Activir Duo 50 mg/g + 10 mg/g cream

Activir Duo contains two active ingredients: aciclovir and hydrocortisone.

How is it used?

What is Activir Duo and what is it used for?

Activir Duo contains two active ingredients: aciclovir and hydrocortisone. Aciclovir is a virus inhibitor that helps fight the virus that causes cold sores. Hydrocortisone is a weak steroid that relieves the inflammation associated with cold sores.

Activir Duo cream is used in adults and young people aged 12 years or older for the treatment of early signs and symptoms (e.g. tingling, itching or redness) of cold sores on lips and the skin around the lips to reduce the risk of a blister forming.

Even if your cold sore has developed into a blister, Activir Duo will shorten the healing process by about half a day to a day compared to the cream without active ingredients.

A cold sore is caused by a virus called herpes simplex. The virus causes blisters and sores mainly on the lips, but sometimes on other parts of the face. A cold sore can develop when the body's immune system is weakened, for example if you have a cold or other infection. Stress, strong sunlight, cold temperatures or menstruation can also trigger a cold sore.

If you do not feel better or even worse after 5 days of stopping treatment, contact your doctor.

What should you remember before taking this medicine?

What should you be aware of before using Activir Duo?
Activir Duo must not be used,
- if you are allergic to aciclovir, valaciclovir, hydrocortisone or any of the other ingredients of this medicine listed in section 6.
- for skin infections other than cold sores.

Warnings and precautions
Please talk to your doctor or pharmacist before using Activir Duo.

Apply Activir Duo only to affected areas of skin on your lips or the skin around your lips.

Talk to your doctor if you have severe recurrent cold sores to make sure you do not have any other health problems.

Do not use Activir Duo:

• in your eyes, mouth, nose or private parts.
• for the treatment of genital herpes.
• if your immune system is not working properly (e.g. if you have had a bone marrow transplant or have AIDS/HIV) or if you have been diagnosed as having a weakened immune system.
• With a dressing such as a plaster or cold sore patch.

Wash your hands before and after applying it to prevent your cold sore from getting worse or you passing the infection on to someone else.

Contact your doctor if you have blurred vision or other vision problems.

Do not use for more than 5 days.

Children and adolescents
Do not use this medicine in children under 12 years of age as it is not known if it will work for them or if it is safe for them to use.

Use Activir Duo with other medicines
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

It is not known whether the effect of Activir Duo can be influenced by the simultaneous use of other medicines.

Use Activir Duo with food and drink
Do not apply the cream immediately before eating, as the cream may be licked off.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

This medicine should not be used during pregnancy or breast-feeding unless your doctor considers that the potential benefits outweigh the possibility of unknown risks.

Driving and ability to operate machinery
The use of Activir Duo does not affect your ability to drive or operate machinery.

Activir Duo contains propylene glycol and cetylstearyl alcohol
This medicine contains 200 mg/g propylene glycol.

Cetylstearyl alcohol may cause local skin irritation (e.g. contact dermatitis).

Activir Duo contains sodium dodecyl sulphate
This medicinal product contains 8 mg/g sodium dodecyl sulphate.
Sodium dodecyl sulphate may cause local skin irritation (such as a stinging or burning sensation) or increase skin reactions caused by other products applied to the same skin site.

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How should the medicine be taken?

How should Activir Duo be used?

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.

Only for use on the skin.

Do not use more than the recommended dose.

Adults and adolescents aged 12 years and over
Apply the cream 5 times a day for 5 days (i.e. approximately every 3-4 hours while you are awake). It is recommended to start treatment as soon as possible, preferably at the first signs or discomfort (e.g. tingling, redness or itching).

Do not use for more than 5 days. If you do not feel better or even worse after 5 days after stopping treatment, contact your doctor.

How to use
Wash your hands before and after applying to avoid making your cold sore worse or spreading the infection to someone else.

If you get a boil, do not touch it more than necessary to avoid spreading the infection to other areas of your body or to your eyes.

If you have used more Activir Duo than you should
If you have accidentally used too much or swallowed too much cream, no adverse effects are expected. However, if you have swallowed a large amount of cream, please talk to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you forget to use Activir Duo
Apply the cream as soon as you remember and continue using it as usual. Do not apply twice the amount if you have forgotten to apply it previously

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What are the possible side effects?

How should Activir Duo be stored?

Store this medicine out of the reach of children.

Do not store above 25°C. Do not store in the refrigerator or freeze.

Do not use this medicine after the expiry date which is stated on the carton and tube after "EXP". The expiry date refers to the last day of the month indicated.

Shelf life after opening: 3 months.

You must not use this medicinal product if you notice that the appearance and/or consistency of the cream has changed.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. By doing so, you are helping to protect the environment.

Special notes on the contents

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Contents of the pack and other information

What Activir Duo contains

- The active ingredients are: Aciclovir and hydrocortisone. One gram of cream contains 50 mg aciclovir and
10 mg hydrocortisone.
- The other ingredients are: thick paraffin, propylene glycol, isopropyl myristate, sodium dodecyl sulphate, cetyl stearyl alcohol, white vaseline, poloxamer 188, citric acid monohydrate, sodium hydroxide, hydrochloric acid and purified water.

What Activir Duo looks like and contents of the pack
Each tube contains 2 g of Activir Duo cream. Activir Duo is a white to yellowish cream.
The tube is made of polyethylene plastic laminated with aluminium,

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