POVIDERM 10% Topical solution

Зміст інструкції

1. POVIDERM 1% cutaneous solution
   1. What is POVIDERM and what is it 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
2. POVIDERM 10% cutaneous solution
   1. What is POVIDERM and what is it 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

POVIDERM 1% cutaneous solution

Iodopovidone

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, ask 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 is POVIDERM and what is it used for

POVIDERM contains the active ingredient povidone-iodine, which belongs to a group of medicines called
antiseptics and disinfectants that reduce or block the growth of bacteria.
POVIDERM is indicated for cleaning and disinfecting the skin
, both intact and in the presence of small, superficial wounds,
POVIDERM is indicated for disinfecting the surgical field before surgical procedures.

2. What you need to know before using POVIDERM

Do not use POVIDERM:

• if you are allergic to povidone-iodine or any of the other ingredients of this medicine (listed in section 6);
• if the person who needs to use this medicine is a child under 6 months of age (See section “Children”);
• if you suffer from thyroid diseases (thyroid pathologies).

Do not apply this medicine to mucous membranes, burns, deep wounds and large areas (see also
section “Warnings and precautions”).
POVIDERM should not be used to disinfect the inside of the abdomen (peritoneal lavage) in
cases of infection (purulent peritonitis).

Warnings and precautions
Consult your doctor or nurse before using POVIDERM.
This medicine should only be applied to the skin (external use).
Avoid applying POVIDERM to the eyes.
The product must not be ingested or inhaled, as serious consequences, even
fatal, may occur.
High levels of iodine in the blood can cause adverse effects such as:

• increased acidity in the blood (metabolic acidosis);
• reduction of white blood cell levels in the blood (neutropenia);
• problems with the thyroid gland (temporary hypothyroidism or thyrotoxic crisis in case of hyperthyroidism);
• alteration of the results of some tests of thyroid function and stool and urine analysis (occult blood research) (See also section “Possible side effects”).

Avoid using POVIDERM on very large areas of skin
or under a non-breathable (occlusive) bandage. If necessary, specific thyroid tests are recommended.
Do not use POVIDERM for prolonged periods of time because allergic reactions may occur
(sensitization phenomena). In this case, treatment should be discontinued and the doctor should be informed who
will establish suitable therapy.
This medicine is flammable. Therefore, allow the medicine to dry completely before using
electrical equipment.
If the patient needs to undergo a thyroid scan, known as an iodine-labeled scintigraphy, discontinue
treatment with POVIDERM at least 10 days before this examination.

Children
In newborns, the application of antiseptic medicines based on iodine can cause thyroid problems
(hypothyroidism, thyroid dysfunction) (See section “Do not use POVIDERM”).
In older children, this medicine should only be used when absolutely 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).
Also, do not apply soaps and ointments containing mercury or benzoin compounds to the affected area.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or nurse for advice before using this medicine.
Do not use this medicine during pregnancy unless absolutely necessary and under strict
medical supervision.

Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.

POVIDERM contains ethanol
This medicine contains 878 mg of alcohol (ethanol) in 100ml of solution, which is equivalent to 0.878% v/v.
It may cause a burning sensation on damaged skin.

3. How to use POVIDERM

This medicine must be used only by a doctor or by specialized personnel.
Apply the medicine undiluted to lesions or intact skin, dabbing with cotton
soaked in solution.
If necessary, repeat the operation for a maximum of 3-4 times a day.
Do not exceed the recommended doses.

If you use more POVIDERM than you should
If this medicine 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;
• irritation and swelling (edema) of the eyes;
• allergic skin reactions (skin rashes);
• stomach and intestinal disorders (gastrointestinal disturbances);
• diarrhea;
• increased levels of acidic substances (metabolic acidosis) and sodium in the blood (hypernatremia);
• kidney problems (decreased kidney function);
• fluid accumulation in the lungs (pulmonary edema).

Furthermore, if the medicine is applied to burns or to very extensive skin lesions (large areas lacking
epithelium), generalized (systemic) adverse effects may occur.
If you have any doubts about the use of this medicine, consult your doctor or nurse.
In case of accidental ingestion/intake of an excessive dose of POVIDERM, immediately
inform your doctor or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

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

• burning or irritation of the skin (intolerance);
• allergic reactions (tuberculous dermatitis, dermatitis);
• iodine intoxication (iodism);
• delayed wound healing;
• alteration of the results of some thyroid tests. If you experience the symptoms listed above, treatment should be discontinued.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can 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 which is stated on the packaging after “Expiry”. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C and in the original package, protected from light.
This medicine is highly flammable.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What POVIDERM contains

