Aciclovir 5% w/w Cream

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Aciclovir 5% w/w Cream is and what it is used for

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

3.    How to use Aciclovir 5% w/w Cream

4.    Possible side effects

5.    How to store Aciclovir 5% w/w Cream

6.    Contents of the pack and other information

OWhat Aciclovir 5% w/w Cream 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) caused by the herpes simplex virus.

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

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 Aciclovir 5% w/w Cream:

• If you are allergic to aciclovir, valaciclovir, propylene glycol, or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions Talk to your doctor or pharmacist before using Aciclovir 5% w/w Cream

• If you suffer from problems with your immune system which may make you more prone to infections (e.g. if you have HIV or AIDS or if you have had a bone marrow transplant).

Aciclovir 5% w/w Cream is not for use in the mouth, eyes, or in the vagina as it may cause skin irritation.

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 on 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.

Other medicines and Aciclovir 5% w/w Cream

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Aciclovir 5% w/w Cream contains propylene glycol and cetyl alcohol:

Propylene glycol may cause skin irritation and cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).

©How to use Aciclovir 5% w/w Cream

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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.

Wash your hands before and after using the cream.

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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.

^4 Possible side effects

Like all medicines, this medicine 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 very rare side effect. You may need urgent medical attention or hospitalisation

Uncommon (may affect up to 1 in

100 people)

•    Burning, stinging, mild drying or flaking of the skin

•    Itching

Rare (may affect up to 1 in 1,000 people)

•    Sudden outbreak of red spots, bumps, and lesions on the skin

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

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.

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.

©Contents of the pack and other information

What Aciclovir 5% w/w Cream contains

Each gram of cream contains Aciclovir 50 mg, which is the active ingredient.

The other ingredients are: propylene glycol, liquid paraffin, white soft paraffin, cetyl alcohol, dimeticone, arlatone 983S, purified water.

What Aciclovir 5% w/w Cream looks like and contents of the pack

Aciclovir 5% w/w Cream is a white cream and comes in an aluminium tube with plastic screw-on cap in pack sizes of 2 g, 5 g, 10 g and 20 g. Not all pack sizes may be marketed.

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 last revised in October 2016

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Approvals

Signed by	Meaning of Signature	Server Date
Annette Huggett	Regulatory Affairs Approval	27-Oct-2016 10:59:58 AM

REG0198537 Version 0.3 Approved Page 3 of 3