GALPHARM COLD SORE CREAM
Active substance(s): ACICLOVIR
PATIENT INFORMATION LEAFLET
FOR EXTERNAL USE ONLY
Careway Cold Sore 5% w/w Cream
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:
What Cold Sore 5% w/w Cream is and what it is used for
Before you use Cold Sore 5% w/w Cream
How to use Cold Sore 5% w/w Cream
Possible side effects
How to store Cold Sore 5% w/w Cream
Always use Cold Sore 5% w/w Cream exactly as instructed in this leaflet. If you are not sure, ask your doctor or
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:
Wash your hands thoroughly before use.
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.
Wash your hands again, to avoid spreading the infection.
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 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 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.
WHAT COLD SORE 5% W/W CREAM IS AND WHAT IT IS USED FOR
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.
HOW TO USE COLD SORE 5% W/W CREAM
BEFORE YOU USE COLD SORE 5% W/W CREAM
Do not use Cold Sore 5% w/w Cream if you:
are allergic to aciclovir, valaciclovir, propylene glycol or to any of the ingredients of Cold Sore
5% w/w Cream (see Section 6 and end of Section 2).
Take special care with 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 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 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
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
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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, 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 Cold Sore 5% w/w Cream and seek medical advice immediately.
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
Rare (affects less than 1 in 1,000 people)
redness of your skin
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.
HOW TO STORE COLD SORE 5% W/W CREAM
Keep out of the sight and reach 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 Cold Sore 5% w/w Cream after the expiry date which is stated on the tube/carton.
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.
What Cold Sore 5% w/w Cream contains:
The active substance is aciclovir and the cream contains 50 mg in every 1 g (5%).
The other ingredients are stearoyl macrogolglycerides, dimeticone, cetyl alcohol, liquid paraffin,
white soft paraffin, propylene glycol and purified water (see end of Section 2 for further information).
What 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 2 g.
Marketing Authorisation Holder: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
Manufacturer: CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF or
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
This leaflet was last updated in 07/2017
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.