Braunoderm colored

Package leaflet: Information for the patient

Braunoderm colored
(50 g + 1 g)/100 g, solution for skin application
Isopropyl alcohol + Povidone-iodine
Please read carefully all the information in this leaflet before using the medicine, because
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 physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, consult your doctor.

Table of contents of the leaflet:

1. What Braunoderm colored is and what it is 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. Contents of the pack and other information

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

Braunoderm colored is a solution for skin application containing the active substances isopropyl alcohol and povidone-iodine with 10% available iodine. Braunoderm colored exerts the rapid antibacterial action of isopropyl alcohol and the antimicrobial activity of iodine. Due to the additive effect of the active substances, the product acts against Gram-positive and Gram-negative bacteria, including Mycobacterium tuberculosis, protozoa, and spores; it also shows fungicidal and virucidal activity.
Indications:
Disinfection of intact skin prior to:

• surgical procedures,
• injections,
• punctures,
• catheterization,
• blood sampling,
• vaccinations.

2. Important information before using Braunoderm zabarwiony

When not to use Braunoderm zabarwiony:
if the patient is allergic to povidone-iodine, isopropyl alcohol, or to any of the
other components of this medicine (listed in section 6),
in hyperthyroidism or other thyroid disorders in medical history, or if the patient has previously suffered
from thyroid disease,
in dermatitis herpetiformis (Duhring's disease),
1 to 2 weeks before and after radioisotope iodine therapy (until completion of treatment),
in newborns, especially premature infants,
in infants under 6 months of age.

Warnings and precautions
This medicine is intended for topical use on the skin. Avoid contact with eyes and mucous membranes.
Avoid use in patients with damaged skin (e.g. extensive, deep wounds or burns), or renal insufficiency,
as alcohol and iodine contained in the medicine may be absorbed and cause systemic adverse reactions.
During preoperative skin disinfection, care should be taken to prevent pooling of the medicine under the
patient’s body, which may lead to skin irritation.
Do not use this medicine simultaneously with, or after, mercury-containing wound treatment or antiseptic
products due to the risk of severe skin irritation caused by the formation of corrosive mercury iodide (I).
The medicine is flammable. Wait until the medicine has dried on the skin before operating electrical devices.
Keep away from sources of fire. Do not smoke near the product.
Consult a doctor, even if the above warnings relate to conditions that occurred in the past.

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

Use in elderly patients:
Due to the increased risk of iodine-induced hyperthyroidism, use only on a doctor’s advice and under medical supervision.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should
consult a doctor or pharmacist before using this medicine.

Driving and operating machinery:
Braunoderm zabarwiony does not affect the ability to drive or operate machinery.

Interaction of Braunoderm zabarwiony with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Povidone-iodine reacts with proteins and certain other organic substances, such as blood or pus components,
which may reduce its effectiveness.
Concurrent use of povidone-iodine with antiseptics containing silver, hydrogen peroxide, or taurolidine may
lead to mutual inactivation.
Iodine may react with mercury-containing products, forming corrosive mercury iodide (I).

Effect on diagnostic tests
Povidone-iodine may cause falsely positive results in certain laboratory tests (e.g. faecal or urinary haemoglobin and glucose tests).
Povidone-iodine may reduce thyroid uptake of radioactive iodine, thereby interfering with thyroid diagnostic tests (scintigraphy, protein-bound iodine measurement, radioisotope iodine diagnostics). A new scintigram should not be performed within 1 to 2 weeks after application of the medicine.

3. How to use Braunoderm zabarwiony

For use by qualified medical personnel only.
The Braunoderm zabarwiony solution must never be diluted. Apply the undiluted solution directly to the skin and spread with a sterile swab. The skin surface to be disinfected should be thoroughly moistened with the product, then left to dry. Excess liquid should be removed with a swab.
Contact time: minimum 15 seconds. For procedures involving joint puncture or body cavities containing fluid – minimum contact time of 1 minute (the product should be reapplied if necessary). For virus inactivation – minimum contact time of 2 minutes.
On skin areas rich in sebaceous glands (e.g. scalp, area around the sternum, and between the shoulder blades), the contact time is 10 minutes (application must be repeated, i.e. after the first application has dried, apply the product again).
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
In case of use of a larger than recommended dose of Braunoderm zabarwiony
There are no data regarding overdose when the product is used according to the instructions.
However, if large doses are used on large skin areas, wounds or burns, symptoms of iodine poisoning may occur.
In case of accidental ingestion of Braunoderm zabarwiony
In the event of accidental ingestion, seek immediate medical advice from a doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Important adverse reactions or symptoms to be aware of, and actions to be taken if any of them occur.
Very rare (may occur in not more than 1 in 10,000 people):

• Anaphylactic reactions up to anaphylactic shock (severe allergic reactions),
• Hypersensitivity skin reactions, e.g. delayed-type contact allergy manifesting as itching, redness, blisters, etc. Discontinue use of Braunoderm colored and consult a doctor immediately if any of these adverse reactions occur.

Other adverse reactions
Not common (may occur in not more than 1 in 100 people):

• Local irritation symptoms caused by alcohol (e.g. itching, redness, especially after frequent use of Braunoderm colored).
• Dry skin symptoms may occur in seasons with low air humidity (especially in winter). In such cases, the use of a skin moisturizing cream is recommended.

When applied to large areas of skin, wounds or burns, systemic adverse reactions of iodine may occur (including thyroid dysfunction, metabolic acidosis, hypernatremia, or kidney function disorders).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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/ )
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide 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 below 25°C.
Flammable medicine.
Keep the container tightly closed.
Shelf life after first opening of the bottle or canister – 12 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information

What Braunoderm coloured contains:

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

What Braunoderm coloured looks like and contents of the pack:
Braunoderm coloured is a transparent alcoholic solution with an orange-brown colour.
Bottle containing 250 ml of skin solution.
Bottle containing 1000 ml of skin solution.
Canister containing 5 l of skin solution.

Marketing Authorisation Holder:
B. Braun Melsungen AG
Carl-Braun Strasse 1
D-34212 Melsungen
Germany

For further information, please contact the representative of the Marketing Authorisation Holder:
Aesculap Chifa Sp. z o.o.
ul. Tysiąclecia 14
64-300 Nowy Tomyśl
tel. +48 61 44 20 100
fax. +48 61 44 23 936