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GALPHARM COLD SORE 5% W/W CREAM

Active substance(s): ACICLOVIR

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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

FOR EXTERNAL USE ONLY
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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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