Braunol: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Braunol 10% Ointment

Povidone-iodine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
➢ Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
➢ Keep this leaflet. You may need to read it again.
➢ If you need more information or advice, consult your pharmacist.
➢ If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if you notice worsening of symptoms.
Contents of this leaflet:

What Braunol 10% Ointment is and what it is used for.
What you need to know before using Braunol 10% Ointment.
How to use Braunol 10% Ointment.
Possible side effects.
How to store Braunol 10% Ointment.
Contents of the pack and other information.

1. WHAT BRAUNOL 10% OINTMENT IS AND WHAT IT IS USED FOR

Braunol 10% Ointment contains the active substance iodopovidone, which belongs to a group of medicines called antiseptics and disinfectants.
Braunol 10% Ointment is indicated for the disinfection of superficial skin wounds and mild pressure ulcers (skin lesions affecting areas of the body subjected to prolonged pressure) and for the antiseptic treatment of fungal infections (fungal infections).

2. WHAT YOU SHOULD KNOW BEFORE USING BRAUNOL 10% OINTMENT

Do not use Braunol 10% Ointment

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
in case of hyperthyroidism or other thyroid diseases.
in case of herpetiform dermatitis (a rare skin disease).
before and after radiotherapy with iodine (until the end of treatment).
in children under 6 months of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Braunol 10% Ointment.
Braunol 10% Ointment is for external use only; do not ingest.

Before application, consider your allergy history, as povidone-iodine may cause anaphylactic reactions in susceptible individuals (see section 4 “Possible side effects”).
If you have goitre or a history of thyroid disease, or if you are predisposed due to autonomous adenoma or functionally autonomous adenoma, use Braunol 10% Ointment only on medical advice. Furthermore, in these cases avoid prolonged use and application over large areas of the body (e.g., more than 10% of total body surface area and for longer than 14 days) due to the risk of iodine-induced hyperthyroidism. Even after treatment ends (up to 3 months), be alert for early symptoms of hyperthyroidism (see section 4 “Possible side effects”). If necessary, thyroid function should be monitored.
If you are concurrently undergoing lithium therapy, regular use of Braunol 10% Ointment should be avoided (see “Other medicines and Braunol 10% Ointment”).
If you have renal dysfunction, regular application of Braunol 10% Ointment should be avoided.
Avoid applying Braunol 10% Ointment over large skin surfaces or under occlusive dressings.
Avoid contact with eyes or eye mucous membranes.
Do not use Braunol 10% Ointment for prolonged periods. Prolonged use, especially, of topical products may lead to allergic reactions (sensitization); if this occurs, consult your doctor, who may decide to discontinue treatment.

Effect on laboratory tests:

Due to the oxidizing effect of the active substance povidone-iodine, false positive results may occur in certain diagnostic tests during treatment with Braunol 10% Ointment (e.g., toluidine tests or guaiac tests for detection of hemoglobin or glucose in feces or urine).
Povidone-iodine may reduce iodine uptake by the thyroid gland. During treatment with Braunol 10% Ointment, thyroid function tests may be altered (scintigraphy, determination of iodine-binding proteins, radioiodine diagnostics), which could make radioiodine therapy impossible. A new scintigraphy should not be performed within 1–2 weeks after treatment with Braunol 10% Ointment.

Children and adolescents
Braunol 10% Ointment must not be used in children under 6 months of age (see
“Do not use Braunol 10% Ointment”).
In pediatric patients, use only under strict medical supervision and when clearly necessary. Children are at higher risk of developing hypothyroidism following application of high doses of iodine due to increased skin permeability and higher sensitivity to iodine. After use of Braunol 10% Ointment, thyroid function testing is recommended.
Take care to prevent accidental ingestion of Braunol 10% Ointment by children.

Elderly patients
If you are elderly, avoid regular and extensive application, especially if you are predisposed to thyroid disorders. Your doctor will monitor your thyroid function during use of Braunol 10% Ointment, if necessary.

Other medicines and Braunol 10% Ointment
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

When Braunol 10% Ointment is used concomitantly with antiseptics containing silver, hydrogen peroxide, or taurolidine, reduced efficacy may occur.
Braunol 10% Ointment must not be used concomitantly or immediately after application of antiseptics containing mercury, due to the possible formation of an agent causing acid burns.
In patients undergoing concurrent lithium therapy, avoid regular use of Braunol 10% Ointment, especially if the treated surface area is large. Absorbed iodine may promote lithium-induced hypothyroidism.
Braunol 10% Ointment must not be used concomitantly with other antiseptics and detergents.
When Braunol 10% Ointment is used concomitantly with enzymatic wound treatment preparations, the effects of both may be reduced.

Other interactions
Povidone-iodine reacts with proteins and certain other organic compounds, e.g., blood or pus components, which may reduce the efficacy of Braunol 10% Ointment. Use of Braunol 10% Ointment may interfere with diagnostic tests (see “Warnings and precautions”).

Pregnancy, breast-feeding and fertility
During pregnancy and breast-feeding, use of Braunol 10% Ointment should be avoided. Prolonged use of povidone-iodine on large wounds or mucous membranes may affect fertility.

