Betadona mouth antiseptic

Povidone-iodine has a comprehensive germicidal effect (broad-spectrum microbicide).

Application

1. What is Betadona and what is it used for?

Povidone-iodine has a comprehensive germicidal effect (broad-spectrum microbicide). It is effective against bacteria, fungi, spores, viruses and certain protozoa, i.e. it is bactericidal, virucidal, fungicidal, protozide and sporocidal.

Reliable disinfection largely prevents infections and promotes rapid, problem-free healing.
Due to its mode of action, resistance of infectious agents (resistance) to povidone-iodine is not to be feared.
By binding to povidone, the iodine largely loses the irritating properties of alcoholic iodine preparations and is well tolerated by skin, mucous membranes and wounds.
The iodine discolours during the action process, the depth of the brown colouring therefore indicates its effectiveness. In case of discolouration, a subsequent dosage is required.
Betadona Mouth Antiseptic is a therapeutic anti-inflammatory mouthwash with a pleasant taste and strong odour-inhibiting properties.

Applications
for infectious-inflammatory diseases of the mucous membranes of the mouth and throat and of the gums caused by fungi, viruses and bacteria (e.g. thrush, aphthae, superinfected and fever blister-like ulcers, gingivitis, inflammation of the gums).
in the case of injuries in the mouth and throat area
for disinfection of the mouth mucous membranes
for disinfection of the mouth mucous membranes
for disinfection of the mouth mucous membranes
for disinfection of the mouth mucous membranes
for disinfection of the mouth mucous membranes
for disinfection of the oral mucosa (e.g. before surgery), especially in patients with disorders of the body's own defences and in patients at risk of inflammation of the inner lining of the heart and the heart.
for the prevention of radiation-induced inflammation of the oral mucosa (mucositis) in patients undergoing radiation treatment or radiation treatment together with chemotherapy

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How is it applied?

What is Betadona and what is it used for?

Povidone-iodine has a comprehensive germicidal effect (broad-spectrum microbicide). It is effective against bacteria, fungi, spores, viruses and certain protozoa, i.e. it is bactericidal, virucidal, fungicidal, protozidal and sporicidal.

Reliable disinfection largely prevents infections and promotes rapid, problem-free healing.
Resistance of infectious agents (resistance) to povidone-iodine is not to be feared due to the mode of action.
By binding to povidone, the iodine largely loses the irritating properties of alcoholic iodine preparations and is well tolerated by skin, mucous membranes and wounds.
During the action process, the iodine decolours, the depth of the brown colouring therefore indicates its effectiveness. If discolouration occurs, re-dosing is necessary.
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Betadona Mouth Antiseptic is a therapeutic anti-inflammatory mouthwash, pleasant in taste and strongly odour-inhibiting.

Applications

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• for infectious-inflammatory diseases of the oral and pharyngeal mucosa and the gums caused by fungi, viruses and bacteria (for example thrush, aphthae, superinfected and fever blister-like ulcers, gingivitis, inflammation of the oral mucosa, inflammation of the mucous membrane of the pharynx).infected and fever blister-like ulcers, gingivitis, inflammation of the oral mucosa, inflammation of the mucosa of the pharynx, supportive treatment for tonsillitis)
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• for injuries in the mouth and throat
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• For disinfection of the oral mucosa (for example before surgical procedures), especially in patients with disorders of the body's own defences and in patients at risk of inflammation of the inner lining of the heart and heart valves (endocarditis) due to bacteria carried into the bloodstream (bacteraemia)
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• For the prevention of radiation-induced inflammation of the oral mucosa (mucositis) in patients undergoing radiotherapy or radiotherapy together with chemotherapy
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What should you pay attention to before taking it?

What should you be aware of before using Betadona?
Betadona Oral Antiseptic must NOT be used,

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• If you are allergic to povidone-iodine or any of the other ingredients of this medicine listed in section 6,
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• If you suffer from hyperthyroidism or other thyroid diseases,
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• if you suffer from the rare chronic skin inflammation dermatitis herpetiformis Duhring,
• before and after radiotherapy of the thyroid gland with iodine (radio-iodine therapy) until completion of the treatment.

