BRAUNOL 10% Krem

Treść ulotki

1. Braunol 10 % Ointment
   1. WHAT IS BRAUNOL 10% OINTMENT AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING BRAUNOL 10% OINTMENT
   3. HOW TO USE BRAUNOL 10% OINTMENT
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE BRAUNOL 10% OINTMENT
   6. CONTENTS OF THE PACK AND OTHER INFORMATION
2. Braunol 10 % Unguento
   1. WHAT IS BRAUNOL 10% OINTMENT AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING BRAUNOL 10% OINTMENT
   3. HOW TO USE BRAUNOL 10% OINTMENT
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE BRAUNOL 10% OINTMENT
   6. CONTENTS OF THE PACK AND OTHER INFORMATION
3. Braunol 7,5% Cutaneous Solution
   1. WHAT IS BRAUNOL 7.5% CUTANEOUS SOLUTION AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING BRAUNOL 7.5% CUTANEOUS SOLUTION
   3. HOW TO USE BRAUNOL 7.5% CUTANEOUS SOLUTION
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE BRAUNOL 7,5% CUTANEOUS SOLUTION
   6. CONTENTS OF THE PACK AND OTHER INFORMATION
4. Braunol 7,5% Cutaneous Solution
   1. WHAT IS BRAUNOL 7.5% CUTANEOUS SOLUTION AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING BRAUNOL 7.5% CUTANEOUS SOLUTION
   3. HOW TO USE BRAUNOL 7.5 CUTANEOUS SOLUTION
5. Braunol 7,5% Cutaneous Solution is only for external use. After accidental ingestion of
   1. POSSIBLE UNDESIRABLE EFFECTS
   2. HOW TO STORE BRAUNOL 7,5% CUTANEOUS SOLUTION
   3. CONTENTS OF THE PACK AND OTHER INFORMATION

Braunol 10 % Ointment

Iodopovidone

Read this leaflet carefully before using this medicine as it contains important information for you.
➢ Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
➢ Keep this leaflet. You may need to read it again.
➢ If you want more information or advice, ask your pharmacist.
➢ If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contact your doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

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

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

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

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

Do not use Braunol 10% Ointment

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

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

• Before application, your medical history of allergies should be considered, as iodopovidone can cause anaphylactic reactions in susceptible individuals (see section 4 “Possible side effects”).
• If you suffer from goiter or after a thyroid disease, and in predisposed patients with autonomous adenoma or with functionally autonomous adenoma, use Braunol 10% Ointment only on the advice of a doctor; furthermore, in these cases, do not use Braunol 10% Ointment for long periods and on large areas of the body (for example, for more than 10% of the total body area and for more than 14 days) due to the risk of iodine-induced hyperthyroidism. Even after the conclusion of treatment (up to 3 months) pay attention to the first symptoms of hyperthyroidism (see section 4 “Possible side effects”). If necessary, thyroid function should be monitored.
• If you are simultaneously undergoing therapy with lithium, 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 to extensive surfaces, or with occlusive dressings.
• Avoid contact with the eyes or mucous membranes of the eyes.
• Do not use Braunol 10% Ointment for long periods. The use, especially if prolonged, of products for local use can give rise to allergic reactions (sensitization); in this case, consult your doctor who may decide to interrupt the treatment.

Effect on laboratory tests:

• Due to the oxidizing effect of the active ingredient iodopovidone, during treatment with Braunol 10% Ointment, some diagnostic tests may show false positives in counts (for example, tests with toluidine or guaiac test for the determination of hemoglobin or glucose in stool or urine).
• Iodopovidone can reduce the absorption of iodine by the thyroid gland. During treatment with Braunol 10% Ointment, tests on the thyroid gland may be altered (scintigraphy, determination of iodine-binding proteins, radio-iodine diagnostics) and this can make radio-iodine 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 should not be used in children under the age of 6 months (see
“Do not use Braunol 10% Ointment”)
In pediatric age, use only under strict medical control and in cases of actual need. Children have a higher risk of developing hypothyroidism following applications of high doses of iodine due to the permeability of the skin and their high sensitivity to iodine. After Braunol 10% Ointment has been used, a test for thyroid function is required.
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. The doctor will monitor your thyroid function with the use of Braunol 10% Ointment if necessary.