Driving and using machines
Braunol 10% Ointment does not impair the ability to drive or operate machinery.

3. HOW TO USE BRAUNOL 10% OINTMENT

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Apply the ointment 1 to 3 times daily to the affected area until it is completely covered.
Do not exceed the recommended doses.

Note:
The brown color of the ointment is a characteristic feature of the preparation, indicating its efficacy. A significant loss of color indicates that the preparation has lost its effectiveness and should be reapplied. Since povidone-iodine is water-soluble, any stains on fabrics can be easily removed with water and soap; in more stubborn cases, with ammonia or sodium thiosulfate solution.

Incompatibilities
Povidone-iodine is incompatible with reducing agents, alkaloid salts, carbonates, tannic acid, salicylic acid, silver salts, mercury salts, bismuth salts, taurolidine, and hydrogen peroxide.

Use in children
Braunol 10% Ointment must not be used in children under 6 months of age (see "Do not use Braunol 10% Ointment").

Special populations
Avoid regular or extensive application in patients predisposed to hyperthyroidism and in patients with renal impairment (see "Warnings and precautions").

If you use more Braunol 10% ointment than you should
Braunol 10% Ointment is for external use only. In case of accidental ingestion of large amounts, contact your doctor immediately or go to the nearest hospital, as severe thyroid dysfunction may occur. After accidental ingestion of large quantities of povidone-iodine, symptoms of acute iodine poisoning may occur, including abdominal pain, cramps, malaise, vomiting, diarrhea, dehydration, drop in blood pressure with a tendency toward collapse, laryngeal swelling, bleeding (from mucous membranes and kidneys), bluish discoloration of the skin and mucous membranes (cyanosis), kidney damage (globular and tubular necrosis) potentially leading to anuria (after 1–3 days), paresthesia, fever, and pulmonary edema. After excessively high iodine intake over prolonged periods, symptoms of hyperthyroidism may develop, such as tachycardia, restlessness, tremor, and headache.

In case of accidental ingestion/overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to use Braunol 10% Ointment
Do not use a double dose to make up for the missed dose.

If you stop using Braunol 10% Ointment
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicinal product can cause adverse effects, although not everyone experiences them.
Uncommon (may affect up to 1 in 100 people):
Very rare (may affect up to 1 in 10,000 people):

Hypersensitivity skin reactions (allergy), e.g. contact allergic reactions, including delayed-type reactions such as itching, redness, blisters, etc.
Acute immune system reactions up to anaphylactic shock (anaphylactic reactions)
Iodine-induced hyperthyroidism in predisposed patients.

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

Disorders of serum electrolyte osmolarity
Renal failure
Severe metabolic acidosis
Skin rashes due to allergic reaction

Other adverse effects

Prolonged treatment may affect the wound healing process.
Povidone-iodine can cause the same adverse effects as iodine, although it is less irritating. Children Hypothyroidism may occur following regular use in children due to iodine absorption.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or nurse. You may also report adverse effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BRAUNOL 10% OINTMENT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube or label following the word EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Braunol 10% Ointment contains

The active substance is iodopovidone. 100 g of ointment contain 10 g of iodopovidone, providing 10% available iodine.
The other components are macrogol 400, macrogol 4000, purified water and sodium bicarbonate.

Description of the appearance of Braunol 10% Ointment and contents of the pack
Braunol 10% Ointment is a brown ointment.
It is available in the following pack sizes: a 20 g tube and a 100 g tube.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen,
Germany
Represented in Italy by:
B. Braun Milano S.p.A.
Via Vincenzo da Seregno, 14
20161 Milano
Manufacturer
B. Braun Medical AG
CH-6204 Sempach

PACKAGE LEAFLET: INFORMATION FOR THE USER

Braunol 10% Ointment

Povidone-iodine
Please read this leaflet carefully before using this medicine as it contains
important information for you.
➢ Keep this leaflet. You may need to read it again.
➢ If you have any questions, ask your doctor or nurse.
➢ This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
➢ If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or nurse. See section 4.
Contents of this leaflet:

What Braunol 10% Ointment is and what it is used for.
What you need to know before using Braunol 10% Ointment.
How to use Braunol 10% Ointment.
Possible side effects.
How to store Braunol 10% Ointment.
Contents of the pack and other information.

1. WHAT BRAUNOL 10% OINTMENT IS AND WHAT IT IS USED FOR

Braunol 10% Ointment contains the active substance povidone-iodine, which belongs to a group of medicines called antiseptics and disinfectants.
Braunol 10% Ointment is indicated for the disinfection of superficial skin wounds and mild pressure sores (skin lesions affecting areas of the body subjected to prolonged pressure), and for the antiseptic treatment of fungal infections (mycoses).

2. WHAT YOU NEED TO KNOW BEFORE USING BRAUNOL 10% OINTMENT

Do not use Braunol 10% Ointment

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
if you have hyperthyroidism or other thyroid diseases.
if you have dermatitis herpetiformis (a rare skin disease).
before and after radiotherapy with iodine (until the end of treatment).
in children under 6 months of age.

