Braunoderm zabarvioni

Leaflet attached to the packaging: patient information

Braunoderm colored

(50 g + 1 g)/100 g, solution for the skin
Isopropyl alcohol + Povidone iodine

Read the 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 according to the doctor's or pharmacist's instructions.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Braunoderm colored and what is it used for
• 2. Important information before using Braunoderm colored
• 3. How to use Braunoderm colored
• 4. Possible side effects
• 5. How to store Braunoderm colored
• 6. Package contents and other information

1. What is Braunoderm colored and what is it used for

Braunoderm colored is a solution for the skin, containing the active substances isopropyl alcohol and povidone iodine with a 10% iodine content. Braunoderm colored has a rapid antibacterial effect of isopropyl alcohol and an antiseptic effect of iodine. Due to the additive effect of the active substances, the medicine acts on Gram-positive and Gram-negative bacteria, including tuberculosis bacilli, protozoa, and spores, and also has a fungicidal and virucidal effect.

Indications for use:

Disinfection of intact skin before:

• surgical operations,
• injections,
• puncture,
• catheterization,
• blood sampling,
• vaccinations.

2. Important information before using Braunoderm colored

When not to use Braunoderm colored:

if the patient is allergic to povidone iodine, isopropyl alcohol, or any of the other ingredients of this medicine (listed in section 6),
in hyperthyroidism or other thyroid diseases in history, or in case of a history of thyroid disease,
in herpetic skin lesions (Duhring's disease),
1 to 2 weeks before and after radioisotope therapy with iodine (until the end of treatment),
in newborns, especially premature babies,
in infants up to 6 months.

Warnings and precautions

The medicine is intended for use on the skin. Avoid contact with the eyes and mucous membranes.
Avoid using the medicine in patients with damaged skin (e.g., extensive, deep wounds, or burns), renal failure, as the alcohol and iodine in the medicine may be absorbed and cause systemic side effects.
During preoperative skin disinfection, care should be taken to avoid the accumulation of the medicine under the patient's body, as this may cause skin irritation.
Do not use the medicine simultaneously with wound treatment or disinfection products containing mercury compounds, as this may cause severe skin irritation due to the highly corrosive mercury iodide (I).
The medicine is flammable. Before turning on electrical devices, wait until the medicine has dried on the skin. Keep the medicine away from sources of ignition. Do not smoke near the medicine.
Consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Children and adolescents

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

Use in elderly patients:

Due to the increased risk of hyperthyroidism caused by iodine, use only on a doctor's prescription and under their supervision.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Driving and using machines:

Braunoderm colored does not affect the ability to drive and use machines.

Braunoderm colored and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Povidone iodine reacts with proteins and some other organic substances, e.g., blood or pus components, which may weaken its effect.
Concomitant use of povidone iodine with disinfectants containing silver, hydrogen peroxide, or taurolidine may cause mutual inactivation.
Iodine may react with products containing mercury compounds, forming highly corrosive mercury iodide (I).
Effect on diagnostic tests
Povidone iodine may cause false-positive results in some laboratory tests (e.g., hemoglobin or glucose tests in stool and urine).
Povidone iodine may reduce the uptake of radioactive iodine by the thyroid gland, thereby disrupting the results of thyroid function tests (scintigraphy, iodine-bound protein concentration, radioisotope diagnosis). For 1 to 2 weeks after using the medicine, a new scintigram should not be performed.

3. How to use Braunoderm colored

For use only by qualified medical personnel.
The medicine should never be diluted. Undiluted Braunoderm colored should be applied to the skin and spread with a sterile swab. The disinfected skin surface should be thoroughly moistened with the medicine, then left to dry. Excess medicine should be removed with a swab.
Exposure time: at least 15 seconds. In procedures such as joint or body cavity puncture – exposure time at least 1 minute (if necessary, the medicine should be reapplied). For inactivation of viruses – exposure time at least 2 minutes.
On skin with a large number of sebaceous glands (e.g., head, chest, and between the shoulder blades), the exposure time is 10 minutes (application should be repeated after the first application has dried).
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

In case of using a higher dose of Braunoderm colored than recommended

There are no data on overdose when using the medicine according to the indications and instructions for use.
When using large doses of the medicine on large skin surfaces, wounds, or burns, systemic side effects of iodine may occur (e.g., thyroid dysfunction, metabolic acidosis, hypernatremia, or kidney dysfunction).

In case of accidental ingestion of Braunoderm colored

In case of accidental ingestion of the medicine, contact a doctor immediately.

4. Possible side effects

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

Important side effects or symptoms to watch for and measures to take if they occur.

Very rare (may occur in up to 1 in 10,000 people):

• Anaphylactic reactions up to anaphylactic shock (severe hypersensitivity reactions),
• Hypersensitive skin reactions, e.g., contact allergy of the delayed type, manifested by itching, redness, blisters, etc. Stop using Braunoderm colored and consult a doctor immediately if any of these side effects occur.

Other side effects
Uncommon (may occur in up to 1 in 100 people):

• Local signs of irritation caused by alcohol (e.g., itching, redness, especially after frequent use of Braunoderm colored).
• Dry skin symptoms may occur during periods of low air humidity (especially in winter). In such cases, it is recommended to use a skin care cream.

When used on large skin surfaces, wounds, or burns, systemic side effects of iodine may occur (e.g., thyroid dysfunction, metabolic acidosis, hypernatremia, or kidney dysfunction).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl ( https://smz.ezdrowie.gov.pl/ )
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Braunoderm colored

Keep the medicine out of the reach and sight of children.
Store in a temperature below 25°C.
The medicine is flammable.
Store the packaging tightly closed.
Shelf life after opening the bottle or canister – 12 months.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.

6. Package contents and other information

What Braunoderm colored contains:

• The active substances of the medicine are isopropyl alcohol and povidone iodine. 100 g of the solution for the skin contains: 50 g of isopropyl alcohol and 1 g of povidone iodine.
• The other ingredients (excipients) are: purified water, potassium iodide, sodium dihydrogen phosphate dihydrate, orange yellow (E 110), cosin (E 124), brilliant black BN (E 151).

What Braunoderm colored looks like and what the packaging contains:

Braunoderm colored is a transparent alcoholic solution with an orange-brown color.
A bottle containing 250 ml of the solution for the skin.
A bottle containing 1000 ml of the solution for the skin.
A canister containing 5 liters of the solution for the skin.

Marketing authorization holder:

• B. Braun Melsungen AG Carl-Braun-Strasse 1 D-34212 Melsungen Germany

To obtain more detailed information, contact the representative of the marketing authorization holder:
Aesculap Chifa Sp. z o.o.
ul. Tysiąclecia 14
64-300 Nowy Tomyśl
phone: +48 61 44 20 100
fax: +48 61 44 23 936

Date of the last update of the leaflet: