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ACICLOVIR CREAM BP 5%W/W

Active substance(s): ACICLOVIR

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TEVA UK Ref:

Version:

231-30-12345-A LEA ACICLOVIR 5% W/W CREAM 10g TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
270 mm
120 mm
N/A
N/A

3

10 October 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

12 mm

12 mm

12 mm

Aciclovir 5% w/w Cream is not for
use in the mouth, eyes, or in the
PACKAGE LEAFLET:
vagina as it may cause skin
INFORMATION FOR THE USER
irritation.
Read all of this leaflet carefully
Other important information
before you start using this
Cold sores are infectious and you
medicine because it contains
should try not to pass the infection
important information for you.
on to other people. Taking the
• Keep this leaflet. You may need
following precautions may help to
to read it again.
reduce the risk of passing on the
• If you have further questions,
infection:
please ask your doctor or
• Do not touch the cold sore with
pharmacist.
your hands or towel, if possible
• This medicine has been
• Wash your hands immediately if
prescribed for you only. Do not
you do touch the cold sore
pass it on to others. It may harm • Do not share your towels with
them, even if their signs of
other people
illness are the same as yours.
• Do not share eating or drinking
• If you get any side effects, talk to
utensils with other people
your doctor or pharmacist. This
• Try not to kiss other people,
includes any possible side
especially children, until your
effects not listed in this leaflet.
cold sore has healed.
See section 4.
Other medicines and Aciclovir
What is in this leaflet:
5% w/w Cream
1. What Aciclovir 5% w/w Cream is Tell your doctor or pharmacist if
you are taking, have recently taken
and what it is used for
or might take any other medicine.
2. What you need to know before
you use Aciclovir 5% w/w Cream Pregnancy, breast-feeding and
3. How to use Aciclovir 5% w/w
fertility
Cream
If you are pregnant or
4. Possible side effects
breast-feeding, think you may be
5. How to store Aciclovir 5% w/w
pregnant or are planning to have a
Cream
baby, ask your doctor or
6. Contents of the pack and other
pharmacist for advice before
information
taking this medicine.
Aciclovir 5% w/w Cream contains
What Aciclovir 5% w/w
propylene glycol and cetyl alcohol:
Cream is and what it is
Propylene glycol may cause skin
used for
irritation and cetyl alcohol may
This medicine belongs to a group
cause local skin reactions (e.g.
of medicines called antivirals,
contact dermatitis).
which act to treat infections caused
How to use Aciclovir
by viruses.
5% w/w Cream
It can be used to treat cold sores of
the lips and face (herpes labialis)
Always use this medicine exactly
or genital herpes (herpes genitalis) as your doctor has told you. Check
caused by the herpes simplex
with your doctor or pharmacist if
virus.
you are not sure.

1

3

What you need to know
before you use Aciclovir
5% w/w Cream

The label on your pack will tell you
how much you should use and
how often you should use it. It is
important to start using the cream
This medicine can be used by
as soon as the infection begins.
adults and children. However,
You will feel a tingling or an itching
some people should not use this
when you are about to get a
medicine or should seek the advice herpes blister. You should use the
of their pharmacist or doctor first. cream when you first notice this
Do not use Aciclovir 5% w/w
tingling or itching feeling as it may
Cream:
prevent the blister from
• If you are allergic to aciclovir,
developing.
valaciclovir, propylene glycol, or
Wash your hands before and after
any of the other ingredients of this using the cream.
medicine listed in section 6.
The recommended dose is:
Warnings and precautions
Adults and children
Age
Talk to your doctor or pharmacist
before using Aciclovir 5% w/w
How
A thin layer on the
Cream
much to affected area making
• If you suffer from problems with use
sure the whole area
your immune system which may
is covered
make you more prone to
How
Every 4 hours, 5 times
infections (e.g. if you have HIV
often to a day
or AIDS or if you have had a
use it
Cold sores: Use for
bone marrow transplant).
4 days
Genital herpes: Use for
5 days