Warnings and precautions
Talk to your doctor or nurse before using Braunol 10% Ointment.
Braunol 10% Ointment is for external use only; do not swallow.

Before application, consider your history of allergies, as povidone-iodine may cause anaphylactic reactions in susceptible individuals (see section 4 “Possible side effects”).
If you have goitre or a history of thyroid disease, or in patients predisposed to autonomous adenoma or functionally autonomous adenoma, Braunol 10% Ointment should only be used on medical advice. Furthermore, in these cases Braunol 10% Ointment should not be used for prolonged periods or over large body areas (e.g., more than 10% of total body surface and for longer than 14 days) due to the risk of iodine-induced hyperthyroidism. Even after completion of treatment (up to 3 months), be alert for early symptoms of hyperthyroidism (see section 4 “Possible side effects”). If necessary, thyroid function should be monitored.
If you are concurrently undergoing lithium therapy, regular use of Braunol 10% Ointment should be avoided (see “Other medicines and Braunol 10% Ointment”).
If you have renal dysfunction, regular application of Braunol 10% Ointment should be avoided.
Avoid applying Braunol 10% Ointment over large surface areas or under occlusive dressings.
Avoid contact with eyes or eye mucous membranes.
Braunol 10% Ointment should not be used for prolonged periods. Prolonged use of topical products may lead to allergic reactions (sensitization); if this occurs, your doctor may decide to discontinue treatment.

Effect on laboratory tests:

Due to the oxidizing effect of the active ingredient povidone-iodine, false positive results may occur in certain diagnostic tests during treatment with Braunol 10% Ointment (e.g., tests using toluidine or guaiac tests for detecting hemoglobin or glucose in feces or urine).
Povidone-iodine may reduce iodine uptake by the thyroid gland. During treatment with Braunol 10% Ointment, thyroid function tests may be altered (scintigraphy, determination of iodine-binding proteins, diagnostic radioiodine tests), which could make radioiodine therapy impossible. A new scintigraphy should not be performed within 1–2 weeks after treatment with Braunol 10% Ointment.

Children and adolescents
Braunol 10% Ointment must not be used in children under 6 months of age (see “Do not use Braunol 10% Ointment”).
In pediatric patients, use only under strict medical supervision and only when strictly necessary. Children are at higher risk of developing hypothyroidism following application of high doses of iodine due to skin permeability and increased sensitivity to iodine. After use of Braunol 10% Ointment, thyroid function testing is required.
Take care to prevent accidental ingestion of Braunol 10% Ointment by children.

Elderly patients
In elderly patients, regular and extensive application should be avoided, especially if predisposed to thyroid disorders. Your doctor will monitor your thyroid function during use of Braunol 10% Ointment, if necessary.

Other medicines and Braunol 10% Ointment
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

When Braunol 10% Ointment is used concomitantly with disinfectants containing silver, hydrogen peroxide, or taurolidine, a reduction in efficacy may occur.
Braunol 10% Ointment must not be used concomitantly with, or immediately after, mercury-containing disinfectants due to the possible formation of an agent causing acid burns.
In patients undergoing concurrent lithium therapy, avoid regular use of Braunol 10% Ointment, especially if the treated surface area is large. Absorbed iodine may promote lithium-induced hypothyroidism.
Braunol 10% Ointment should not be used concomitantly with other antiseptics and detergents.
When Braunol 10% Ointment is used concomitantly with enzymatic wound treatment preparations, the effects of both may be reduced.

Other interactions
Povidone-iodine reacts with proteins and certain other organic compounds, e.g., blood or pus components, which may reduce the efficacy of Braunol 10% Ointment.
Use of Braunol 10% Ointment may interfere with diagnostic tests (see “Warnings and precautions”).

Pregnancy, breastfeeding and fertility
Use of Braunol 10% Ointment should be avoided during pregnancy and breastfeeding.
Prolonged use of povidone-iodine on large wounds and mucous membranes may affect fertility.

Driving and using machines
Braunol 10% Ointment does not impair the ability to drive vehicles or operate machinery.

3. HOW TO USE BRAUNOL 10% OINTMENT

Braunol 10% Ointment will be administered by a healthcare professional. The ointment will be applied once to three times daily to the affected area until it is completely covered.
Do not exceed the recommended doses.

Note:
The brown color of the ointment is a characteristic of the preparation indicating its efficacy. A significant loss of color indicates that the preparation has lost its effectiveness and should be reapplied.
Since povidone-iodine is water-soluble, any stains on fabrics can be easily removed with water and soap; in more stubborn cases, with ammonia or sodium thiosulfate solution.

Use in children
Braunol 10% Ointment must not be used in children under 6 months of age (see "Do not use Braunol 10% Ointment").

Special populations
Regular or extensive application should be avoided in patients predisposed to hyperthyroidism and in patients with renal insufficiency (see "Warnings and precautions").

