Amukine Med

Package leaflet: Information for the user

Amukine Med 0.05% cutaneous spray, solution

Sodium hypochlorite
Please read all of this leaflet carefully before you start 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.
• 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 you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Amukine Med is and what it is used for

Amukine Med contains sodium hypochlorite, a local antiseptic.
Amukine Med is indicated for:

• disinfecting and cleaning minor skin injuries such as small superficial wounds, mild pressure ulcers (skin lesions affecting body parts subjected to prolonged pressure), and mild burns (first-degree burns);
• disinfecting external genitalia.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Amukine Med

Do not use Amukine Med
if you are allergic to sodium hypochlorite or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Amukine Med is for external use only.
The use, especially if prolonged, of topical products may cause allergic reactions (see section "Possible side effects"). If this occurs, discontinue treatment and consult your doctor, who will initiate appropriate therapy.
The presence of organic materials (proteins, serum, blood, etc.) reduces the antiseptic activity.
Application of the product may dissolve blood clots and cause bleeding.
Avoid contact with the eyes.

Other medicines and Amukine Med
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid simultaneous use of other antiseptics and detergents.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine can be used during pregnancy and breastfeeding.

Driving and using machines
Not applicable.

3. How to use Amukine Med

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Amukine Med 0,05% cutaneous spray is ready to use.
Apply the spray locally:

• directly onto the area to be treated (wounds, ulcers, burns),
• onto gauze compresses,
• onto dressings.
  Spray until the area to be treated is uniformly moistened. A single spray delivers 0.7 ml of solution.

Disinfection may be repeated whenever deemed necessary, up to a maximum of 6 times daily.
Use this medicine only for short-term treatment.
If you use more Amukine Med than you should
Accidental ingestion or inhalation may have serious consequences, potentially leading to death. In case of accidental ingestion, consult a doctor immediately or go to the nearest hospital.
If you forget to use Amukine Med
Do not use a double dose to make up for the forgotten dose.
If you stop using Amukine Med
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone gets them.
If you experience an allergic reaction while using Amukine Med, STOP treatment immediately and consult your doctor.
The following side effects have been reported with the use of Amukine Med:

• intolerance (burning or irritation);
• redness and itching of the skin that has come into contact with the medicine (allergic contact dermatitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://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 Amukine Med

Keep this medicine out of the sight and reach of children.
Keep the bottle tightly closed to protect the medicine from light.
Replace the protective cap on the dispenser after each use.
Do not use this medicine more than 6 months after first opening.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date which is stated on the bottle after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Amukine Med contains
100 ml of solution contain:
The active substance is sodium hypochlorite 0.057 g (available chlorine 0.055 g).
The other components are: sodium chloride, sodium hydroxide, sodium bicarbonate, purified water.

Description of the appearance of Amukine Med and contents of the pack
Amukine Med 0.05% cutaneous spray solution is a solution for external use, delivered via a spray device.
Pack contents: 200 ml.

Marketing Authorization Holder and Manufacturer
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome

Manufacturer
A.C.R.A.F. S.p.A. Via Pontasso, 13 – 16015 Casella (Genoa)
A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio, 22 60131 ANCONA

INFORMATION TO BE INDICATED ON THE PRIMARY PACKAGING
BOTTLE

1. CONTENTS

200 ml bottle

2. EXPIRY DATE

Expired

3. BATCH NUMBER

Batch No.

4. MARKETING AUTHORISATION NUMBER(S)

A.I.C. No. 032192041

5. GENERAL SUPPLY CONDITION

Medicinal product for self-medication

6. INFORMATION IN BRAILLE

Amukine med 0,05% cutaneous spray, solution

17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE

Two-dimensional barcode including the unique identifier.

18. UNIQUE IDENTIFIER - READABLE DATA

PC:
SN:
NN:

Package leaflet: information for the user

Amukine Med 0.05% cutaneous solution

Sodium hypochlorite
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 any of the side effects occur, 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 after a short period of treatment.

Contents of this leaflet:

1. What Amukine Med is and what it is used for
2. What you need to know before using Amukine Med
3. How to use Amukine Med
4. Possible side effects
5. How to store Amukine Med
6. Package contents and other information

1. What Amukine Med is and what it is used for

Amukine Med contains sodium hypochlorite, an antiseptic for local use.
Amukine Med is indicated for:

• disinfecting and cleaning minor skin injuries such as small superficial wounds, mild pressure ulcers (skin lesions affecting body parts subjected to prolonged pressure), and mild burns (first-degree burns);
• disinfecting external genitalia.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Amukine Med

Do not use Amukine Med
if you are allergic to sodium hypochlorite or to any of the other ingredients of this medicinal product (listed in
section 6).

Warnings and precautions
Amukine Med is for external use only.
The use, especially if prolonged, of topical products may cause allergic reactions (see section “Possible side effects”). If this occurs, discontinue treatment and consult your doctor, who will initiate appropriate therapy.
The presence of organic materials (proteins, serum, blood, etc.) may reduce the antiseptic activity.
Topical application of the product may dissolve blood clots and cause bleeding.
Avoid contact with the eyes.

