NOTICE
ANSM - Updated on : 09/12/2022
Product name
GLYCO-THYMOLINE 55, oral solution
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Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any 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 do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is GLYCO-THYMOLINE 55, oral solution and what is it used for?
2. What do I need to know before using GLYCO-THYMOLINE 55, solution buccale?
3. How do I use GLYCO-THYMOLINE 55, solution buccale?
4. What are the possible side effects?
5. How to store GLYCO-THYMOLINE 55, solution buccale?
6. Package contents and other information.
1. WHAT IS GLYCO-THYMOLINE 55, solution buccale AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: STOMATOLOGY/LOCAL ANTISEPTIC TREATMENT (A: digestive system and metabolism)
This medicine is recommended for the top-up local treatment of mouth disorders in adults and children over 6 years of age.
You should consult your doctor if you do not feel any improvement or if you feel worse after 5 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING GLYCO-THYMOLINE 55, solution buccale?
Never use GLYCO-THYMOLINE 55, oral solution:
- if you are allergic to salicylates, to related drugs (anti-inflammatory drugs, aspirin), or to any of the other components of this medicine, as listed in section 6.
- in children under 6 years of age.
Warnings and precautions
- If symptoms worsen, fever develops or there is no improvement after 5 days, consult your doctor.
- Consult your doctor if you have a history of seizures.
- Microbial contamination may occur as soon as the packaging is opened.
Consult your doctor or pharmacist before using GLYCO-THYMOLINE 55, solution buccale.
Children and adolescents
- Excessive doses of certain ingredients (eucalyptol, menthol, thymol) may cause neurological accidents such as convulsions in children.
Follow the instructions for use and dosage recommended in this leaflet.
Other medicinal products and GLYCO-THYMOLINE 55, oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
GLYCO-THYMOLINE 55, solution buccale with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Before the beginning of the 6th month of pregnancy (up to the 24th week of amenorrhea), you should not take this medicine unless absolutely necessary, as determined by your doctor, due to the potential risk of miscarriage or malformations. In such cases, the dose should be kept as low as possible and the duration of treatment as short as possible.
GLYCO-THYMOLINE 55, solution buccale may cause kidney problems in your babyfrom 12 weeks of amenorrhea onwards, if taken for several days, leading to a low level of amniotic fluid in the baby (oligohydramnios). A narrowing of the blood vessels (constriction of the ductus arteriosus) in your baby's heart may be observed as early as 20 weeks of amenorrhea. If treatment over several days is required, your doctor may recommend additional monitoring.
From the beginning of the 6th month to the end of pregnancy (beyond the 24th week of amenorrhea), this medicine is contraindicated, and you should under NO CIRCUMSTANCES take this medicine, as its effects on your child may have serious or even fatal consequences, particularly on the heart, lungs and/or kidneys, even with a single dose. It may also affect you and your baby by increasing bleeding, leading to a later or longer than expected delivery.
If you have taken this medicine while pregnant, speak to your obstetrician-gynecologist immediately, so that suitable monitoring can be offered if necessary.
It is preferable not to use this medicine while breast-feeding.
Driving and using machines
Not applicable.
GLYCO-THYMOLINE 55, solution buccale contains cochineal red A (E 124) and alcohol (ethanol).
This medicine contains 9.510 g of alcohol (ethanol) per 250 mL bottle of oral solution, equivalent to 0.04 g/mL. This may cause a burning sensation on damaged skin. Since this drug is an oral solution and is therefore not swallowed, the small amount of alcohol contained in it is unlikely to have any noticeable effect in the usual clinical setting. However, care should be taken to ensure that children using the product do not swallow it.
This product contains cochineal red A (E124) and may cause allergic reactions.
3. HOW TO USE GLYCO-THYMOLINE 55, oral solution?
Always use this product exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE
Do not swallow, or apply to skin or mucous membranes other than the oral mucosa.
Local use. 2 to 3 times a day:
- Apply undiluted to areas to be treated, using compresses or absorbent cotton.
- This product can also be used as a mouthwash: use half diluted with warm water.
Method and route of administration
STRICT ORAL USE
Duration of treatment
Treatment should not exceed 5 days without medical advice.
If you have used more GLYCO-THYMOLINE 55, oral solution than you should have
Not applicable.
If you forget to use GLYCO-THYMOLINE 55, solution buccale
Not applicable.
If you stop using GLYCO-THYMOLINE 55, solution buccale
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
As with all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
- Allergic reactions and local irritation may occur.
- If recommended doses are not followed:
o Risk of convulsions in children,
o Possibility of agitation and confusion in the elderly.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: www.signalement.social-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE GLYCO-THYMOLINE 55, solution buccale ?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
No special storage precautions.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What GLYCO-THYMOLINE 55 oral solution contains
- The active ingredients are :
Sodium benzoate....................................................................................................... 2.040 g
Sodium salicylate...................................................................................................... 0.090 g
Borax............................................................................................................................. 2.000 g
Thymol........................................................................................................................... 0.037 g
Cineole.......................................................................................................................... 0.075 g
Levomenthol.................................................................................................................. 0.037 g
Per 100 g oral solution
- Other ingredients: Scots pine essential oil, sodium bicarbonate, glycerol, ethanol (alcohol), polysorbate 80, cochineal red A (E124), purified water.
What GLYCO-THYMOLINE 55 oral solution is and what it contains
This medicine is available as an oral solution in 200 mL, 250 mL, 500 mL or 1000 mL bottles. Not all presentations may be marketed.
Marketing authorization holder
SOCIETE DETUDES ET DE RECHERCHES PHARMACEUTIQUES (S.E.R.P.)
5, RUE DU GABIAN
IMMEUBLE LE TRITON
98000 MONACO
MONACO
Marketing authorization holder
SOCIETE DETUDES ET DE RECHERCHES PHARMACEUTIQUES (S.E.R.P.)
5, RUE DU GABIAN
IMMEUBLE LE TRITON
98000 MONACO
MONACO
Manufacturer
SOCIETE DETUDES ET DE RECHERCHES PHARMACEUTIQUES (S.E.R.P.)
5, RUE DU GABIAN
IMMEUBLE LE TRITON
98000 MONACO
MONACO
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