If you use more Braunol 10% ointment than you should
Braunol 10% Ointment is for external use only. In case of accidental ingestion of large amounts, contact a doctor immediately, as severe thyroid dysfunction may occur. Following accidental ingestion of large quantities of povidone-iodine, symptoms of acute iodine poisoning may occur, including abdominal pain, cramps, malaise, vomiting, diarrhea, dehydration, drop in blood pressure with tendency toward collapse, laryngeal swelling, hemorrhage (of mucous membranes and kidneys), cyanosis, renal damage (globular and tubular necrosis) potentially progressing to anuria (after 1–3 days), paresthesia, fever, and pulmonary edema. After excessive iodine intake over prolonged periods, symptoms of hyperthyroidism may develop, such as tachycardia, restlessness, tremor, and headache.

If you forget to use Braunol 10% Ointment
Do not use a double dose to make up for a forgotten dose.

If you stop using Braunol 10% Ointment
If you have any doubts about the use of this medicinal product, consult your doctor or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
Very rare (may affect up to 1 in 10,000 people):

hypersensitivity skin reactions (allergy), e.g. contact allergic reactions, including delayed-type reactions such as itching, redness, blisters, etc.
acute immune system reactions up to anaphylactic shock (anaphylactic reactions)
iodine-induced hyperthyroidism in predisposed patients

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

disturbances in electrolytic and serum osmolarity
renal failure
severe metabolic acidosis
urticaria-like lesions
Other adverse reactions
Prolonged treatment may affect the wound healing process.
Povidone-iodine may cause the same adverse reactions as iodine, although it is less irritating.

Children
Hypothyroidism may occur following regular use in children due to iodine absorption.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform your doctor or nurse. You may also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BRAUNOL 10% OINTMENT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube or label following the word "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Braunol 10% Ointment contains

The active substance is iodopovidone. 100 g of ointment contain 10 g of iodopovidone, corresponding to 10% available iodine.
The other components are macrogol 400, macrogol 4000, purified water and sodium bicarbonate.

Description of the appearance of Braunol 10% Ointment and contents of the pack
Braunol 10% Ointment is a brown ointment.
It is available in the following pack sizes: 20 tubes of 20 g and 10 tubes of 100 g.
Not all pack sizes may be marketed.

Manufacturer
B. Braun Medical AG
CH-6204 Sempach, Switzerland

PATIENT LEAFLET: INFORMATION FOR THE USER

Braunol 7.5% Cutaneous Solution

Povidone-Iodine
Please read this leaflet carefully before using this medicine as it contains
important information for you.
➢ Use this medicine exactly as described in this leaflet or as directed by your
doctor or pharmacist.
➢ Keep this leaflet. You may need to read it again.
➢ If you need more information or advice, consult your pharmacist.
➢ If you experience any side effects, including those not listed in this
leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if symptoms worsen.

Contents of this leaflet:

What Braunol 7.5% Cutaneous Solution is and what it is used for
What you need to know before using Braunol 7.5% Cutaneous Solution
How to use Braunol 7.5% Cutaneous Solution
Possible side effects
How to store Braunol 7.5% Cutaneous Solution
Contents of the pack and other information

1. WHAT BRAUNOL 7.5% CUTANEOUS SOLUTION IS AND WHAT IT IS USED FOR
This medicine contains the active substance povidone-iodine, which belongs to a group of
medicines called antiseptics and disinfectants.
Braunol 7.5% Cutaneous Solution is indicated for:

Skin disinfection, including injured skin (superficial skin wounds and pressure sores, i.e., skin lesions affecting body parts subjected to prolonged pressure, mild in severity)
Antisepsis of the surgical field (skin disinfection prior to surgery)

2. WHAT YOU NEED TO KNOW BEFORE USING BRAUNOL 7.5% CUTANEOUS SOLUTION

Do not use Braunol 7.5% Cutaneous Solution

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
in case of hyperthyroidism or other thyroid disorders.
in case of dermatitis herpetiformis, a rare skin disease.
before and after radiotherapy with iodine (until the end of treatment).
in children under 6 months of age.

Warnings and precautions
Consult your doctor or pharmacist before using Braunol 7.5% Cutaneous Solution.
Braunol 7.5% Cutaneous Solution is for external use only; do not ingest.

Prior to application, consider allergy history, as povidone-iodine may cause anaphylactic reactions in susceptible individuals (see section 4 “Possible side effects”).
If you have goitre or a history of thyroid disease, or if you are predisposed due to autonomous adenoma or functionally autonomous adenoma, use Braunol 7.5% Cutaneous Solution only on medical advice. In such cases, do not use it for prolonged periods or over large body areas (e.g., more than 10% of total body surface area and for longer than 14 days) due to the risk of iodine-induced hyperthyroidism. Even after treatment ends (up to 3 months), monitor for early symptoms of hyperthyroidism (see section 4 “Possible side effects”). Thyroid function should be monitored if necessary.
If you are concurrently undergoing lithium therapy, regular use of Braunol 7.5% Cutaneous Solution should be avoided (see “Other medicines and Braunol 7.5% Cutaneous Solution”).
If you have renal impairment, avoid regular application of Braunol 7.5% Cutaneous Solution (see section 4 “Possible side effects”).
Avoid applying Braunol 7.5% Cutaneous Solution over large areas and under occlusive dressings.
Avoid contact with eyes and ocular mucous membranes.
Do not use Braunol 7.5% Cutaneous Solution for prolonged periods. Prolonged use of topical products may lead to allergic reactions (sensitization); if this occurs, consult your doctor, who may decide to discontinue treatment.