Other medicines and Amukine Med
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid simultaneous use of other antiseptics or detergents.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicinal product.
This medicinal product may be used during pregnancy and breastfeeding.

Driving and using machines
Not applicable.

3. How to use Amukine Med

Use this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Amukine Med 0.05% cutaneous solution is ready to use.
Apply the solution locally by means of:

• washing or bathing,
• soaked compresses,
• moistened dressings.

Disinfection may be repeated as necessary, up to a maximum of 6 times a day.
Use this medicine only for short periods of treatment.
If you use more Amukine Med than you should
Accidental ingestion or inhalation may have serious consequences, possibly leading to death. In case of accidental ingestion of the product, consult a doctor immediately or go to the nearest hospital.
If you forget to use Amukine Med
Do not use a double dose to make up for the forgotten dose.
If you stop using Amukine Med
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience an allergic reaction while using Amukine Med, STOP the treatment immediately and consult your doctor.
The following side effects may occur with the use of Amukine Med:

• intolerance (burning or irritation);
• redness and itching of the skin that has come into contact with the medicine (allergic contact dermatitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website https://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 Amukine Med

Keep this medicine out of the sight and reach of children.
Keep the bottle tightly closed to protect the medicine from light.
Do not use this medicine after 6 months from first opening.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date which is stated on the bottle after {EXP}. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amukine Med contains
100 ml of solution contain:
The active substance is sodium hypochlorite, 0.057 g (active chlorine 0.055 g).
The other components are: sodium chloride, sodium hydroxide, sodium bicarbonate, purified water.

Description of the appearance of Amukine Med and contents of the pack
Amukine Med 0.05% cutaneous solution is supplied as a solution for external use.
Pack sizes are 250 ml, 500 ml or 1000 ml.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome

Manufacturer
A.C.R.A.F. S.p.A. Via Pontasso, 13 – 16015 Casella (Genoa)
A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio, 22 60131 ANCONA

---

MINIMUM INFORMATION TO BE INDICATED ON THE PRIMARY PACKAGING
TOGETHER WITH THE PACKAGE LEAFLET
BOTTLE

1. CONTENTS

250 ml bottle

2. EXPIRY DATE

Exp.

3. BATCH NUMBER

Batch no.

4. GENERAL SUPPLY CONDITION

Medicinal product for self-medication

5. MARKETING AUTHORISATION NUMBER(S)

AIC n.032192015

6. BRaille INFORMATION

Amukine Med 0.05% cutaneous solution

17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE

Two-dimensional barcode including unique identifier.

18. UNIQUE IDENTIFIER - READABLE DATA

PC:
SN:
NN:

Package leaflet: information for the user

Amukine Med 0.05% cutaneous solution

Sodium hypochlorite
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 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 you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Amukine Med is and what it is used for

Amukine Med contains sodium hypochlorite, a local antiseptic.
Amukine Med is indicated for:

• disinfecting and cleaning minor skin lesions such as small superficial wounds, mild pressure ulcers (skin lesions affecting body parts subjected to prolonged pressure), and mild burns (first-degree burns);
• disinfecting external genitalia.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Amukine Med

Do not use Amukine Med
If you are allergic to sodium hypochlorite or to any of the other ingredients of this medicinal product (listed in
section 6).

Warnings and precautions
Amukine Med is for external use only.

The use, especially if prolonged, of topical products may lead to allergic reactions (see section “Possible side effects”). If this occurs, discontinue treatment and consult your doctor, who will initiate appropriate therapy.

The presence of organic materials (proteins, serum, blood, etc.) may reduce the antiseptic activity.

Topical application of the product may dissolve blood clots and cause bleeding.

Avoid contact with the eyes.

Other medicines and Amukine Med
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Avoid simultaneous use of other antiseptics or detergents.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicinal product.

This medicinal product can be used during pregnancy and breastfeeding.

Driving and using machines
Not applicable.

3. How to use Amukine Med

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Amukine Med 0,05% cutaneous solution is ready to use.
Apply the solution locally by means of:

• washing or bathing,
• soaked compresses,
• moistened dressings.

Disinfection may be repeated as necessary, up to a maximum of 6 times a day.
Use this medicine only for short treatment periods.
If you use more Amukine Med than you should
Accidental ingestion or inhalation may have serious consequences, possibly leading to death. In case of accidental ingestion, consult a doctor immediately or go to the nearest hospital.
If you forget to use Amukine Med
Do not use a double dose to make up for the forgotten dose.
If you stop using Amukine Med
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience an allergic reaction while using Amukine Med, STOP treatment immediately and consult your doctor.
The following side effects may occur with the use of Amukine Med:

• intolerance (burning or irritation);
• redness and itching of the skin that has come into contact with the medicine (allergic contact dermatitis).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://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 Amukine Med

Keep this medicine out of the sight and reach of children.
Keep the bottle tightly closed to protect the medicine from light.
Do not use this medicine more than 6 months after first opening.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the bottle after {EXP}. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amukine Med contains
100 ml of solution contain:
The active substance is sodium hypochlorite, 0.057 g (active chlorine 0.055 g).
The other components are: sodium chloride, sodium hydroxide, sodium bicarbonate, purified water.

