Braunol 7.5%, solution for skin

Package leaflet: Information for the patient

Braunol
7.5% solution for skin application
(Povidone iodine)

• Please read all of this leaflet carefully before using this medicine, as it contains important information for you.
• This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.
• 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 possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of contents

1. What Braunol is and what it is used for
2. What you need to know before using Braunol
3. How to use Braunol
4. Possible side effects
5. How to store Braunol
6. Contents of the pack and other information

1. What Braunol is and what it is used for

Braunol is a solution intended for external use only—on the skin and mucous membranes.
The medicine contains the active substance povidone iodine, which provides 10% available iodine.
Braunol is indicated:

• For single use: Disinfection of intact external skin and antisepsis of mucous membranes, e.g. prior to surgical procedures, biopsy, injections, punctures, blood sampling, and catheterization.
• For repeated, time-limited use: Antisepsis of wounds (e.g. pressure ulcers, leg ulcers), burns, and skin diseases with infection or superinfection. Hygienic and surgical hand disinfection.

2. Important information before using Braunol

When not to use Braunol:

• if the patient is allergic to povidone-iodine or any of the other ingredients of this medicine (listed in section 6),
• in hyperthyroidism or other clinically apparent thyroid disorders,
• in case of bromhidrosis dermatitis (a rare skin disease characterized by burning, itching and other symptoms, primarily affecting the skin of hands, feet, arms and buttocks),
• if planning or having recently completed therapy with radioactive iodine (until completion of therapy).

Warnings and precautions
Before starting treatment, discuss this with your doctor or pharmacist.
In the situations described below, Braunol should be used only under strict adherence to recommendations:

• patients with mild nodular goitre or with a history of thyroid disease should not use Braunol long-term or over large areas of skin (e.g. over an area larger than 10% of total body surface for more than 14 days). In such cases, within 3 months after treatment ends, the patient should consult a doctor to be examined for early signs of hyperthyroidism and to have thyroid function checked;
• avoid using Braunol in patients undergoing lithium therapy;
• elderly patients should consult their doctor before using Braunol, as their risk of iodine-induced hyperthyroidism is increased. In elderly patients with nodular goitre or predisposed to functional thyroid disorders, prolonged use of Braunol or application over large skin areas should be discussed with a doctor. If necessary, thyroid function should be monitored;
• due to the oxidizing action of the active ingredient of Braunol – povidone-iodine – false results may occur in certain diagnostic tests (e.g. faecal or urinary haemoglobin or glucose tests using o-toluidine or guaiac resin);
• the medicine may reduce iodine uptake by the thyroid gland. During treatment with Braunol, thyroid function tests (scintigraphy, protein-bound iodine measurement, radioisotope diagnosis) may yield misleading results, making radioisotope therapy with iodine impossible. A subsequent scintigram should not be performed within 1 to 2 weeks after discontinuation of Braunol treatment.

Children
Braunol may be used in newborns and infants up to 6 months of age only when prescribed by a doctor, after weighing the expected benefits against the risk of thyroid dysfunction. After application, thyroid function in the child should be monitored.
It is essential to protect the child from accidental ingestion of the medicine.

Braunol and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Povidone-iodine reacts with proteins and certain organic compounds, e.g. blood components or pus, which may reduce its effectiveness.
Concurrent use of povidone-iodine and enzyme-containing wound treatment products leads to oxidation of enzyme components, rendering them ineffective. The same applies to hydrogen peroxide and taurolidine, as well as disinfectants containing silver, hydrogen peroxide and taurolidine.
Braunol should not be used simultaneously with mercury-containing disinfectants, or shortly after their use, due to the risk of chemical burns.
Avoid using Braunol in patients undergoing lithium therapy, especially when the treated area is large. Absorbed iodine may exacerbate lithium-induced hyperthyroidism.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use, especially from the 3rd month of pregnancy and during breastfeeding.
During pregnancy and breastfeeding, Braunol may be used only if prescribed by a doctor, strictly according to indications, and its use should be very limited. After application, thyroid function testing in the infant is recommended.
During breastfeeding, take care to avoid accidental transfer of Braunol from treated areas of the mother’s body into the infant’s mouth.

Driving and operating machinery
Braunol has no effect on the ability to drive or operate machinery.

