Erazaban 10% cream

Patient Information Leaflet

ERAZABAN 10% Cream
Docosanol
100 mg/g cream
Please read this leaflet carefully before using this medicine, as it contains
important information for you.
This medicine is available without a prescription. However, to achieve effective treatment,
ERAZABAN 10% Cream should be used carefully.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your pharmacist. See section 4.
• If there is no improvement after 10 days, or if your condition worsens, consult your doctor.

Leaflet contents:

1. What ERAZABAN 10% Cream is and what it is used for
2. Before you use ERAZABAN 10% Cream
3. How to use ERAZABAN 10% Cream
4. Possible side effects
5. How to store ERAZABAN 10% Cream
6. Contents of the pack and other information

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

Docosanol is an antiviral medicine. ERAZABAN 10% Cream is a white cream used for the treatment of early symptoms of recurrent oral herpes infections caused by Herpes simplex virus in adults and children (over 12 years of age).
For effective treatment, ERAZABAN 10% Cream should be started as early as possible, at the first sign of a cold sore, before blisters appear. Treatment should begin immediately upon noticing any symptoms of oral herpes, such as redness, itching, pain, tingling or burning. Treatment should be continued until the lesion heals, usually 4–6 days.
Cold sores are caused by infection with the herpes simplex virus – Herpes simplex. Infection may occur when the immune system is weakened, during periods of stress, or during menstruation. The virus causes the formation of blisters or ulcers, primarily on the lips.

2. Important information before using ERAZABAN 10% Cream

When not to use ERAZABAN 10% Cream

• if the patient is allergic to docosanol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• ERAZABAN 10% Cream is intended for topical use only. Avoid contact with or near the eyes, as this may cause irritation. If the cream accidentally gets into the eyes, rinse thoroughly with plenty of water.
• Do not use ERAZABAN 10% Cream in patients with a weakened immune system (if the ability of the immune system to fight infectious diseases is reduced, e.g. due to serious illnesses such as leukemia or AIDS, or after organ transplantation). If a patient with a weakened immune system develops herpes, they should consult a doctor immediately.
• Do not use the cream if blisters or ulcers have already developed as a result of herpes infection.

Use in children
Do not use ERAZABAN 10% Cream in children under 12 years of age.

ERAZABAN 10% Cream and other medicines
Do not use ERAZABAN 10% Cream simultaneously with other products applied topically to the same areas (medicines, cosmetics, creams).
It is unlikely that ERAZABAN 10% Cream affects other medicines or that other medicines affect ERAZABAN 10% Cream, as it is intended for topical use only. However, do not use other topical medicines for the treatment of herpes at the same time as ERAZABAN 10% Cream.
For any questions regarding how ERAZABAN 10% Cream may interact with other medicines or how other medicines may affect ERAZABAN 10% Cream, consult a pharmacist.
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those available without a prescription.

Pregnancy and breastfeeding
ERAZABAN 10% Cream may be used during pregnancy and breastfeeding.

Driving and operating machinery
ERAZABAN 10% Cream has no effect on the ability to drive or operate machinery.

ERAZABAN 10% Cream contains propylene glycol
This medicine contains 50 mg of propylene glycol in each 1 gram of cream.

ERAZABAN 10% Cream contains benzyl alcohol
This medicine contains 27 mg of benzyl alcohol in each 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 of age:

• Begin treatment as soon as the first symptoms of cold sore appear, such as itching, tingling, burning, or stabbing sensation at the site of infection.
• Wash hands thoroughly before and after applying the medicine to avoid spreading the infection.
• Carefully apply a thin layer of the cream over the entire area of the cold sore lesions five times daily (at approximately 3-hour intervals during the day).
• Apply the medicine using the fingertip or, preferably, a clean applicator, avoiding contact of the tube's tip with the affected area after touching the lesions.
• Continue treatment until complete healing, which usually occurs between day 4 and 6 of treatment.
• If there is no improvement in symptoms after 10 days, discontinue use and consult a physician.
• Remember that ERAZABAN 10% Cream should be used by only one person. Sharing the tube with others may result in transmission of infection.

Use of more than the recommended amount of ERAZABAN 10% Cream
Serious problems are unlikely to occur following application of a large amount of cream to the skin. Specific treatment is not necessary.
Missed application of ERAZABAN 10% Cream
If the patient forgets to apply ERAZABAN 10% Cream, it should be applied as soon as remembered.
For any additional questions regarding the use of this medicine, consult a pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody will get them.
The following convention has been used to describe the frequency of adverse reactions:
very common (more than 1 in 10 patients), common (between 1 in 100 and 1 in 10 patients),
uncommon (between 1 in 1,000 and 1 in 100 patients), rare (between 1 in 10,000 and 1 in 1,000 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.

If more severe skin reactions occur, treatment should be discontinued and, if they persist, a doctor should be consulted.
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ERAZABAN 10% Cream

Keep this medicine 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 stated month.
Discard 6 months after first opening the tube.
Shelf-life after first opening of the tube - 6 months.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging 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: sucrose stearate and distearate, light liquid paraffin, 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 packages containing 2 g, 5 g, and 15 g.
Not all package sizes may be marketed.
Marketing Authorisation 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 authorised for marketing in the European Economic Area countries under the following names:
Austria Erazaban 100 mg/g Creme
Belgium ERAZABAN 100 mg/g Crème
France ERAZABAN 10 %, crème
Poland ERAZABAN 10 % Cream