Betadine Green 10 percent, mouthwash solution,is a medication used in the oral and pharyngeal cavity for rinsing and gargling in cases of bacterial or viral infections of the oral cavity.
For warnings, precautions,and contraindications, please refer to the package insert.
Betadine Green 10% mouthwash solutionis an antiseptic (iodine-containing) solution for use as a mouthwash. It is an adjunctive topical treatment for bacterial or viral infections of the oral cavity and is used for postoperative carein dentistry.
The active ingredient is: Povidone-iodine 10.00 g in 85 percent glycerol, mint flavoring, sodium saccharin, sodium hydroxide, purified water. Mouthwash solution. 125-mL bottle.
This medication should generally not be used: in children under 6 years of age, or in combination with mercury-based antiseptics.
Precautions for use:
If taken in large quantities or repeatedly: this medication may alter the natural microbial balance of the mouth; it may also affect thyroid function or interfere with thyroid function tests.
If you have a history of epilepsy, whether past or recent. Consult your doctor; if in doubt, do not hesitate to ask your pharmacist or dental specialist for advice.
125-ml bottle. Solution for topical application
Please note: Betadine mouthwash is not like other products. Read the medication instructions carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.
Betadine Green 10 percent mouthwash should not be used in patients with hyperthyroidism or other existing thyroid disorders, or Duhring’s herpetiform dermatitis (a very rare herpes-like skin condition), in cases of hypersensitivity to iodine or any other ingredient, in patients scheduled to undergo radiotherapy with labeled iodine, and in newborns and infants under 6 months of age. Following a thyroid disorder, do not use Betadine Green 10 percent mouthwash solution in infants younger than 6 months. In young children, Betadine Green 10% mouthwash should only be used as prescribed by a doctor and only if the child is able to rinse their mouth and gargle properly. The solution must be spit out after use. Betadine Green 10% mouthwash should not be used simultaneously with products containing chlorhexidine, silver sulfadiazine, alkaline substances, or mercury, as these may reduce its effectiveness. Please inform your doctor or pharmacist if you have any other medical conditions, are allergic to anything, or are already taking or using other medications for external use (including over-the-counter medications!).
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 20/07/2017
BETADINE 10 PER CENT, mouth wash solution
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, seek medical attention.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this notice :
1. WHAT IS BETADINE 10 PER CENT, mouthwash solution AND IN WHAT CASES IS IT USED?
2. WHAT TO DO ABOUT BEFORE USING BETADINE 10 PER CENT, mouthwash solution?
3. HOW TO USE BETADINE 10 PER CENT, mouthwash solution?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BETADINE 10 PER CENT, mouthwash solution?
6. ADDITIONAL INFORMATION
1. WHAT IS BETADINE 10 PER CENT, mouthwash solution AND IN WHAT CASES IS IT USED?
PREPARATIONS FOR ODONTO-STOMATOLOGY / OTHER AGENTS FOR ORAL LOCAL TREATMENT / MISCELLANEOUS.
This medication is an antiseptic solution (containing iodine) for mouthwash.
It is a local remedy for infections of the oral cavity and allows post-operative care in stomatology.
2. WHAT TO DO ABOUT BEFORE USING BETADINE 10 PER CENT, mouthwash solution?
List of information needed before taking the medication
Not applicable.
Never use BETADINE 10 PERCENT, mouth wash solution in the following cases:
· A history of allergy to any of the constituents, particularly povidone. There are no cross-reactions with iodinated contrast media. The history of allergic-type accidents to iodinated contrast agents or anaphylaxis ( possibility of allergic reaction ) to seafood is not a contraindication to the use of BETADINE 10%, mouthwash solution.
· In preterm infants and infants less than one month old.
· Prolonged during the second and third trimesters of pregnancy.
· In case of breastfeeding.
Precautions for use; special warnings
Take special care with BETADINE 10 PER CENT, mouth wash solution:
Warnings
THIS MEDICINE MUST NOT BE USED GENERALLY
· in children under 6 years of age;
· in combination with mercury-derived antiseptics.
Precautions for use
If symptoms persist for more than 5 days and / or with fever, consult a doctor or dental specialist.
The iodine contained in this medication can pass through the mucous membranes and pass into the general circulation ( see Possible side effects ).
This specialty contains terpene derivatives (mint flavoring).
