ACICLOVIR 5% W/W CREAM - patient leaflet, side effects, dosage

i. what lipsore 5% w/w cream is and what it is used for

Lipsore 5% w/w Cream is used for the treatment of cold sores.

The active ingredient is aciclovir, an antiviral agent. Apply at the first signs of a cold sore (such as tingling and itching). It can also be used to speed up healing if one has already appeared.

2. what you need to know before you use lipsore 5% w/w cream

Do not use Lipsore 5% w/wCream:

• If you have ever had an allergic reaction to Aciclovir, valaciclovir, propylene glycol or any other ingredients ofthe preparation (see section 6 for a complete list of ingredients).
• Inside your mouth (e.g. for mouth ulcers)

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• For any skin infection other than a cold sore.
• In the eyes or genital area.

Take special care with Lipsore 5% w/w Cream:

• Always wash your hands before and after applying Lipsore cream.
• 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. Consultyour 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 ifyou are concerned.
• Avoid touching a cold sore to prevent transferring the infection or making it worse.
• Ifyou have been told byyour doctor that you have a weakened immune system, contact your doctor before treating any type of infection.
• If you are in any doubt if you have a cold

sore, contact your doctor.

• If your cold sore gets very severe, contact

your doctor.

• Tell your doctor or pharmacist before use ifyou are taking any regular medication on prescription or over the counter products.

Pregnancy and Breastfeeding:

Talk to your doctor or pharmacist before using Lipsore cream ifyou are pregnant, trying to become pregnant or are breast-feeding.

Important information about some of the ingredients of Lipsore cream

Lipsore 5% w/w cream contains cetyl alcohol and propylene glycol which may cause local skin reactions (skin irritation and redness).

• 3. Howto use Lipsore 5% w/wCream

Suitable for all ages:

• Apply at the first signs of a cold sore (such as tingling and itching).
• Apply liberally to the affected area 5 times a day.
• Continue treatment for 4 days. If your cold sore hasn't healed after this time, you can use the cream for up to I0 days in total.
• Treat your cold sore for 4 full days to ensure rapid healing.
• If you forget a dose, apply when you remember and continue as before.
• If your cold sore hasn't healed fully after I0 days, or if it gets worse at any time, contact your doctor.
• Never give your Lipsore 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.
• Do not use more than the recommended dose.

4. possible side effects

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

Stop using the medicine and tell your doctor if you experience:

• Allergy-like reactions, for example swelling ofthe lips, face and eyelids.

The following side effects could also occur:

• Mild burning or stinging after application. This will quickly go away.
• Redness, itching or a mild drying or flaking of the skin, skin rashes, hives or weals.

Reporting of side effects

Ifyou 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

".

By reporting side effects you can help provide more information on the safety of this medicine.

• 5. Howto store Lipsore 5%w/wCream

6. contents of the pack and other information

What the cream contains:

The active ingredient is Aciclovir. Each gram of the cream contains 50mg of Aciclovir.

The other ingredients are stearoyl macrogolglycerides, dimethicone, cetyl alcohol, liquid paraffin, white soft paraffin, propylene glycol and purified water.

What Lipsore 5% w/wCream looks like and contents of the pack

Lipsore 5% w/w cream is available from your pharmacist without prescription in a 2g tube.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited, Cheshire House, Gorsey Lane,Widnes, Cheshire, WA8 0RP UK.

Date Leaflet Approved: March 20I7.

PL20395/000I | GSL|