Warnings and precautions
Please talk to your doctor or pharmacist before using Betadona Oral Antiseptic.

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• After thyroid diseases (especially in elderly patients) or in the case of goitre, povidone-iodine should only be used over a longer period of time or on a large scale after a strict risk/benefit assessment by a doctor.The use of povidone-iodine over a longer period of time or on a large scale should only be carried out after a strict risk/benefit assessment by the doctor, as a subsequent hyperthyroidism cannot be completely ruled out.
  Even after treatment has ended (up to 3 months afterwards), these patients should be watched for signs of hyperthyroidism and, if necessary, their thyroid function should be monitored.
• Before or after radio-iodine scintigraphy or radio-iodine treatment for thyroid cancer, Betadona Oral Antiseptic should not be used
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• Influence on diagnostic investigations: With the use of povidone-iodine, the iodine uptake of the thyroid gland may be reduced, this may lead to disturbances in various examinations of the thyroid gland and make a planned treatment (radio-iodine therapy) impossible. An interval of 1 - 2 weeks after stopping treatment with povidone-iodine should be observed.
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• Due to the oxidising effect of povidone-iodine, various laboratory tests may give false-positive results (including toluidine and guaiac resin for haemoglobin or glucose determination in faeces or urine).
• When Betadona Oral Antiseptic is applied to the throat, inhalation of the solution into the lungs must be avoided, as otherwise breathing difficulties or even pneumonia may occur. This can occur especially with intubated patients.
• Due to the oxidative property of povidone-iodine, metals can become rusty, plastics are generally povidone-iodine resistant. From case to case, a discolouration may occur that usually disappears again. Therefore, remove your non-fixed dentures for a short time before rinsing.
• Children, newborns and infants
  In newborns and infants up to 6 months of age, povidone-iodine should only be used after a strict benefit/risk assessment by the doctor. If necessary, thyroid function should be monitored.
• Swallowing of Betadona Oral Antiseptic by newborns, infants and young children must be avoided.
  Please read section Pregnancy, lactation and reproductive capacity for safe use during this time.

Use of Betadona Oral Antiseptic with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

Do NOT use at the same time

• Betadona Mouth Antiseptic and hydrogen peroxide, enzymatic or silver- and taurolidine-containing wound treatment products or disinfectants, as they weaken each other's effect,
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• Betadona oral antiseptic and preparations containing mercury, as a corrosive compound (mercury iodide) may form,
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• Betadona oral antiseptic and octenidine-containing wound treatment products, as dark discolouration may occur temporarily,
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• Betadona oral antiseptic and taurolidine, as taurolidine can be converted to an acid (formic acid) that causes intense burning
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Protein, blood or pus components may affect the effectiveness of Betadona Oral Antiseptic.

If you are receiving lithium therapy, you should only use Betadona Oral Antiseptic for a short time. Otherwise, larger amounts of iodine could be absorbed into the body.

Pregnancy, lactation and fertility
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If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Use in pregnant women and during breast-feeding may only be made according to the express instructions of the doctor, monitoring of thyroid function in the mother and infant respectively is indicated. A treatment should only last a short time.
Iodine passes via the placenta into the unborn child (foetus) and also passes into breast milk.

Driving and ability to operate machinery
Betadona Oral Antiseptic has no or negligible effect on the ability to drive and operate machinery.

Betadona Mouth Antiseptic contains small amounts of ethyl alcohol, but less than 100 mg per dose.

How should the medicine be taken?

How to use Betadona?

Always use this medicine exactly as described in this leaflet or as agreed with your doctor or pharmacist.Ask your doctor or pharmacist if you are not sure.

