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Aciclovir 5%W/W Cream

Document: leaflet MAH GENERIC_PL 04917-0056 change

PATIENT INFORMATION LEAFLET


ACICLOVIR 5% w/w CREAM Aciclovir 50 mg/g

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 Aciclovir Cream is and what it is used for

2.    Before you use Aciclovir Cream

3.    How to use Aciclovir Cream

4.    Possible side effects

5.    How to store Aciclovir Cream

6.    Further information

1.    WHAT ACICLOVIR CREAM IS AND WHAT IT IS USED FOR

Aciclovir 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 ACICLOVIR CREAM Do not use Aciclovir Cream If you:

•    are allergic to aciclovir, valaciclovir, proplylene glycol or to any of the ingredients of Aciclovir Cream (see Section 6 and end of Section 2).

Take special care with Aciclovir 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 Aciclovir 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 Aciclovir 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

Aciclovir Cream contains:

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

   propylene glycol which may cause skin irritation.


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3.


HOW TO USE ACICLOVIR CREAM


FOR EXTERNAL USE ONLY


Always use Aciclovir 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 Aciclovir 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 Aciclovir 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, Aciclovir 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 Aciclovir Cream and seek medical advice immediately.

Occasionally the following effects may be experienced:

•    reddening, dehydration or scaling of your skin

•    burning or stinging sensation of treated skin which passes quickly after application.

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

5.    HOW TO STORE ACICLOVIR 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 Aciclovir 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.

6.    FURTHER INFORMATION What Aciclovir 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 Aciclovir 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.

PL 04917/0056

Manufacturer: CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF.


This leaflet was last updated in 06/2014


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