Poviderm

Package leaflet: Information for the user

POVIDERM 1% 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, ask your doctor or nurse.
• 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:

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

1. What POVIDERM is and what it is used for

POVIDERM contains the active substance iodopovidone, which belongs to a group of medicines called antiseptics and disinfectants that reduce or inhibit the growth of bacteria.
POVIDERM is indicated for cleaning and disinfecting the skin, both intact and in the presence of minor superficial wounds.
POVIDERM is indicated for disinfecting the surgical field prior to surgical procedures.

2. What you need to know before using POVIDERM

Do not use POVIDERM:

• if you are allergic to povidone-iodine or to any of the other ingredients of this medicine (listed in section 6);
• if the person using this medicine is a child under 6 months of age (see section “Children”);
• if you have thyroid disorders (thyroid diseases).

Do not apply this medicine to mucous membranes, burns, deep wounds, or over large areas of skin (also see section “Warnings and precautions”).
POVIDERM must not be used to disinfect the inside of the abdomen (peritoneal washing) in cases of infection (purulent peritonitis).
Warnings and precautions
Talk to your doctor or nurse before using POVIDERM.
This medicine is for external use only and must be applied only to the skin.
Avoid applying POVIDERM to the eyes.
Do not swallow or inhale this product, as serious, even fatal, consequences may occur.
High levels of iodine in the blood may cause adverse effects such as:

• increased levels of acid in the blood (metabolic acidosis);
• reduced levels of white blood cells in the blood (neutropenia);
• thyroid problems (temporary hypothyroidism or thyrotoxic crisis in case of hyperthyroidism);
• interference with the results of certain thyroid function tests and stool and urine tests (occult blood testing) (See also section “Possible side effects”).

Avoid using POVIDERM on very large skin areas
or under non-breathable (occlusive) dressings. If necessary, specific thyroid function tests are recommended.
Do not use POVIDERM for prolonged periods, as allergic reactions (sensitization phenomena) may occur. In such cases, treatment must be discontinued and your doctor informed so that appropriate therapy can be established.
This medicine is flammable. Therefore, allow the medicine to dry completely before using electrical equipment.
If the patient is due to undergo a thyroid scan test, known as iodine-131 scintigraphy, treatment with POVIDERM must be stopped at least 10 days before the test.
Children
In newborns, the application of antiseptic medicines containing iodine may cause thyroid problems (hypothyroidism, thyroid dysfunction) (See section “Do not use POVIDERM”).
In older children, this medicine should be used only when strictly necessary.
Other medicines and POVIDERM
Inform your doctor or nurse if you are currently using, have recently used, or might use any other medicines.
During treatment with POVIDERM, avoid using other similar medicines (disinfectants, detergents).
Also, do not apply soaps or ointments containing mercury or benzoin compounds to the treated area.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or nurse before using this medicine.
Do not use this medicine during pregnancy unless strictly necessary and under close medical supervision.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
POVIDERM contains ethanol
This medicine contains 878 mg of alcohol (ethanol) in 100 ml of solution, equivalent to 0.878% w/v.
It may cause a burning sensation on damaged skin.

3. How to use POVIDERM

This medicinal product must only be used by a doctor or by trained medical personnel.
Apply the undiluted medicinal solution directly to the lesions or intact skin, dabbing with cotton thoroughly soaked in the solution.
If necessary, repeat the procedure up to a maximum of 3–4 times daily.
Do not exceed the recommended doses.

If you use more POVIDERM than you should
When used correctly, there is no risk of overdose.
In case of overdose, the following symptoms may occur:

• thyroid disorders (hypothyroidism, hyperthyroidism);
• metallic taste;
• increased salivation;
• burning or pain in the mouth and throat;
• eye irritation and swelling (tumefaction);
• allergic skin reactions (skin rashes);
• stomach and intestinal disturbances (gastrointestinal disturbances);
• diarrhoea;
• increased levels of acid substances in the blood (metabolic acidosis) and increased sodium levels in the blood (hypernatraemia);
• kidney problems (impaired renal function);
• fluid accumulation in the lungs (pulmonary oedema).

In addition, if the medicinal product is applied to burns or to very extensive skin lesions (large denuded surfaces), generalized (systemic) adverse effects may occur.
If you have any doubts about how to use this medicinal product, consult your doctor or nurse.
In case of accidental ingestion/overdose of POVIDERM, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from available data):

• burning or irritation of the skin (intolerance);
• allergic reactions (tuberous dermatitis, dermatitis);
• iodine poisoning (iodism);
• delayed wound healing;
• alteration of results in certain thyroid function tests. If any of the above symptoms occur, treatment must be discontinued.

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 through 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 POVIDERM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Store below 30°C and in the original packaging, protected from light.
This medicine is highly flammable.
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 POVIDERM contains

• The active substance is povidone-iodine. 100 g of solution contain 1 g of povidone-iodine (10% available free iodine).
• The other components are: isopropyl alcohol, ethyl alcohol 96%, colourants E110, E122, E131, purified water.