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

• When Braunol 10% Ointment is used in conjunction with disinfectants containing silver, hydrogen peroxide and taurolidine, a reduction in efficacy may occur.
• Braunol 10% Ointment should not be used in conjunction with or immediately after the application of disinfectants containing mercury, due to the possible formation of an agent that causes acid burns.
• In patients undergoing simultaneous therapy with lithium, avoid regular use of Braunol 10% Ointment, especially if the area to be treated is large. Iodine absorbed can promote lithium-induced hypothyroidism.
• Braunol 10% Ointment should not be used in conjunction with other antiseptics and detergents.
• When Braunol 10% Ointment is used in conjunction with preparations with enzymatic components for the treatment of wounds, the effects of both may be reduced. Other interactionsIodopovidone reacts with proteins and with certain other organic compounds, e.g. blood components or pus, so the effectiveness of Braunol 10% Ointment may be reduced. The use of Braunol 10% Ointment may interfere with diagnostic tests (see “Warnings and precautions”). Pregnancy, breastfeeding and fertilityDuring pregnancy and breastfeeding, the use of Braunol 10% Ointment should be avoided. Prolonged use of iodopovidone on large wounds and mucous membranes may have an effect on fertility.

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

3. HOW TO USE BRAUNOL 10% OINTMENT

Always use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Apply the ointment 1 to 3 times a day 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 that indicates its effectiveness. A significant loss of color reveals that the preparation has lost its effectiveness and
must be applied again. Since Povidone-Iodine is soluble in water, any stains
on fabrics can be easily removed with water and soap; in more stubborn cases with
ammonia or sodium thiosulfate solution.

Incompatibilities
Iodopovidone is incompatible with reducing substances, alkaloid salts, carbonates, tannic acid,
salicylic acid, silver salts, mercury salts and bismuth salts, taurolidine and,
hydrogen peroxide.

Use in children
Braunol 10% Ointment should 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 insufficiency (see “Warnings and precautions”).

If you use more Braunol 10% ointment than you should
Braunol 10% Ointment is for external use only. After accidental ingestion of large
quantities of ointment, immediately notify your doctor or go to the nearest hospital
as severe thyroid dysfunction may occur. After accidental ingestion of
large amounts of iodopovidone, symptoms of acute iodine poisoning may occur, including abdominal pain, cramps, malaise, vomiting, diarrhea, dehydration, a
decrease in blood pressure with a tendency to collapse, swelling of the larynx,
bleeding (from mucous membranes and kidneys), bluish discoloration of the skin and mucous membranes
(cyanosis), kidney damage (globular and tubular necrosis) which may develop a failure
to pass urine (after 1-3 days), paresthesia, fever and pulmonary edema. After
excessively high intake of iodine for long periods, symptoms of
hyperthyroidism may develop with tachycardia, agitation, tremor and headache.

In case of ingestion/accidental intake of an excessive dose, immediately notify the
doctor or go to the nearest hospital.
If you forget to use Braunol 10% Ointment
Do not use a double dose to make up for a missed dose.

If you stop treatment with Braunol 10% Ointment
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this drug can cause side effects, although not everybody gets 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. allergic contact reactions, including delayed-type reactions such as itching, redness, blisters, etc.
• acute reactions of the immune system up to anaphylactic shock (anaphylactic reactions)
• iodine-induced hyperthyroidism in predisposed patients.

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

• disorders of electrolyte and serum osmolarity
• renal failure
• severe metabolic acidosis
• skin rashes from allergic reaction

Other side effects

• Prolonged treatment may affect the wound healing process.
• Iodopovidone may cause the same side effects as iodine, although it is less irritating. ChildrenHypothyroidism may be induced by regular use in children due to iodine absorption.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side 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 the medicine after the expiry date which is stated on the tube or the label
after the word EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Braunol 10% Ointment contains

• The active ingredient is povidone-iodine. 100 g of ointment contains 10 g of povidone-iodine with a content of 10% available iodine.
• The other ingredients 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 packs: a tube of 20 g and a tube of 100 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

• B. Braun Melsungen AG Carl-Braun-Straß 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

Braunol 10 % Unguento

Iodopovidone

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
➢ If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Braunol 10% Unguento is and what it is used for.
• 2. What you need to know before you use Braunol 10% Unguento.
• 3. How to use Braunol 10% Unguento.
• 4. Possible side effects.
• 5. How to store Braunol 10% Unguento.
• 6. Contents of the pack and other information.

