Healip
PACKAGE LEAFLET: INFORMATION FOR THE USER
Healip10% cream
Docosanol
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Healipcarefully to get the best results from it.
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Keep this leaflet. You may need to read it again.
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Ask your pharmacist if you need more information or advice.
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You must stop using the cream and contact a doctor if your symptoms worsen or do not improve after 10 days.
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If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
What is Healip and what it is used for
Before you use Healip
How to use Healip
Possible side effects
How to store Healip
Further information
WHAT HEALIP IS AND WHAT IT IS USED FOR
Docosanol is an antiviral agent. Healipis a white cream used for the treatment of early stages of recurrent labial herpes simplex infection (cold sores) in adults and adolescents (over 12 years old).
To be effective, treatment with Healipmust start in the early stages of a cold sore, before the blisters appear. Start using Healipas soon as you get any of the symptoms of a cold sore,such as redness, itching, pain, tingling or prickling. Continue using until the cold sore is healed, usually 4-6 days.
The cause of cold sores is a herpes simplex virus infection. The infection may break out when the immune system is weakened, during stress or during a menstrual period. The virus causes blisters or sores, mainly on the lips.
BEFORE YOU USE HEALIP
Do not use Healip
If you are allergic (hypersensitive) to docosanol or any of the other ingredients in the cream listed at the end of this leaflet (see section 6).
Take special care with Healip
Healip is intended for cutaneous use only. Avoid getting the cream in or close to your eyes as this may cause irritation. If you accidentally get cream in your eyes rinse them thoroughly with plenty of water.
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Do not use this product if you have been told you are immunocompromised (if your immune system’s ability to fight infectious diseases is known to be reduced, e.g. by a serious illness such as leukaemia or AIDS or if you may have had an organ transplant). If you are immunocompromised and you develop a cold sore you should consult your doctor immediately.
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Do not apply the cream if the cold sore has already formed a blister or ulcer like appearance.
Children
Children under 12 years should not use Healip.
Using other medicines
Healip should not be used with other topical products (medicines, cosmetic products, creams) at the same application site”. It is unlikely that Healipaffects or is affected by other medicines since Healipis intended for cutaneous use only, however do not apply other cold sore medicines whilst using Healip.
Ask your pharmacist if you have any questions regarding how Healipis affected by, or affects, 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
Healipcan be used during pregnancy and breast-feeding.
Driving and using machines
Healiphas no effect on driving or using machines.
Important information about some of the ingredients of Healip
Healipcontains propylene glycol which can cause skin irritation.
HOW TO USE HEALIP
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Adults and adolescents over 12 years: Start treatment as soon as you notice the first symptoms or signs of a cold sore, for instance itching, stinging, burning or prickling in the affected area.
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Wash your hands thoroughly before and after treatment to avoid spreading the infection.
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Apply a thin film carefully over the entire cold sore five times a day. (Approximately every 3 hours during waking hours).
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Use a fingertip or, preferably, a cotton bud and avoid touching the end of the tube after you have touched the cold sore.
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Continue treatment until healing is complete, usually between 4 and 6 days.
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If you notice no difference after 10 days you should stop the treatment and contact your doctor.
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Remember that Healip is your medicine. If you lend the tube to anyone you risk spreading the infection to others.
If you use more Healipthan you should
No serious problem should arise if you have used a large amount of the cream on your skin. No special treatment is necessary.
If you forget to use Healip
If you forget to use Healip, use it as soon as you remember.
If you have any further questions on the use of this product, ask your pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Healipcan cause side effects, although not everybody gets them.
For the frequency of occurrence of side effects, the following phrases are used: verycommon (more than 1 in 10 users), common (between 1 in 100 users and 1 in 10 users), uncommon (between 1 in 1000 users and 1 in 100 users), rare (between 1 in 10000 users and 1 in 1000 users), very rare (in less than 1 in 10000 users).
Nervous system problems:
Very common: headache.
Skin problems:
Common: skin disorders including dry skin, skin rashes and facial swelling occurring where the cream has been applied.
If a more severe skin reaction occurs you should cease treatment, and if the problem does not disappear you should contact your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE HEALIP
Keep out of the reach and sight of children.
Do not use Healipafter the expiry date which is stated on the cartonand on the tubeas “Expiry date month/year”. The expiry date refers to the last day of that month.
Discard 6 months after first opening the tube.
Do not store above 25ºC.
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 Healipcontains
The active substance is docosanol. One gram of cream contains 100 mg docosanol.
The other ingredients are sucrose stearates, light mineral oil, propylene glycol, benzyl alcohol and purified water.
What Healiplooks like and contents of the pack
Healipis a white cream.
It is available in pack sizes of 2 g, 5 g and 15 g.
Not all pack sizes may be marketed.
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:
Austria ERAZABAN 10 % - Creme
Belgium ERAZABAN 10 % Crème
Bulgaria ERAZABAN
Czech Republic ERAZABAN 10 % Krém
France ERAZABAN 10% crème
Germany Muxan
Hungary ERAZABAN 10 % krém
Ireland ERAZABAN 100 mg/g Cream
Poland ERAZABAN 10 % Krem
Portugal Erazaban 10% Creme
Romania Erazaban 100 mg/g crema
Spain Muxan
Slovakia ERAZABAN 10 % Krém
Slovenia ERAZABAN 10 % krema
Sweden Healip 10% Kräm
United Kingdom Blistex Cold Sore Cream
This leaflet was last approved in 19 June 2014