Description of the appearance of Amukine Med and contents of the pack
Amukine Med 0.05% cutaneous solution is presented as a solution for external use.
Pack sizes are 250, 500 or 1000 ml.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome

Manufacturer
A.C.R.A.F. S.p.A. Via Pontasso, 13 – 16015 Casella (Genoa)
A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio, 22 60131 ANCONA

---

MINIMUM INFORMATION TO BE INDICATED ON THE PRIMARY PACKAGING
TOGETHER WITH THE PACKAGE LEAFLET
BOTTLE

1. CONTENT

500 ml bottle

2. EXPIRY DATE

Exp.

3. BATCH NUMBER

Batch no.

4. GENERAL SUPPLY CONDITION

Medicinal product for self-medication

5. MARKETING AUTHORISATION NUMBER(S)

AIC n.032192027

6. BRaille INFORMATION

Amukine Med 0,05% cutaneous solution

17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE

Two-dimensional barcode including unique identifier.

18. UNIQUE IDENTIFIER - READABLE DATA

PC:
SN:
NN:

Package leaflet: Information for the user

Amukine Med 0.05% cutaneous solution

Sodium hypochlorite
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 want 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 you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Amukine Med is and what it is used for
2. What you need to know before using Amukine Med
3. How to use Amukine Med
4. Possible side effects
5. How to store Amukine Med
6. Package contents and other information

1. What Amukine Med is and what it is used for

Amukine Med contains sodium hypochlorite, a local antiseptic.
Amukine Med is indicated for:

• disinfecting and cleaning minor skin injuries such as small superficial wounds, mild pressure ulcers (skin lesions affecting body parts subjected to prolonged pressure), and mild burns (first-degree burns);
• disinfecting external genital areas.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Amukine Med

Do not use Amukine Med
if you are allergic to sodium hypochlorite or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Amukine Med is for external use only.
The use, especially if prolonged, of topical products may cause allergic reactions (see section “Possible side effects”). If this occurs, discontinue treatment and consult your doctor, who will initiate appropriate therapy.
The presence of organic materials (proteins, serum, blood, etc.) may reduce the antiseptic activity.
Topical application of the product may dissolve blood clots and cause bleeding.
Avoid contact with the eyes.

Other medicines and Amukine Med
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid simultaneous use of other antiseptics or detergents.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
This medicine can be used during pregnancy and breastfeeding.

Driving and using machines
Not applicable.

3. How to use Amukine Med

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Amukine Med 0.05% cutaneous solution is ready for use.
Apply the solution locally by means of:

• Washing or bathing,
• soaked compresses,
• moistened dressings.

Disinfection may be repeated whenever deemed necessary, up to a maximum of 6 times a day.
Use this medicine only for short treatment periods.
If you use more Amukine Med than you should
Accidental ingestion or inhalation may have serious consequences, possibly even fatal. In case of accidental ingestion, consult a doctor immediately or go to the nearest hospital.
If you forget to use Amukine Med
Do not use a double dose to make up for the missed dose.
If you stop using Amukine Med
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience an allergic reaction during treatment with Amukine Med, STOP the treatment immediately and consult your doctor.
The following side effects may occur with the use of Amukine Med:

• intolerance (burning or irritation);
• redness and itching of the skin that has come into contact with the medicine (allergic contact dermatitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://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 Amukine Med

Keep this medicine out of the sight and reach of children.
Keep the bottle tightly closed to protect the medicine from light.
Do not use this medicine after 6 months from first opening.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the bottle after {EXP}. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amukine Med contains
100 ml of solution contain:
The active substance is sodium hypochlorite, 0.057 g (active chlorine 0.055 g).
The other components are: sodium chloride, sodium hydroxide, sodium bicarbonate, purified water.

Description of the appearance of Amukine Med and contents of the pack
Amukine Med 0.05% cutaneous solution is presented as a solution for external use.
Pack sizes: 250 ml, 500 ml or 1000 ml.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy

Manufacturer
A.C.R.A.F. S.p.A. Via Pontasso, 13 – 16015 Casella (Genoa), Italy
A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio, 22 – 60131 ANCONA, Italy

---

MINIMUM INFORMATION TO BE INDICATED ON THE PRIMARY PACKAGING
TOGETHER WITH THE PACKAGE LEAFLET
BOTTLE

1. CONTENTS

1000 ml bottle

2. EXPIRY DATE

Exp.

3. LOT NUMBER

Lot No.

4. GENERAL SUPPLY CONDITION

Medicinal product for self-medication

5. MARKETING AUTHORISATION NUMBER(S)

AIC n.032192039

6. BRaille INFORMATION

Amukine Med 0,05% cutaneous solution

17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE

Two-dimensional barcode including unique identifier.

18. UNIQUE IDENTIFIER - DATA MADE READABLE

PC:
SN:
NN: