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BLISTEX COLD SORE CREAM

Active substance(s): DOCOSANOL

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STUDIO DETAILS
Client: Dendron
Job No: 1098-10
Version No: v7
Date: 09/03/2015

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 Blistex Cold Sore Cream carefully to
get the best results from it.

in the cream listed at the end of this leaflet
(see section 6).

Take special care with Blistex
Cold Sore Cream
• Keep this leaflet. You may need to
• Blistex Cold Sore Cream is intended for
read it again.
cutaneous use only. Avoid getting the
• Ask your doctor or pharmacist if you
cream in or close to your eyes as this
need more information or advice.
may cause irritation. If you accidentally
• You must stop using the cream and get cream in your eyes rinse them
thoroughly with plenty of water.
contact a doctor if your symptoms
worsen or do not improve after 10 days.
• Do not use this product if you have been
told you are immunocompromised (if your
• If any of the side effects get serious,
immune system’s ability to fight infectious
or if you notice any side effects not listed
diseases is known to be reduced, e.g.
in this leaflet, please tell your doctor
by a serious illness such as leukaemia or
or pharmacist.
AIDS or if you may have had an organ
In this leaflet:
transplant). If you are immunocompromised
1. What Blistex Cold Sore Cream
and you develop a cold sore consult
is and what it is used for
your doctor immediately.
2. Before you use Blistex Cold Sore Cream
• Do not apply the cream if the cold sore
3. How to use Blistex Cold Sore Cream
has already formed a blister or ulcer like
4. Possible side effects
appearance.
5. How to store Blistex Cold Sore Cream
6. Further information
Children
• Children under 12 years should not use
1. WHAT BLISTEX COLD
Blistex Cold Sore Cream.
SORE CREAM IS AND WHAT

IT IS USED FOR

Docosanol is an antiviral agent. Blistex Cold
Sore Cream is a white cream used for the
treatment of early stages of recurrent labial
herpes simplex infection (cold sores) in
adults and adolescents (over 12 years old).
To be effective, treatment with Blistex Cold
Sore Cream must start in the early stages
of a cold sore before the blisters appear.
Start using Blistex Cold Sore Cream as
soon as you get any of the symptoms of
a cold sore such as redness, itching, pain,
tingling or prickling. Continue using until
the cold sore is healed, usually 4-6 days.
The cause of cold sores is a herpes
simplex virus infection. The infection
may break out when the immune system
is weakened, during stress or during a
menstrual period. The virus causes blisters
or sores, mainly on the lips.

2. BEFORE YOU USE BLISTEX
COLD SORE CREAM
Do not use Blistex Cold Sore Cream
• If you are allergic (hypersensitive) to
docosanol or any of the other ingredients

Using other medicines
It is unlikely that Blistex Cold Sore Cream
affects, or is affected by, other medicines
since Blistex Cold Sore Cream is intended
for cutaneous use only, however do not
apply other cold sore medicines whilst
using Blistex Cold Sore Cream.
Ask your doctor or pharmacist if you
have any questions regarding how Blistex
Cold Sore Cream is affected by, or affects,
other medicines.
Please tell your doctor if you are taking,
or have recently taken, any other medicines,
including medicines obtained without
a prescription.
Pregnancy and breast-feeding
Blistex Cold Sore Cream can be used
during pregnancy and breast-feeding.
Driving and using machines
Blistex Cold Sore Cream has no effect
on driving or using machines.

Originator:
Dave Godfrey
Amended by:
Steve Holman
Description:
Blistex Cold Sore Cream
PIL Amends LTD0150
TA:

195 x 104 mm

Trim: 205 x 110 mm
Bleed: 3 mm
% of actual size: 100%
Data Matrix: P0322
Colour:
PMS 294
PMS 206

brayleino.co.uk
Filleigh / Barnstaple / Bristol /
London / Chester

01598 760 700
Accurate for content only. Refer to
printers proofs for colour matching.

Important information about some
of the ingredients of Blistex Cold
Sore Cream

Nervous system problems:
Very common: headache.

Skin problems:
Blistex Cold Sore Cream contains propylene Common: skin disorders including dry skin,
glycol which can cause skin irritation.
skin rashes and facial swelling occurring
where the cream has been applied.
3. HOW TO USE BLISTEX

COLD SORE CREAM

If a more severe skin reaction occurs
you should cease treatment, and if the
Start treatment as soon as you notice the problem does not disappear you should
contact your doctor.
first symptoms or signs of a cold sore,
for instance itching, stinging, burning or
Reporting of side effects
prickling in the affected area.
If you experience any side effects, consult

• Wash your hands thoroughly
your doctor or pharmacist. This includes any
before and after treatment to
possible side effects not listed in this leaflet.
avoid spreading the infection.
You can also report side effects directly via
the Yellow Card Scheme at www.mhra.gov.

• Apply a thin film carefully over
uk/yellowcard. By reporting side effects you
the entire cold sore 5 times
can help provide more information on the
a day. (Approximately every
safety of this medicine.
3 hours during waking hours.)

• Adults and adolescents over 12 years:


• Use a fingertip or, preferably,
a cotton bud and avoid
touching the end of the
tube after you have touched
the cold sore.
4-6 days • Continue treatment until
healing is complete, usually
between 4-6 days.
• If you notice no difference after 10 days
you should stop the treatment and
contact your doctor.
• Remember that Blistex Cold Sore Cream
is your medicine. If you lend the tube to
anyone you risk spreading the infection
to others.
If you use more Blistex Cold Sore
Cream than you should
No serious problem should arise if you have
used a large amount of the cream on your
skin. No special treatment is necessary.
If you forget to use Blistex Cold
Sore Cream
If you forget to use Blistex Cold Sore
Cream, use it as soon as you remember.
If you have any further questions on the
use of this product, ask your pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Blistex Cold Sore
Cream can cause side effects, although
not everybody gets them.
For the frequency of occurrence of side
effects, the following phrases are used:
very common (more than 1 in 10 users),
common (between 1 in 100 users and 1 in
10 users), uncommon (between 1 in 1000
users and 1 in 100 users), rare (between 1
in 10000 users and 1 in 1000 users, very
rare (in less than 1 in 10000 users).

5. HOW TO STORE BLISTEX
COLD SORE CREAM
Keep out of the reach and sight of children.
Do not use Blistex Cold Sore Cream after
the expiry date which is stated on the carton
as “Expiry date month/year”. The expiry
date refers to the last day of that month.
The cream is stable for 6 months after first
opening the tube.
Do not store above 25°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

6. FURTHER INFORMATION
What Blistex Cold Sore Cream contains
The active substance is docosanol.
One gram of cream contains 100mg
docosanol.
The other ingredients are sucrose stearates,
light mineral oil, propylene glycol, benzyl
alcohol and purified water.
What Blistex Cold Sore Cream looks
like and contents of the pack
Blistex Cold Sore Cream is a white cream.
It is available in pack size of 2g.
Marketing Authorisation Holder
DDD Ltd., Watford, Herts,
WD18 7JJ, UK.
Manufacturers
Fleet Laboratories Limited,
94 Rickmansworth Road, Watford,
Hertfordshire, WD18 7JJ, England.
This leaflet was last updated in
March 2015.
LTD0150
© 2015 Blistex Ltd.

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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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