2

12 mm

REG0198537

120x270 Merckle.indd 1

Version 0.3

Approved
120 mm

13.03.2006 16:20:18

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270 mm

Aciclovir 5% w/w Cream

TEVA UK Ref:

Version:

231-30-12345-A LEA ACICLOVIR 5% W/W CREAM 10g TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
270 mm
120 mm
N/A
N/A

3

10 October 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

12 mm

12 mm

12 mm

If the affected area has not healed
you can continue to apply the
cream for a further 5 days.
If after this time the area still has
not healed stop using the cream
and talk to your doctor.
For use on the skin only.
Do not apply the cream to the
inside of the mouth, the eyes or
inside the vagina as it might cause
irritation.
Do not use more than the amount
recommended above.
If your symptoms worsen at any
time stop using the cream and talk
to your doctor.
If you use more Aciclovir 5% w/w
Cream than you should:
Talk to your doctor or pharmacist if
you use too much Aciclovir
5% w/w Cream. If you swallow the
cream accidentally talk to your
doctor or pharmacist.
If you forget to use Aciclovir
5% w/w Cream:
If you forget to use the cream, use
it as soon as you remember. Then
go on as before. However, if it is
nearly time for your next
application, skip the missed
application. Do not use a double
application to make up for a
forgotten application.

Reporting of side effects
If you get any side effects, talk to
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 Aciclovir
5% w/w Cream

Keep this medicine in a safe place
out of the sight and reach of
children, preferably in a locked
cupboard.
Do not store above 30°C.
Use by the date printed on the
tube and carton. Aciclovir 5% w/w
Cream should be used within 4
weeks of first opening of the tube.
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 protect the environment.

6

Contents of the pack and
other information

What Aciclovir 5% w/w Cream
contains
Each gram of cream contains
Possible side effects
Aciclovir 50 mg, which is the active
ingredient.
Like all medicines, this medicine
The other ingredients are:
can cause side effects, although
propylene glycol, liquid paraffin,
not everybody gets them.
white soft paraffin, cetyl alcohol,
Stop using the cream and tell your dimeticone, arlatone 983S, purified
water.
doctor immediately or go to the
casualty department at your
What Aciclovir 5% w/w Cream
nearest hospital if the following
looks like and contents of the pack
happens:
Aciclovir 5% w/w Cream is a white
• an allergic reaction causing
cream and comes in an aluminium
swelling of the lips, face or neck tube with plastic screw-on cap in
leading to severe difficulty in
pack sizes of 2 g, 5 g, 10 g and 20 g.
breathing, or severe skin rash or
Not all pack sizes may be
hives. This is a very serious but
marketed.
very rare side effect. You may
need urgent medical attention or Marketing Authorisation Holder
and Manufacturer
hospitalisation
Uncommon (may affect up to 1 in Marketing Authorisation Holder:
ratiopharm GmBH Graf-Arco-Str 3
100 people)
• Burning, stinging, mild drying or d-89079 Ulm Germany.
flaking of the skin
Manufacturer:
• Itching
Merckle GmbH,
Ludwig-Merckle-Str. 3, D-89143
Rare (may affect up to 1 in 1,000
Blaubeuren, Germany.
people)
• Sudden outbreak of red spots,
This leaflet was last revised in
bumps, and lesions on the skin
October 2016
Very rare (may affect up to 1 in
10,000 people)
• Raised, red, itchy skin
(symptoms of urticaria, which is
often known as hives or nettle
rash)
Other potential side effects
include:
• Redness, tense skin
• Painful sensation of the skin
where the cream has been
applied
12345-A
120 x 270

12 mm

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Version 0.3

Approved
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13.03.2006 16:20:19

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4

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-pil-uk-pl-15773-0093-aciclovir-5%-cream-teva

APPROVALS
Signed by
Annette Huggett

REG0198537

Meaning of Signature
Regulatory Affairs Approval

Version 0.3

Approved

Server Date
27-Oct-2016 10:59:58 AM

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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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