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

Braunol 10% Unguento contains the active ingredient iodopovidone which belongs to a
group of medicines called antiseptics and disinfectants.
Braunol 10% Unguento is indicated for the disinfection of superficial skin wounds and of
mild pressure ulcers (skin lesions that affect parts of the body
subjected to pressure for prolonged periods) and for the antiseptic treatment of fungal infections
(fungal infections).

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

Do not use Braunol 10% Ointment

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

Warnings and precautions
Consult your doctor or nurse before using Braunol 10% Ointment.
Braunol 10% Ointment is for external use only, do not ingest.

• Before application, your medical history of allergies should be considered as iodopovidone may cause anaphylactic reactions in susceptible individuals (see section 4 “Possible side effects”).
• If you suffer from goiter or after a thyroid disease and in predisposed patients with autonomous adenoma or with functionally autonomous adenoma, Braunol 10% Ointment should only be used on the advice of a doctor; moreover, in these cases Braunol 10% Ointment should not be used for long periods and in large areas of the body (for example, for more than 10% of the total body area and for more than 14 days) due to the risk of iodine-induced hyperthyroidism. Even after the conclusion of treatment (up to 3 months) pay attention to the first symptoms of hyperthyroidism (see section 4 “Possible side effects”). If necessary, thyroid function should be monitored.
• If you are simultaneously undergoing therapy with lithium, 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.
• Application of Braunol 10% Ointment to extensive surfaces, or under occlusive dressings, should be avoided.
• Contact with the eyes or mucous membranes of the eyes should be avoided.
• Braunol 10% Ointment should not be used for long periods. The use, especially if prolonged, of products for local use can give rise to allergic reactions (sensitization); in such cases, your doctor may decide to discontinue treatment.

Effect on laboratory tests:

• Due to the oxidizing effect of the active ingredient iodopovidone, during treatment with Braunol 10% Ointment, some diagnostic tests may show false positives in counts (for example, toluidine test or guaiac test for the determination of hemoglobin or glucose in stool or urine).
• Iodopovidone can reduce the absorption of iodine by the thyroid gland. During treatment with Braunol 10% Ointment, tests on the thyroid gland may be altered (scintigraphy, determination of iodine-binding proteins, radio-iodine diagnostics) and this may make radio-iodine 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 should not be used in children under the age of 6 months (see
“Do not use Braunol 10% Ointment”).
In pediatric age, use only under strict medical supervision and in cases of actual need. Children have a higher risk of developing hypothyroidism following applications of high doses of iodine due to the permeability of the skin and their high sensitivity to iodine. After Braunol 10% Ointment has been used, a test for thyroid function 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 with the use of Braunol 10% Ointment if necessary.

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

• When Braunol 10% Ointment is used in conjunction with disinfectants containing silver, hydrogen peroxide and taurolidine, a reduction in efficacy may occur.
• Braunol 10% Ointment should not be used in conjunction with or immediately after the application of disinfectants containing mercury, due to the possible formation of an agent that causes acid burns.
• In patients undergoing simultaneous therapy with lithium, avoid regular use of Braunol 10% Ointment, especially if the area to be treated is large. Iodine absorbed may promote lithium-induced hypothyroidism.
• Braunol 10% Ointment should not be used in conjunction with other antiseptics and detergents.
• When Braunol 10% Ointment is used in conjunction with preparations with enzymatic components for the treatment of wounds, the effects of both may be reduced.

Other interactions
Iodopovidone reacts with proteins and with certain other organic compounds, e.g. components of blood or pus, so the effectiveness of Braunol 10% Ointment may be reduced.
The use of Braunol 10% Ointment may interfere with diagnostic tests (see “Warnings and precautions”).

Pregnancy, breastfeeding and fertility
During pregnancy and breastfeeding, the use of Braunol 10% Ointment should be avoided.
Prolonged use of iodopovidone on large wounds and mucous membranes may have an effect on fertility.

Driving and operating machinery
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 to you by a doctor. The ointment will be applied
one to three times a day 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 that indicates its
effectiveness. A significant loss of color reveals that the preparation has lost its effectiveness and
must be applied again.
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
Iodopovidone is incompatible with reducing substances, alkaloid salts, carbonates, tannic acid,
salicylic acid, silver salts, mercury salts and bismuth salts, taurolidine and,
hydrogen peroxide.

