Document: Healip cream ENG PL change

• Healip cream PL
• Healip cream ENG PL

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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.

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

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

• You must stop using the cream and contact a doctor if your symptoms worsen or do not improve after 10 days.

• 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:

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.

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

• 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.

• Do not apply the cream if the cold sore has already formed a blister or ulcer like appearance.

Children

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.

• 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.

• Wash your hands thoroughly before and after treatment to avoid spreading the infection.

• Apply a thin film carefully over the entire cold sore five times a day. (Approximately every 3 hours during waking hours).

• Use a fingertip or, preferably, a cotton bud and avoid touching the end of the tube after you have touched the cold sore.

• Continue treatment until healing is complete, usually between 4 and 6 days.

• If you notice no difference after 10 days you should stop the treatment and contact your doctor.

• 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.

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.

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.

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