Braunovidon

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Braunovidon

100 mg/g, ointment

Povidone iodine

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.
• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4. If there is no improvement or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Braunovidon and what is it used for
• 2. Important information before using Braunovidon
• 3. How to use Braunovidon
• 4. Possible side effects
• 5. How to store Braunovidon
• 6. Contents of the packaging and other information

1. What is Braunovidon and what is it used for

Pharmaceutical form

Braunovidon is an ointment for application to the skin. The medicine contains the active substance povidone iodine.
The medicine is used as a disinfectant for repeated use over a specified period.
Braunovidon is indicated in cases of skin burns from flames or hot liquids, infected ulcers, bedsores, infected superficial skin defects that do not show a tendency to heal with an inflammatory reaction or deeper ulcers, purulent skin changes (pyoderma), skin diseases of bacterial or fungal origin, or secondary infections with the same agent previously cured.

2. Important information before using Braunovidon

When not to use Braunovidon:

• if you are allergic to povidone iodine or any of the other ingredients of this medicine (listed in section 6),
• in thyroid disease,
• in the case of herpetic dermatitis (a rare skin disease characterized by burning, itching, and other symptoms, mainly on the skin of the hands, feet, arms, and buttocks),
• when planning or recently completed therapy with a radioactive iodine isotope (until the end of therapy).
• in newborns and infants up to 6 months of age.

Warnings and precautions:

You should discuss this with your doctor or pharmacist before starting treatment.

• Due to the risk of mercury iodide burns, povidone iodine should not be used simultaneously or after the use of mercury-containing products.
• Regular use of Braunovidon is not recommended during lithotherapy.
• The oxidizing effect of povidone iodine may cause false-positive results in some laboratory diagnostic tests (e.g., hemoglobin or glucose determination in stool or urine using o-toluidine or guaiac resin).
• Povidone iodine may interfere with thyroid function tests (scintigraphy, iodine binding protein determination, diagnosis using a radioactive iodine isotope), which may prevent treatment with a radioactive iodine isotope. A new scintigram can be performed no earlier than 1-2 weeks after the end of treatment with Braunovidon.
• Stains on clothing can be removed with soap and water. Difficult-to-remove stains can be removed with a liquid ammonia solution or thiiosulfate.

Children

Do not use in newborns, especially premature infants, and in infants up to 6 months of age.

Braunovidon and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Povidone iodine reacts with proteins and some organic compounds, e.g., blood or pus components, which may reduce its effectiveness.
Concomitant use of povidone iodine and enzymes for wound care causes oxidation of the enzyme components, making them ineffective.
Braunovidon should not be used simultaneously or shortly after the use of wound care products or disinfectants containing mercury, as iodine and mercury can react to form corrosive chemical substances.
Braunovidon should not be used with reducing agents, alkaloid salts, tannic acid, salicylic acid, silver salts, bismuth salts, taurolidine, or hydrogen peroxide.
In patients undergoing lithotherapy, concomitant use of Braunovidon is not recommended. Absorbed iodine may exacerbate hypothyroidism, which may be caused by lithotherapy.

Pregnancy, breastfeeding, fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
During pregnancy, Braunovidon may be used up to the ninth week, provided there are significant indications determined by the doctor.
Use of Braunovidon after the ninth week of pregnancy and during breastfeeding is contraindicated, as iodine, including povidone iodine, passes through the placental barrier and into breast milk.

Driving and using machines

Braunovidon does not affect the ability to drive and use machines.

3. How to use Braunovidon

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If you are unsure, you should consult your doctor, pharmacist, or nurse.
The ointment is applied several times a day to the surface of the skin that requires treatment.
In the initial phase of treatment, to maintain optimal bactericidal action, the ointment should be applied every 4-6 hours to the infected or secreting wound.
The duration of use of Braunovidon depends on the patient's clinical condition.
The ointment may remain on the skin for a long time. The dressing should be changed when the brown color of the ointment fades.
For the ointment to work effectively, the entire surface of the wound should be thoroughly covered.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Children

Do not use in newborns, especially premature infants, and in infants up to 6 months of age.
Warning:
The brown color of the ointment is a characteristic feature. It indicates the presence of available iodine and its effectiveness. Fading of the color is a signal to apply a new layer of ointment. It is essential to cover the entire infected skin surface with the ointment, as Braunovidon works antiseptically only locally.

Using a larger dose of Braunovidon than recommended

If you use a larger dose of the medicine than recommended, you should immediately consult your doctor.
There are no data on overdosing when using the medicine according to the indications and method of use.
If large doses of the medicine are used on large skin surfaces, wounds, or burns, symptoms of iodine poisoning may occur.

If you accidentally ingest Braunovidon

If you ingest the medicine, you should immediately consult your doctor.
Symptoms
In case of accidental ingestion of the medicine, you should rinse your stomach with a starch solution or 5% sodium thiosulfate solution and, if necessary, correct water and electrolyte balance disturbances.
Emergency treatment, antidotes
After absorbing too much of the medicine during wound treatment, the toxic level of iodine in the serum can be effectively reduced by hemodialysis or peritoneal dialysis. Further treatment depends on the underlying disease and symptoms of overdosing, e.g., metabolic acidosis, renal impairment, and should be carried out according to general principles. Due to the fact that iodine exacerbates hyperthyroidism, the results of treatment with thyrostatics may be delayed.

4. Possible side effects

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

Important side effects or symptoms to watch out for and preventive measures to be taken if they occur

Frequency not known(cannot be estimated from the available data):
skin reactions in case of hypersensitivity (allergy), e.g., late contact allergy in the form of itching, redness, blisters, etc.
Very rare(may occur in less than 1 in 10,000 patients):
severe hypersensitivity reactions (anaphylactic reactions) affecting other organs (e.g., skin, respiratory system, cardiovascular system).
If you experience any of these side effects, you should stop using Braunovidon and consult your doctor immediately.

Other side effects

Frequency not known(cannot be estimated from the available data):

• unfavorable effect on wound healing and transient pains, burning sensation, and heat when used for a prolonged period;
• thyroid function disorders due to use on a large body surface area or repeated use, especially on damaged skin surfaces - in such cases, routine monitoring of thyroid function is necessary;
• cases of serum osmolality disorders, electrolyte disturbances, renal failure, and severe metabolic acidosis due to the absorption of large amounts of povidone iodine into the body.

If you experience any side effects, including any possible side effects not listed in this leaflet, you should consult your doctor or pharmacist. This includes any side effects not mentioned in this leaflet.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Braunovidon

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Braunovidon contains

• Active substance: povidone iodine with 10% available iodine content. 100 g of ointment contains 10 g of povidone iodine.
• Excipients: macrogol 400, macrogol 4000, purified water, sodium bicarbonate.

What Braunovidon looks like and what the packaging contains

The medicine is a brown-colored ointment.
Polyethylene tubes containing 20 g or 100 g of ointment, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

• B. Braun Melsungen AG Carl-Braun Str. 1, 34212 Melsungen, Germany

Manufacturer:

• B. Braun Melsungen AG Am Schwerzelshof 1, 34212 Melsungen, Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 32/172/98-C

Parallel import authorization number: 148/22 Date of leaflet approval: 31.03.2022