Betadona wound gel

Povidone-iodine has a comprehensive germicidal effect.

Application

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

Povidone-iodine has a comprehensive germicidal effect. It is effective against bacteria, fungi, spores, viruses and protozoa.
Betadona Wound Gel enables reliable wound disinfection, prevents pus formation and promotes rapid, problem-free healing.
Due to its mode of action, there is no risk of infectious agents becoming resistant to povidone-iodine.
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 colour therefore indicates its effectiveness. In case of discolouration, re-dosing is necessary. Povidone-iodine is water-soluble and easily washed off.
Applications
For repeated, temporary use on
burns
cuts and abrasions
pressure and lower leg ulcers (decubitus ulcers, varicose ulcers)
infected and superinfected skin diseases

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How is it applied?

What is Betadona Wound Gel and what is it used for?

Povidone-iodine has a comprehensive germicidal effect. It is effective against bacteria, fungi, spores, viruses and protozoa.
Betadona Wound Gel enables reliable wound disinfection, largely prevents pus formation 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.
During the action process, the iodine decolours, the depth of the brown colouring therefore indicates its effectiveness. In case of decolourisation, a subsequent dosage is necessary. Povidone-iodine is water-soluble and easily washed off.
Applications
For repeated, time-limited use in

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• Burns
• Cuts and abrasions
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• Pressure ulcers and lower leg ulcers (decubitus ulcers, varicose ulcers)

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• infected and superinfected skin diseases
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What should you pay attention to before taking it?

What should you bear in mind before using Betadona Wound Gel?
Betadona Wound Gel 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 with iodine (radio-iodine therapy) until completion of the treatment,
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Warnings and precautions.
Please talk to your doctor or pharmacist before using Betadona Wound Gel.

• In newborns and infants up to the age of 6 months, Betadona Wound Gel should only be used after a strict risk/benefit assessment by the doctor and on an extremely limited basis. If necessary, thyroid function should be monitored.
• Accidental swallowing of Betadona wound gel by newborns, infants and young children must be avoided. See section Pregnancy and Lactation for safe use during this time.
• With large-area burn treatment with povidone-iodine, the occurrence of electrolyte disturbances and an associated impairment of renal function may be favoured.
• 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 discontinuing therapy (up to 3 months), watch out for early symptoms of hyperthyroidism and monitor thyroid function if necessary.
• Before or after a radio-iodine scintigraphy or radio-iodine treatment for thyroid cancer, Betadona Wound Gel should not be applied.
• Influence on diagnostic examinations:
  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 discontinuation of treatment with povidone-iodine should be observed.
• 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).

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

Use of Betadona Wound Gel with other medicines.

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Do NOT use at the same time

• Betadona Wound Gel and hydrogen peroxide, enzymatic or silver- as well as taurolidine-containing wound treatment agents or disinfectants, as there is a mutual weakening of effect
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• Betadona wound gel and preparations containing mercury, as a corrosive compound (mercury iodide) can form,
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• Betadona Wound Gel and octenidine-containing wound treatment products, as dark discolouration may occur temporarily,
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• Betadona Wound Gel and taurolidine, a chemotherapeutic agent against bacteria and fungi, as taurolidine can be converted into an acid (formic acid) that causes intensive burning.

Protein, blood or pus components may impair the effectiveness of Betadona Wound Gel.
If you are receiving lithium therapy, Betadona Wound Gel should be used with caution and only for a short time. In this case, larger amounts of iodine can be absorbed through the skin.

Pregnancy, lactation and reproductive capacity.
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 carried out according to the express instructions of the doctor; monitoring of the thyroid function in the mother or infant is indicated. A treatment should only last a short time. Iodine enters the fetus (unborn child) via the placenta (placenta) and also passes into breast milk.
Accidental oral ingestion of Betadona wound gel by the infant through contact with the treated part of the nursing mother's body must be avoided.

Driving ability and ability to operate machinery.
Betadona Wound Gel has no effect on the ability to drive and operate machinery.

How should the medicine be taken?

How to use Betadona Wound Gel?

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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.
The recommended dose is:
The wound gel is applied evenly to the diseased area several times a day.
If the Betadona Wound Gel discolours, it should be re-dosed. Do not use Betadona Wound Gel together with other wound treatment products.

Betadona Wound Gel is for external use.

Duration of use
The use of Betadona Wound Gel should be continued as long as there are still signs of infection or a clear risk of infection. If a recurrence occurs after stopping treatment with Betadona Wound Gel, treatment can be restarted at any time.

Newborns and infants under 6 months of age
In newborns and infants up to 6 months of age, Betadona Wound Gel should only be used after a strict risk/benefit assessment by the doctor and on an extremely limited basis.

If you have used a larger amount of Betadona Wound Gel than you should,
Please read section 4. What are the possible side effects?
Information for healthcare professionals on overdose therapy is given at the end of the leaflet.

If you have forgotten to use Betadona Wound Gel
Do not use twice the amount if you have forgotten to use it before.

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 Wound Gel?

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 tube and 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 Wound Gel?

Do not store above 25 °C.

Keep this medicine out of the reach of children.

Do not use this medicinal product after the expiry date which is stated on the tube and 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 notes on the content

Contents of the pack and further information
What Betadona Wound Gel contains
The active substance is: Povidone-iodine
1 g Betadona Wound Gel contains 100 mg povidone-iodine complex,
Total content: 1 % available iodine.
The other ingredients are:
Macrogol, purified water, sodium hydrogen carbonate.

What Betadona Wound Gel looks like and contents of the pack
Reddish brown gel
Tube of 30 g, 90 g
Jar of 250 g

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