Mundi Pharma Betadona Antiseptic 120 ml

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

Reliable disinfection largely prevents infections and promotes rapid, problem-free healing.
A 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 the skin, mucous membranes and wounds.
During the process of action, the iodine discolors, so the depth of the brown color indicates its effectiveness. In the event of discoloration, additional dosing is required.
Betadona Mund-Antisepticum is a therapeutic anti-inflammatory mouthwash, pleasant in taste and strongly odor-inhibiting.

field of use

• in infectious-inflammatory diseases of the oral and pharyngeal mucosa and gums caused by fungi, viruses and bacteria (e.g. thrush, aphthae, superinfected and fever blister-like ulcers, gingivitis, inflammation of the oral mucosa, inflammation of the mucous membrane of the pharynx, supportive treatment for tonsillitis)
• for injuries in the mouth and throat
• for disinfecting the oral mucosa (e.g. before surgical interventions), especially in patients with disorders of the body's own defenses 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 (bacteremia)
• to prevent radiation-induced inflammation of the lining of the mouth (mucositis) in patients receiving radiation treatment or radiation treatment together with chemotherapy

Contraindications

Betadona mouth antiseptic must NOT be used

• if you are allergic to povidone-iodine or any of the other ingredients of this medicine (listed in section 6),
• if you suffer from an overactive thyroid gland (hyperthyroidism) or other thyroid diseases,
• 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 the end of the treatment.

interactions

DO NOT use at the same time

• Betadona mouth antiseptic and hydrogen peroxide, enzymatic or silver and taurolidine-containing wound treatment agents or disinfectants, as there is a mutual weakening of the effect,
• Betadona oral antiseptic and preparations containing mercury, since a corrosive compound (mercury iodide) can form,
• Betadona mouth antiseptic and octenidine-containing wound treatment agents, since dark discoloration can temporarily occur,
• Betadona oral antiseptic and taurolidine, as taurolidine can be converted to an acid (formic acid) that causes intense burning.

Protein, blood or pus components can impair the effectiveness of Betadona Mouth 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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
An application in pregnant women and during the lactation period may only be carried out on the express instructions of the doctor; monitoring of thyroid function in the mother or infant is indicated. A treatment should only last a short time. Iodine enters the unborn child (foetus) via the placenta and also passes into breast milk. 

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

application

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

For use in the mouth and throat. Apply Betadona mouth antiseptic undiluted or use diluted to rinse the mouth and throat and to gargle.
The cap can be used as a dosing aid for dilutions. A cap holds 5 ml.
Unless otherwise prescribed by the doctor, Betadona Mouth Antiseptic is used as follows:

For 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 in about 1/8 liter glass of water). Rinse and/or gargle mouth for at least 30 seconds every 1-4 hours until symptoms resolve.

Before operations or other dental procedures
, Betadona mouth antiseptic is applied undiluted in the area of ​​the procedure. The exposure time should not be less than 30 seconds.

To prevent radiation-induced inflammation of the oral mucosa (mucositis)
, Betadona oral antiseptic is diluted (1 part oral antiseptic, 8 parts lukewarm water = about 4 capfuls to about 1/8 liter glass of water) and used to rinse the oral cavity. Rinse several times a day for over 3 minutes and always after meals.

Betadona Mund-Antisepticum should only be used on small children if it is ensured that the child will not swallow the solution.

• Lukewarm tap water is suitable for dilution. Do not pour into hot water and do not heat!
• Prepare the dilution just before use, otherwise the effect cannot be guaranteed. This can be indicated by discoloration of the diluted solution. The iodine discolors during the process of action. The depth of the brown color 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. Any discolouration of the material can thus also be avoided.

Do not use Betadona Mouth Antiseptic together with other gargles.

Duration of use
The duration of use of Betadona Mouth Antiseptic depends on the respective area of ​​application.
The use of Betadona Mund-Antisepticum 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 sure.

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

side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequencies are used as a basis for evaluating side effects:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people Affects people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

Rare side effects
Hypersensitivity, hypersensitivity reactions of the skin, which can manifest themselves in the form of itching, redness, blisters or similar

Very rare side effects
Acute allergic general reactions (anaphylactic reaction) often accompanied by a drop in blood pressure, dizziness, nausea and possibly shortness of breath, hyperthyroidism in patients who tend to (sometimes with the symptoms of tachycardia or restlessness) ¹⁾ , allergic, painful swelling of the skin and mucous membrane (angioedema)

Unknown side effects
Hypothyroidism ²⁾ , electrolyte imbalance ³⁾ , metabolism-related hyperacidity of the blood and body ³⁾ , acute kidney failure ³⁾ , number of dissolved substances in the blood too large or too small ³⁾ , inflammation of the lungs caused by physical or chemical Influences (pneumonitis) ⁴⁾

¹⁾ In patients with a history of thyroid dysfunction (see Warnings and Precautions) after ingestion of a large amount of iodine, for example in the course of extensive use of povidone-iodine in the treatment of wounds and burns over a long period of time
²⁾ Hypothyroidism after prolonged or excessive use of povidone-iodine
³⁾ May occur after ingestion of large amounts of povidone-iodine (e.g. treatment of burns)
⁴⁾ discomfort from inhalation - see section 2

composition

The active substance 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% vol. ethanol, menthol, methyl salicylate, glycerol, anhydrous citric acid, anhydrous disodium phosphate, sodium hydroxide, purified water and sodium saccharin dihydrate.