ACICLOVIR 5 % CREAM

PACKAGE LEAFLET: INFORMATION FOR THE USER

TEVA UK Ref: 231-30-01040-C LEA ACICLOVIR 5% CREAM 10G TUK <RAT    Version: 1    12 May 2015

Read all of this leaflet carefully because it contains important information for you

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

•    Ask your pharmacist if you need more information or advice

•    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

•    You must contact a doctor if your symptoms worsen or do not improve after 10 days

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

OWHAT ACICLOVIR CREAM IS AND WHAT IT IS USED FOR

Aciclovir Cream contains the active ingredient aciclovir. Aciclovir Cream belongs to a group of medicines known as antivirals, which are used to treat viral infections. Aciclovir Cream is used to treat labial herpes (cold sores) caused by the Herpes simplex virus.

©BEFORE YOU USE ACICLOVIR CREAM

Do not take Aciclovir Cream if you

• are allergic (hypersensitive) to aciclovir, valaciclovir, propylene glycol or any of the other ingredients of Aciclovir Cream (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Take special care with Aciclovir Cream if you

• are severely immunocompromised (have a weak immune system)

• develop a skin reaction. Aciclovir Cream should not come into contact with the mucous membranes, such as

in the mouth, eye or vagina, as it may cause irritation.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

You may use Aciclovir Cream while pregnant and while breast-feeding unless your doctor tells you not to. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Aciclovir Cream is unlikely to interfere with your ability to drive or use machines.

Important information about some of the ingredients of Aciclovir Cream

This medicinal product contains propylene glycol and cetyl alcohol. Propylene glycol and cetyl alcohol may cause skin irritation (e.g. contact dermatitis).

©HOW TO USE

ACICLOVIR CREAM

Dosage

Adults and children

Aciclovir Cream should be applied to the affected area five times daily at intervals of approximately four hours, (but not during the night). Aciclovir Cream should be applied to the sore or the start of a sore as early as possible.

Do not apply the cream to the inside of the mouth, the eyes or inside the vagina as it might cause irritation. Treatment should be continued for five days. If healing is not complete, treatment may be continued for up to another five days.

If you miss a dose of Aciclovir Cream

If you miss a dose, use the cream as soon as you can. However, do not apply a double dose to make up for a forgotten dose. If you have any further questions on the use of this product ask your doctor or pharmacist.

TEVA UK Ref: 231-30-01040-C LEA ACICLOVIR 5% CREAM 10G TUK <RAT    Version: 1    12 May 2015

O POSSIBLE SIDE EFFECTS

Like all medicines, Aciclovir Cream can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

The following side effects have been reported:

Uncommon (between 1 and 10 patients out of 1000):

• temporary burning or stinging

• mild drying or scaling of the skin

• itching.

Rare (between 1 and 10 patients out of 10,000):

• erythema (redness)

• contact dermatitis (skin rash).

Very rare (less than 1 patient out of 10,000):

• hypersensitivity (allergic) reactions including angioedema (swelling of the face and hands), urticaria (nettle rash).

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

0HOW TO STORE ACICLOVIR CREAM

Keep out of the reach and sight of children

Do not store above 25°C.

Do not refrigerate or freeze.

Do not use after the expiry date which is stated on the carton. Aciclovir Cream should be used within 28 days of first opening of the tube. 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.

©FURTHER

INFORMATION

What Aciclovir Cream contains:

The active substance is aciclovir. The other ingredients are: propylene glycol, white soft paraffin, liquid paraffin, cetyl alcohol, dimeticone, stearoyl macrogolglycerides and purified water.

What Aciclovir Cream looks like and contents of the pack

Aciclovir Cream is a white cream and comes in aluminium tubes of 2 g or 3 g with plastic screw caps. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited,

Eastbourne,

BN22 9AG.

Manufacturer

Merckle GmbH Ludwig Merckle Str. 3 89143 Blaubeuren Germany.

This leaflet was last revised in May 2015

PL 00289/1606

01040-C