In this manual :
1. WHAT IS SYNTHOL, solution for cutaneous application AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING SYNTHOL, solution for cutaneous application
3. HOW DO I USE SYNTHOL, solution for cutaneous application?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE SYNTHOL, solution for cutaneous application?
6. ADDITIONAL INFORMATION
1. WHAT IS SYNTHOL, solution for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
OTHER TOPICALS FOR JOINT AND MUSCULAR PAIN: ATC Code M02 AX10
This medicine is recommended for adults and children over 7 years of age as an adjunct to the treatment of minor trauma (bruises, blows) or insect bites.
2. WHAT YOU SHOULD KNOW BEFORE USING SYNTHOL, solution for cutaneous application
List of information needed before taking the medicine
Not applicable.
Never use SYNTHOL, solution for cutaneous application in the following cases:
- history of allergy to salicylates, related drugs (NSAIDs, aspirin) or any of the other components,
- 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, to injured skin, whatever the lesion: oozing lesions, eczema, infected lesions, burns or wounds.
Precautions for use; special warnings
Be careful with SYNTHOL, solution for cutaneous application:
This medicine is FOR ADULTS AND CHILDREN OVER 7 YEARS OF AGE.
This speciality contains terpene derivatives (levomenthol) which may cause accidents such as convulsions in children in excessive doses. Follow the advice for use:
- never apply a higher dose than recommended (see section 3. HOW TO USE SYNTHOL, solution for cutaneous application),
- do not apply to a large area of the body,
- respect the recommended frequency and duration of treatment,
- do not use in children under 7 years of age.
In case of old or recent epilepsy, SEEK ADVICE FROM YOUR DOCTOR
After application, it is necessary to wash your hands to avoid any involuntary contact of the product with the eyes.
Interactions with other drugs
Taking or using other medicines:
If you are taking or have recently taken any other medication, including medication obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
If you are breastfeeding, it is preferable not to use this medicine and under no circumstances should it be applied to the breasts.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO USE SYNTHOL, solution for cutaneous application
Instructions for proper use
Not applicable.
Dosage, method and/or route of administration, frequency of administration and duration of treatment
Method of administration
Dermal route.
Do not swallow.
Dosage/Frequency of administration2 to 3 times a day.
- Dermal use as compresses or rubs (minor trauma or insect bites):
o in compresses: dilute this product 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;
o in frictions: the product is used pure.
Wash hands after application.
Duration of treatment
If there is no improvement after 5 days of treatment, consult your doctor.
Symptoms and instructions in case of overdose
If you have used more SYNTHOL, solution for cutaneous application than you should have:
Rinse with plenty of water.
Instructions in case of missed dose(s)
If you forget to take SYNTHOL, solution for cutaneous application :
Do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of undesirable effects
Like all medicines, SYNTHOL, solution for cutaneous application is likely to have undesirable effects, although not everyone is subject to them.
Risk of local reaction.
Rare cases of contact eczema requiring discontinuation of treatment have been reported. Redness of the skin at the application site may occur.
Due to the presence of terpene derivatives and if the recommended doses are not followed:
- risk of convulsions in children,
- possibility of agitation, confusion in the elderly.
Due to the presence of alcohol, frequent application to the skin may cause irritation and dryness of the skin.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE SYNTHOL, solution for cutaneous application
Keep out of the reach and sight of children.
Do not use SYNTHOL, solution for cutaneous application after the expiry date stated on the bottle.
For bottles: Store in the outer packaging, protected from light.
For the spray: Store in the original primary packaging, protected from light.
Below 8°C, a slight opalescence may appear. The solution becomes clear again as soon as the room temperature rises.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does SYNTHOL, solution for cutaneous application, contain?
The active ingredients are
Levomenthol ................................................................................................................................. 0.2600 g
Veratrol ....................................................................................................................................... 0.2600 g
Resorcinol ..................................................................................................................................... 0,0210 g
Salicylic acid ........................................................................................................................... 0.0105 g
Per 100 g of solution.
The other components are: rose geranium essential oil, citron essential oil, quinoline yellow (E104), 96 percent ethanol, purified water.
Alcoholic strength: 34.5° (V/V).
Pharmaceutical form and content
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