Cold Sore Cream
PATIENT INFORMATION LEAFLET Aciclovir 5% w/w Cream (Aciclovir)
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told 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 talk to a doctor if you do not feel better or if you feel worse
What is in this leaflet:
1. What Aciclovir 5% w/w Cream is and what it is used for
2. What you need to know before you use Aciclovir 5% w/w Cream
3. How to use Aciclovir 5% w/w Cream
4. Possible side effects
5. How to store Aciclovir 5% w/w Cream
6. Contents of the pack and other information
1. What Aciclovir 5% w/w Cream is and what it is used for
Aciclovir 5% w/w Cream is used for the treatment of cold sores. The active ingredient is aciclovir, an antiviral agent.
2. What you need to know before you use Aciclovir 5% w/w Cream Do not use Aciclovir 5% w/w Cream:
If you are allergic to aciclovir, valaciclovir, propylene glycol, cetyl alcohol or any of the other ingredients (listed in Section 6)
Warnings and Precautions
• If you have been told by your doctor that you have a weakened immune system, contact your doctor before treating any type of infection.
• Always wash your hands before and after applying Aciclovir 5% w/w Cream.
• Avoid touching a cold sore to prevent transferring the infection or making it worse.
• Do not apply the cream to mucous membranes such as the eyes, mouth or vagina
• Do not touch your eyes until you have washed your hands after application.
• If you accidentally get cream in your eye, wash out thoroughly with warm water. Consult your doctor if you are concerned.
• Do not swallow the cream. If you accidentally swallow any cream, it is unlikely to cause any ill effects but consult your doctor if you are concerned.
• If you are in any doubt if you have a cold sore, contact your doctor.
Other medicines and Aciclovir 5% w/w Cream
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without prescription, including herbal medicines.
Pregnancy and breast feeding
Talk to your doctor or pharmacist before using Aciclovir 5% w/w Cream if you are pregnant, trying to become pregnant or are breast feeding.
Aciclovir 5% w/w Cream contains propylene glycol and cetyl alcohol
These ingredients can cause skin irritation and local skin reactions, for example contact dermatitis
3. How to use Aciclovir 5% w/w Cream
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Never give your Aciclovir 5% w/w Cream to others, even if their symptoms are the same as yours
• The amount of cream inside this pack is enough for one cold sore attack. For any future attacks, start treatment at the first signs of a cold sore developing (such as tingling or itching). It can also be started during the blister stage.
Applying the cream
• Always wash your hands before and after applying Aciclovir 5% w/w Cream.
• You should not mix Aciclovir 5% w/w Cream with anything before you use it, not even water.
Adults and children
• Apply at the first signs of a cold sore (such as tingling and itching).
• Apply liberally to the affected area 5 times a day, leaving at least 4 hours between applications. Do not use more than the recommend dose.
• Continue treatment for 5 days. If your cold sore hasn’t healed after this time, you can use the cream for up to 10 days in total.
• If your cold sore hasn’t healed fully after 10 days, or if it gets worse at any time, contact your doctor
If you forget to use Aciclovir 5% w/w Cream
• If you forget a dose, apply when you remember and continue as before.
• Do not use a double application to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Aciclovir 5% w/w Cream can cause side effects, although not everybody gets them.
Allergic reactions are very rare (may affect up to 1 in 10, 000 people), however STOP using this medicine and tell your doctor immediately if you experience the following Allergy-like reactions:
• Difficulty in breathing
• Swelling of the face, neck, tongue or throat (severe allergic reactions)
If you get any of the following side effects, see your pharmacist or doctor
Uncommon side effects: (May affect up to1 in100 people)
• Burning or stinging sensation of the skin where the cream has been applied
• Itching
• Dryness or flaking of the skin
Rare side effects: (May affect up to 1 in 1000 people)
• Flushed skin
• Contact dermatitis (redness and swelling of the skin)
The following side effects could also occur:
• Mild burning or stinging after application. This will quickly go away.
• Skin rashes
• Hives or weals (red, swollen mark)
Reporting of side effects
If you do 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 internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information of the safety of this medicine
5. How to store Aciclovir 5% w/w Cream
Keep this medicine out of the sight and reach of children.
Do not use this medicine after ‘EXP’ date shown on the pack.
Do not store above 25°C but do not keep it in a refrigerator or freezer.
6. Contents of the pack and other information What Aciclovir Contains
Active ingredient: 5% w/w Aciclovir.
Other ingredients: PEG-5-glycerol stearate, dimeticone, cetyl alcohol, liquid paraffin, white soft paraffin, propylene glycol and purified water.
The marketing authorisation holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, NN8 6GT
The Manufacturer responsible For Batch Release:
Lalahem Health and Beauty Limitedltd., Sycamore Park, Mill lane, Alton, Hampshire, GU34 2PR.
This Leaflet was last revised May 2015