Aciclovir 5% Cream
ACICLOVIR 5 % CREAM
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
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
OWHAT ACICLOVIR CREAM IS AND WHAT IT IS USED FOR
Aciclovir Cream contains the active ingredient aciclovir. Aciclovir Cream belongs to a group of medicines known as antivirals, which are used to treat viral infections. Aciclovir Cream is used to treat immunocompetent patients (patients with a normal immune system) with skin infections caused by the Herpes simplex virus. These include:
• new and recurring herpes genitalis (genital herpes)
• herpes labialis (cold sores on the lips).
BEFORE YOU USE ACICLOVIR CREAM
Do not take Aciclovir Cream if you
• are allergic (hypersensitive) to aciclovir, valaciclovir, propylene glycol or any of the other ingredients of Aciclovir Cream (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
Take special care with Aciclovir Cream if you
• are severely immunocompromised (have a weak immune system)
• have genital herpes (you should not have sex while you have sores to avoid infecting your partner)
• develop a skin reaction.
Aciclovir Cream should not come into contact with the mucous membranes, such as in the mouth, eye or vagina, as it may cause irritation.
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
You may use Aciclovir Cream while pregnant and while breast-feeding unless your doctor tells you not to. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Aciclovir Cream is unlikely to interfere with your ability to drive or use machines.
Important information about some of the ingredients of Aciclovir Cream
This medicinal product contains propylene glycol and cetyl alcohol. Propylene glycol and cetyl alcohol may cause skin irritation (e.g. contact dermatitis).
©HOW TO USE
ACICLOVIR CREAM
Dosage
Adults and children
Aciclovir Cream should be applied to the affected area five times daily at intervals of approximately four hours, (but not during the night). Aciclovir Cream should be applied to the sore or the start of a sore as early as possible.
Do not apply the cream to the inside of the mouth, the eyes or inside the vagina as it might cause irritation. Treatment should be continued for five
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days. If healing is not complete, treatment may be continued for up to another five days.
If you miss a dose of Aciclovir Cream
If you miss a dose, use the cream as soon as you can. However, do not apply a double dose to make up for a forgotten dose. If you have any further questions on the use of this product ask your doctor or pharmacist.
O POSSIBLE SIDE EFFECTS
Like all medicines, Aciclovir Cream can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
The following side effects have been reported:
Uncommon (between 1 and 10 patients out of 1000):
• temporary burning or stinging • mild drying or scaling of the skin
• itching.
Rare (between 1 and 10 patients out of 10,000):
• erythema (redness)
• contact dermatitis (skin rash).
Very rare (less than 1 patient out of 10,000):
• hypersensitivity (allergic) reactions including angioedema (swelling of the face and hands), urticaria (nettle rash).
Reporting of side effects
If you 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:
www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
©HOW TO STORE ACICLOVIR CREAM
Keep out of the reach and sight of children
Do not store above 25°C.
Do not refrigerate or freeze.
Do not use after the expiry date which is stated on the carton. Aciclovir Cream should be used within 28 days of first opening of the tube. 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.
©FURTHER
INFORMATION
What Aciclovir Cream contains:
The active substance is aciclovir. The other ingredients are: propylene glycol, white soft paraffin, liquid paraffin, cetyl alcohol, dimeticone, stearoyl macrogolglycerides and purified water.
What Aciclovir Cream looks like and contents of the pack
Aciclovir Cream is a white cream and comes in aluminium tubes of 2 g or 3 g 10 g and 15 g, with plastic screw caps. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited,
Eastbourne,
BN22 9AG.
Manufacturer
Merckle GmbH Ludwig Merckle Str. 3 89143 Blaubeuren Germany.
This leaflet was last revised in January 2015
PL 00289/1605
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