NOTICE
ANSM - Updated on : 01/02/2022
Product name
CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle
Chlorhexidine/Chlorobutanol
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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/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in a bottle and what is it used for?
2. What do I need to know before using CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in a bottle?
3. How do I use CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in a bottle?
4. What are the possible side effects?
5. How to store CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle?
6. Package contents and other information.
1. WHAT IS CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: anti-infective and antiseptic stomatological preparations for local oral treatment - ATC code: A01AB03.
This medicine is a combination of 2 antiseptics (chlorhexidine digluconate and chlorobutanol hemihydrate) which acts by combating bacteria present on teeth (dental plaque) and in the mouth.
By limiting the development of bacterial plaque, it also helps reduce gingival inflammation.
This medicine is used as an adjunctive local treatment for infections of the mouth (gingivitis, slight bleeding) as well as during post-operative care in odontostomatology.
This situation occurs :
- if you suffer from an oral pathology;
- after oral surgery.
This medicine is reserved for adults and children over 6 years of age.
You should contact your doctor if you do not feel any improvement or if you feel less well after 5 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle?
Never use CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle:
- if you are allergic to chlorhexidine, chlorobutanol or any of the other ingredients listed in section 6;
- in children under 6 years of age.
Warnings and precautions
Ask your doctor, pharmacist or nurse before using CHLORHEXIDINE/CHLOROBUTANOL VIATRIS.
This medicine is for topical use as a mouthwash.
Do not swallow the solution.
Do not get this product in your eyes, nose or ears. In case of contact, wash immediately with plenty of water.
Prolonged use may lead to discoloration of the tongue, teeth, dentures and filling materials. This discoloration is reversible and can be avoided by brushing teeth daily before using the mouthwash, or by using a dental solution for dentures and filling materials.
If symptoms persist for more than 5 days and/or fever develops, the advice of a doctor or dental surgeon should be sought. This drug may cause severe generalized allergic reactions due to its chlorhexidine content, which may occur within minutes of exposure.
Children
This product is not recommended for children under 6 years of age.
If the drug is given to a child over 6 years of age, you must ensure that the child does not drink it, as it contains alcohol.
Other drugs and CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle
The active substance, chlorhexidine, is incompatible with some toothpastes.
Mouthwash solution should therefore only be used after a short delay following tooth brushing and careful rinsing of the mouth. A short period of time should elapse between use of toothpaste and mouthwash solution.
Tell your doctor or pharmacist if you are using, have recently used or may use any other medication, including over-the-counter medicines.
CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle 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 or pharmacist for advice before taking this medicine.
This medicine must not be taken during pregnancy or while breast-feeding.
Driving and use of machinery
No studies have been carried out on the ability to drive vehicles or use machines with chlorhexidine/chlorobutanol.
CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle contains ethanoland cochineal red A (E124).
- 7.13 g alcohol (ethanol) per 20 mL dose of solution is equivalent to 0.36g/mL. Since this drug is a mouthwash solution and is therefore not swallowed, the amount of alcohol contained in it is unlikely to have any noticeable effect in the usual clinical context. However, care should be taken to ensure that children using the product do not swallow it. The presence of alcohol should be taken into account in cases of alcohol withdrawal.
- An azo dye "cochineal red A (E124)" which may cause allergic reactions.
3. HOW TO USE CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is 10 to 15 mL of solution 2 times a day (to be diluted in the measuring cup).
If necessary, this dose can be increased to 3 times a day, although the maximum dose is 20 mL (to be diluted), 3 times a day.
This product should be used as a mouthwash.
- Brush your teeth before each use and rinse your mouth thoroughly with water before using CHLORHEXIDINE/CHLOROBUTANOL VIATRIS.
- Pour the recommended dose into the measuring cup.
- Top up with lukewarm water (to dilute the medication).
- Then rinse until the measuring cup is empty.
- Do not swallow the mouthwash solution. Hold the solution for 1 minute, then spit it out into a sink once the mouthwash is finished, and do not rinse your mouth.
For the 15 mL single-dose bottle, dilute the contents of the bottle in half a glass of water and perform the mouthwash.
The measuring cup should be rinsed and dried after each use. Keep the bottle and measuring cup together in the carton until next use, in a safe place where your child can't see or reach them. Discard the measuring cup when the bottle is finished.
Treatment duration can be up to 2 weeks for gingival inflammation and periodontitis. Treatment may be extended beyond 2 weeks only on medical advice.
Use in children
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE.
If you have used more CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in a bottle than you should have:
An overdose is not expected under normal conditions of use of this mouthwash solution. If swallowed, local effects such as aburning sensation in the mouth and throat, local irritation of the throat and esophagus may occur. If a large quantity is swallowed, you may experience symptoms of digestive discomfort (nausea, vomiting, stomach pain and diarrhoea), slight incoordination of movement or liver toxicity.
Contact your doctor, dentist or poison control center if a large amount has been swallowed.
Due to the alcohol content of the undiluted product, accidental ingestion of large quantities of mouthwash by children requires immediate medical attention for appropriate action.
If you forget to use CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle:
Do not take a double dose to make up for the one you forgot to take.
If you stop using CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle:
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 product may cause undesirable effects, but these do not always occur in everyone.
Undesirable effects encountered with CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution are generally mild and disappear after treatment has been discontinued.
The following adverse reactions may occur (frequency unknown):
- severe rash on the skin, itching, swelling of the mouth, face or neck which may cause difficulty in breathing. This could be an allergic reaction to the drug. If you notice any of these effects, you should stop treatment immediately and contact your doctor as soon as possible;
- change in taste or burning sensation of the tongue, particularly at the start of treatment. These effects disappear with continued treatment;
- brown discoloration of the tongue. This is not harmful and disappears when treatment is stopped;
- brown discoloration of teeth, dentures and tooth restoration materials. This discoloration can easily be avoided by daily brushing of the teeth, and can be removed by your dentist;
- swelling of the salivary glands (parotid glands), which disappears when treatment is stopped;
- skin detachment inside the mouth. If this happens, dilute the mouthwash with 50% water and seek medical advice.
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: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in bottle?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the bottle. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Once opened, the solution will keep for 14 days.
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. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g per 100 mL mouthwash solution in bottle contains
- The active ingredients are :
chlorhexidine digluconate solution ........................................................................... 0.500 mL
chlorobutanol hemihydrate .................................................................................................. 0.500 g
per 100 mL.
Alcoholic strength: 42.8% (v/v)
- Other components are :
docusate sodium, glycerol, 96% ethanol, purified water, levomenthol, mint flavor, cochineal red A (E124).
What is CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0.5 mL/0.5 g for 100 mL, mouthwash solution in a bottle and what does it contain?
This medicine is available as a mouthwash solution in 15 mL bottles, boxes of 6, or in 90 mL, 200 mL and 500 mL bottles with dosing cups.
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
21 RUE JACQUES TATI
ZAC LA CROIX BONNET
78390 BOIS D'ARCY
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
Detailed information on this drug is available on the ANSM (France) website.
