BRAUNOVIDON

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Braunovidon (Braunovidon Salbe 10%)
100 mg/g, ointment
Povidone-iodine
Braunovidon and Braunovidon Salbe 10% are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information
for the patient.

• This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.
• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of contents of the leaflet:

1. What Braunovidon is and what it is 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 pack and other information

1. What Braunovidon is and what it is used for

Pharmaceutical form
Braunovidon is an ointment for topical application to the skin. The medicine contains the active substance povidone-iodine.
The medicine is used as a disinfectant for repeated use over a defined period.
Braunovidon is indicated in cases of skin burns caused by flame or hot liquid, infected ulcers, pressure sores, infected superficial skin defects not showing a tendency to heal with inflammatory reaction or deeper ulceration, purulent skin lesions (pyoderma), bacterial or fungal skin diseases, or secondary infections with the same agent following previous treatment.

2. Important information before using Braunovidon

When not to use Braunovidon:

• if the patient is allergic to povidone-iodine or any of the other ingredients of this medicine (listed in section 6),
• in thyroid disorders,
• in herpes gestationis (a rare skin disease characterized by burning, itching and other symptoms, primarily affecting the skin of the hands, feet, arms and buttocks),
• during planned or recently completed therapy with radioactive iodine (until completion of therapy),
• in newborns and infants up to 6 months of age.

Warnings and precautions:
Before starting treatment, discuss this with your doctor or pharmacist.

• Due to the risk of mercury iodide burns, povidone-iodine should not be used simultaneously with or after products containing mercury derivatives.
• Regular use of Braunovidon during lithium therapy is not recommended.
• The oxidizing effect of povidone-iodine may lead to false-positive results in certain diagnostic laboratory tests (e.g. determination of hemoglobin or glucose in feces or urine using o-toluidine or guaiac resin).
• Povidone-iodine may interfere with thyroid function tests (scintigraphy, protein-bound iodine determination, diagnosis using radioactive iodine isotopes), which may in turn prevent treatment with radioactive iodine. A new scintigram may be performed no earlier than 1–2 weeks after discontinuation of Braunovidon.
• Stains on clothing can be removed with soap and water. Stubborn stains may be removed using a solution of liquid ammonia or sodium thiosulfate.

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, have recently taken, or plan to take.
Povidone-iodine reacts with proteins and certain organic compounds, e.g. blood or pus components, which may reduce its effectiveness.
Concomitant use of povidone-iodine and enzyme-containing wound treatment products leads to oxidation of enzyme components, rendering them ineffective.
Braunovidon should not be used simultaneously with or shortly after mercury-containing wound care products or disinfectants, as iodine and mercury may react to form corrosive chemical substances.
Braunovidon should not be used simultaneously with reducing agents, alkaloid salts, tannic acid, salicylic acid, silver salts, bismuth salts, taurolidine, or hydrogen peroxide.
In patients undergoing lithium therapy, concomitant use of Braunovidon is not recommended. Absorbed iodine may exacerbate hypothyroidism, which may be induced by lithium.

Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
During pregnancy, Braunovidon may be used up to the ninth week only if there are significant medical indications as determined by a physician.
Use of Braunovidon after the ninth week of pregnancy and during breastfeeding is contraindicated, as iodine, including in the form of povidone-iodine, crosses the placental barrier and is excreted in breast milk.

Driving and operating machinery
Braunovidon has no influence on the ability to drive or operate machinery.

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 in doubt, consult a doctor, pharmacist, or nurse.
Apply the ointment several times daily to the affected area of skin.
During the initial phase of treatment, to maintain optimal bactericidal action, apply the ointment every 4–6 hours to infected or exuding wounds.
The duration of Braunovidon treatment depends on the patient's clinical condition.
The ointment may remain on the skin for a prolonged period. Dressings should be changed when the brown color of the ointment fades.
For optimal efficacy, the entire wound surface must be completely covered with ointment.
If the effect of the medicine seems too strong or too weak, consult a doctor.

Children
Do not use in newborns, especially premature infants, or in infants under 6 months of age.

Note:
The brown color of the ointment is a characteristic feature. It indicates the presence of available iodine and thus confirms its effectiveness. Fading of the color signals that a new layer of ointment should be applied. It is important that the ointment covers the entire infected skin surface, as Braunovidon acts as an antiseptic only locally.

Use of a higher than recommended dose of Braunovidon
If more than the recommended dose has been used, consult a doctor immediately.
There is no data available on overdose when the medicine is used according to the recommended indications and method of administration.
When large doses of the medicine are applied over extensive skin areas, wounds, or burns, symptoms of iodine poisoning may occur.

In case of accidental ingestion of Braunovidon
If the medicine is accidentally swallowed, seek immediate medical advice.

Symptoms
In case of accidental ingestion, gastric lavage should be performed using a starch solution or a 5% sodium thiosulfate solution. If necessary, correct disturbances in fluid and electrolyte balance.

Emergency treatment and antidote
Following excessive systemic absorption of Braunovidon during wound treatment, toxic plasma iodine levels can be effectively reduced by hemodialysis or peritoneal dialysis. Further treatment should be based on the underlying disease and symptoms of overdose (e.g. metabolic acidosis, renal dysfunction) and should follow general principles. Since iodine may exacerbate hyperthyroidism, treatment with antithyroid agents may be delayed.

4. Possible adverse reactions

Like all medicines, Braunovidon may cause adverse reactions, although not everybody experiences them.
Significant adverse reactions or symptoms to which attention should be paid, and preventive
measures to be taken if they occur
Frequency unknown (cannot be estimated based on available data):
skin reactions in cases of hypersensitivity (allergy), e.g. delayed contact allergy manifesting as itching, redness, blisters, etc.
Very rare (may occur in not more than 1 in 10,000 patients):
severe hypersensitivity reactions (anaphylactic reactions) affecting other organs (e.g. skin, respiratory system, circulatory system).
If any of the above adverse reactions occur, use of Braunovidon must be discontinued and immediate medical advice must be sought.
Other adverse reactions
Frequency unknown (cannot be estimated based on available data):

• unfavourable effect on wound healing, as well as transient pain, burning sensation and warmth following prolonged use;
• thyroid function disorders resulting from use over large body surface areas or repeated use, particularly on damaged skin – routine monitoring of thyroid function is necessary in such cases;
• cases of serum osmolality disturbances, electrolyte imbalances, renal failure, and severe metabolic acidosis due to systemic absorption of large amounts of povidone-iodine.

If any adverse reactions occur, consult a doctor or pharmacist. This includes reactions not listed in this leaflet.
Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Braunovidon

Keep the medicine out of sight and reach of children.
Do not store above 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Braunovidon contains

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

What Braunovidon looks like and contents of the pack
The medicine is a brown ointment.
Aluminum tube with a screw cap, containing 20 g or 100 g of ointment, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Germany, country of export:
B. Braun Melsungen AG
Carl-Braun-Str. 1, 34212 Melsungen, Germany
Manufacturer:
B. Braun Melsungen AG
Carl-Braun-Str. 1, 34212 Melsungen, Germany
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Germany, country of export: 5861.00.00
Parallel import authorisation number: 335/25