Erazaban 10% krem

Leaflet attached to the packaging: information for the user

ERAZABAN 10% Cream

Docosanolum

100 mg/g cream

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine is available without a prescription. However, to achieve good treatment results,
ERAZABAN 10% Cream should be used carefully.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, please consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform the pharmacist. See section 4.
• If there is no improvement after 10 days or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

• 1. What is ERAZABAN 10% Cream and what is it used for
• 2. Important information before using ERAZABAN 10% Cream
• 3. How to use ERAZABAN 10% Cream
• 4. Possible side effects
• 5. How to store ERAZABAN 10% Cream
• 6. Package contents and other information

1. What is ERAZABAN 10% Cream and what is it used for

Docosanol is an antiviral medicine. ERAZABAN 10% Cream is a white cream,
used to treat early symptoms of recurring herpes simplex virus infections - Herpessimplex,in adults and children (over 12 years old).
To be effective, treatment with ERAZABAN 10% Cream should be started at an early stage of the herpes infection, before the blisters appear. The patient should start
treatment as soon as they notice any symptoms of cold sores, such as redness, itching, pain, tingling, or stinging. Treatment should be continued until the cold sore has healed, usually

• 4 - 6 days.

The cause of cold sores is herpes simplex virus infection.
Infection can occur when the immune system is weakened, during stress, or during menstruation. The virus causes blisters or sores,
mainly on the lips.

2. Important information before using ERAZABAN 10% Cream

When not to use ERAZABAN 10% Cream

Warnings and precautions

• ERAZABAN 10% Cream is for skin use only. Avoid getting the cream in or around the eyes, as it may cause irritation. If the cream accidentally gets into the eyes, they should be rinsed thoroughly with plenty of water.
• The medicine should not be used if the patient has a weakened immune system (if the body's ability to fight infections is reduced, e.g., due to severe diseases such as leukemia or AIDS, or after organ transplantation). If a patient with a weakened immune system develops a cold sore, they should consult a doctor immediately.
• The cream should not be used if blisters or sores have already appeared due to the cold sore.

Use in children

ERAZABAN 10% Cream should not be used in children under 12 years old.

ERAZABAN 10% Cream and other medicines

ERAZABAN 10% Cream should not be used at the same time as other products applied to the same areas (medicines, cosmetics, creams).
It is unlikely that ERAZABAN 10% Cream will affect other medicines or that other medicines will affect ERAZABAN 10% Cream, as it is for skin use only.
However, other topical medicines should not be used to treat cold sores at the same time as ERAZABAN 10% Cream.
For any questions about how ERAZABAN 10% Cream interacts with other medicines, please consult a pharmacist.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription.

Pregnancy and breastfeeding

ERAZABAN 10% Cream can be used during pregnancy and breastfeeding.

Driving and using machines

ERAZABAN 10% Cream does not affect the ability to drive or use machines.

ERAZABAN 10% Cream contains propylene glycol

This medicine contains 50 mg of propylene glycol in every 1 gram of cream.

ERAZABAN 10% Cream contains benzyl alcohol

This medicine contains 27 mg of benzyl alcohol in every 1 gram of cream. Benzyl alcohol may cause allergic reactions.
Benzyl alcohol may cause mild local irritation.

3. How to use ERAZABAN 10% cream

Adults and adolescents over 12 years old:

• Treatment should be started as soon as the first symptoms of a cold sore appear, such as itching, burning, stinging, or tingling in the affected area.
• Wash your hands carefully before and after applying the medicine to avoid spreading the infection.
• Apply a thin layer of cream to the entire surface of the cold sore five times a day (at approximately 3-hour intervals during the day).
• Apply the medicine with the tip of your finger or, preferably, use a hygiene stick, avoiding touching the end of the tube after touching the cold sore.
• Continue treatment until the cold sore has healed, which usually occurs between the 4th and 6th day of treatment.
• If there is no reduction in the severity of the symptoms after 10 days, the use of the medicine should be stopped, and a doctor should be consulted.
• Please remember that ERAZABAN 10% Cream should only be used by one person. Passing the tube to other people may spread the infection.

Using more than the recommended dose of ERAZABAN 10% Cream

There should be no serious problem if a large amount of cream is applied to the skin. No specific treatment is necessary.

Missing a dose of ERAZABAN 10% Cream

If the patient forgets to use ERAZABAN 10% Cream, they should use it as soon as they remember.
For any additional questions about using this medicine, please consult a pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following convention has been used to determine the frequency of side effects:
very common (more than 1 in 10 patients), common (between 1 in 100 patients and 1 in 10 patients), uncommon (between 1 in 1000 patients and 1 in 100 patients), rare
(between 1 in 10,000 patients and 1 in 1000 patients), very rare (less than 1 in 10,000 patients).
Very common:

• Headache

Common:

• Skin disorders, including dry skin, rash, and facial swelling at the site of cream application.

In case of severe skin reactions, treatment should be discontinued, and if they do not resolve, a doctor should be consulted.
If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301,
Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store ERAZABAN 10% Cream

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after “Expiry Date (EXP)”. The expiry date refers to the last day of the month.
Discard 6 months after first opening the tube.
Shelf life after first opening the tube - 6 months.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ERAZABAN 10% Cream contains

• The active substance is docosanol. One gram of cream contains 100 mg of docosanol (10%).
• The other ingredients are stearyl and distearyl saccharose, light mineral oil, propylene glycol, benzyl alcohol, and purified water.

What ERAZABAN 10% Cream looks like and contents of the pack

ERAZABAN 10% Cream is a white cream.
It is available in packs of 2 g, 5 g, and 15 g.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Phoenix Healthcare Limited
Suite 12 Bunkilla Plaza
Bracetown Business Park
Clonee, Co. Meath
Ireland

Manufacturer

DAU Laboratori
C / Lletra C, 12 14, P. I. Zona Franca
08040 Barcelona
Spain

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Austria
Erazaban 100 mg/g Creme
Belgium
ERAZABAN 100 mg/g Crème
France
ERAZABAN 10 %, crème
Poland
ERAZABAN 10 % Krem
Date of revision of the leaflet:14.01.2022