Use in children
Braunol 10% Ointment should 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. After accidental ingestion of large
quantities of ointment, a doctor must be notified immediately as severe thyroid dysfunction may occur. After accidental ingestion of large
quantities of iodopovidone, symptoms of acute iodine poisoning may occur, which
include abdominal pain, cramps, malaise, vomiting, diarrhea, dehydration, a drop in
blood pressure with a tendency to collapse, swelling of the larynx, bleeding
(from mucous membranes and kidneys), cyanosis, kidney damage (globular and tubular necrosis) which may
develop into anuria (after 1-3 days), paresthesia, fever and pulmonary edema. After
excessively high intake of iodine for long periods, symptoms of hyperthyroidism may develop with tachycardia, agitation, tremor and headache.

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

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

4. POSSIBLE SIDE EFFECTS

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

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

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

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

• disorders of electrolyte and serum osmolarity
• renal failure
• severe metabolic acidosis
• urticarial lesions Other side effects
• Prolonged treatment may affect the wound healing process.
• Iodopovidone may cause the same side effects as iodine, although it is less irritating.

Children
Hypothyroidism may be induced by regular use in children due to iodine absorption.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side 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 the medicine after the expiry date which is stated on the tube or on the label
after the wording EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Braunol 10% Ointment contains

• The active ingredient is povidone-iodine. 100 g of ointment contains 10 g of povidone-iodine with a content of 10% available iodine.
• The other ingredients 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 packs: 20 tubes of 20 g and 10 tubes of 100 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

• B. Braun Melsungen AG Carl-Braun-Straß 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

Braunol 7,5% Cutaneous Solution

Iodopovidone

Read this leaflet carefully before using this medicine as it contains
important information for you.
➢ Always use this medicine exactly as described in this leaflet or as your
doctor or pharmacist has told you.
➢ Keep this leaflet. You may need to read it again.
➢ If you want more information or advice, ask your pharmacist.
➢ If any side effects occur, including those not listed in this
leaflet, tell your doctor or pharmacist. See section 4.
Contact your doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

• 1. What Braunol 7,5% Cutaneous Solution is and what it is used for.
• 2. What you need to know before using Braunol 7,5% Cutaneous Solution.
• 3. How to use Braunol 7,5% Cutaneous Solution.
• 4. Possible side effects.
• 5. How to store Braunol 7,5% Cutaneous Solution.
• 6. Contents of the pack and other information

1. WHAT IS BRAUNOL 7.5% CUTANEOUS SOLUTION AND WHAT IS IT USED FOR

This medicine contains the active ingredient povidone-iodine, which belongs to a group of
medicines called antiseptics and disinfectants.
Braunol 7.5% Cutaneous Solution is indicated for:

• Disinfection of the skin, even if damaged (superficial skin wounds and pressure sores, i.e. skin lesions affecting parts of the body subjected to pressure for prolonged periods, of mild severity)
• Antisepsis of the surgical field (disinfection of the skin before a surgical intervention)

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

CUTANEOUS
Do not use Braunol 7.5% Cutaneous Solution

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).
• in case of hyperthyroidism or in the presence of other thyroid diseases.
• in case of dermatitis herpetiformis, a rare skin disease.
• before and after iodine radiotherapy (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.

• Before application, your allergy history must be considered as iodopovidone can cause anaphylactic reactions in susceptible individuals (see section 4 “Possible side effects”).
• If you suffer from goiter or have had a thyroid disease and in predisposed patients with autonomous adenoma or functionally autonomous adenoma, use Braunol 7.5% Cutaneous Solution only on the advice of your doctor; furthermore, in these cases, do not use Braunol 7.5% Cutaneous Solution for long periods and on large areas of the body (e.g. for more than 10% of the total body area and for more than 14 days) due to the risk of iodine-induced hyperthyroidism. Also, after the end of treatment (up to 3 months), pay attention to the first symptoms of hyperthyroidism (see paragraph 4 “possible side effects”). If necessary, thyroid function should be monitored.
• If you are simultaneously 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 suffer from renal insufficiency, avoid regular application of Braunol 7.5% Cutaneous Solution (see section 4 “Possible side effects”).
• Avoid applying Braunol 7.5% Cutaneous Solution to large areas and with occlusive dressings.
• Avoid contact with the eyes and mucous membranes of the eyes.
• Do not use Braunol 7.5% Cutaneous Solution for long periods. The use, especially if prolonged, of products for local use can give rise to allergic reactions (sensitization); in this case, consult your doctor who may decide to interrupt the treatment.

