NOTICE
ANSM - Last updated: 09/07/2009
Name of the medicinal product
CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g for 100 ml, mouthwash solution in a vial
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you notice any of the effects mentioned as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial AND WHAT CASES IS IT FOR?
2. BEFORE YOU TAKE CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, solution for mouthwash in a vial?
3. HOW TO TAKE CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial?
6. ADDITIONAL INFORMATION
1. WHAT IS CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial AND WHAT CASES IS IT FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
This medication is recommended as a local adjunctive treatment for oral cavity disorders and for postoperative care in odonto-stomatology.
2. BEFORE YOU TAKE CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, solution for mouthwash in a vial?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial in the following cases:
The use of CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial is contraindicated in case of hypersensitivity ( allergy ) to chlorhexidine, chlorobutanol or other constituents of the solution.
Precautions for use; special warnings
Take special care with CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g for 100 ml, solution for mouthwash in a vial:
Do not put the product in contact with the eyes and nose. Do not insert the product into the ear canal.
If the symptoms persist beyond 5 days and / or associated fever, the course to be taken should be re-evaluated.
Prolonged use may expose to tooth colouration, filling and dentures.
Interaction with other medicines
Taking or using other medicines
The simultaneous or successive use of other antiseptics should be avoided considering possible interference (antagonism, inactivation ...).
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
During pregnancy or breast-feeding, do not hesitate to seek the advice of your doctor or pharmacist before taking any medication
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect:
Ethanol.
Red cochineal A (E124).
3. HOW TO TAKE CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS
Administration mode
Local use in mouthwash.
Do not swallow.
Usual dosage : 10 to 15 ml of solution twice a day (to be diluted in the measuring cup by completing to the upper line with warm water): perform the mouthwash until the measuring cup is exhausted.
If necessary, this dose may be increased to 3 times daily, given that the maximum dose is 20 ml (to be diluted) 3 times a day.
Brush your teeth before each use and thoroughly rinse the mouth with water before using CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial.
For the single-dose vial, dilute the contents of the vial in half a glass of water and perform the mouthwash.
Duration of the treatment
The duration of treatment may be 2 weeks in gingival inflammations and periodontitis. The duration of treatment can not be extended beyond 2 weeks on medical advice.
Symptoms and Instructions for Overdose
If you used more than CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in bottle as expected?
An overdose is not expected under normal conditions of use of this mouthwash solution. However, in case of systemic ( general ) passage, manifestations of neurological toxicity may appear. They would have to be treated in a specialized environment.
Instructions for omission of one or more doses
If administration of one dose of CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial has been forgotten
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial is likely to have undesirable effects, although not everyone is subject to it.
Risk of sensitization to any component of the solution.
If you notice any side effects not listed in this leaflet, or if certain side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial?
Keep out of the reach and sight of children.
Expiration date
Do not use CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial after the expiry date stated on the bottle.
Storage conditions
Store at a temperature not exceeding 25 ° C.
After opening the bottle, the solution is kept for 14 days.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN contain? 0.5 ml / 0.5 g per 100 ml, mouthwash solution in a vial?
The active substances are:
Chlorhexidine digluconate solution ............................................. ............................................. 0.500 ml
Chlorobutanol hemihydrate ................................................ .................................................. .............. 0.500 g
For 100 ml.
Alcohol content: 42.8% v / v
The other components are:
Docusate sodium, glycerol, 96% ethanol, purified water, levomenthol, mint flavor, cochineal red A (E124).
Pharmaceutical form and content
What is CHLORHEXIDINE / CHLOROBUTANOL BIOGARAN 0.5 ml / 0.5 g per 100 ml, mouth wash solution in bottle and contents of the pack?
This medication is in the form of a mouthwash solution in 15 ml vials (boxes of 6) or in a 90 ml, 200 ml or 500 ml flask with a measuring cup.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
BIOGARAN
15, boulevard Charles de Gaulle
92700 Colombes
exploiting
BIOGARAN LABORATORIES
15 BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
Maker
H2 PHARMA
21 RUE JA CQUES TATI
ZAC LA CROIX BONNET
78390 BOIS D'ARCY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.
