Braunol 7,5%, roztvur na skurem

Package Leaflet: Information for the Patient

7.5%, solution for the skin

• Read the package leaflet carefully before using the medicine, as it contains important information for the patient
• This medicine should always be used exactly as described in the package leaflet for the patient or as directed by the doctor
• Keep this package leaflet, you may need to read it again
• If you need advice or additional information, consult a pharmacist
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. If there is no improvement or the patient feels worse, they should contact

Table of Contents of the Package Leaflet

what the medicine is and what it is used for
Important information before using the medicine
How to use it
Possible side effects
How to store the medicine
Contents of the package and other information

What is Braunol and what is it used for

Braunol is a solution for external use only on the skin and mucous membranes
contains the active substance povidone-iodine with a 10% content

• Disinfection of intact skin and mucous membranes, e.g. before surgical procedures, biopsies, injections, punctures, blood sampling, and catheterization
• For repeated use, limited in time:Antiseptics for wounds (e.g. bedsores, leg ulcers), burns, skin diseases with infection and superinfection. Hygienic and surgical hand disinfection

Important Information Before Using the Medicine

Warning

• if the patient is allergic to any of the other ingredients of this medicine
• in case of hyperthyroidism or other revealed thyroid diseases
• in case of erythema multiforme (a rare skin disease characterized by burning, itching, and other symptoms, mainly on the skin of the hands, feet, arms, and buttocks)
• in case of planned or recently completed radioiodine therapy (until the end of

Warnings and Precautions

Before starting treatment, discuss it with your doctor or pharmacist.
In the cases described below, Braunol can only be used under strict adherence to the recommendations
patients with mild goiter should not use it for a long time and on large areas (e.g. on a surface larger than
10% of the entire body surface for more than 14 days). In such cases, within 3 months after
completion of treatment, the patient should consult a doctor to check for
the possibility of developing hyperthyroidism and thyroid dysfunction
it is recommended to avoid using Braunol in patients undergoing lithium therapy, especially when
the treated area is large. Absorbed iodine can exacerbate lithium-induced hyperthyroidism
it is recommended to consult a doctor, as the risk of developing hyperthyroidism induced by iodine is increased in elderly patients
or those with a history of thyroid dysfunction, long-term use of Braunol on large areas should be consulted with a doctor.
it is necessary to monitor thyroid function
due to its oxidizing properties –
interactions with other substances, false results of hemoglobin or glucose tests in stool or urine using toluidine or resin
may occur, making it impossible to use iodine-containing products. The next scintigram should not be performed for 1
to 2 weeks after the end of treatment
in newborns and infants up to 6 months of age, Braunol can only be used if a doctor decides to do so, after weighing the expected benefits against the risks
of thyroid dysfunction. After using the medicine, thyroid function should be monitored
it is essential to protect the child from accidentally ingesting the medicine.
you should tell your doctor or pharmacist about any other medicines you are currently taking or plan to take
that may interact with Braunol, as it reacts with proteins and some organic compounds, which may reduce its effectiveness.
medicines containing mercury, silver, or other substances that may interact with Braunol should not be used simultaneously or shortly after its application, due to the risk of burns
it is recommended to avoid using Braunol in patients undergoing lithium therapy, especially when
the treated area is large, as absorbed iodine may exacerbate lithium-induced hyperthyroidism

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
it should not be used, especially from the 3rd month of pregnancy, during breastfeeding
During pregnancy and breastfeeding, it can only be used under strict indications, and its use should be very limited. After
it is recommended to perform a thyroid function test
During breastfeeding, caution should be exercised to prevent accidental ingestion of Braunol by the child from the treated area of the mother's body.
driving and operating machinery
there is no effect on the ability to drive and operate machinery

