NOTICE
ANSM - Updated: 28/05/2018
Name of the drug
INONGAN, cream
Methyl salicylate / racemic camphor
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use 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. 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 INONGAN, cream and in which cases is it used?
2. What information do you need to know before using INONGAN cream?
3. How to use INONGAN, cream?
4. What are the possible side effects?
5. How to store INONGAN, cream?
6. Contents of the package and other information.
1. WHAT INONGAN, CREAM AND WHAT IT IS USED FOR
Pharmacotherapeutic group - ATC code: A targeted analgesic - M02AC.
Adjunctive local treatment of pain of muscle origin and tendino-ligament of the adult.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE INONGAN, cream?
Never use INONGAN, cream:
· If you are allergic (hypersensitive) to methyl salicylate, racemic camphor or any of the other ingredients of this medicine, listed in section 6.
· If you are allergic to salicylates, a related drug (NSAID, aspirin) or any of the other ingredients.
· Do not apply to mucous membranes, eyes, wound, oozing lesion, infected lesion or occlusive dressing.
Warnings and precautions
Talk to your doctor or pharmacist before using INONGAN, cream .
Special warnings
This specialty contains camphor and menthol (terpene derivatives) which can cause excessive doses of convulsions in infants and children.
Follow the advice of use:
· never apply a higher dose than recommended ( see section 3 "Dosage"),
· do not apply over an extended area of the body,
· respect the recommended frequency and duration of treatment.
Precautions for use
· This medicine is only for adults.
· 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 mucous membranes.
Children and adolescents
Not applicable.
Other medicines and INONGAN, cream
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
INONGAN, cream with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
In case of breastfeeding, it is best not to use this medicine and in no case it should be applied on the breasts.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
INONGAN, cream contains:
Not applicable.
3. HOW TO USE INONGAN, cream?
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
RESERVED FOR ADULTS.
In local massages on the painful area, 1 to several times a day.
Wash hands after use.
Administration mode
Dermal.
Duration of treatment
Do not use for prolonged periods without medical advice.
If you have used more INONGAN, cream than you should have:
Rinse thoroughly with water.
If you forget to use INONGAN, cream:
Not applicable.
If you stop using INONGAN, cream:
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 necessitating discontinuation of treatment,
· possible normal redness at the point of application,
· in case of non-compliance with the recommended doses, possibility of agitation and confusion in the elderly (due to the presence of camphor and menthol).
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 INONGAN, cream?
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. The expiry date refers to the last day of the month.
Store at a temperature of 25 ° C or less
Do not use this medicine after the expiry date which is stated on the package. 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 INONGAN contains, cream
· The active substances are:
Methyl salicylate ............................................... .................................................. 12.50 g
Racemic camphor ................................................ .................................................. ....... 1.00 g
For 100 g of cream.
· The other components are:
Sédéfos 75 (ethylene glycol diethylene glycol distearate combined with a polyoxyethylenated fatty alcohol phosphate), Labrafil M2130 (saturated polyglycolized glycerides), liquid paraffin, racemic menthol, eucalyptus essential oil, purified water.
What INONGAN, cream and contents of the pack
This medicine comes in the form of cream in a tube of 55 g.
Marketing Authorization Holder
SOFIBEL
110-114 VICTOR HUGO STREET
92300 LEVALLOIS-PERRET
LA FRANCE
Operator of the marketing authorization
ALLOGA FRANCE
INDUSTRIAL ZONE OF SOUTH CHAPOTIN
69970 CHAPONNAY
LA FRANCE
Maker
SPPH
7 IMPASSE OF BOUSSENOTS
21800 QUETIGNY
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
Detailed information on this medicine is available on the ANSM website (France).