Effects on laboratory tests:

Due to the oxidizing effect of the active substance povidone-iodine, false positive results may occur in certain diagnostic tests during treatment with Braunol 7.5% Cutaneous Solution (e.g., toluidine test or guaiac test for detection of hemoglobin or glucose in feces or urine).
Povidone-iodine may reduce iodine uptake by the thyroid gland. During treatment with Braunol 7.5% Cutaneous Solution, thyroid function tests may be altered (e.g., scintigraphy, determination of iodine-binding proteins, radioiodine diagnostics), potentially making radioiodine therapy impossible. A new scintigraphy should not be performed within 1–2 weeks after treatment with Braunol 7.5% Cutaneous Solution.

Children and adolescents
Braunol 7.5% Cutaneous Solution must not be used in children under 6 months of age (see “Do not use Braunol 7.5% Cutaneous Solution”).
In pediatric patients, use only under strict medical supervision and when clearly necessary. Children are at higher risk of developing hypothyroidism following application of high iodine doses due to skin permeability and increased sensitivity to iodine.
After use of Braunol 7.5% Cutaneous Solution, thyroid function testing is required.
Care must be taken to prevent accidental ingestion of Braunol 7.5% Cutaneous Solution by children.

Elderly patients
If you are elderly, avoid regular and extensive application, especially if predisposed to thyroid disorders. Your doctor should monitor thyroid function if use of Braunol 7.5% Cutaneous Solution is necessary.

Other medicines and Braunol 7.5% Cutaneous Solution
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

When Braunol 7.5% Cutaneous Solution is used concomitantly with antiseptics containing silver, hydrogen peroxide, or taurolidine, a reduction in efficacy may occur.
Braunol 7.5% Cutaneous Solution must not be used concomitantly or immediately after application of antiseptics containing mercury, due to the possible formation of an agent causing acid burns.
In patients undergoing concurrent lithium therapy, regular use of Braunol 7.5% Cutaneous Solution should be avoided, especially if the treated surface area is large. Absorbed iodine may promote lithium-induced hypothyroidism.
Braunol 7.5% Cutaneous Solution must not be used concomitantly with other antiseptics and detergents.
When used concomitantly with enzymatic wound treatment preparations, the effects of both may be reduced.

Other interactions
Povidone-iodine reacts with proteins and certain other organic compounds, e.g., blood components or pus, which may reduce the efficacy of Braunol 7.5% Cutaneous Solution.
Use of Braunol 7.5% Cutaneous Solution may interfere with diagnostic tests (see “Warnings and precautions”).

Pregnancy, breastfeeding, and fertility
Use of Braunol 7.5% Cutaneous Solution should be avoided during pregnancy and breastfeeding.
Prolonged use of povidone-iodine on large wounds and mucous membranes may affect fertility.

Driving and use of machinery
Braunol 7.5% Cutaneous Solution does not impair the ability to drive or operate machinery.

3. HOW TO USE BRAUNOL 7.5% CUTANEOUS SOLUTION
Always use Braunol 7.5% Cutaneous Solution exactly as described in this leaflet or as instructed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.

Skin disinfection and antisepsis of the surgical field
Apply Braunol 7.5% Cutaneous Solution undiluted to disinfect skin or mucous membranes, e.g., before surgery, biopsies, injections, punctures, blood draws, or catheterization. Allow to dry. Repeat if necessary.

Disinfection of injured skin (superficial wounds, mild pressure sores)
For antiseptic treatment of superficial wounds, apply Braunol 7.5% Cutaneous Solution undiluted to the affected area.
For small lesions: do not exceed 5–6 applications per day.
Braunol 7.5% Cutaneous Solution may also be diluted for antiseptic purposes. The following dilutions are provided as guidelines:

Irrigation as part of superficial wound treatment and preoperative infection prevention (from 1:2 up to 1:20).

Do not exceed recommended doses.

Use in children
Braunol 7.5% Cutaneous Solution must not be used in children under 6 months of age (see “Do not use Braunol 7.5% Cutaneous Solution”).

Special populations
Avoid regular or extensive application in patients predisposed to hyperthyroidism or in patients with renal impairment (see “Warnings and precautions”).

Method of administration
Braunol 7.5% Cutaneous Solution is intended for external use, either undiluted or diluted.
The solution may be diluted with ordinary tap water. A physiological solution or Ringer’s solution may be used when isotonic conditions are required.
All dilutions must be prepared fresh and used immediately.
Apply Braunol 7.5% Cutaneous Solution to the area to be treated until the area is completely moist. The antiseptic film formed upon drying can be easily washed off with water.
The brown color of Braunol 7.5% Cutaneous Solution is a characteristic feature indicating its efficacy. A significant loss of color indicates loss of effectiveness. Since povidone-iodine is water-soluble, stains on fabrics can be removed easily with water and soap; stubborn stains may require ammonia or sodium thiosulfate solution.