3. How to use Braunol
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist or nurse. If in doubt, consult your doctor, pharmacist or nurse.
For external use only, on skin and mucous membranes.
Braunol is intended for external use, either undiluted or diluted.
The treated area should be completely moistened with Braunol. The antiseptic film formed after drying can be easily washed off with water.
Undiluted Braunol should be used for skin disinfection procedures and as an antiseptic for mucous membranes prior to surgical procedures, biopsies, injections, punctures, blood collection and catheterization.
For disinfection of skin areas with few sebaceous glands, effective disinfection requires at least 15 seconds of contact time; for areas with more sebaceous glands, at least 10 minutes. The skin must remain moistened with undiluted solution throughout this period.
When using Braunol for preoperative skin disinfection, care should be taken to avoid pooling of the solution under the patient, as this may cause skin irritation.
For hand disinfection, use undiluted solution.
For hygienic hand disinfection, rub 3 ml of solution into the skin of hands for 1 minute, then wash hands.
For surgical hand disinfection, rub 5 ml of solution into the hands twice, each time for 5 minutes. The skin must remain moistened with undiluted solution throughout.
Undiluted Braunol should be used for antiseptic treatment of superficial wounds.
Undiluted Braunol is usually used for antiseptic treatment of burns.
Diluted Braunol may be used for antiseptic rinsing, irrigation and soaking. Use the following dilution ratios:

• Rinsing, as one of the stages in wound treatment (e.g. pressure ulcers, leg ulcers, gangrene) and for perioperative infection prevention – from 1:2 to 1:20
• Antiseptic washing – from 1:2 to 1:25
• Antiseptic soaking of a limb: approximately 1:25
• Antiseptic whole-body soaking: approximately 1:100

Tap water may be used for dilution. If an isotonic preparation is required, use physiological saline or Ringer’s solution. The product should be diluted immediately before use. For antiseptic whole-body washing, first fill the bathtub with water, then add the required volume of Braunol. This prevents release of iodine-containing vapours, which may yellow nearby objects. The brown colour indicates the medicine’s effectiveness. A noticeable fading of colour indicates loss of effectiveness.

Frequency and duration of use
With repeated use of Braunol, frequency and duration depend on individual indications. Braunol may be used once or several times daily.
Disinfect the wound until signs of infection disappear or until there is no longer an obvious risk of wound edge infection.
If after several days (2–5 days) of regular use there is no improvement, or if infection recurs after stopping Braunol, inform your doctor.

Use of more than the recommended dose of Braunol
If more than the recommended dose is used, consult a doctor immediately.
When large doses are applied to large skin areas, wounds or burns, symptoms of iodine poisoning may occur, such as abdominal cramps and pain, malaise, vomiting, diarrhoea, dehydration, hypotension, laryngeal oedema, bleeding, cyanosis, kidney damage, inability to pass urine, elevated temperature and pulmonary oedema.

In case of accidental ingestion of Braunol
If the medicine is swallowed, seek immediate medical advice from a doctor or hospital.

4. Possible adverse reactions

Like all medicines, Braunol may cause adverse reactions, although not everyone will experience them.
Significant adverse reactions or symptoms to which attention should be paid and preventive
measures to be taken in case they occur
Very rare ( may occur in no more than 1 in 10,000 patients:

• skin reactions due to hypersensitivity (allergy), e.g. delayed contact allergy manifested by itching, redness, blisters, etc.
• severe life-threatening hypersensitivity reactions (anaphylactic reactions) affecting other organs (e.g. skin, respiratory system, circulatory system).

Other adverse reactions
Frequency unknown (cannot be estimated from available data)

• thyroid function disorders (hyperthyroidism, hypothyroidism), as significant amounts of povidone-iodine may be absorbed into the body during prolonged use of Braunol (e.g. in the treatment of extensive wounds and burns).
• serum osmolality disturbances, electrolyte imbalances, renal failure, and severe metabolic acidosis due to absorption of large amounts of povidone-iodine into the body (e.g. during burn treatment).

If any of the above-mentioned adverse reactions occur, or if any adverse reactions not listed in this leaflet occur, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl ( https://smz.ezdrowie.gov.pl/ )
Reporting adverse reactions helps to gather further information on the safety of using the medicine.

5. How to store Braunol 7,5%, roztwór na skórę

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
Braunol 7,5%, roztwór na skórę in containers with a capacity of 30 ml, 100 ml and 250 ml should be stored below 25°C.
Braunol 7,5%, roztwór na skórę in containers with a capacity of 500 ml, 900 ml and 1000 ml – no special storage conditions apply.
Period of use after first opening: 12 months.

6. Contents of the pack and other information

What Braunol contains
100 g of solution contains:

• active substance: 7.5 g of povidone-iodine, containing 10% iodine;
• excipients: sodium iodate, disodium dihydrogen diphosphate dihydrate, macrogol 9 lauryl ether 9, sodium hydroxide, purified water.

What Braunol looks like and contents of the pack
The medicinal product is a solution for skin application.
The medicinal product is available in the following pack types and sizes:

• 30 ml bottle made of brown-coloured HDPE with dropper made of LDPE and white HDPE screw cap;
• 100 ml, 500 ml, 900 ml and 1000 ml bottles made of brown-coloured HDPE with PP screw cap in brown colour;
• 250 ml bottle made of brown-coloured HDPE with spray pump.

Not all pack types and sizes may be marketed.

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