NOTICE
ANSM - Last updated: 30/05/2017
Name of the medicinal product
SYNTHOL, solution for skin application
Levomenthol, veratrole, resorcinol, salicylic acid
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 of the 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 contact your doctor if you experience no improvement or feel less well after 5 days.
Do not use this medication for children.
What is in this leaflet?
1. What is SYNTHOL, a solution for dermal application and in which cases it is used?
2. What information should be known before using SYNTHOL, a dermal application solution?
3. How to use SYNTHOL, solution for skin application?
4. What are the possible side effects?
5. How to store SYNTHOL, solution for skin application?
6. Package contents and other information.
1. WHAT IS SYNTHOL, a dermal application solution AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: OTHER TOPICS FOR ARTICULAR AND MUSCULAR PAIN - ATC code: M02AX10
This medication is recommended for adults and children over the age of 7 years in dermal application, as an adjunct to benign trauma (blues, strokes) or insect bites.
2. BEFORE YOU USE SYNTHOL, solution for skin application?
Do not use SYNTHOL, solution for skin application:
· if you are allergic (hypersensitive) to levomenthol, veratrole, resorcinol, salicylic acid or any of the other ingredients of this medication mentioned in section 6,
· if you have a history of allergy to salicylates, a related drug (NSAIDs, aspirin) or any of the other ingredients,
· in children and elderly subjects with a history of convulsions (febrile or not), due to the presence of terpene derivatives (levomenthol).
Do not apply to the eyes, on damaged skin regardless of lesion: oozing lesions, eczema, infected lesion, burn or wound.
Warnings and Precautions
Talk to your doctor or pharmacist before using SYNTHOL, a skin care solution.
This specialty contains terpenic derivatives (levomenthol) which can lead to excessive doses of seizure-type accidents in children. Observe the instructions for use:
· never apply a dose higher than recommended (see section 3. How to use SYNTHOL, solution for skin application)
· do not apply over an extended surface of the body,
· respect the recommended frequency and duration of treatment,
· do not use in children under 7 years of age.
In case of epilepsy old or recent, REQUEST ADVICE TO YOUR DOCTOR
After application, it is necessary to wash your hands to avoid any involuntary contact of the product with the eyes.
children
This medication is RESERVED FOR ADULTS AND CHILDREN OVER 7 YEARS.
Other medicines and SYNTHOL, solution for skin application
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
SYNTHOL, solution for skin application with food and beverages
Not applicable.
Pregnancy and breast feeding
In case of breast-feeding, it is preferable not to use this medication and in no case should it be applied to the breasts.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
Sport
Not applicable.
Driving and using machines
Not applicable.
SYNTHOL, solution for skin application contains
Not applicable.
3. HOW TO USE SYNTHOL, solution for skin application?
Administration mode
Dermal.
Do not swallow.
Dosage
2 to 3 times a day.
Cutaneous use in compresses or frictions (mild trauma or insect bites):
· in compresses: dilute this product to 50% with water. The application time of the compress impregnated with the diluted solution on the skin varies from 1/2 hour to 1 hour maximum;
· in friction: the product is used pure.
Wash hands after application.
Duration of the treatment
If there is no improvement after 5 days of treatment, consult your doctor.
If you used more SYNTHOL, a dermal application solution than you should:
Immediately consult your doctor or pharmacist.
Rinse thoroughly with water.
If you forget to use SYNTHOL, solution for skin application:
Do not take a double dose to make up for a missed dose.
If you stop using SYNTHOL, solution for skin application:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Risk of local reaction.
Rare cases of contact dermatitis requiring discontinuation of treatment have been reported. Possibility of skin redness at the point of application.
Due to the presence of terpene derivatives and in case of non-respect of the recommended doses:
· risk of convulsions in children,
· possibility of agitation, confusion in the elderly.
Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist or nurse. 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 SYNTHOL, solution 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 vial after EXP. The expiry date refers to the last day of that month.
For bottles: Store in the outer carton, protected from light.
For spray: Store in the original package, protected from light.
Below 8 ° C, a slight opalescence may appear. The solution becomes clear as soon as the ambient temperature rises.
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 SYNTHOL contains, solution for skin application
The active substances are:
Levomenthol .............................................................................. ..0,2600 g
Vératrole .................................................................................... .0,2600 g
Resorcinol ................................................................................. ..0,0210 g
Salicylic Acid ..................................................................... 0.0105 g
For 100 g of solution.
· The other ingredients are: essential oil of rosat geranium, citron essential oil, quinoline yellow (E104), 96 per cent ethanol, purified water.
Alcohol content: 35.0 ° (V / V).
What is SYNTHOL, solution for skin application and contents of the outer packaging
This medication is in the form of a solution for skin application. Bottle of 115 ml, 225 ml or 450 ml or spray bottle of 75 ml or 125 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100, ROUTE DE VERSAILLES
CS 80001
78164 MARLY-LE-ROI CEDEX
Marketing Authorization Operator
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100, ROUTE DE VERSAILLES
CS 80001
78164 MARLY-LE-ROI CEDEX
Maker
FARMACLAIR
440, AVENUE DU GENERAL DE GAULLE
14200 HEROUVILLE SAINT CLAIR
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]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).