NOTICE
ANSM - Last updated: 24/04/2017
Name of the medicinal product
ERAZABAN 10% cream
docosanol
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is ERAZABAN 10%, cream and in what cases is it used?
2. What should I know before using ERAZABAN 10%, cream?
3. How to use ERAZABAN 10%, cream?
4. What are the possible side effects?
5. How to store ERAZABAN 10%, cream?
6. Package contents and other information.
1. WHAT IS ERAZABAN 10%, cream AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: chemotherapy for topical use, antivirals, ATC code: D06BB11.
Docosanol is an antiviral agent. ERAZABAN is a white cream used in the treatment of early stages of recurrent Herpes simplex labial (fever) infection in adults and adolescents over 12 years of age. To be effective, treatment with ERAZABAN should begin at the early stages of the cold sore, before the blister appears. Start using ERAZABAN as soon as you feel signs of a cold sore, such as redness, itching, pain, tingling and burning sensation. Continue to use it until healing the cold sore, usually for 4 to 6 days.
The origin of cold sores is linked to an infection with Herpes simplex virus. Infection can occur when the immune system is weakened, during a period of stress or during menstruation. The virus is responsible for the appearance of blisters or "pimples", mostly on the lips.
2. BEFORE YOU USE ERAZABAN 10%, cream?
Do not use ERAZABAN 10%, cream:
· if you are allergic to docosanol or to any of the other ingredients in the cream and mentioned at the end of this leaflet (see section 6).
Warnings and Precautions
· ERAZABAN is for external use only. Inappropriate contact may cause irritation: avoid eye contact and eye contact. Do not ingest and do not apply to the genitals. In case of accidental contact with eyes, rinse thoroughly with water.
· Do not use if you have been informed that you are immunocompromised (if it is known that your immune system's ability to fight infectious diseases is reduced, for example in a serious illness such as leukemia or AIDS) have undergone an organ transplant. If you are immunocompromised and develop a cold sore, consult your doctor immediately.
· Children: Children under 12 years old should not use ERAZABAN.
Other medicines and ERAZABAN 10%, cream
ERAZABAN should not be used with other topical products (medicines, cosmetics, creams) on the same application site. It is unlikely that ERAZABAN will cause interactions or be affected by other medicines, as ERAZABAN is for topical use only.
If you have any questions about the influence of other medicines on ERAZABAN or the influence of ERAZABAN on other treatments, ask your pharmacist.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Pregnancy and breast feeding
ERAZABAN 10% cream can be used during pregnancy and lactation.
Driving and using machines
ERAZABAN has no effect on driving or operating machinery.
ERAZABAN 10%, cream contains propylene glycol.
This component may cause skin irritation.
3. HOW TO USE ERAZABAN 10%, cream?
Dosage
Adults and adolescents (children over 12 years of age):
· Begin treatment as soon as you notice the first signs or symptoms of a cold sore, such as itching, stinging, burning or tingling in the affected area.
· Wash your hands thoroughly before and after treatment so as not to spread the infection.
· Apply a thin layer of cream thoroughly to the entire cold sore five times a day. (Approximately every 3 hours until bedtime).
· Use your finger or preferably a cotton swab to avoid contaminating the tube after touching the cold sore.
· Continue treatment until complete healing. The treatment usually lasts between 4 and 6 days.
· If symptoms persist after 10 days, stop treatment and contact your doctor.
· ERAZABAN is a medicine. Never lend it to anyone else: you may transmit your infection.
If you used more ERAZABAN 10%, cream than you should have
There should not be any major problem if you have spread too much cream on your skin. No specific treatment will be necessary .
If you forget to use ERAZABAN 10%, cream
If you forget to use ERAZABAN 10% cream, resume your treatment as soon as possible.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The frequencies of occurrence of side effects are defined with the following terms: very common (more than 1 times out of 10); frequent (between 1 time out of 100 and once out of 10); uncommon between 1 time in 1000 and once in 100); rare between 1 time out of 10000 and once out of 1000); very rare (less than 1 in 10000), unknown frequency (can not be estimated from the available data).
Nervous System Disorders
Very common: headache.
Skin and subcutaneous tissue disorders
Common: Skin conditions such as dryness of the skin, redness of the skin and swelling of the face may appear on areas where the cream has been applied.
If there is a more severe skin reaction, discontinue the treatment immediately. If the problem persists, contact your doctor.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ERAZABAN 10%, cream?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
To be discarded 6 months after the first opening of the tube.
Store at a temperature not exceeding 25 ° C.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ERAZABAN contains 10%, cream
· The active substance is: docosanol.
One gram of cream contains 100 mg of doconasol (10%).
· The other components are:
Sucrose stearates , light liquid paraffin, propylene glycol, benzyl alcohol, purified water.
What is ERAZABAN 10%, cream and contents of the pack
ERAZABAN is a cream of white color available in presentations of 2 g, 2 g with a transparent case protector tube, 5 g and 15 g.
Not all packaging may be marketed.
Marketing Authorization Holder
CAG PHARMA
8 RUE DE LA SOURCE
92310 SEVRES
Marketing Authorization Operator
TONIPHARM
3 rue des Quatre Chimneys
92100 Boulogne-Billancourt
Maker
Fleet Laboratories Limited
94 Rickmansworth Road
Watford
Hertfordshire WD18 7JJ
UK
OR
JENSON PHARMACEUTICAL SERVICES LTD.
CARRADINE HOUSE, 237 REGENTS PARK ROAD
LONDON N3 3LF
UK
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names: In accordance with the regulations in force.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).
ADVICE / HEALTH EDUCATION
Cold sores or cold sores are due to an infection caused by a virus called Herpes Simplex . After a primary infection, the virus persists in the body without causing symptoms.
During an event such as fatigue, menstruation, fever, emotion or sun exposure, the virus can sometimes be reactivated and cause the appearance of vesicles (blisters) in bouquets around the lips, called fever. These vesicles are contagious until the appearance of scabs, sign of scarring.
There are warning signs located at the usual location of the lesion, which usually result in burning and / or tingling sensations.
These signs are important to know:
· it is as soon as they appear that the treatment must be started which prevents viral multiplication and makes it possible to prevent or limit the development of the cold sore,
· it is also as soon as they appear that you must respect the hygiene rules given to you in the precautions of use, in order to reduce the risk of transmission of the virus.
On the other hand, docosanol can not act on viruses that persist in the latent state in the body and docosanol does not prevent the occurrence of recurrences after the interruption of the treatment.