NOTICE
ANSM - Updated on: 16/06/2017
Name of the medicinal product
BIAFINE, emulsion for skin application
trolamine
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 BIAFINE, an emulsion for dermal application and in which cases it is used?
2. What should I know before using BIAFINE, an emulsion for skin application?
3. How to use BIAFINE, emulsion for skin application?
4. What are the possible side effects?
5. How to store BIAFINE, emulsion for skin application?
6. Package contents and other information.
1. WHAT IS BIAFINE, an emulsion for dermal application AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: CUTANEOUS PROTECTOR (D. Dermatology).
· Erythema secondary to radiotherapeutic treatments.
· First and second degree burns and other uninfected cutaneous wounds.
2. BEFORE YOU USE BIAFINE, an emulsion for skin application?
Talk to your doctor or pharmacist before using BIAFINE, an emulsion for skin application.
Do not use BIAFINE, emulsion for skin application
· if you are allergic to trolamin or any of the other ingredients of this medication mentioned in section 6.
· if you have a hemorrhagic wound (with bleeding).
· if you have an infected lesion.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
In the event of burning with blistering or extensive burning, or in the case of a deep or extended wound, a medical consultation is essential before applying a medication to the lesion.
This medicine contains propylene glycol and may cause skin irritation.
This medicine contains potassium sorbate and may cause local skin reactions (eg, eczema).
This medicine contains sodium methyl parahydroxybenzoate and soda propyl parahydroxybenzoate and may cause allergic reactions.
This medication is not a sunscreen.
This medication should not be used as a care cream on healthy skin.
Do not apply near eyes.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
children
Not applicable.
Other medicines and BIAFINE, emulsion for skin application
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
BIAFINE, emulsion for skin application with food and beverages
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or your pharmacist before taking this medicine.
Driving and using machines
Not applicable.
BIAFINE, emulsion for dermal application contains propylene glycol, potassium sorbate, sodium methyl parahydroxybenzoate (E 219) and soda propyl parahydroxybenzoate (E 217).
3. HOW TO USE BIAFINE, emulsion for skin application?
Always use this medication exactly as prescribed in the package leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
· Erythema secondary to radiotherapeutic treatments: follow the recommendations of your doctor. In general, 2 to 3 daily applications, regularly spaced, making penetrate by a light massage.
· Second-degree burns and other skin sores: Consultation with your doctor is necessary (see Warnings and Precautions). After the wound has been cleaned, apply in a thick layer, spreading largely over the surface of the lesion and renewing the applications in order to always maintain an excess of emulsion on the lesion. Cover with a moistened compress if necessary and finish the dressing. Do not use dry absorbent dressings.
· First degree burns: In case of extensive burns, a consultation with your doctor is essential (see Warnings and Precautions). Apply in a thick layer until skin refuses. Have a light massage. Renew 2 to 4 times a day.
Administration mode
Dermal.
Use in children
Not applicable.
If you used more BIAFINE, emulsion for skin application than you should have
Not applicable.
If you forget to use BIAFINE, emulsion for skin application
Not applicable.
If you stop using BIAFINE, emulsion for skin application
Not applicable.
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.
· Moderate and transient pain (tingling) (15 to 30 minutes) that may occur after application.
· Rare contact allergy.
· Very rare cases of contact eczema requiring immediate cessation of treatment.
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 BIAFINE, emulsion for skin application?
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 package. The expiry date refers to the last day of that month.
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 BIAFINE contains, emulsion for skin application
· The active substance is:
Trolamine ................................................. .................................................. ........................... 0,670g
For 100 g of emulsion for dermal application.
· The other components are:
Ethylene glycol stearate, stearic acid, cetyl palmitate, solid paraffin, liquid paraffin, perhydrosqualene, propylene glycol, avocado oil, trolamin and sodium alginate, potassium sorbate, sodium methyl parahydroxybenzoate (E 219), parahydroxybenzoate propyl soda (E 217), yerbatone flavor, purified water.
What is BIAFINE, emulsion for skin application and contents of the outer packaging
This medicinal product is in the form of an emulsion for dermal application.
Tube of 46.5 g, 93 g, 139.5 g or 186 g and 50 ml and 150 ml pressurized flask.
Marketing Authorization Holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Marketing Authorization Operator
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Maker
JANSSEN-CILAG
DOMAIN OF MAIGREMONT
27100 VAL DE REUIL
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
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).