Betadona® oral antiseptic, 120 ML

Betadona® Oral Antiseptic exerts its comprehensive germicidal effect when used in diluted or undiluted form for gargling and rinsing, and is therefore suitable for the treatment of infectious and inflammatory conditions of the oral and pharyngeal mucosa, as well as the gums, caused by fungi, viruses and bacteria. Betadona Oral Antiseptic is well tolerated by the mucous membranes, has a pleasant taste and is highly odour-suppressing.

What is Betadona® and what is it used for?

Povidone-iodine has a broad-spectrum germicidal effect (broad-spectrum microbicide). It is effective against bacteria, fungi, spores, viruses and certain single-celled organisms (protozoa); in other words, it has bactericidal, virucidal, fungicidal, protozoicidal and sporocidal effects. Reliable disinfection largely prevents infections and promotes rapid, trouble-free healing. Due to its mode of action, there is no risk of infectious agents developing resistance to povidone-iodine. 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 disinfection process, the iodine discolours; the depth of the brown colour therefore indicates its effectiveness. If discolouration occurs, a further dose is required. Betadona® Oral Antiseptic is a therapeutic, anti-inflammatory mouthwash with a pleasant taste and strong odour-masking properties.

Indications

• for infectious and inflammatory conditions of the oral and pharyngeal mucosa and the gums caused by fungi, viruses and bacteria (for example, thrush, aphthous ulcers, superinfected and cold-sore-like ulcers, gingivitis, inflammation of the oral mucosa, inflammation of the pharyngeal mucosa, and as an adjunctive treatment for tonsillitis)
• for injuries in the mouth and throat
• for the disinfection of the oral mucosa (for example, prior to surgical procedures), particularly in patients with impaired immune systems and in patients at risk of inflammation of the inner lining of the heart and heart valves (endocarditis) caused by bacteria entering the bloodstream (bacteraemia)
• for the prevention of radiation-induced inflammation of the oral mucosa (mucositis) in patients undergoing radiotherapy or radiotherapy in combination with chemotherapy

Dosage form

Solution

Directions for use

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 unsure.

For use in the mouth and throat.

Apply Betadona® Oral Antiseptic undiluted, or use it diluted for rinsing the mouth and throat and for gargling. The cap can be used as a measuring aid for dilutions. One cap holds 5 ml. Unless otherwise prescribed by your doctor, Betadona® Oral Antiseptic should be used as follows.

For infectious and inflammatory conditions and injuries in the mouth and throat

• Betadona® Oral Antiseptic is used in diluted form (1 part oral antiseptic to 8 to 16 parts lukewarm water = approximately 2 to 4 capfuls in a glass of water holding about 1/8 litre). Rinse the mouth and/or gargle for at least 30 seconds every 1–4 hours until the condition has subsided.

Before operations or other dental procedures

• Betadona® Oral Antiseptic is applied undiluted to the area to be treated. It should be left to act for at least 30 seconds.

To prevent radiation-induced inflammation of the oral mucosa (mucositis)

• Betadona® Oral Antiseptic is used diluted (1 part oral antiseptic to 8 parts lukewarm water = approximately 4 capfuls to about 1/8 litre of water) for rinsing 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.
• Lukewarm tap water is suitable for dilution. Do not pour into hot water and do not heat it up!
• Prepare the diluted solution only shortly before use; otherwise, its effectiveness cannot be guaranteed. This may be indicated by the diluted solution losing its colour. During the reaction, the iodine loses its colour. The depth of the brown colour therefore indicates its effectiveness.
• Do not swallow the solution.
• Spit it out after rinsing. Do not rinse with water afterwards.

Remove dentures, braces and similar items from your mouth before use, so that your gums and oral mucosa are more easily accessible. This will also help to prevent any discolouration of the material. Do not use Betadona® Oral Antiseptic together with other mouthwashes.

Duration of use

• The duration of use of Betadona® Oral Antiseptic depends on the specific condition being treated. Use of Betadona® Oral Antiseptic should be continued for as long as there are still signs of infection or a clear risk of infection. Please consult your doctor or pharmacist if you are unsure. Povidone-iodine can be easily removed from textiles and other materials using warm water and soap; in stubborn cases, use ammonia (sal ammoniac) or a sodium thiosulphate solution (fixing salt).

Ingredients

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% by volume ethanol, menthol, methyl salicylate, glycerol, anhydrous citric acid, anhydrous sodium monohydrogen phosphate, sodium hydroxide, purified water and sodium saccharin dihydrate.