Effects on laboratory tests:

• Due to the oxidizing effect of the active ingredient iodopovidone, during treatment with Braunol 7.5% Cutaneous Solution, some diagnostic tests may result in false positives in counts (for example, tests with toluidine or guaiac tests for the determination of hemoglobin or glucose in feces or urine).
• Iodopovidone can reduce the absorption of iodine by the thyroid gland. During treatment with Braunol 7.5% Cutaneous Solution, tests on the thyroid gland may be altered (scintigraphy, determination of iodine-binding proteins, radio-iodine diagnostics) and this may make radio-iodine 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 should not be used in children under 6 months of age
(see “Do not use Braunol 7.5% Cutaneous Solution”)
In pediatric age, use only under strict medical supervision and in cases of actual need. Children have a higher risk of developing hypothyroidism following applications of high doses of iodine due to the permeability of the skin and their high sensitivity to iodine.
After use of Braunol 7.5% Cutaneous Solution, a test on thyroid function is necessary.
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 will monitor your thyroid function with the use of Braunol 7.5% Cutaneous Solution if necessary.

Other medicines and Braunol 7.5% Cutaneous Solution
Tell 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 in conjunction with disinfectants containing silver, hydrogen peroxide or taurolidine, a reduction in efficacy may occur.
• Braunol 7.5% Cutaneous Solution should not be used in conjunction with or immediately after the application of disinfectants containing mercury, due to the possible formation of an agent that causes acid burns.
• In patients undergoing simultaneous therapy with lithium, avoid regular use of Braunol 7.5% Cutaneous Solution, especially if the area to be treated is large. The absorbed iodine may promote hypothyroidism probably caused by lithium.
• Braunol 7.5% Cutaneous Solution should not be used in conjunction with other antiseptics and detergents.
• When Braunol 7.5% Cutaneous Solution is used in conjunction with preparations with enzymatic components for the treatment of wounds, the effects of both may be reduced.

Other interactions
Iodopovidone reacts with proteins and with certain other organic compounds, e.g. blood components or pus, so the effectiveness of Braunol 7.5% Cutaneous Solution may be reduced.
The use of Braunol 7.5% Cutaneous Solution may interfere with diagnostic tests (see “Warnings and precautions”).

Pregnancy, breastfeeding and fertility
During pregnancy and breastfeeding, the use of Braunol 7.5% Cutaneous Solution should be avoided.
Prolonged use of iodopovidone on large wounds and mucous membranes may have an effect on fertility.

Driving and operating machinery
Braunol 7.5% Cutaneous Solution does not interfere with the ability to drive vehicles 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 you have any doubts, ask your doctor or pharmacist.

Skin disinfection and antisepsis of the surgical field
Braunol 7.5% Cutaneous Solution should be applied undiluted to disinfect the skin or mucous membranes, for example before surgery, biopsies, injections, punctures, blood sampling and catheterization. Allow to dry. If necessary, repeat the operation.

Disinfection of damaged skin (superficial wounds, mild pressure ulcers
For the antiseptic treatment of superficial wounds, Braunol 7.5% Cutaneous Solution should be applied undiluted to the area requiring treatment.
Small lesions: do not exceed 5-6 applications/day.
Braunol 7.5% Cutaneous Solution is also diluted for antiseptic purposes. The following dilutions are provided as guidelines:

• Irrigation performed as part of the treatment of superficial wounds and for pre-operative infection prevention. (from 1:2 to 1:20).

Do not exceed the recommended doses.

Use in children
Braunol 7.5% Cutaneous Solution should 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 and in patients
with renal insufficiency (see “Warnings and precautions”).

Method of administration
Braunol 7.5% Cutaneous Solution is intended for external use in diluted and undiluted form.
The preparation can be diluted with ordinary tap water. Physiological saline
or Ringer's solution can be used when isotonic conditions are required.
All dilutions must be prepared immediately before use and used immediately.
Braunol 7.5% Cutaneous Solution should be applied to the area to be treated until
the area is completely wet. The antiseptic film that forms due to
the drying of the preparation can be easily washed away with water.
The brown color of Braunol 7.5% Cutaneous Solution is a characteristic of the preparation
that indicates its effectiveness. A significant loss of color shows reveals that the preparation has
lost its effectiveness. 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
Iodopovidone is incompatible with reducing substances, alkaloid salts, carbonates, tannic acid,
salicylic acid, silver salts, mercury salts and bismuth salts, taurolidine and,
hydrogen peroxide.