If you use more Braunol 7.5% Cutaneous Solution than you should
Braunol 7.5% Cutaneous Solution is for external use only. In case of accidental ingestion of large quantities, contact your doctor immediately or go to the nearest hospital.
Accidental ingestion of large amounts may cause acute iodine poisoning, including abdominal pain, cramps, malaise, vomiting, diarrhea, dehydration, drop in blood pressure with tendency toward collapse, laryngeal swelling, bleeding (from mucous membranes and kidneys), bluish discoloration of skin and mucous membranes (cyanosis), kidney damage (glomerular and tubular necrosis) potentially leading to anuria (after 1–3 days), paresthesia, fever, and pulmonary edema. Excessive iodine intake over long periods may lead to symptoms of hyperthyroidism such as tachycardia, agitation, tremor, and headache.

If you forget to use Braunol 7.5% Cutaneous Solution
Do not use a double dose to make up for the missed dose.

If you stop using Braunol 7.5% Cutaneous Solution
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Braunol 7.5% Cutaneous Solution can cause side effects, although not everyone experiences them.

Uncommon (may affect up to 1 in 100 people):

At the beginning of treatment, a temporary local burning sensation may occur after application.

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

Hypersensitivity skin reactions (allergy), e.g., contact allergic reactions including delayed-type reactions such as itching, redness, blisters, etc.
Acute immune system reactions up to anaphylactic shock (anaphylactic reactions).
Iodine-induced hyperthyroidism in predisposed patients.

Frequency not known (frequency cannot be estimated from available data):

Electrolyte and serum osmolarity disturbances
Renal failure
Severe metabolic acidosis
Allergic skin rashes

Discontinue use of Braunol 7.5% Cutaneous Solution and consult your doctor immediately if you experience any of these side effects.

Other side effects

Prolonged treatment may impair wound healing.
Povidone-iodine may cause the same side effects as iodine, although it is less irritating.

Children
Regular use may induce hypothyroidism in children due to iodine absorption.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. You may also report side effects directly via the national reporting system at:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. HOW TO STORE BRAUNOL 7.5% CUTANEOUS SOLUTION
Keep this medicine out of sight and reach of children.
Keep the bottle tightly closed and away from heat sources.
30 ml and 100 ml bottles: do not store above 25°C.
1000 ml bottles: no special storage conditions required.
Do not use Braunol 7.5% Cutaneous Solution after the expiry date stated on the label after “EXP”. The expiry date refers to the last day of that month.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Braunol 7.5% Cutaneous Solution contains

The active substance is povidone-iodine. 100 g of solution contains 7.5 g of povidone-iodine with a 10% free iodine content.
The other ingredients are disodium dihydrogen phosphate dihydrate, sodium iodate, macrogol 9 lauryl ether, sodium hydroxide, purified water.

Description of the appearance of Braunol 7.5% Cutaneous Solution and pack contents
Braunol 7.5% Cutaneous Solution is a brown cutaneous solution.
It is available in polyethylene bottles in the following pack sizes: 30 ml bottle, 100 ml bottle, and 1000 ml bottle.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Represented in Italy by:
B. Braun Milano S.p.A.
Via Vincenzo da Seregno, 14
20161 Milano
Manufacturer
B. Braun Medical AG
CH-6204 Sempach

PACKAGE LEAFLET: INFORMATION FOR THE USER

Braunol 7.5% Cutaneous Solution

Povidone-Iodine
Please read this leaflet carefully before using this medicine because it contains important information for you.
➢ Keep this leaflet. You may need to read it again.
➢ If you have any questions, consult your doctor or nurse.
➢ This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
➢ If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

What Braunol 7.5% Cutaneous Solution is and what it is used for
What you need to know before using Braunol 7.5% Cutaneous Solution
How to use Braunol 7.5% Cutaneous Solution
Possible side effects
How to store Braunol 7.5% Cutaneous Solution
Contents of the pack and other information

1. WHAT BRAUNOL 7.5% CUTANEOUS SOLUTION IS AND WHAT IT IS USED FOR
This medicine contains the active substance povidone-iodine, which belongs to a group of medicines called antiseptics and disinfectants.
Braunol 7.5% Cutaneous Solution is indicated for:

Skin disinfection, including damaged skin (superficial skin wounds and mild pressure ulcers, i.e., skin lesions affecting body parts subjected to prolonged pressure).
Antisepsis of the surgical site (skin disinfection before surgery).

2. WHAT YOU NEED TO KNOW BEFORE USING BRAUNOL 7.5% CUTANEOUS SOLUTION

Do not use Braunol 7.5% Cutaneous Solution

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
in case of hyperthyroidism or other thyroid disorders.
in case of dermatitis herpetiformis, a rare skin disease.
before and after radiotherapy with iodine (until the end of treatment).
in children under 6 months of age.