Description of the appearance of POVIDERM and contents of the pack
24 bottles of 250 ml, 20 bottles of 500 ml and 12 bottles of 1000 ml of solution.
Marketing Authorization Holder and Manufacturer
Nuova Farmec S.r.l. – Via W. Flemming, 7 – Settimo di Pescantina (VR)

Package leaflet: Information for the user

POVIDERM 10% 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, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What POVIDERM is and what it is used for

POVIDERM contains the active substance iodopovidone, which belongs to a group of medicines called antiseptics and disinfectants that reduce or inhibit the growth of bacteria.
POVIDERM is indicated for cleaning and disinfecting the skin, both intact and in the presence of minor superficial wounds.
POVIDERM is indicated for disinfecting the surgical site prior to surgical procedures.

2. What you need to know before using POVIDERM

Do not use POVIDERM:

• if you are allergic to povidone-iodine or to any of the other ingredients of this medicine (listed in section 6);
• if the person using this medicine is a child under 6 months of age (see section “Children”);
• if you have thyroid disorders (thyroid diseases). Do not apply this medicine on mucous membranes, burns, deep wounds, or over large skin areas (see also section “Warnings and precautions”).

POVIDERM must not be used to disinfect the inside of the abdomen (peritoneal washing) in cases of infection (purulent peritonitis).
Warnings and precautions
Consult your doctor or nurse before using POVIDERM.
This medicine is for topical use only (external use on the skin).
Avoid applying POVIDERM to the eyes.
Do not ingest or inhale this product, as serious, even fatal, consequences may occur.
High levels of iodine in the blood may cause adverse effects such as:

• increased levels of acid in the blood (metabolic acidosis);
• reduced levels of white blood cells in the blood (neutropenia);
• thyroid problems (temporary hypothyroidism or thyrotoxic crisis in case of hyperthyroidism);
• interference with the results of certain thyroid function tests and analyses of feces and urine (occult blood testing) (see also section “Possible side effects”).

Avoid using POVIDERM over large skin areas
or under non-breathable (occlusive) dressings. If necessary, specific thyroid function tests are recommended.
Do not use POVIDERM for prolonged periods, as allergic reactions (sensitization phenomena) may occur. In such cases, treatment must be discontinued and your doctor should be informed so that appropriate therapy can be established.
If the patient is scheduled for a thyroid test known as iodine-labeled scintigraphy, treatment with POVIDERM must be stopped at least 10 days before the test.
Children
In newborns, application of antiseptic medicines containing iodine may cause thyroid problems (hypothyroidism, thyroid dysfunction) (see section “Do not use POVIDERM”).
In older children, this medicine should be used only when strictly necessary.
Other medicines and POVIDERM
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
During treatment with POVIDERM, avoid using other similar medicines (disinfectants, detergents).
In addition, do not apply soaps or ointments containing mercury or benzoin compounds to the affected area.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine.
Do not use this medicine during pregnancy unless clearly necessary and under strict medical supervision.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use POVIDERM

This medicinal product should only be used by a doctor or trained healthcare professional.
Apply the undiluted medicinal product to the lesions or intact skin by dabbing with cotton wool thoroughly soaked in the solution.
If necessary, repeat the procedure up to 3–4 times daily.
Do not exceed the recommended doses.

If you use more POVIDERM than you should
When this medicinal product is used correctly, there is no risk of overdose.
In case of overdose, the following symptoms may occur:

• thyroid disorders (hypothyroidism, hyperthyroidism);
• metallic taste;
• increased salivation;
• burning or pain in the mouth and throat;
• eye irritation and swelling (tumefaction);
• allergic skin reactions (skin rashes);
• stomach and intestinal disorders (gastrointestinal disturbances);
• diarrhoea;
• increased levels of acidic substances (metabolic acidosis) and sodium in the blood (hypernatraemia);
• kidney problems (renal function impairment);
• fluid accumulation in the lungs (pulmonary oedema).

Additionally, if the medicinal product is applied to burns or very extensive skin lesions (large denuded surfaces), generalized (systemic) adverse effects may occur.
If you have any doubts about the use of this medicinal product, consult your doctor or nurse.
In case of accidental ingestion/overdose of a large amount of POVIDERM, inform your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• burning and irritation of the skin (intolerance);
• allergic reactions (tubercular dermatitis, dermatitis);
• iodine poisoning (iodism);
• delayed wound healing;
• alteration of results in certain thyroid function tests.

If any of the symptoms listed above occur, treatment must be discontinued.
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 POVIDERM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
Store below 30°C and in the original packaging, protected from light.
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 POVIDERM contains

• The active substance is iodopovidone. 100 g of solution contain 10 g of iodopovidone (10% available free iodine).
• The other components are: ethoxylated alcohol, dibasic sodium phosphate, anhydrous citric acid, glycerin, sodium hydroxide, purified water.

Description of the appearance of POVIDERM and contents of the package
48 bottles of 100 ml, 24 bottles of 250 ml, 20 bottles of 500 ml and 12 bottles of 1000 ml of solution.
Marketing Authorization Holder and Manufacturer
Nuova Farmec S.r.l. – Via W. Flemming, 7 – Settimo di Pescantina (VR)