If you use more Braunol 7.5% Cutaneous Solution than you should
Braunol 7.5% Cutaneous Solution should only be used externally. After accidental ingestion
of large quantities, immediately notify your doctor or go to the nearest hospital.
After accidental ingestion of large quantities of Braunol 7.5% Cutaneous Solution, seek
immediate medical advice as acute iodine poisoning may occur, including abdominal pain, cramps, malaise, vomiting, diarrhea, dehydration, a
drop in blood pressure with a tendency to collapse, swelling of the larynx,
bleeding (from mucous membranes and kidneys), bluish discoloration of the skin and mucous membranes
(cyanosis), kidney damage (globular and tubular necrosis) which may develop a failure
to pass urine (after 1-3 days), paresthesia, fever and pulmonary edema. After
excessively high intake of iodine for long periods, symptoms of
hyperthyroidism with tachycardia, agitation, tremor and headache may develop.

If you forget to use Braunol 7.5% Cutaneous Solution
Do not use a double dose to make up for a 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 may cause side effects,
although not everybody gets them.

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

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

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

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

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

• disorders of electrolyte and serum osmolarity
• renal failure
• severe metabolic acidosis
• skin rashes from allergic reaction

Stop using 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 the wound healing process.
• Iodopovidone may cause the same side effects as iodine, although it is less irritating.

Children
Hypothyroidism may be induced by regular use in children due to iodine absorption.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help 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 sources of heat.
Bottles of 30 ml, 100 ml: do not store the bottle at a temperature above 25°C.
Bottles of 1000 ml: this medicine does not require any particular storage conditions.
Do not use Braunol 7,5% Cutaneous Solution after the expiry date which is reported
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 ingredient is povidone-iodine. 100 g of solution contains 7.5 g of povidone-iodine with a content of 10% free iodine.
• The other components are disodium hydrogen phosphate dihydrate, sodium iodide, macrogol 9 lauryl ether, sodium hydroxide, purified water.

Description of the appearance of Braunol 7,5% Cutaneous Solution and content of the
pack
Braunol 7,5% Cutaneous Solution is a brown cutaneous solution.
It is available in polyethylene bottles in the following packs: a 30 ml bottle, a
100 ml bottle and a 1000 ml bottle.
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

Braunol 7,5% Cutaneous Solution

Iodopovidone

Read this leaflet carefully before you use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
➢ If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Braunol 7,5% Cutaneous Solution is and what it is used for.
• 2. What you need to know before you use Braunol 7,5% Cutaneous Solution.
• 3. How to use Braunol 7,5% Cutaneous Solution.
• 4. Possible side effects.
• 5. How to store Braunol 7,5% Cutaneous Solution.
• 6. Contents of the pack and other information

1. WHAT IS BRAUNOL 7.5% CUTANEOUS SOLUTION AND WHAT IS IT USED FOR

This medicine contains the active ingredient povidone-iodine, which belongs to a group of
medicines called antiseptics and disinfectants.
Braunol 7.5% Cutaneous Solution is indicated for:

• Disinfection of the skin, even if damaged (superficial skin wounds and pressure ulcers, i.e. skin lesions affecting parts of the body subjected to pressure for prolonged periods, of minor severity).
• Antisepsis of the surgical field (disinfection of the skin before a surgical operation)

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

CUTANEOUS
Do not use Braunol 7.5% Cutaneous Solution

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• in case of hyperthyroidism or in the presence of other thyroid diseases.
• in case of dermatitis herpetiformis, a rare skin disease.
• before and after iodine radiotherapy (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 ingest.