• The active substance is povidone-iodine. 100 g of solution contains 1 g of povidone-iodine (10% of available free iodine).
• The other components are: isopropyl alcohol, ethyl alcohol 96%, colourings 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 authorisation holder and manufacturer
Nuova Farmec S.r.l. – Via W. Flemming, 7 – Settimo di Pescantina (VR)

POVIDERM 10% cutaneous solution

Iodopovidone

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, ask 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 is POVIDERM and what is it used for

POVIDERM contains the active ingredient povidone-iodine which belongs to a group of medicines called
antiseptics and disinfectants that reduce or stop the growth of bacteria.
POVIDERM is indicated for cleaning and disinfecting the skin, both intact and in the presence of superficial
wounds of small size.
POVIDERM is indicated for disinfecting the surgical field before 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 who needs to use this medicine is a child under 6 months of age (See section “Children”);
• if you suffer from thyroid diseases (thyroid pathologies). Do not apply this medicine to mucous membranes, burns, deep wounds and large areas (see also section “Warnings and precautions”).

POVIDERM should not be used to disinfect the inside of the abdomen (peritoneal lavage) in
cases of infection (purulent peritonitis).

Warnings and precautions
Consult your doctor or nurse before using POVIDERM.
This medicine should only be applied to the skin (external use).
Avoid applying POVIDERM to the eyes.
The product must not be ingested or inhaled, as serious consequences, including
death, may occur.
High levels of iodine in the blood can cause undesirable effects such as:

• increased acidity in the blood (metabolic acidosis);
• reduction of white blood cell levels in the blood (neutropenia);
• problems with the thyroid gland (temporary hypothyroidism or thyroid storm in case of hyperthyroidism);
• alteration of the results of some tests of thyroid function and stool and urine tests (occult blood search) (See also section “Possible side effects”).

Avoid using POVIDERM on very large areas of skin
or under a non-breathable (occlusive) bandage. If necessary, specific thyroid tests are recommended.
Do not use POVIDERM for prolonged periods of time as allergic reactions may occur
(sensitization phenomena). In this case, treatment should be discontinued and the doctor should be informed who
will establish appropriate therapy.
If the patient needs to undergo a thyroid examination, known as a scan with marked iodine, discontinue
treatment with POVIDERM at least 10 days before this examination.

Children
In newborns, the application of antiseptic medicines based on iodine can cause thyroid problems
(hypothyroidism, thyroid dysfunction) (See section “Do not use POVIDERM”).
In older children, this medicine should only be used when absolutely necessary.

Other medicines and POVIDERM
Tell 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).
Also, do not apply soaps and ointments containing mercury or benzoic compounds to the affected area.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or nurse for advice before using this medicine.
Do not use this medicine during pregnancy unless absolutely necessary and under strict
medical supervision.

Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.

3. How to use POVIDERM

This medicine must be used only by a doctor or specialized personnel.
Apply the medicine undiluted to lesions or intact skin, dabbing with cotton
soaked in solution.
If necessary, repeat the operation for a maximum of 3-4 times a day.
Do not exceed the recommended doses.

If you use more POVIDERM than you should
If this medicine 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;
• irritation and swelling (edema) of the eyes;
• allergic skin reactions (skin rashes);
• stomach and intestinal disorders (gastrointestinal disturbances);
• diarrhea;
• increased levels of acidic substances (metabolic acidosis) and sodium in the blood (hypernatremia);
• kidney problems (renal function deficit);
• fluid accumulation in the lungs (pulmonary edema).

Furthermore, if the medicine is applied to burns or to very extensive skin lesions (large areas lacking
epithelium), generalized (systemic) adverse effects may occur.
If you have any doubts about the use of this medicine, consult your doctor or nurse.
In case of ingestion/accidental intake of an excessive dose of POVIDERM, immediately notify
your doctor or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

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

• burning and irritation of the skin (intolerance);
• allergic reactions (tuberculous dermatitis, dermatitis);
• iodine intoxication (iodism);
• delayed wound healing;
• alteration of the results of some thyroid tests.

If the symptoms described above occur, treatment should be discontinued.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can 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 to
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 which is stated on the packaging after “Expiry”. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C and in the original package, protected from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What POVIDERM contains

• The active ingredient is povidone-iodine. 100 g of solution contains 10 g of povidone-iodine (10% of available free iodine).
• The other ingredients are: ethoxylated alcohol, disodium phosphate, anhydrous citric acid, glycerin, sodium hydroxide, purified water.

Description of the appearance of POVIDERM and contents of the pack
48 bottles of 100 ml, 24 bottles of 250 ml, 20 bottles of 500 ml and 12 bottles of 1000 ml of solution.

Marketing authorisation holder and manufacturer
Nuova Farmec S.r.l. – Via W. Flemming, 7 – Settimo di Pescantina (VR)