PATIENT INFORMATION LEAFLET GALPHARM COLD SORE 5% W/W CREAM (ACICLOVIR)

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

This medicine is available without prescription. However, you still need to use the product carefully to get the best results from it.

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

•    Ask your doctor or pharmacist if you need more information or advice.

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

•    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 Galpharm Cold Sore 5% w/w Cream is and what it is used for

2.    Before you use Galpharm Cold Sore 5% w/w Cream

3.    How to use Galpharm Cold Sore 5% w/w Cream

4.    Possible side effects

5.    How to store Galpharm Cold Sore 5% w/w Cream

6.    Further information

1.    WHAT GALPHARM COLD SORE 5% W/W CREAM IS AND WHAT IT IS USED FOR

Galpharm Cold Sore 5% w/w Cream is a smooth off-white cream for application to the lips and face. It contains aciclovir which belongs to a group of medicines called antivirals.

This cream is used for the treatment of cold sores (Herpes simplex virus infections); it slows the growth of the virus, and speeds the healing of cold sore blisters.

2.    BEFORE YOU USE GALPHARM COLD SORE 5% W/W CREAM

Do not use Galpharm Cold Sore 5% w/w Cream if you:

•    are allergic to aciclovir, valaciclovir, propylene glycol or to any of the other ingredients in Galpharm Cold Sore 5% w/w Cream (see Section 6 and end of Section 2).

Take special care with Galpharm Cold Sore 5% w/w Cream:

•    do not use on mucous membranes as the cream can cause irritation. The areas to avoid include the inside of the mouth and nose, the eyes and inside the vagina.

•    do not use this product to treat mouth ulcers, or for herpes infections which are in or near your eyes, or in the genital area.

•    do not use this cream if your cold sore is severe; you must see a doctor for advice on how to treat it.

•    only use Galpharm Cold Sore 5% w/w Cream to treat blisters on your lips and face.

If your immune system is weakened for any reason e.g. HIV infection, a bone marrow transplant or cancer treatment, do not treat yourself with Galpharm Cold Sore 5% w/w Cream; you must seek advice from your doctor.

While you have a cold sore, avoid spreading the infection to others by washing your hands carefully before and after applying the cream, and avoid touching the infected skin with anything else, especially with your hands or with towels.

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

Tell your doctor or pharmacist if you are or may be pregnant. Ask your doctor for advice before taking any medicine during pregnancy. The active ingredient aciclovir has been found to pass into breast milk.

Important information about some of the ingredients

Galpharm Cold Sore 5% w/w Cream contains:

•    cetyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

•    propylene glycol which may cause skin irritation.

3. HOW TO USE GALPHARM COLD SORE 5% W/W CREAM

Always use Galpharm Cold Sore 5% w/w Cream exactly as instructed in this leaflet. If you are not sure, ask your doctor or pharmacist.

Do not exceed the stated dose.

It is best to apply the product as soon as possible after the start of the infection.

For application to the surface of the skin only:

1.    Wash your hands thoroughly before use.

2.    Apply a thin layer of the cream to the infected area and the skin immediately next to it, 5 times a day at intervals of about 4 hours. Take care not to rub the infected skin any more than you need to.

3.    Wash your hands again, to avoid spreading the infection.

4.    Use the cream for up to 5 days. If the infection has not healed after this time, you can continue to use it for a further 5 days.

If your cold sore gets worse during the treatment period, or if it has not healed after 10 days of treatment, STOP using the cream and seek advice from your doctor.

If you use more Galpharm Cold Sore 5% w/w Cream than you should or if you or a child accidentally swallow the cream, contact your doctor or nearest hospital immediately. Take the packet with you to help identification.

If you forget to use Galpharm Cold Sore 5% w/w Cream

If you miss a treatment, apply the cream as soon as you remember, and apply the remaining doses for that day at evenly spaced intervals.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Galpharm Cold Sore 5% w/w Cream can cause side effects, although not everybody gets them.

If you notice the following: rash, itchy skin, weal, swelling of the lips, face and/or eyelids, they may be signs of an allergic reaction. Stop using Galpharm Cold Sore 5% w/w Cream and seek medical advice immediately.

Other side effects include:

Common (affects less than 1 in 10 people)

•    mild drying or flaking of your skin

Uncommon (affects less than 1 in 100 people)

•    a burning or stinging feeling after applying the cream that goes away

•    itching

Rare (affects less than 1 in 1,000 people)

•    redness of your skin

•    skin rash

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5.    HOW TO STORE GALPHARM COLD SORE 5% W/W CREAM

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package and keep the tube in the outer carton. Do not refrigerate.

Do not use Galpharm Cold Sore 5% w/w Cream after the expiry date which is stated on the tube/carton. Discard 6 weeks after first opening. 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 Galpharm Cold Sore 5% w/w Cream contains:

•    The active substance is aciclovir and the cream contains 50 mg in every 1g (5% w/w).

•    The other ingredients are Arlatone 983S, dimeticone, cetyl alcohol, liquid paraffin, white soft paraffin, propylene glycol (E1520) and purified water (see end of Section 2 for further information).

What Galpharm Cold Sore 5% w/w Cream looks like and contents of the pack

The product is a smooth white to off-white cream and is available in aluminium tubes containing 2g.

MA Holder: Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.

Manufacturer: Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Text Updated: 04/2016.