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ACICLOVIR CREAM BP 5%W/W

Active substance(s): ACICLOVIR

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PACKAGE LEAFLET : INFORMATION FOR THE USER

Aciclovir Cream 5% w/w
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Aciclovir Cream 5% w/w is and what it is used for
2. Before you use Aciclovir Cream 5% w/w
3. How to use Aciclovir Cream 5% w/w
4. Possible side effects
5. How to store Aciclovir Cream 5% w/w
6. Further information

1. What Aciclovir Cream 5% w/w is and what it is used for
This medicine belongs to a group of medicines called antivirals, which act
to treat infections caused by viruses.
It can be used to treat cold sores of the lips and face (herpes labialis) or
genital herpes (herpes genitalis).

2. Before you use Aciclovir Cream 5% w/w
This medicine can be used by adults and children. However, some people
should not use this medicine or should seek the advice of their pharmacist
or doctor first.
Do not use this medicine:
• If you are allergic to aciclovir, propylene glycol, any of the other
ingredients of this medicine or if you are allergic to valaclovir.
• To treat herpes infection (which may appear as ulcers or blisters) on
your eye, inside the mouth or vagina.
Talk to your pharmacist or doctor:
• If you suffer from problems with your immune system which may make
you more prone to infections (this problem may be caused by an illness,
some medicines or radiotherapy)
• If you are pregnant, planning to become pregnant or breast-feeding
Other important information
Cold sores are infectious and you should try not to pass the infection on
to other people. Taking the following precautions may help to reduce the
risk of passing the infection:
• Do not touch the cold sore with your hands or towel, if possible
• Wash your hands immediately if you do touch the cold sore
• Do not share your towels with other people
• Do not share eating or drinking utensils with other people
• Try not to kiss other people, especially children, until your cold sore has
healed
Information about some of the ingredients in this medicine: Propylene
glycol may cause skin irritation and cetyl alcohol could cause a local skin
reaction (e.g contact dermatitis).
If you take other medicines
This medicine is not expected to affect any other medicines that you may
be using.
If you are unsure about interactions with any medicines, talk to your pharmacist.
This includes medicines prescribed by your doctor and medicine you have
bought for yourself, including herbal and homeopathic remedies.

3. How to use Aciclovir Cream 5% w/w
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 as soon
as the infection begins. You will feel a tingling or an itching when you are
about to get a herpes blister. You should use the cream when you first
notice this tingling or itching feeling as it may prevent the blister from
developing. Please follow the instructions overleaf:

Wash your hands before and after using the cream.
Age

How much to use

How often to use it

Adults
and
children

A thin layer on the
affected area making
sure the whole cold
sore is covered

Every 4 hours, 5 times
a day, for 5 days

If after 5 days the cold sore has not healed you can continue to apply the
cream for a further 5 days if necessary.
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 cold sore has not healed after 10 days stop using the cream and
talk to your doctor.
If your symptoms worsen at any time stop using the cream and talk to
your doctor.
If you forget to use the cream:
If you forget to use the cream, use it as soon as you remember. Then go
on as before.
If you swallow the cream accidentally, please consult your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Aciclovir can cause side effects, although not
everybody gets them.
Stop using the cream and tell your doctor immediately or go to the
casualty department at your nearest hospital if the following happens:
• an allergic reaction causing swelling of the lips, face or neck leading to
severe difficulty in breathing, or severe skin rash or hives. This is a very
serious but rare side effect. You may need urgent medical attention or
hospitalisation.
Uncommon (less than 1 in 100, but more than 1 in 1,000 people treated)
• Burning, stinging, mild drying or flaking of the skin
• Itching
Rare (less than 1 in 1,000, but more than 1 in 10,000 people treated)
• Sudden outbreak of red spots, bumps, and lesions on the skin
Very rare (less than 1 in 10,000 people treated)
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
If any side effect becomes severe, or you notice any side effect not listed
here, please tell your pharmacist or doctor.

5. How to store Aciclovir Cream 5% w/w
Do not store above 25°C.
Do not refrigerate or freeze the cream.
Keep this medicine in a safe place out of the sight and reach of children,
preferably in a locked cupboard.
Use by the date printed on the tube and carton.

6. Further information
What Aciclovir Cream 5% w/w contains
Each gram of cream contains Aciclovir 50 mg, which is the active ingredient.
As well as the active ingredient, the cream also contains propylene glycol,
liquid paraffin, white soft paraffin, cetyl alcohol, dimeticone, arlatone
983S, purified water.
The cream is available in pack sizes of 2 g and 10 g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ratiopharm GmBH Graf-Arco-Str 3 d-89079 Ulm Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Str. 3, D-89143 Blaubeuren, Germany.
This leaflet was prepared: May 2011
20137-D

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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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