Document: Contra 5% cream ENG PL change

• Contra cream PL
• Contra 5% cream ENG PL

---

Package leaflet: Information for the user

Contra 5 % cream

Aciclovir

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

• Ask your pharmacist if you need more information or advice.

• 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.

• You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

What is in this leaflet:

1. What Contra is and what it is used for

2. What you need to know before you take Contra

3. How to take Contra

4. Possible side effects

6. Contents of the pack and other information

Contra is used for the treatment of cold sores and blisters, on or around the lips or in the face, caused by herpes simplex virus.

The cause of cold sores (herpes lablialis) is a virus called herpes simplex. The virus causes blisters or sores, on the lips primarily but also in other parts of the face. The virus infection can be activated when the immune system is weakened, e.g. by colds or other infections. Strong sun, stress or menstruation can also trigger the symptoms. Contra inhibits the virus ability to reproduce and therefore make the infection to reverse.

Do not take Contra

Talk to your doctor or pharmacist before taking Contra

- if you are allergic to aciclovir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

- if you are very sensitive to infections, e.g. if you have AIDS or have had a bone marrow transplant, Contra should only be used when recommended by a doctor.

Contra is only intended for cutaneous use. The cream may sting slightly on mucous membranes. Avoid cream in the eyes, in the mouth or on other mucous membranes. If you accidentally get cream into your eyes, wash it out with plenty of water. If you accidentally get any cream into your mouth it is not dangerous to unintentionally swallow the cream.

Children

Contra is not recommended for use in children below 12 years.

Other medicines and Contra

No clinically significant interactions have been identified when using Contra at the same time as other medicinal products. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The uptake of aciclovir is low after topical application of Contra.

It is unlikely that the use of Contra during breast feeding would affect the child. Ask your doctor for advice before prolonged use of Contra.

Driving and using machines

It is unlikely that Contra would affect the ability to drive or use machines.

Contra contains propylene glycol and cetyl alcohol

Contra contains propylene glycol which may cause skin irritation and cetyl alcohol that may cause local skin reactions (e.g. contact dermatitis).

Always take 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.

Adults and children over 12 years: Start using the cream as soon as you feel the first symptoms of cold sore, preferably with in 4 hours. It might feel like tingling, smarting or itching on the place of the infection. Wash your hands before and after applying the cream, this will prevent the infection getting worse or spreading. It is preferred to use a cotton bud to apply the cream to avoid spreading the virus or getting bacteria in the wound.

Apply the cream to the affected area of skin five times daily about every four hours for five days. If your symptoms worsen or do not improve after 5 days, you should discontinue the treatment.

You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

Do no apply the cream prior to a meal as it could easily be ingested. To avoid spreading the infection to other parts of the body or the eyes, avoid touching the wound or letting others do so.

If you take more Contra than you should

If you have used large amounts of cream, it is not likely that this will cause any problems. No special actions are required.

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

4. Possible side effects

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

If you experience serious skin reactions you may be allergic to any of the ingredients of the cream. Stop using the cream. If the side effects do not improve tell your doctor.

Common (seen in more than 1 in 100 users): Numbness where the cream has been applied.

Uncommon (seen in less than 1 of 100 and more than 1 of 1,000 users):Transient burning or stinging following application. Mild drying or flaking of the skin. Itching.

Rare: (seen in less than 1 of 1,000 and more than 1 of 10,000 users):Erythema. Contact dermatitis following application. Where sensitivity tests have been conducted, the reactive substances have most often been shown to be components of the cream rather than aciclovir.

Very rare: (seen in less than 1 of 10 000 users): Immediate hypersensitivity reactions including swelling of face, tounge or throat or urticaria (angioedema), if this happens you should immediately stop taking Contra and contact a doctor.

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 Contra

Keep out of the sight and reach of children.

Do not store above 25 ºC

Do not use this medicine after the expiry date which is stated on the carton.

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 otherinformation

What Contra contains

• The active substance is aciclovir. 1 gram cream contains aciclovir 50 mg.

• The other ingredients are stearoyl macrogolglycerides, dimeticone, cetyl alcohol, light liquid paraffin, white vaseline, propylene glycol and purified water.

What Contra looks like and contents of the pack

Contra 5 % cream is white and shiny. Contra is available in two types of packs; plastic bottle with pump dispenser and aluminium tubes both containing 2 g and available without prescription. Aluminium tubes containing 5 g (prescription) are also available.

Marketing Authorisation Holder

Meda OTC AB

Box 906

170 09 Solna

Sweden

Manufacturer:

C.P.M. ContractPharma GmbH & Co. KG

Frühlingstraße 7

DE-83620 Feldkirchen-Westerham

Germany

This leaflet was last approved in 21 January 2016