Warnings and precautions
Consult your doctor or nurse before using Braunol 7.5% Cutaneous Solution.
Braunol 7.5% Cutaneous Solution is for external use only. Do not swallow.

Before application, consider your history of allergies, as povidone-iodine may cause anaphylactic reactions in susceptible individuals (see section 4 “Possible side effects”).
When used to disinfect the skin preoperatively, special care must be taken to avoid pooling under the patient, as this may cause skin irritation.
If you have goiter or a history of thyroid disease, or if you are predisposed to autonomous adenoma or functionally autonomous adenoma, Braunol 7.5% Cutaneous Solution should only be used on medical advice. Furthermore, in such cases, it should not be used for prolonged periods or over large areas of the body (e.g., more than 10% of total body surface area and for longer than 14 days) due to the risk of iodine-induced hyperthyroidism. Even after treatment ends (up to 3 months), monitor for early signs of hyperthyroidism (see section 4 “Possible side effects”). Thyroid function should be monitored if necessary.
If you are concurrently receiving lithium therapy, regular use of Braunol 7.5% Cutaneous Solution should be avoided (see “Other medicines and Braunol 7.5% Cutaneous Solution”).
If you have renal impairment, regular application of Braunol 7.5% Cutaneous Solution should be avoided (see section 4 “Possible side effects”).
Avoid applying Braunol 7.5% Cutaneous Solution over large skin areas and under occlusive dressings.
Avoid contact with eyes and ocular mucous membranes.
Do not use Braunol 7.5% Cutaneous Solution for prolonged periods. Prolonged or repeated use of topical products may lead to allergic reactions (sensitization); if this occurs, your doctor may decide to discontinue treatment.

Effects on laboratory tests:

Due to the oxidizing effect of the active substance povidone-iodine, false positive results may occur in certain diagnostic tests during treatment with Braunol 7.5% Cutaneous Solution (e.g., toluidine tests or guaiac tests for detecting hemoglobin or glucose in feces or urine).
Povidone-iodine may reduce iodine uptake by the thyroid gland. Thyroid function tests (e.g., scintigraphy, determination of iodine-binding proteins, diagnostic radioiodine tests) may be altered during treatment with Braunol 7.5% Cutaneous Solution, potentially making radioiodine therapy impossible. A new scintigraphy should not be performed within 1–2 weeks after treatment with Braunol 7.5% Cutaneous Solution.

Children and adolescents
Braunol 7.5% Cutaneous Solution must not be used in children under 6 months of age (see “Do not use Braunol 7.5% Cutaneous Solution”).
In pediatric patients, use only under strict medical supervision and when clearly necessary. Children are at higher risk of developing hypothyroidism following high-dose iodine application due to increased skin permeability and heightened sensitivity to iodine. A thyroid function test should be performed after use of Braunol 7.5% Cutaneous Solution. Care must be taken to prevent accidental ingestion by children.

Elderly patients
Regular and extensive application should be avoided in elderly patients, especially if predisposed to thyroid disorders. Your doctor may monitor your thyroid function if Braunol 7.5% Cutaneous Solution is used.

Other medicines and Braunol 7.5% Cutaneous Solution
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

When Braunol 7.5% Cutaneous Solution is used concomitantly with disinfectants containing silver, hydrogen peroxide, or taurolidine, a reduction in efficacy may occur.
Braunol 7.5% Cutaneous Solution must not be used concurrently or immediately after application of mercury-containing disinfectants, due to the possible formation of an agent causing acid burns.
In patients receiving concurrent lithium therapy, regular use of Braunol 7.5% Cutaneous Solution should be avoided, especially if treating large surface areas. Absorbed iodine may promote lithium-induced hypothyroidism.
Braunol 7.5% Cutaneous Solution should not be used concurrently with other antiseptics and detergents.
When Braunol 7.5% Cutaneous Solution is used concomitantly with enzymatic wound treatment preparations, the effects of both may be reduced.

Other interactions
Povidone-iodine reacts with proteins and certain other organic compounds, such as blood or pus components, which may reduce the efficacy of Braunol 7.5% Cutaneous Solution.
Use of Braunol 7.5% Cutaneous Solution may interfere with diagnostic tests (see “Warnings and precautions”).

Pregnancy, breastfeeding, and fertility
During pregnancy and breastfeeding, use of Braunol 7.5% Cutaneous Solution should be avoided.
Prolonged use of povidone-iodine on large wounds or mucous membranes may affect fertility.

Driving and using machines
Braunol 7.5% Cutaneous Solution does not impair the ability to drive or operate machinery.

3. HOW TO USE BRAUNOL 7.5% CUTANEOUS SOLUTION
Braunol 7.5% Cutaneous Solution will be administered by a healthcare professional.

Skin disinfection and antisepsis of the surgical site
Apply Braunol 7.5% Cutaneous Solution undiluted to disinfect the skin or mucous membranes, for example before surgery, biopsies, injections, venipuncture, blood sampling, or catheterization. Allow to dry. Repeat if necessary.

