Betadine 10 PERCENT SOLUTION FOR GREEN BATH MOUTH

Betadine 10 PERCENT SOLUTION FOR GREEN BATH MOUTH View larger

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Green 10 percent betadine solution for mouthwash is used in the oropharyngeal cavity to rinse and gargle.

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The advice of your pharmacist

Used for : Local adjunctive treatment of i, and post-operative care in sto

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Betadine 10 PERCENT SOLUTION FOR GREEN BATH MOUTH

For warnings, precautions for use

and cons-indications, please refer to the notice no use data.

DO NOT LET THIS MEDICINE OUT OF REACH OF CHILDREN

Description Betadine 10 percent green solution for mouth bath

Green 10 percent betadine solution for mouthwash is an antiseptic solution (containing iodine) mouthwash. It is a local booster infections of the oral cavity treatment and allows post-operative care in dentistry .

Tips util ization

Green 10 percent Betadine mouthwash is admnistre by local road mouthwash Dosage. Only for adults and children over 6 years Do not swallow.. The dosage is 1 to 2 teaspoons in a glass of lukewarm water, mouthwash, 4 times daily. Route of administration, frequency of administration, duration of treatment: follow the advice of your dental specialist.

Composition

The active substance is: Povidone iodine 10.00g for glycerol to 85 percent, mint flavor, sodium saccharin, sodium hydroxide, purified water. Solution for mouthwash. 125 ml bottle.

Precautions green Betadine 10 percent solution for mouthwash

This medication should generally not be used: in children under 6 years, together with the mercury derivatives antiseptics. Precautions: If symptoms persist beyond 5 days and / or associated fever, consult a doctor or dental specialist. The iodine contained in this medication can pass through the mucosa and into the systemic circulation (see section 4), the medicine contains terpene derivatives (mint flavor). Prolonged use (more than 5 days) of the drug is not desirable because it can change the natural microbial balance in the mouth. Follow the dosage and duration of treatment recommended (see Dosage). Taken in large quantities or repeatedly: This medication may alter the natural microbial balance in the mouth, this drug is liable to affect the thyroid function or cause interference with function tests thyroid gland. If old or new epilepsy. Ask your doctor if in doubt, do not hesitate to seek advice from your pharmacist or dental specialist.

Introducing the 10 percent green betadine solution for mouthwash

125 ml bottle. Solution for local application

The advice of your pharmacist

Un Conseil ? Une Question ?

Green 10 percent betadine solution for mouthwash should not be used in patients with hyperthyroidism and other thyroid diseases present, dermatitis herpetiformis Duhring (very rare skin disease herpes-like) in case hypersensitivity to iodine or to another component, in patients who undergo radiation therapy with iodine and marked in neonates and infants less than 6 months. Following a disease thyroid, use 10 percent green betadine solution mouthwash should not be used in infants less than 6 months. In small children, the green 10 percent betadine mouthwash solution should be used only on prescription medical and if they are able to rinse your mouth and gargle properly. It should spit out the solution after use. The green solution betadine 10 percent mouthwash should not be used simultaneously with preparations containing chlorhexidine, silver sulfadiazine, alkaline substances or mercury because they could reduce the effect. Tell your doctor or pharmacist if you have any other illness, you are allergic or you take or are already using other drugs for external use (bought yourself!).

Warnings on drugs

Please note, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your products in.

 

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a field of customized message provided for that purpose.

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Pharmacovigilance : Report or a related side effect (s) (s) (s) the use of a drug

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All products in the laboratory MEDA PHARMA

All products disinfectants antispetiques

 

VIDAL OF THE FAMILY

BÉTADINE mouthwash

Oral antiseptic preparation

povidone iodine

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

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

COMPOSITION (summary)
p 100 ml
Povidone iodine 10 g
Mint, gasoline +

INDICATIONS (summary)
This medication is an antiseptic solution for mouthwash and gargle . It contains iodine.
It is used in the adjuvant treatment of infections of the mouth and in the suites of operation of the teeth or the gums.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • history of allergy to polyvidone iodine;
  • newborn (less than 1 month old);
  • pregnancy (from the 4th month onwards, for prolonged use);
  • breastfeeding in case of prolonged treatment.
WARNING (Contents)
Gargle or mouthwash is not readily usable in young children who may swallow the solution, which is why they are intended for children over 6 years of age.
This drug of iodine; repeated or prolonged use may disrupt the thyroid function .
Prolonged use of local antiseptic treatments ( gargle , mouthwash , lozenge) is undesirable; it can alter the natural microbial balance of the throat.
If there is no improvement after 5 days or in case of fever, consult your doctor.
DRUG INTERACTIONS (summary)
The combination with other antiseptics , especially mercurial derivatives, is not recommended: risk of cancellation of their effects or formation of caustic substances.
PREGNANCY AND BREAST-FEEDING (summary)
This medication contains iodine, which may pass into the blood of the pregnant woman or into the milk of the breastfeeding woman and interfere with the functioning of the child's thyroid gland. This risk, theoretical, is only to be taken into account in case of prolonged use.
If in doubt, do not use this medicine more than a few days without medical advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
The solution should not be used purely and in no case should be swallowed.

Usual dosage:

  • Adult and children over 6 years: 1 to 2 teaspoons of solution in a vial in a glass of lukewarm water in mouthwashes 4 times a day or 1 unidose in a glass of lukewarm water, gargle mouthwashing, 4 times a day.
TIPS (summary)
Avoid eating or drinking within 1 hour of mouthwashing or gargling , in order to allow the active substances to act.
Some dentists and stomatologists do not recommend mouthwashing within hours of dental extraction to avoid bleeding the wound.
POSSIBLE ADVERSE EFFECTS (summary)
Allergic reaction , local irritation.
Disorders of thyroid function during prolonged treatment.


GLOSSARY (summary)


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


antiseptic
A substance that locally destroys bacteria, reducing their numbers and preventing their proliferation. Some antiseptics are also active on microscopic fungi and viruses.


mouthwash
A local treatment method which consists in leaving on the contact of lesions of the mouth or the gums a medicine pure or diluted in cold or lukewarm water.


mouthwash
Medication that acts by contact on the throat and internal walls of the mouth. It is administered by spraying or brushing.


gargle
A method of local treatment which aims to leave in contact with the throat a drug pure or diluted in cold or lukewarm water. The head is tilted backwards, a continuous exhalation preventing the liquid from descending into the lungs. The solution used must not be swallowed.


new born
Child less than one month old.


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


thyroid
Gland located at the base of the neck, which secretes hormones rich in iodine.


treatment
Treatment that complements the action of a specific treatment, but generally does not achieve healing on its own.

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NOTICE

ANSM - Updated on: 20/07/2017

Name of the medicinal product

BETADINE 10 PER CENT, mouth wash solution

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, 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.

Review summary

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?

Pharmacotherapeutic group

PREPARATIONS FOR ODONTO-STOMATOLOGY / OTHER AGENTS FOR ORAL LOCAL TREATMENT / MISCELLANEOUS.

Therapeutic indications

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.

Cons-indications

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.

Sport

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?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

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.

Risk of withdrawal syndrome

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.

Expiration date

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.

Storage conditions

Before opening: no special precautions for storage.

If necessary, warnings against visible signs of deterioration

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

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.

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

MEDA PHARMA

40-44 WASHINGTON STREET

75008 PARIS

exploiting

MYLAN MEDICAL SAS

40-44 Washington Street

75008 PARIS

Maker

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.

Internet Information

Detailed information on this medicine is available on the Afssaps website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

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Betadine antiseptic is a drug for external use, for the disinfection and the antisepsis of skin or mucous membranes.

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