Document: leaflet GENUS_PL 11204-0033 change

• leaflet GENUS_PL 11204-0033
• leaflet MAH BRAND_PL 11204-0033

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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.

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.