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BLISTEX COLD SORE CREAM

Active substance(s): DOCOSANOL / DOCOSANOL / DOCOSANOL

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STUDIO DETAILS
Client: Dendron
Job No: 52629-01
Version No: V17
Date: 31/05/2017
Originator:
Shellie Magson

docosanol
Read all this leaflet carefully before you start
using this medicine because it contains
important information for you. Always use this
medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• This medicine is intended for recurrent cold sores
only. If you have not previously had a cold sore
or if you are unsure if the lesion (sore) is a cold sore,
you should consult your doctor or pharmacist.
• To be effective, treatment with Blistex Cold Sore
Cream must start in the early stages of a cold sore
before the cold sore has progressed to a blister
or ulcer-like appearance.
• If you have a weakened immune system and you
develop a cold sore, do not use this medicine
and consult your doctor or pharmacist.
• If you experience any side effects, consult your
doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
• You must stop using the cream and contact
a doctor if your symptoms worsen or do not
improve after 10 days.
In this leaflet:
1. What Blistex Cold Sore Cream is and what
it is used for
2. What you need to know before you use
Blistex Cold Sore Cream
3. How to use Blistex Cold Sore Cream
4. Possible side effects
5. How to store Blistex Cold Sore Cream
6. Contents of the pack and other information
1. WHAT BLISTEX COLD SORE CREAM
IS AND WHAT IT IS USED FOR
Blistex Cold Sore Cream contains the active substance
docosanol, an anti-viral. This is for the treatment
of early stages of recurrent cold sores on the lips for
adults and adolescents (aged 12 years and over).
To be effective, treatment with Blistex Cold Sore
Cream must start in the early stages of a cold sore
before the blisters appear on the lips. 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.
2. WHAT YOU NEED TO KNOW 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 in the cream
listed at the end of this leaflet (see section 6).
! Should only be used for cold sores on the
mouth and face.
8 Must not be used to treat genital herpes
infections or herpes infections of the eyes.
! To avoid spreading the infection, wash hands
thoroughly before and after treatment,
particularly when the sore is visible (see section 3).
! If the recurrent cold sore is particularly severe,
consult your doctor or pharmacist.
Warnings and precautions
Blistex Cold Sore Cream is intended for use
on the skin only. Avoid getting the cream in or
close to your eyes as this may cause irritation.
If you accidentally get cream in your eyes rinse
them thoroughly with plenty of water.
8 Do not use this product if you have been told
you have a weakened immune system (if your
immune system’s ability to fight infectious
disease is known to be reduced, e.g. by serious
illness such as leukaemia or HIV infection or
if you have had an organ transplant). If you
have a weakened immune system and you
develop a cold sore, consult your doctor or
pharmacist immediately.

Amended by:
Shellie Magson
Description/Publication:
Blistex CSC PIL
MHRA SUBMISSION
TA:

N/A

Trim:

205x140mm

Bleed: 211x146mm
% of actual size: 100%
Data Matrix code: P0287
Colour:
PMS
432

PMS
200

!

8 Do not apply the cream if the cold sore has
!

already formed a blister or ulcer like appearance.
Blistex Cold Sore Cream contains propylene
glycol which can cause skin irritation.

!

Children
Children under 12 years should not use
Blistex Cold Sore Cream.

Other medicines and Blistex Cold Sore Cream
It is unlikely that Blistex Cold Sore Cream affects,
or is affected by, other medicines since Blistex Cold
Sore Cream is intended for use on the skin only,
however do not apply other cold sore medicines
whilst using Blistex Cold Sore Cream.

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

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

Ask your doctor or pharmacist if you have any
questions regarding how Blistex Cold Sore Cream
is affected by, or affects, other medicines.
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.
3. HOW TO USE BLISTEX COLD SORE CREAM
Adults and adolescents aged 12 years and over
Start treatment as soon as you notice the first
symptoms or signs of a cold sore, for instance itching,
stinging, burning or prickling in the affected area.
• Wash your hands thoroughly before
and after treatment to avoid spreading
the infection.
• Apply a thin film carefully over the entire
cold sore 5 times a day. (Approximately
every 3 hours during waking hours).
• Use a fingertip or, preferably, a cotton bud
and avoid touching the end of the tube
after you have touched the cold sore.
• Continue treatment until
healing is complete,
usually between 4-6 days.
• If you notice no difference after 10 days or if your
symptoms worsen, you should stop the treatment
and contact your doctor.
• Remember that Blistex Cold Sore Cream is your
medicine. Do not lend the tube to anyone as you
risk spreading the infection to others.
Children under 12 years of age
Children under 12 years should not use Blistex
Cold Sore Cream.
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
(may affect more than 1 in 10 people) and common
(may affect up to 1 in 10 people).
Very common:
Headaches.

Common:
Skin disorders, including dry skin, skin rashes
and facial swelling occurring where the cream
has been applied.
If a more severe skin reaction occurs you should
cease treatment, and if the problem does not
disappear you should contact your doctor.
Reporting of side effects
If you experience any side effects, consult your
doctor or pharmacist. 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 BLISTEX
COLD SORE CREAM
Keep this medicine out of the sight and reach
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. Once opened any unused
cream must be discarded after 6 months.
Do not store above 25°C.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how
to throw away medicines you no longer use.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK
AND OTHER 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 a pack size of 2g.
Marketing Authorisation Holder
Forvivo Associates Ltd., D7 Basepoint 110 Butterfield, Luton, Beds, LU2 8DL, UK.
Manufacturer
Fleet Laboratories Limited, 94 Rickmansworth Road,
Watford, Hertfordshire, WD18 7JJ, England.
Other sources of information
To listen to or request a copy of this leaflet in
Braille, large print or audio, please call the RNIB
free of charge on 0800 198 5000 (UK only).
This leaflet was last updated
in June 2017.

© 2017 Blistex Ltd.
LTD0147

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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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