How to Use Braunol

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by the doctor, pharmacist, or nurse. In case of doubt, consult a doctor, pharmacist, or nurse
only on the skin and mucous membranes.
Braunol is intended for external use, both in diluted and undiluted form
The treated area should be completely moistened with Braunol. The antiseptic film that forms after
drying can be easily washed off with water.
Braunol should be used undiluted for
antiseptic treatment of mucous membranes, injections,
In cases of skin disinfection with a small number of sebaceous glands, the time required for effective disinfection is at least 15 seconds, and with a larger number of sebaceous glands – at least 10 minutes. The skin should be kept moist with the undiluted solution throughout.
when using Braunol for preoperative skin disinfection, care should be taken to avoid accumulation of the solution under the patient, as it may cause skin irritation.
for skin disinfection of hands, the undiluted solution should be used.
for hygienic hand disinfection, 3 ml of the solution should be rubbed into the skin for 1 minute. Then, the hands should be washed.
for surgical hand disinfection, 2 ml of the solution should be rubbed into the skin for 5 minutes. The skin should be kept moist with the undiluted solution throughout.
Braunol should be used undiluted for
burns, it is usually recommended to use Braunol undiluted.
Braunol can be used diluted for antiseptic rinsing, washing, and

• Rinsing, as one of the stages of wound treatment (e.g. bedsores, leg ulcers, gangrene) and for
• Antiseptic soaking of a limb: approximately 1:25
• Antiseptic soaking of the body, approximately 1:100 for dilution, tap water can be used. If an isotonic preparation is required for dilution, a physiological saline solution or Ringer's solution should be used. The preparation should be diluted immediately before use. In case of antiseptic washing of the entire body, the bathtub should be filled with water first, and then the required amount of Braunol should be added. This will prevent the release of iodine vapors that can stain objects nearby. The brown color indicates the effectiveness of the solution. A noticeable decrease in color indicates a loss of its effectiveness.

Frequency and Duration of Use

The frequency and duration of use will depend on individual indications. Braunol can be used once or several times a day
The wound should be disinfected until signs of infection disappear or until there is no longer an obvious risk of infection.
If after several days (2-5 days) of regular use, there is no improvement or the condition worsens, the patient should inform their doctor or pharmacist

Use of a Higher Than Recommended Dose

In case of using a higher than recommended dose of the medicine, the patient should immediately consult a doctor.
If large doses of the medicine are used on large areas of skin, wounds, or burns, symptoms of iodine poisoning may occur, such as abdominal cramps and pain, malaise, diarrhea, dehydration, decreased blood pressure, laryngeal edema, bleeding, cyanosis, kidney damage, inability to urinate, elevated temperature, and pulmonary edema

In Case of Accidental Ingestion of Braunol

if the medicine is swallowed, the patient should immediately consult a doctor

Possible Side Effects

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

Important Side Effects or Symptoms to Watch Out for and Preventive Measures

may occur in less than 1 in 10,000 patients
in case of hypersensitivity (allergy), e.g. late contact allergy characterized by
redness, blistering
severe hypersensitivity reactions that can be life-threatening (anaphylactic reactions) affecting other
organs (e.g. skin, respiratory system, cardiovascular system).

Other Side Effects

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

• thyroid dysfunction (hyperthyroidism, hypothyroidism), as large amounts of iodine may be absorbed during long-term use, e.g. in the treatment of extensive wounds and burns
• severe kidney damage due to absorption of large amounts of povidone-iodine (e.g. during burn treatment

in case of the above-mentioned side effects or if side effects not listed in this package leaflet occur, the patient should consult a doctor or pharmacist

Reporting Side Effects

If any side effects occur, including any possible side effects not listed in the package leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Reporting side effects will help to gather more information on the safety of the medicine

How to Store the Medicine

The medicine should be stored in a place inaccessible to children and out of sight.
The medicine should not be used after the expiry date stated on the packaging.
Braunol in packaging with a capacity of
should be stored at a temperature below 25°C
Braunol in packaging with a capacity of special recommendations regarding
Shelf life after first opening: 12 months.

Contents of the Packaging and Other Information

• 10% iodine content

What Braunol Looks Like

The medicine is a solution for the skin.
The medicine is available in the following types and sizes of packaging:

• bottle with a capacity of 30 ml with a brown HDPE cap and a white insert
• containers with a capacity of 100 ml, 500 ml, and 1000 ml with a brown HDPE cap
• bottle with a capacity of 250 ml with a brown HDPE cap and a spray pump Not all packaging types may be available on the market.