NOTICE
ANSM - Updated on : 14/03/2024
Product name
CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution
Chlorhexidine digluconate
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution and what is it used for?
2. What do I need to know before using CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution?
3. How do I use CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution?
4. What are the possible side effects?
5. How do I keep CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution?
6. Package contents and other information.
1. WHAT IS CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: ANTIINFECTIOUS AND ANTISEPTIC FOR LOCAL ORAL TREATMENT, ATC code: A01AB03.
This medicine is indicated for the adjunctive treatment of infections of the mouth and care following surgery of the oral cavity.
You should consult your doctor if you do not feel better or feel worse after 5 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution?
Never use CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution:
- if you are allergic (hypersensitive) to chlorhexidine or to any of the other ingredients of this product, as listed in section 6;
- in children under 6 years of age.
Warnings and precautions
Ask your doctor, pharmacist or nurse before using CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution.
KEEP OUT OF THE REACH OF CHILDREN.
Prolonged use of this medicine is undesirable as it may alter the natural microbial balance of the mouth and throat.
If signs of infection worsen, or if there is no improvement after 5 days: CONSULT YOUR DENTIST OR STOMATOLOGIST.
Due to its chlorhexidine content, this product may cause hypersensitivity reactions, including generalized allergic reactions and anaphylactic shock.
Do not get in eyes.
Do not get into nose or ears.
KEEP OUT OF REACH OF CHILDREN.
DO NOT SWALLOW.
Children and teenagers
Not applicable.
Other drugs and CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Do not use several medicines containing antiseptics at the same time or in close proximity.
The active substance, chlorhexidine, is incompatible with certain constituents commonly used in toothpastes.
Mouthwash solution should therefore only be used after careful rinsing of the mouth and a short delay after brushing the teeth.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this product.
Pregnancy
As a precautionary measure, CHLORHEXIDINE VIATRIS should not be used during pregnancy.
Breast-feeding
It is not known whether CHLORHEXIDINE VIATRIS passes into breast milk. CHLORHEXIDINE VIATRIS should not be used during breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving vehicles and operating machinery
Effects on the ability to drive vehicles or operate machinery are not expected.
CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution contains
- Lexcipient azorubine (E122) which may cause allergic reactions.
- 0.7 mg alcohol (ethanol) per 15 mL dose of solution is equivalent to 0.04 mg/mL. The amount in a 15 mL dose of this drug is equivalent to less than 1 mL of beer or less than 1 mL of wine. The small amount of alcohol contained in this medicine is unlikely to have any noticeable effect.
- contains macrogolglycerol ricinoleate, which may cause stomach upset and diarrhoea.
- 300 mg propylene glycol per 15 mL dose.
3. HOW TO USE CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE.
For each mouthwash, use the contents of the cup (15 mL). Rinse your mouth thoroughly for about one minute with the pure solution.
This drug is incompatible with the anionic agents generally present in conventional toothpastes. Therefore, before using this product, rinse your mouth thoroughly with water after brushing your teeth with toothpaste. There should be a short delay between use of the 2 products.
Method and route of administration
Use locally as a mouthwash.
DO NOT SWALLOW.
This solution must be used undiluted.
Brush teeth before each use and rinse mouth thoroughly with water before using CHLORHEXIDINE VIATRIS.
Frequency and timing of administration
The number of mouthwashes is 1 to 3 per day.
Duration of treatment
Do not continue treatment for more than 5 days without medical advice.
Use in children and adolescents
FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE ONLY.
If you have taken more CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution than you should have
An overdose is not expected under normal conditions of use of this mouthwash solution.
If you accidentally swallow CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution, you may experience symptoms such as esophageal or stomach pain. In all cases, consult your dentist, stomatologist or physician.
In the event of accidental eye contact, rinse eyes immediately with plenty of clean water and consult your doctor.
This product contains terpene derivatives as excipients, which can lower the epileptogenic threshold and, in excessive doses, cause neurological accidents in children (convulsions) and the elderly (agitation and confusion).
Follow the recommended dosage and duration of treatment (see "Dosage" and "Duration of treatment").
If you forget to use CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution
Do not take a double dose to make up for the one you forgot to use.
If you stop using CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Brown discoloration of the tongue and teeth, particularly in tea and coffee drinkers, disappearing on discontinuation of treatment.
- Possible allergic reactions: irritation, skin reactions, swelling of the salivary glands, swelling of the neck or face, which may lead to anaphylactic shock. If you experience any of these symptoms, discontinue treatment and consult your doctor.
- Possible alteration of taste or burning sensation of the tongue at the start of treatment.
- Occasional desquamation of the oral mucosa.
Additional adverse reactions in children and adolescents
Not applicable.
Reporting side effects
If you experience any side effects, please tell your doctor, 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging and bottle. The expiration date refers to the last day of this month.
Once opened, this medicine can be stored for up to 30 days.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What does CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution contain?
- The active substance is :
chlorhexidine digluconate: ............................................................................................ 0.1200 g
as chlorhexidine digluconate solution....................................................... 0.6360 g
per 100 mL mouthwash solution.
- Other components include :
glycerol, acesulfame potassium macrogolglycerol ricinoleate, propylene glycol, azorubin (E122), mint flavor*, purified water.
*Composition of mint flavor SC379118 : eucalyptol, menthone, isomenthone, menthol, carvone, anethol, menthylacetate, triacetin, propylene glycol, ethanol, menthofuran, pulegone, estragol, thujone, methylugenol.
What CHLORHEXIDINE VIATRIS 0.12%, mouthwash solution is and what it contains
This medicine comes in the form of a mouthwash solution. Available in 100 mL, 300 mL and 500 mL bottles.
Not all presentations may be marketed.
Marketing authorization holder
VIATRIS SANTE
1, RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1, RUE DE TURIN
69007 LYON
Manufacturer
H2 PHARMA
ZA La Croix Bonnet 21 rue Jacques Tati
78390 Bois dArcy
France
Product 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
Not applicable.
