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DIFFLAM 0.15% SPRAY

Active substance(s): BENZYDAMINE HYDROCHLORIDE / BENZYDAMINE HYDROCHLORIDE / BENZYDAMINE HYDROCHLORIDE

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Package leaflet: Information for the patient

Difflam 0.15% Spray
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 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 Spray is and what it us used for
2. What you need to know before you use Difflam
Spray
3. How to use Difflam Spray
4. Possible side effects
5. How to store Difflam Spray
6.Contents of the pack and other information.

may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Difflam Spray Contains:
This medicine contains glycerol which may cause
headache, stomach upset and diarrhoea.
This product contains only a small amount of ethanol
(alcohol), less than 100 mg per dose.
Each puff contains 15 microlitres of ethanol.
3. How to use Difflam Spray
Important:
Always use Difflam Spray exactly as your pharmacist
has told you.You should check with your doctor or
pharmacist if you are not sure.
Do not use Difflam Spray in or near your eyes. If any
spray gets in your eyes, wash them immediately with
cold water.

How much Difflam Spray to use
• Adults, adolescents and elderly – spray 4 - 8
puffs to the sore area every 1½ to 3 hours.
• Children 6-12 years of age – spray 4 puffs to the
sore area every 1½ to 3 hours.
• Children under 6 years of age – spray 1 puff for
1. What Difflam Spray is and what it is used for
every 4 kilograms of body weight, up to a maximum
of 4 puffs, to the sore area every 1½ to 3 hours.
Difflam Spray contains the active substance
benzydamine hydrochloride and belongs to a group Contact your doctor if your symptoms worsen or they
of medicines called non-steroidal anti-inflammatory do not improve.
drugs or NSAIDS.
How to use the spray
Difflam Spray works by stopping pain
1. To use the spray, hold the bottle in an upright
and swelling (inflammation). It is used to treat many
position.
painful conditions of the mouth or throat including: 2. Lift the spray-tube through 90° until it is
• Mouth ulcers
horizontal. Do not raise the spray-tube more than
• Teething
shown in the diagram.
• Sore throat
• Sore tongue or gums
• Discomfort associated with dentures or dental
work.
2. What you need to know before you take
Difflam Spray
Do not use Difflam Spray if:
• You are allergic to benzydamine hydrochloride
• You are allergic to any of the other ingredients
in Difflam Spray (listed in section 6).
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before
using Difflam Spray:
• If you have a history of asthma
• If you are allergic to acetylsalicylic acid or other
non-steroidal anti-inflammatory (NSAID) drugs

3. The first time you use the spray you need to prime
it. Point the spray-tube away from your face. Press
down firmly on the green plunger until a fine spray
appears from the end of the spray-tube. The spray
is now ready to use.

If any of these apply, talk to your doctor or
pharmacist.
Other medicines and Difflam Spray
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

4. Aim the spray-tube at the sore part of your mouth
or throat and press down on the green plunger
again. One press releases one puff.
5. After spraying the desired number of puffs, wipe

OBJECT

LEAFLET
DIFFLAM SPRAY 30 ML UK - MEDA
ARTWORK

PS27851

date

FRONT

VERSION

Colour 1

N. 0 OLD ARTWORK
PS27491

DIECUT
140X210 mm

DESIGNER

M.SOCIONOVO
Firmato
digitalmente da
Manuela
Socionovo
Data: 2016.11.02
14:19:28 +01'00'

PACKAGING DESIGN

02/11/2016

SIGNED - CUSTOMER

K

This design is 'property' of a.c.r. angelini francesco s.p.a. and must not
be delivered or exhibition to another person in original or in copy.

SIGNED - CUSTOMER

SIGNED - CUSTOMER

SIGNED - OTHER

TECHNICAL CHECK

the end of the spray-tube with a tissue. This helps
to stop it becoming blocked.
6. Push the spray-tube back down as shown in the
diagram. This stops any puffs being accidentally
released.

7. Do not push anything into the end of spray-tube if
it becomes blocked. Return the spray to your
pharmacist.

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 Spray
Keep out of the sight and reach of children.
Do not use Difflam Spray 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 use more Difflam Spray 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.

Medicines should not be disposed of via wastewater
or household waste. Return any medicine you no
longer need to your pharmacist.
6. Contents of the pack and other information

If you forget to use Difflam Spray
Do not take a double dose to make up for
a missed dose. Simply take the next dose
as planned.

What Difflam Spray contains
The active substance is benzydamine
hydrochloride at a concentration of 0.15%.
Each puff contains 262.5 micrograms of
benzydamine hydrochloride.

If you have any further questions about
the use of this medicine, ask your doctor or
pharmacist.

The other ingredients are glycerol, saccharin, sodium
bicarbonate, ethanol, methylhydroxybenzoate,
mouthwash flavour, polysorbate 20 and purified water.

4. Possible side effects

For advice on what to do if you are allergic to any of
these ingredients see section 2.

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

What Difflam Spray looks like and content of
the pack
Some side effects could be serious. If you have Difflam Spray is an oromucosal or mouth spray. It is a
clear, colourless liquid that comes in a plastic bottle
any of the side effects listed below, seek
fitted with a metered dose valve pump. This means it
immediate medical help:
Serious allergic reaction (anaphylactic shock), signs of provides a measured amount of spray each time it is
used. Each bottle contains 30 ml of liquid and comes
which may include difficulty breathing, chest pain or
in a carton.
chest tightness, and/or feeling dizzy/faint, severe
itching of the skin or raised lumps on the skin, swelling Marketing Authorisation Holder
of the face, lips, tongue and/or throat, and which may Meda Pharmaceuticals Ltd,
be potentially life-threatening.
Skyway House, Parsonage Road, Takeley,
Bishop's Stortford, CM22 6PU
Other side effects include the following, if they
get serious, please tell your doctor:
Manufacturer
Aziende Chimiche Riunite,
Uncommon (affects 1 in 1,000 people):
Angelini Francesco, SpA (Acraf),
- Numbness and/or stinging in the mouth and/or throat. Via Vecchia del Pinocchio,
22 – 60100, Ancona, Italy
Very rare (affects less than 1 in 10,000 people):
This leaflet was last revised in October 2016.
- Difficulty breathing and wheezing
- Itching
If this leaflet is difficult to see or read
- Skin rash
or you would like it in a different
format, please contact Meda
Not known (frequency cannot be estimated
Pharmaceuticals Ltd, Skyway House,
from the available data):
Parsonage Road, Takeley, Bishop's
- Skin redness or swelling
Stortford, CM22 6PU.
- Allergic reaction (Hypersensitivity)
932946
56UK1812110-04

OBJECT

LEAFLET
DIFFLAM SPRAY 30 ML UK - MEDA
ARTWORK

PS27851

date

BACK

VERSION

Colour 1

N. 0 OLD ARTWORK
PS27491

DESIGNER

M.SOCIONOVO
Firmato digitalmente da
Manuela Socionovo
Data: 2016.11.02
14:19:42 +01'00'

DIECUT
140X210 mm

PACKAGING DESIGN

02/11/2016

SIGNED - CUSTOMER

K

This design is 'property' of a.c.r. angelini francesco s.p.a. and must not
be delivered or exhibition to another person in original or in copy.

SIGNED - CUSTOMER

SIGNED - CUSTOMER

SIGNED - OTHER

TECHNICAL CHECK

Expand Transcript

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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