Document: Xerclear cream ENG PL change

• Xerclear cream PL
• Xerclear cream ENG PL

---

PACKAGE LEAFLET: INFORMATION FOR THE USER

Xerclear 50 mg/g and 10 mg/g cream

aciclovir and hydrocortisone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

Xerclear cream is used for the treament of early signs and symptoms (e.g. tingling, itching or redness) of cold sores on the lips and face to reduce progression of cold sores episodes to ulcerative lesions.

If you have developed a cold sore, Xerclear will shorten the healing process by approximately half to one day compared to the cream without the active ingredients.

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

Xerclear consists of two active ingredients: aciclovir and hydrocortisone. The active ingredient aciclovir stops the growth of the virus. The other active ingredient, hydrocortisone, helps treating the inflammation that develops when you have a cold sore.

Do not use Xerclear

- if you are allergic to aciclovir, valaciclovir or hydrocortisone or any of the other ingredients of Xerclear (listed in section 6 ).

- if you have other skin lesions on your lips and face that you do not recognize as your normal cold sore (e.g. fungal, bacterial or parasitic skin infection).

Warnings and precautions

Talk to your doctor before using Xerclear

- if you have an increased risk of infections due to a weak immune system, for example if you have HIV or if you have had a bone marrow transplant. Please contact your doctor before using Xerclear.

- Xerclear should only be used to treat cold sores on the lips and skin close to the lips. Do not apply Xerclear to to mucous membranes such as eyes, inside the mouth, nose or genitals since this can cause slight irritation. If you by mistake get some cream in your eyes, rinse thoroughly with water. It is not harmful if you swallow some cream by mistake. The cream has a bitter taste.

- Do not cover the cold sore area with a bandage or dressing, as this might increase the risk of skin irritation

Children and adolescents

-Xerclear should not be used by children below 12 years of age.

Other medicines and Xerclear

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

It is not known if the effect of Xerclear can be affected by use of other medicines at the same time as Xerclear.

Xerclear with food and drink

Do not put the cream on just before eating since the cream may then be licked off.

Pregnancy and breast-feeding

There is limited experience of using Xerclear during pregnancy. Xerclear should not be used during pregnancy or breast feeding unless clearly necessary. Ask your doctor for advice before taking any medicine.

Driving and using machines

Using Xerclear does not affect your ability to drive and use machines.

Xerclear contains propylene glycol and cetosteryl alcohol

Propylene glycol which can cause skin irritationCetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

Always use Xerclear exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosing instructions

Xerclear is for external use only.

Adults and children over 12 years:The cream works best if you start treatment as soon as possible after the first signs of infection, (e.g. tingling, itching or redness). Spread a layer of cream onto the affected area 5 times a day. This corresponds to every 3-4 hours during daytime. Continue the treatment for 5 days. If your symptoms worsen or do not improve after 5 days, you should discontinue the treatment and seek medical advice.

Administration

Wash your hands before and after you use the cream to avoid spreading the infection.

If you do develop an ulcer, do not touch the ulcer more than necessary in order not to spread the infection to other areas of the body, or to your eyes.

If you use more Xerclear than you should

It is unlikely that Xerclear will cause any problems if you use too much cream. There should not be any risks if you accidentally use a large amount of cream on the skin. No special treatment is necessary. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xerclear can cause side effects, although not everybody gets them.

For Xerclear, the following side effects can occur:

Common (affects 1 to 10 users in 100)

Uncommon (affects 1 to 10 users in 1000)

Rare (affects 1 to 10 users in 10000)

• Signs of inflammation such as swelling of the lip

• Erythema

• Pigmentation changes,

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Xerclear

Keep this medicine out of the sight and reach of children.

Store below 25°C. Do not refrigerate or freeze.

Do not use Xerclear after the expiry date which is stated on the carton and tube after EXP. The expiry date refers to the last day of that month. Shelflife after opening of the tube: 12 months.

Do not use Xerclear if you notice that the cream has changed in appearance and/or texture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Xerclear contains

• The active substances are aciclovir and hydrocortisone. One gram cream contains 50 mg aciclovir and 10 mg hydrocortisone.

• The other ingredients are liquid paraffin, propylene glycol, isopropyl myristate, sodium lauril sulphate, cetostearyl alcohol, white soft paraffin, poloxamer 188, citric acid monohydrate, sodium hydroxide, hydrochloric acid and purified water.

What Xerclear looks like and contents of the pack

Each tube contains 2g or 5g of Xerclear cream. The cream is white to slight yellow.

The tube is made of polyethylene plastic laminated with aluminium.

Marketing Authorisation Holder and Manufacturer

<[To be completed nationally]>

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden: Xerclear

This leaflet was last revised in 26 May 2015