NOTICE
ANSM - Updated: 01/02/2018
Name of the drug
BALM AROMA , cream
Methyl salicylate, Clove essential oil, Essential oil of Allspice
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is BAUME AROMA and in what cases is it used?
2. What information do you need to know before taking BAUME AROMA ?
3. How to take BALM AROMA?
4. What are the possible side effects?
5. How to store BALM AROMA?
6. Contents of the package and other information.
1. WHAT IS AROMA BALM AND WHAT IT IS USED FOR
Pharmacotherapeutic group - ATC code: M02AC
Adjunctive local treatment of muscular and tendon-ligament pain
You should talk to your doctor if you do not feel better or if you feel worse.
2. WHAT YOU SHOULD KNOW BEFORE USING AROMA BALM?
Do not take BALM AROMA:
· if you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
Do not apply to mucous membranes, eyes, wound, oozing lesion, infected lesion or occlusive dressing
Do not use in children under 7 years old.
This medicine MUST NOT BE USED because of the presence of terpene derivatives in the formula in the following cases:
- infants under 30 months,
- Children having convulsions due to fever or not.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before taking BAUME AROMA .
This specialty contains terpene derivatives that can cause, in excessive doses, neurological seizures in infants and children.
Follow the advice of use:
- Never apply a higher dose than recommended (see section 3).
- Do not apply on a large area of the body.
- Respect the recommended frequency and duration of treatment.
- This medication is for adults and children over 7 years old.
- In case of old or recent epilepsy, ASK ADVICE TO YOUR DOCTOR.
- After use, it is necessary to wash your hands to avoid any unintentional contact of the product with the eyes and the mucous membranes.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
children
Not applicable.
Other medicines and BALM AROMA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you have anticoagulant therapy (Antivitamines K): Possibility of increased bleeding risk, INR monitoring should be performed.
BALM AROMA with food and drinks
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice or pharmacist before taking this medicine.
The use of BALM AROMA, cream is not recommended during pregnancy.
In case of breastfeeding, it is best not to use this drug and in no case it should be applied on the breasts.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
BAUME AROMA contains terpene derivatives.
3. HOW TO TAKE AROMA BALM?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
RESERVED FOR ADULTS AND CHILDREN OVER 7 YEARS
Dermal
Wash hands after use.
Apply in local massages on the painful area 1 to 2 times a day until complete penetration.
Do not use for prolonged periods without medical advice.
If you take more BALM AROMA than you should
Rinse thoroughly with water.
If you forget to take BAUME AROMA
Not applicable.
If you stop taking BAUME AROMA
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Possible local allergic reaction requiring the STOPPING OF TREATMENT.
- Possibility of normal skin redness at the point of application.
Due to the presence of terpene derivatives and in case of non-compliance with the recommended doses:
- Risk of convulsions in children and infants.
- Possibility of agitation, confusion in the elderly.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE BAUME AROMA?
Keep this medicine out of the sight and reach 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 this month.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What BAUME AROMA contains
· The active substances are:
METHYL SALICYLATE ............................................... ............................................. 10.00 g
ESSENTIAL OIL OF CLOVER .............................................. .................................... 3.00 g
ESSENTIAL OIL OF PEPPER FROM JAMAICA ........................................... ............. 0.20 g
For 100 g of cream
· The other components are:
Nonionic emulsifiable wax with Macrogol 800, Light liquid paraffin, Purified water, Carbomer 5984, Trolamine, Levomenthol.
What BAUME AROMA looks like and contents of the pack
Cream
50 g sealed aluminum tube.
100 g aluminum sealed tube.
Polypropylene pump bottle with 50 ml multilayer bag containing 50 g of cream.
Marketing Authorization Holder
MAYOLY SPINDLER LABORATORIES
6, Avenue of Europe
BP 51
78401 CEDEX SHATOU
Operator of the marketing authorization
MAYOLY SPINDLER LABORATORIES
6, Avenue of Europe
BP 51
78401 CEDEX SHATOU
Maker
MAYOLY SPINDLER LABORATORIES
6, Avenue of Europe
BP 51
78401 CEDEX SHATOU
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Not applicable.