• Before application, a history of allergies should be considered as iodopovidone may cause anaphylactic reactions in susceptible individuals (see section 4 “Possible side effects”).
• When used for skin disinfection during the pre-operative phase, particular caution must be taken to prevent pooling under the patient as it may cause skin irritation.
• If you suffer from goiter or after a thyroid disease and in predisposed patients with autonomous adenoma or functionally autonomous adenoma, Braunol 7.5% Cutaneous Solution should only be used on the advice of a doctor; furthermore, in these cases Braunol 7.5% Cutaneous Solution should not be used for long periods and on large areas of the body (e.g. for more than 10% of the total body area and for more than 14 days) due to the risk of iodine-induced hyperthyroidism. Also, after the end of treatment (up to 3 months) pay attention to the first symptoms of hyperthyroidism (see paragraph 4 “possible side effects”). If necessary, thyroid function should be monitored.
• If you are simultaneously 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 suffer from renal insufficiency, regular application of Braunol 7.5% Cutaneous Solution should be avoided (see section 4 “possible side effects”).
• Application of Braunol 7.5% Cutaneous Solution to extensive surfaces and with occlusive dressings should be avoided.
• Contact with the eyes and mucous membranes of the eyes should be avoided.
• Braunol 7.5% Cutaneous Solution should not be used for long periods. The use, especially if prolonged, of products for local use can give rise to allergic reactions (sensitization); in such cases, the doctor may decide to discontinue treatment.

Effects on laboratory tests:

• Due to the oxidizing effect of the active ingredient iodopovidone, during treatment with Braunol 7.5% Cutaneous Solution, some diagnostic tests may show false positives in counts (for example, tests with toluidine or guaiac for the determination of hemoglobin or glucose in stool or urine).
• Iodopovidone can reduce the absorption of iodine by the thyroid gland. During treatment with Braunol 7.5% Cutaneous Solution, tests on the thyroid gland may be altered (scintigraphy, determination of proteins that bind iodine, radio-iodine diagnostics) and this may make radio-iodine 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 should not be used in children under 6 months of age
(see “Do not use Braunol 7.5% Cutaneous Solution”).
In pediatric age, use only under strict medical control and in cases of actual need. Children
have a higher risk of developing hypothyroidism following applications of high doses
of iodine due to the permeability of the skin and their high sensitivity to iodine. After
use of Braunol 7.5% Cutaneous Solution, a test of thyroid function is necessary.
Care should be taken to prevent accidental ingestion of Braunol 7.5%
Cutaneous Solution by children.

Elderly patients
In elderly patients, regular and extensive application should be avoided, especially if
predisposed to thyroid disorders. The doctor will monitor your thyroid function with
the use of Braunol 7.5% Cutaneous Solution if necessary.

Other medicines and Braunol 7.5% Cutaneous Solution
Tell 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 in conjunction with disinfectants containing silver, hydrogen peroxide or taurolidine, a reduction in efficacy may occur.
• Braunol 7.5% Cutaneous Solution should not be used in conjunction with or immediately after the application of disinfectants containing mercury, due to the possible formation of an agent that causes acid burns.
• In patients undergoing simultaneous therapy with lithium, regular use of Braunol 7.5% Cutaneous Solution should be avoided, especially if the area to be treated is large. Absorbed iodine may promote hypothyroidism probably caused by lithium.
• Braunol 7.5% Cutaneous Solution should not be used in conjunction with other antiseptics and detergents.
• When Braunol 7.5% Cutaneous Solution is used in conjunction with preparations with enzymatic components for the treatment of wounds, the effects of both may be reduced.

Other interactions
Iodopovidone reacts with proteins and with certain other organic compounds, e.g.
blood components or pus, so the effectiveness of Braunol 7.5% Cutaneous Solution may
be reduced.
The use of Braunol 7.5% Cutaneous Solution may interfere with diagnostic tests (see
“Warnings and precautions”).

Pregnancy, breastfeeding and fertility
During pregnancy and breastfeeding, the use of Braunol 7.5% Cutaneous Solution should be
avoided.
Prolonged use of iodopovidone on large wounds and mucous membranes may have an effect on
fertility.

Driving and operating machinery
Braunol 7.5% Cutaneous Solution does not impair the ability to drive vehicles or operate
machinery

3. HOW TO USE BRAUNOL 7.5 CUTANEOUS SOLUTION

Braunol 7.5% Cutaneous Solution will be administered to you by a doctor.

Skin disinfection and antisepsis of the surgical field
Braunol 7.5% Cutaneous Solution must be applied undiluted to disinfect the skin or
mucous membranes, for example before surgery, biopsies, injections, punctures, blood sampling and catheterization. Allow to dry. If necessary, repeat the operation.

Disinfection of damaged skin (superficial wounds, mild pressure ulcers)
For the antiseptic treatment of superficial wounds, Braunol 7.5% Cutaneous Solution must
be applied undiluted to the area requiring treatment.
Small lesions: do not exceed 5-6 applications/day.
Braunol 7.5% Cutaneous Solution is also diluted for antiseptic purposes. The following
dilutions are provided as guidelines:

• Irrigation performed as part of the treatment of superficial wounds and for pre-operative infection prevention. (from 1:2 to 1:20).

