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
5.
How to store Contra
6.
Contents of the pack and other information
1.
What Contra is and what it is used for
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.
2.
What you need to know before you take Contra
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
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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).
3.
How to take Contra
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.
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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 other information
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
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