For use in the mouth and throat.
Apply Betadona Oral Antiseptic undiluted or use diluted for rinsing the mouth and throat and for gargling.
The cap can be used as a dosing aid for dilutions. One sealing cap holds 5 ml.
If not otherwise prescribed by the doctor, Betadona Oral Antiseptic is used as follows:

In case of infectious-inflammatory diseases and injuries in the mouth and throat Betadona Mouth Antiseptic is used diluted (1 part Mouth Antiseptic, 8 to 16 parts lukewarm water = about 2 to 4 capfuls to about 1/8 litre glass of water). Rinse the mouth and/or gargle for at least 30 seconds every 1 - 4 hours until the disease subsides.

Before operations or other dental procedures
Betadona Oral Antiseptic is applied undiluted in the area of the procedure. An exposure time of 30 seconds should not be undercut.

For the prevention of radiation-induced inflammation of the oral mucosa (mucositis)Betadona Mouth Antiseptic is diluted in water.(1 part mouth antiseptic, 8 parts lukewarm water = about 4 capfuls to about 1/8 litre glass of water) to rinse the oral cavity. Rinse several times a day for 3 minutes and always after meals.

In young children, Betadona oral antiseptic should only be used if it is ensured that the child does not swallow the solution.
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• Lukewarm tap water is suitable for dilution. Do not pour into hot water and do not heat!
• Make the dilution just before use, otherwise the effect cannot be guaranteed. This may be indicated by decolourisation of the diluted solution. During the action process, the iodine decolours. The depth of the brown colouring therefore indicates its effectiveness.
• Do not swallow the solution.
• Spit out after rinsing. Do not rinse with water.

Take dentures, braces and the like out of your mouth before use so that your gums and oral mucosa are more accessible. This can also prevent any discolouration of the material.

Do not use Betadona Oral Antiseptic together with other gargles.

Duration of use
The duration of use of Betadona Oral Antiseptic depends on the respective area of application.
The use of Betadona Oral Antiseptic should be continued as long as there are still signs of infection or a clear risk of infection.
Please check with your doctor or pharmacist if you are not completely sure.

Povidone-iodine is easily removed from textiles and other materials with warm water and soap, in stubborn cases with ammonia (ammonia solution) or sodium thiosulphate solution (fixing salt).

If you have swallowed a large amount of Betadona Oral Antiseptic please contact a doctor or go to hospital immediately.

After improper swallowing of a very large amount of povidone-iodine (oral intoxication, ingestion of more than 10 g povidone-iodine), the following symptoms may occur: Abdominal pain and cramps, nausea, vomiting, diarrhoea, dehydration, drop in blood pressure, bleeding tendency, kidney damage, urinary retention, oxygen deficiency, circulatory collapse, nerve sensitivity disorder, swelling of the larynx, pulmonary oedema and fever.

For the doctor:
For information on the treatment of an overdose, see the end of the leaflet.________________________________________________________________________

If you forget to use Betadona Oral AntisepticDo not use twice the amount if you have forgotten to use it before.
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If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Betadona?

Do not store above 25 °C.

Keep this medicine out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the plastic bottle and outer carton after "Use by:". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste.
Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5 How to store Betadona?

Do not store above 25 °C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the plastic bottle and outer carton after ,,Use by:". The expiry date refers to the last day of the month indicated.

Do not dispose of medicinal products in waste water or household waste.
Consult your pharmacist on how to dispose of the medicinal product when you no longer use it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information
What Betadona Oral Antiseptic contains
The active ingredient is: povidone-iodine.
100 ml Betadona Oral Antiseptic contains 7.5 mg povidone-iodine complex,total content: 0.75 % available iodine.

The other ingredients are:
96% ethanol by volume, menthol, methyl salicylate, glycerol, anhydrous citric acid, anhydrous sodium monohydrogen phosphate, sodium hydroxide, purified water and saccharin sodium dihydrate.

What Betadona Oral Antiseptic looks like and contents of the pack
Alcoholic, reddish-brown, clear solution in plastic bottle with dropper insert and screw cap containing 120 ml
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