In this manual :
1. WHAT IS SYNTHOL, gel AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING SYNTHOL, gel?
3. HOW TO USE SYNTHOL, gel?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE SYNTHOL, gel?
6. ADDITIONAL INFORMATION
1. WHAT IS SYNTHOL, gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
OTHER TOPICAL PRODUCTS FOR JOINT AND MUSCLE PAIN.
This medicine is recommended for adults and children over 7 years of age, as an adjunct to local treatment of minor trauma (bruises, blows).
2. WHAT DO YOU NEED TO KNOW BEFORE USING SYNTHOL, gel?
List of information needed before taking the medicine
Not applicable.
Never use SYNTHOL, gel in the following cases:
- history of allergy to salicylates, to a related drug (NSAID, aspirin) or to any of the other components,
- children with a history of convulsions due to fever or not, due to the presence of terpene derivatives (levomenthol, lavandin essential oil and linalool).
Do not apply to the eyes, on injured skin whatever the lesion: oozing lesions, eczema, infected lesion, burn or wound.
Precautions for use; special warnings
Be careful with SYNTHOL, gel:
This medicine is FOR ADULTS AND CHILDREN OVER 7 YEARS.
This speciality contains terpene derivatives (levomenthol, lavandin essential oil and linalool) which may cause accidents such as convulsions in children in excessive doses. Follow the advice for use:
- do not use in children under 7 years,
- never apply a higher dose than that recommended(see section 3 "How to use SYNTHOL, gel"),
- do not apply to a large area of the body,
- respect the recommended frequency and duration of treatment.
In case of old or recent epilepsy, ASK YOUR DOCTOR FOR ADVICE
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 medications:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if it is obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
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 medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: Alcohol.
3. HOW TO USE SYNTHOL, gel
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Method of administration
Dermal route.
Dosage
1 application on the painful area 2 to 3 times a day.
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, gel than you should have: rinse with plenty of water.
Instructions in case of missed dose(s)
If you forget to take SYNTHOL, gel: 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 side effects
Like all medicines, SYNTHOL, gel is likely to have adverse 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 inform your doctor or pharmacist.
5. HOW TO USE SYNTHOL, gel
Keep out of the reach and sight of children.
Do not use SYNTHOL, gel after the expiry date stated on the box.
The expiry date refers to the last day of the month.
This medicine should be stored at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewage system or in your household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does SYNTHOL gel contain?
The active ingredients are
Levomenthol .................................................................................................................................... 0.520 g
Veratrol ......................................................................................................................................... 0,250 g
Resorcinol ....................................................................................................................................... 0.030 g
Salicylic acid .............................................................................................................................. 0.100 g
Per 100 g of gel.
Other components are:
Aromatic composition (linalyl acetate, lavandin essential oil, linalool, coumarin, geraniol), benzyl alcohol, hydroxyethyl cellulose, citric acid monohydrate, macrogol lauryl ether, 96 per cent ethanol, purified water
Pharmaceutical form and content
What is SYNTHOL gel and what does it contain?
This medicine is in the form of a gel. Tube of 75 g and 100 g.
Not all presentations may be marketed.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
GLAXOSMITHKLINE SANTE GRAND PUBLIC
100, ROUTE DE VERSAILLES
B.P. 23
78164 MARLY LE ROI CEDEX
Operator
GLAXOSMITHKLINE SANTE GRAND PUBLIC
100, ROUTE DE VERSAILLES
B.P. 23
78164 MARLY LE ROI CEDEX
Manufacturer
BOOTS COMPANY PLC
BEESTON SITE THANE ROAD
NOTTINGHAMSHIRE NG2 3AA
UNITED KINGDOM
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date of approval of this package insert was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
HEALTH ADVICE/EDUCATION
OTHER TOPICALS FOR JOINT AND MUSCLE PAIN
If you have just had a minor trauma or contusion, you can use the gel to relieve your pain.
However, if there is complete functional impotence, i.e. if you are unable to use your upper or lower limb, and if there is a large haematoma ("bruise"), you should also consult your doctor without delay.
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