FARMAIOD 1 % Topical solution

Зміст інструкції

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

FARMAIOD 1% 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 undesirable effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a few days. Contents of this leaflet:
• 1. What FARMAIOD is and what it is used for
• 2. What you need to know before using FARMAIOD
• 3. How to use FARMAIOD
• 4. Possible side effects
• 5. How to store FARMAIOD
• 6. Contents of the pack and other information

1. What is FARMAIOD and what is it used for

FARMAIOD contains the active substance iodopovidone which belongs to a group of medicines called
antiseptics and disinfectants that reduce or block the growth of germs.
FARMAIOD is indicated for cleaning and disinfecting the skin, both intact and in the presence of superficial wounds of
small size,
FARMAIOD is indicated for disinfecting the surgical field before surgical procedures.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using FARMAIOD

Do not use FARMAIOD:

• 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”).
FARMAIOD 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 pharmacist before using FARMAIOD.
This medicine should only be applied to the skin (external use).
Avoid applying FARMAIOD to the eyes.
Also, do not ingest or inhale it, 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 in the levels of white blood cells in the blood (neutropenia);
• problems with the thyroid (temporary hypothyroidism or thyrotoxic crisis 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 FARMAIOD on very large areas of skin
or under a non-breathable (occlusive) bandage. If necessary, specific thyroid tests are recommended.
Do not use FARMAIOD for prolonged periods of time because allergic reactions
(sensitization phenomena) may occur. In this case, stop treatment and inform your doctor who will establish an
appropriate therapy.
This medicine is flammable. Therefore, allow the medicine to dry completely before using
electrical equipment.
If you need to undergo a thyroid scan with marked iodine, stop treatment
with FARMAIOD at least 10 days before undergoing 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 FARMAIOD”).
In older children, this medicine should only be used when absolutely necessary.

Other medicines and FARMAIOD
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
During treatment with FARMAIOD, avoid using other similar medicines (disinfectants, detergents).
Also, do not apply soaps and ointments containing mercury or benzoine compounds to the affected area.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist 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.

FARMAIOD contains ethanol
This medicine contains 869.2 mg of alcohol (ethanol) in 100ml of solution, which is equivalent to 8.692%
v/v.
It may cause a burning sensation on damaged skin.

3. How to use FARMAIOD

Use FARMAIOD always following exactly the instructions contained in this leaflet or the instructions of your
doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
Apply FARMAIOD undiluted to lesions or intact skin, dabbing with cotton wool
abundantly soaked in solution. If necessary, repeat the operation up to 3-4 times a day.
Do not exceed the recommended doses.

If you use more FARMAIOD than you should
If you use this medicine correctly, there is no risk of overdose.
In case of overdose, you may experience the following symptoms:

• 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 you apply the medicine to burns or to very extensive skin lesions (large areas lacking
epithelium), generalized (systemic) undesirable effects may occur.
In case of accidental ingestion/intake of an excessive dose of FARMAIOD, 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 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 you experience the symptoms listed above, discontinue treatment

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 FARMAIOD

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 not exceeding 30°C and in the original package, protected from light.
This medicine is easily 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 FARMAIOD contains

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

Description of the appearance of FARMAIOD and contents of the pack
Bottle containing 250 ml, 500 ml and 1000 ml of solution.

Marketing Authorisation Holder and Manufacturer
Nuova Farmec S.r.l. – Via W. Flemming, 7 – Settimo di Pescantina (VR)

FARMAIOD 10% 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 would like more information or advice, ask your pharmacist.
• If any side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a few days. Contents of this leaflet:
• 1. What FARMAIOD is and what it is used for
• 2. What you need to know before using FARMAIOD
• 3. How to use FARMAIOD
• 4. Possible side effects
• 5. How to store FARMAIOD
• 6. Contents of the pack and other information

1. What is FARMAIOD and what is it used for

FARMAIOD contains the active ingredient povidone-iodine which belongs to a group of medicines called
antiseptics and disinfectants that reduce or block the growth of germs.
FARMAIOD is indicated for cleaning and disinfecting the skin, both intact and in the presence of superficial wounds of
small size,
FARMAIOD is indicated for disinfecting the surgical field before surgical procedures.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using FARMAIOD

Do not use FARMAIOD:

• 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”).
FARMAIOD 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 pharmacist before using FARMAIOD.
This medicine must be applied only to the skin (external use).
Avoid applying FARMAIOD to the eyes.
Also, do not ingest or inhale it, as serious consequences, including death, 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 (temporary hypothyroidism or thyrotoxic crisis in case of hyperthyroidism);
• alteration of the results of some thyroid function tests and stool and urine analyses (occult blood research) (See also section “Possible side effects”).

Avoid using FARMAIOD on very large areas of skin or under a non-breathable (occlusive) bandage.
If necessary, specific thyroid tests are recommended.
Do not use FARMAIOD for prolonged periods of time because allergic reactions
(sensitization phenomena) may occur. In this case, stop treatment and inform your doctor who will establish a
suitable therapy.
If you need to undergo a thyroid examination, known as a scan with marked iodine, stop treatment
with FARMAIOD at least 10 days before undergoing 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 FARMAIOD”).
In older children, this medicine should only be used when absolutely necessary.

Other medicines and FARMAIOD
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
During treatment with FARMAIOD, avoid using other similar medicines (disinfectants, detergents).
Also, do not apply to the affected area soaps and ointments containing mercury or compounds of
benzoin.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist 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 FARMAIOD

Use FARMAIOD always following exactly the instructions contained in this leaflet or the instructions of your
doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
Apply FARMAIOD to lesions or intact skin, dabbing with cotton wool generously soaked
in solution. If necessary, repeat the operation up to 3-4 times a day.
Do not exceed the recommended doses.

If you use more FARMAIOD than you should
If you use this medicine correctly, there is no risk of overdose.
In case of overdose, you may experience the following symptoms:

• 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 you apply the medicine to burns or to very extensive skin lesions (large areas lacking
epithelium), generalized (systemic) adverse effects may occur.
In case of accidental ingestion/intake of an excessive dose of FARMAIOD, 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(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 you experience these symptoms, discontinue treatment

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 FARMAIOD

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 not exceeding 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 eliminate the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FARMAIOD contains

• The active ingredient is povidone-iodine. 100 g contain 1 g of povidone-iodine (10% of available free iodine).
• The other components are: ethoxylated alcohol, disodium phosphate, anhydrous citric acid, sodium hydroxide, glycerin, purified water.

Description of the appearance of FARMAIOD and contents of the pack
Bottle containing 100 ml, 250 ml, 500 ml and 1000 ml of solution.

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