difflam Sore Throat Rinse_56UK1812210-02.indd 2

23.05.16 13:24

209 mini

0715_GI_Difflam Sore Throat Rinse_56UK1812210-02.indd 3

23.05.16 13:24

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.

Hide