Document: leaflet MAH BRAND_PL 11204-0033 change

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

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1. What Viralief™ is and what it is used for

Viralief™ is an antiviral cream. It contains the active substance aciclovir which is used to treat certain viral infections. It slows down virus growth.

Viralief^TM is used to:

• treat infections of the lips and face caused by herpes simplex virus.

You should apply Viralief™ 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.

Do not use Viralief™ in the eyes.

2. Before you use Viralief™

DO NOT use Viralief™

•    if you are allergic (hypersensitive) to aciclovir, valaciclovir, propylene glycol or to any of the other ingredients of Viralief™ (see section 6. “Further information” at the end of this leaflet).

Take special care with Viralief^TM

Viralief™ is only recommended for use on cold sores on the lips and face.

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 Viralief™ to the eyes or mucous membranes (e.g. in the mouth). This may lead to irritation.

When the active substance of Viralief™ (aciclovir) has been taken for example in tablet or injection form, the effect may be influenced by:

•    probenecid (medicine used to treat gout)

•    any medicine which affects the kidney function. However, this is likely to be of little relevance to the use of Viralief^T™.

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 Viralief™ during breastfeeding.

Driving and using machines

Viralief" has no effect on the ability to drive or use machines.

Important information about some of the ingredients of Viralief^TM

Viralief^T™ contains cetyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

Viralief^T™ also contains propylene glycol which may cause skin irritation.

3. How to use Viralief™

Always use Viralief™ exactly as described in this leaflet. You should check with your doctor or pharmacist if you are not sure.

Use Viralief™ as soon as possible after the start of the infection, ideally when the first signs or lesions appear.

You must NOT apply Viralief™ to the eyes or mucous membranes (e.g. in the mouth). 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.

The usual dose is...

Apply a thin film of cream to the infected and surrounding skin areas 5 times daily every 4 hours.

Use Viralief 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 Viralief™ than you should

Do not use more Viralief" 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 Viralief™

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 have any further questions on the use of this product, ask your doctor or pharmacist.

5. How to store Viralief™

Keep out of the reach and sight of children.

Do not store above 25°C. Do not refrigerate.

Do not use Viralief " after the expiry date which is stated on the card box after EXP. The expiry date refers to the last day of that month.

"edicines 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 Viralief^TM contains

The active substance is aciclovir.

1 gram of Viralief" 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 Viralief^TM looks like and contents of the pack

Viralief^T" is available in pump dispensers of 2 g.

4. Possible side effects

Like all medicines, Viralief" 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 Viralief^TM 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.

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.

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.

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ENG