Prolonged use (more than 5 days) of this medication is undesirable as it can alter the natural microbial balance of the mouth.
Follow recommended dosages and treatment times ( see Dosage ).
Taken in large quantities or repeatedly:
· this medication, may alter the natural microbial balance of the mouth;
· this drug is likely to affect the functioning of the thyroid or to cause interference with functional explorations of the thyroid gland.
In case of epilepsy old or recent, REQUEST ADVICE TO YOUR DOCTOR.
If in doubt, do not hesitate to seek the advice of your doctor, pharmacist or dental specialist.
Interaction with other medicines
Taking or using other medicines
Concomitant use of mercury-derived antiseptics is contraindicated.
Concomitant or sequential use of other oral antiseptics should be avoided.
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
Due to the presence of iodine, repeated use of this medication is contraindicated from the second trimester of pregnancy or when breast-feeding.
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 known effect
List of excipients with well-known effect: mint flavoring (essential oil of mint, alcohol).
3. HOW TO USE BETADINE 10 PER CENT, mouthwash solution?
Not applicable.
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
Local use in mouthwash.
DO NOT SWALLOW.
The dosage is 1 to 2 teaspoons in a glass of warm water, in a mouthwash, four times a day.
Administration mode
COMPLY WITH THE NOTICE OF YOUR DENTAL SPECIALIST.
Frequency of Administration
COMPLY WITH THE NOTICE OF YOUR DENTAL SPECIALIST.
Duration of the treatment
COMPLY WITH THE NOTICE OF YOUR DENTAL SPECIALIST.
Symptoms and Instructions for Overdose
If you take more BETADINE 10 PER CENT, mouthwash solution you should not have: an overdose is not expected under normal conditions of use.
In case of massive oral ingestion, which can lead to serious intoxication, it should be treated in a specialized medium: gastrointestinal and / or electrolytic disorders, especially in renal insufficiency. Thyroid function monitoring is recommended.
Instructions for omission of one or more doses
If you forget to take BETADINE 10%, mouthwash solution: do not take a double dose to compensate. Take the normal course of your treatment.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, BETADINE 10 PER CENT, mouthwash solution is likely to have unwanted effects, although not everyone is subject to it.
Exceptionally, hypersensitivity reactions (allergy): urticaria, angioedema, anaphylactic shock (allergic), anaphylactoid reaction, have been described with products containing povidone, including specialties BETADINE.
If skin reactions occur, treatment should be discontinued immediately.
In the case of repeated administration and excessive use, this product may, on the one hand, prove to be irritating to the mucous membranes and, on the other hand, there may be an iodized overload which may lead to dysfunction of the thyroid gland.
Possible irritation of the mucous membranes.
Due to the presence of terpene derivatives and in case of non-respect of the recommended doses, possibility of agitation and mental confusion in the elderly.
Declaration of side effects
If you experience any side effects, talk to 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 : National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr .
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE BETADINE 10 PER CENT, mouthwash solution?
Keep out of the reach and sight of children.
Do not use BETADINE 10%, mouthwash solution after the expiry date stated on the vial after {EXP}. The expiry date refers to the last day of that month
After first opening the vial, this medication should be stored for up to 6 months at room temperature.
Before opening: no special precautions for storage.
If necessary, warnings against visible signs of deterioration
Full list of active substances and excipients
What does BETADINE 10 PERCENT contain, mouthwash solution?
The active substance is:
Polyvidone iodine ................................................ .................................................. 10.00 g
For 100 ml of solution.
The other components are:
85 percent glycerol, mint flavor, sodium saccharin, sodium hydroxide, purified water.
Pharmaceutical form and content
What is BETADINE 10 PERCENT, mouth wash solution and contents of the pack?
This medication is in the form of a mouthwash solution. Bottle of 125 ml or 500 ml.
40-44 WASHINGTON STREET
75008 PARIS
40-44 Washington Street
75008 PARIS
MEDA MANUFACTURING
Avenue JF Kennedy
33700 MERIGNAC
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.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Not applicable.
Oral antiseptic preparation
povidone iodine
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
BÉTADINE: solution for mouthwash (mint flavoring); 125 ml bottle.
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BÉTADINE: solution for mouthwash and gargle ; box of 10 single-dose containers of 10 ml.
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Laboratory Meda Pharma
| p 100 ml | |
| Povidone iodine | 10 g |
| Mint, gasoline | + |
Usual dosage:
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