Disinfection of damaged skin (superficial wounds, mild pressure ulcers)
For antiseptic treatment of superficial wounds, apply Braunol 7.5% Cutaneous Solution undiluted to the affected area.
For small lesions: do not exceed 5–6 applications per day.
Braunol 7.5% Cutaneous Solution may also be diluted for antiseptic purposes. The following dilutions are provided as guidelines:

Irrigation as part of superficial wound treatment and preoperative infection prevention (from 1:2 up to 1:20).

Do not exceed recommended doses.

Use in children
Braunol 7.5% Cutaneous Solution must not be used in children under 6 months of age (see “Do not use Braunol 7.5% Cutaneous Solution”).

Special populations
Regular or extensive application should be avoided in patients predisposed to hyperthyroidism or with renal impairment (see “Warnings and precautions”).

Method of administration
Braunol 7.5% Cutaneous Solution is intended for external use, either undiluted or diluted.
The solution can be diluted with tap water. A physiological solution or Ringer’s solution may be used when isotonic conditions are required.
All dilutions must be prepared immediately before use and used promptly.
Apply Braunol 7.5% Cutaneous Solution to the treatment area until completely moistened. The antiseptic film formed upon drying can be easily washed off with water.

Caution: When used for preoperative skin disinfection, care must be taken to prevent pooling of the solution under the patient, as this may cause skin irritation.
For surgical site preparation, use a soaked swab and apply to the area to be disinfected. Allow to dry and repeat if necessary.

The brown color of Braunol 7.5% Cutaneous Solution is a characteristic feature indicating its efficacy. Significant loss of color indicates loss of effectiveness. Since povidone-iodine is water-soluble, stains on fabrics can be easily removed with water and soap; persistent stains may require ammonia or sodium thiosulfate solution.

Incompatibilities
Povidone-iodine is incompatible with reducing agents, alkaloidal salts, carbonates, tannic acid, salicylic acid, silver salts, mercury salts, bismuth salts, taurolidine, and hydrogen peroxide.

If you use more Braunol 7.5% Cutaneous Solution than you should
Braunol 7.5% Cutaneous Solution is for external use only. In case of accidental ingestion of large amounts, seek immediate medical advice, as acute iodine poisoning may occur, including abdominal pain, cramps, malaise, vomiting, diarrhea, dehydration, hypotension with tendency to collapse, laryngeal edema, bleeding (from mucous membranes and kidneys), bluish discoloration of skin and mucous membranes, renal damage (glomerular and tubular necrosis) potentially leading to anuria (after 1–3 days), paresthesia, fever, and pulmonary edema. After excessive iodine intake over long periods, symptoms of hyperthyroidism such as tachycardia, agitation, tremor, and headache may develop.

If you forget to use Braunol 7.5% Cutaneous Solution
Do not use a double dose to compensate for a missed dose.

If you stop using Braunol 7.5% Cutaneous Solution
If you have any doubts about using this medicine, consult your doctor or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Braunol 7.5% Cutaneous Solution can cause side effects, although not everyone will experience them.

Uncommon (may affect up to 1 in 100 people):

At the beginning of treatment, a temporary local burning sensation may occur after solution application.

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

Hypersensitivity skin reactions (allergy), e.g., contact allergic reactions (including delayed-type) such as itching, redness, blisters, etc.
(Skin irritation/lesion: when used for preoperative skin disinfection, pooling under the patient must be avoided – see section 3, method of administration)
Acute immune system reactions up to anaphylactic shock (anaphylactic reactions)
Iodine-induced hyperthyroidism in predisposed patients

Frequency not known (frequency cannot be estimated from available data):

Electrolyte and serum osmolarity disturbances
Renal failure
Severe metabolic acidosis
Urticaria-like lesions

Discontinue use of Braunol 7.5% Cutaneous Solution and consult your doctor immediately if you experience any of these side effects.

Other side effects
Prolonged treatment may affect wound healing.
Povidone-iodine may cause the same side effects as iodine, although it is less irritating.

Children
Regular use may induce hypothyroidism in children due to iodine absorption.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. HOW TO STORE BRAUNOL 7.5% CUTANEOUS SOLUTION
Keep this medicine out of the sight and reach of children.
Keep the bottle tightly closed and away from heat sources.
30 ml, 100 ml, and 250 ml bottles: do not store above 25°C.
500 ml and 1000 ml bottles: this medicine does not require special storage conditions.
Do not use Braunol 7.5% Cutaneous Solution after the expiry date stated on the label after the word “EXP”. The expiry date refers to the last day of that month.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Braunol 7.5% Cutaneous Solution contains

The active substance is povidone-iodine. 100 g of solution contains 7.5 g of povidone-iodine with a 10% free iodine content.
Other components: disodium hydrogen phosphate dihydrate, sodium iodate, macrogol 9 lauryl ether, sodium hydroxide, purified water.

Description of the appearance of Braunol 7.5% Cutaneous Solution and contents of the pack
Braunol 7.5% Cutaneous Solution is a brown solution.
Available in the following pack sizes:
20 vials of 30 ml
20 vials of 100 ml
20 vials of 250 ml
20 vials of 500 ml
10 vials of 1000 ml
Not all pack sizes may be marketed.