Do not exceed the recommended doses.

Use in children
Braunol 7.5% Cutaneous Solution should 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
and in patients with renal insufficiency (see “Warnings and precautions”).

Route of administration
Braunol 7.5% Cutaneous Solution is intended for external use in diluted and undiluted form.
The preparation can be diluted with normal tap water. Physiological saline or
Ringer's solution can be used when isotonic conditions are required.
All dilutions must be prepared immediately before use and used immediately.
Braunol 7.5% Cutaneous Solution should be applied to the area to be treated until
the area is completely wet. The antiseptic film that forms due to the drying of the
preparation can be easily washed away with water.
Caution: When used for preoperative skin disinfection, care must be taken to prevent
accumulation of the preparation under the patient, as this may cause
skin irritation.
For the surgical field, use a soaked swab and pass it over the area to be disinfected. Allow to
dry and, if necessary, repeat the operation.
The brown color of Braunol 7.5% Cutaneous Solution is a characteristic of the preparation
that indicates its effectiveness. A significant loss of color reveals that the preparation has lost its
effectiveness. 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 solution of
sodium thiosulfate.

Incompatibilities
Iodopovidone is incompatible with reducing substances, alkaloid salts, carbonates, tannic acid,
salicylic acid, silver salts, mercury salts and bismuth salts, taurolidine and,
hydrogen peroxide.

If you receive more Braunol 7.5% Cutaneous Solution than you should

Braunol 7,5% Cutaneous Solution is only for external use. After accidental ingestion of

large quantities of Braunol 7,5% Cutaneous Solution, seek immediate medical advice
as acute iodine poisoning may occur, including abdominal pain, cramps,
malaise, vomiting, diarrhea, dehydration, a drop in blood pressure with a tendency to collapse,
swelling of the larynx, bleeding (of the mucous membranes and kidneys), bluish discoloration of the skin and
mucous membranes, kidney damage (globular and tubular necrosis) which may develop into failure to pass
urine (after 1-3 days), paresthesia, fever and pulmonary edema. After excessively
high intake of iodine for long periods, symptoms of hyperthyroidism may develop with 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 a missed dose.

If you stop usingBraunol 7,5% Cutaneous Solution
If you have any doubts about using this medicine, ask your doctor or nurse.

4. POSSIBLE UNDESIRABLE EFFECTS

Like all medicines, Braunol 7,5% Cutaneous Solution may cause undesirable effects,
although not everybody gets them.

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

• At the beginning of treatment, a temporary local burning sensation may occur after application of the solution. Very rare (may affect up to 1 in 10,000)
• Skin reactions due to hypersensitivity (allergy) e.g. allergic contact reactions, including delayed-type reactions such as itching, redness, blisters, etc. (irritation/injury of the skin: when used for preoperative skin disinfection, care must be taken to prevent the preparation from pooling under the patient (see section 3, how to administer)
• acute reactions of the immune system up to anaphylactic shock (anaphylactic reactions)
• iodine-induced hyperthyroidism in predisposed patients

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

• disorders of electrolyte and serum osmolarity
• renal insufficiency
• severe metabolic acidosis
• urticarial lesions

Stop using Braunol 7,5% Cutaneous Solution and consult your doctor
immediately if you experience any of these undesirable effects.

Other undesirable effects
Prolonged treatment may affect the wound healing process.
Iodopovidone may cause the same undesirable effects as iodine, although it is generally
less irritating.

Children
Hypothyroidism may be induced by regular use in children due to iodine absorption.

Reporting of undesirable effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help 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 sources of heat.
Bottles of 30 ml, 100 ml and 250 ml: do not store at a temperature above 25°C.
Bottles of 500 ml and 1000 ml: this medicine does not require any particular storage conditions.
Do not use Braunol 7,5% Cutaneous Solution after the expiry date which is reported
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 ingredient is povidone-iodine. 100 g of solution contain 7.5 g of povidone-iodine with a content of 10% of free iodine.
• The other components are 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 cutaneous solution.
It is available in the following packs:
20 bottles of 30 ml
20 bottles of 100 ml
20 bottles of 250 ml
20 bottles of 500 ml
10 bottles of 1000 ml
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