ACICLOVIR CREAM 50 MG/G

Active substance: ACICLOVIR

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Aciclovir Cream 50 mg /g
Active substance: aciclovir
Read all of this leaflet carefully before you start using this medicine.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor or 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 is and what it is used for
2. Before you use Aciclovir Cream
3. How to use Aciclovir Cream
4. Possible side effects
5. How to store Aciclovir Cream
6. Further information
1. What Aciclovir Cream is and what it is used for
Aciclovir Cream is an antiviral cream. It contains the active
substance aciclovir which is used to treat certain viral
infections. It slows down virus growth.
Aciclovir Cream is used to:
• treat infections of the skin caused by herpes simplex
virus, including cold sores, genital herpes and lip herpes.
You should apply Aciclovir Cream to the skin within 24 hours
of the onset of early signs of infection or recurrence. This
typically begins with reddening of the skin and formation
of blisters (lip herpes) or tingling, itching, and pain (genital
herpes).
Do not use Aciclovir Cream in the eyes.
2. Before you use Aciclovir Cream
DO NOT use Aciclovir Cream
• if you are allergic (hypersensitive) to aciclovir, valaciclovir,
propylene glycol or to any of the other ingredients of
Aciclovir Cream (see section 6. “Further information” at
the end of this leaflet).
Take special care with Aciclovir Cream
Please tell your doctor if you have or in the past have had
any medical conditions or illnesses, especially
• severe deficiency of the immune system, e.g.
− AIDS patients
− people who have received a bone marrow transplant.
In this case, your doctor may decide to prescribe you
tablets instead.
You must NOT apply Aciclovir Cream to the eyes or
mucous membranes (e.g. in the mouth or vagina). This
may lead to irritation.
If you have genital herpes, please ask your doctor for
advice before starting the treatment with Aciclovir Cream.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines, herbal remedies, health foods or supplements
that you have obtained without a prescription.
Aciclovir Cream is not known to interact with other
medicines. Some medicines are known to affect the way
Aciclovir Tablets or Injection work. These are
• probenecid (used to treat gout)
• any medicine that affects the way your kidneys work
However, these medicines are unlikely to affect the way
Aciclovir Cream works.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
Please tell your doctor if you are pregnant, think you might
be pregnant or if you intend to become pregnant. Your
doctor will assess the risks.
Please ask your doctor about the use of Aciclovir Cream
during breastfeeding.
Driving and using machines
Aciclovir Cream has no effect on the ability to drive or use
machines.
Important information about some of the ingredients
of Aciclovir Cream
Aciclovir Cream contains cetyl alcohol which may cause
local skin reactions (e.g. contact dermatitis).
Aciclovir Cream also contains propylene glycol which may
cause skin irritation.
3. How to use Aciclovir Cream
Always use Aciclovir Cream exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
Use Aciclovir Cream as soon as possible after the start of
the infection, ideally when the first signs or lesions appear.
You must NOT apply Aciclovir Cream to the eyes or
mucous membranes (e.g. in the mouth or vagina). This
may lead to irritation.

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Method of administration
To avoid worsening the infection or infecting other areas of
the body:
• Always wash your hands before and after applying the
cream.
• Avoid unnecessary rubbing of the lesions or touching
them with a towel.
If you have genital herpes, please ask your doctor for
advice before starting the treatment with Aciclovir Cream.
They can inform you on the best method of application.
The usual dose is...
Apply a thin film of cream to the infected and surrounding
skin areas 5 times daily every 4 hours.
Use Aciclovir Cream for 5 days. If healing has not occurred
within this period, continue the treatment for further 5
days (i.e. for a total of 10 days).
You must contact a doctor if your symptoms worsen or do
not improve after 10 days.
If you use more Aciclovir Cream than you should
Do not use more Aciclovir Cream or apply more frequently
than instructed. If you or anyone else swallows the cream
accidentally, please contact your doctor for advice.
If you forget to use Aciclovir Cream
Do not worry. Simply leave out that dose completely and
then use your next dose at the right time. Do not apply a
double amount to make up for a forgotten dose.
If you stop using Aciclovir Cream
You should not stop using Aciclovir Cream before the
recommended course of treatment (5 days). In some cases
you may need to continue treatment for up to 10 days.
If you want to stop using the cream, please check with
your doctor first.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Aciclovir Cream can cause side effects,
although not everybody gets them.
The following side effects have been reported:
Allergic reactions (affects less than 1 in 10,000 people)
If you have an allergic reaction, stop taking Aciclovir and
see a doctor straight away.
The signs may include:
• rash, itching or hives on your skin
• swelling of your face, lips, tongue or other parts of your
body
• shortness of breath, wheezing or having trouble breathing
• unexplained fever and feeling faint, especially when
standing up.
Other side effects include:
Uncommon (affects less than 1 in 100 people)
• a burning or stinging feeling after applying the cream
that goes away
• mild drying or flaking of your skin
• itching.

Rare (affects less than 1 in 1,000 people)
• redness of your skin
• skin rash.
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.
5. How to store Aciclovir Cream
Keep out of the reach and sight of children.
Do not store above 25°C. Do not refrigerate.
Do not use Aciclovir Cream after the expiry date which
is stated on the card box after EXP. The expiry date refers
to the last day of that month.
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 Aciclovir Cream contains
The active substance is aciclovir.
1 gram of Aciclovir Cream contains 50 mg aciclovir
(Ph. Eur.).
The other ingredients are:
• PEG-5-glycerol-stearate
• dimeticone (Ph. Eur.)
• cetyl alcohol (Ph. Eur.)
• liquid paraffin (Ph. Eur.)
• white soft paraffin (B.P.)
• propylene glycol (Ph. Eur.)
• purified water (Ph. Eur.).
What Aciclovir Cream looks like and contents of the
pack
Aciclovir Cream is available in tubes of 2, 5, 10, 20 g.
Not all pack sizes may be marketed.
The tube consisting of aluminium is closed with a polyethylene cap, and is packed into a card box together with
the package leaflet.
Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG,
Stadastrasse 2–18, 61118 Bad Vilbel,
Germany
Distributed by
Genus Pharmaceuticals,
Park View House, 65 London Road,
RG 14 1JN Newbury Berkshire
This leaflet was last approved in February 2011.

9239360
1202
ENG

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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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