ACIDO 3% Ointment

Зміст інструкції

1. ACIDO BORICO AFOM 3% cutaneous solution
   1. What is ACIDO BORICO AFOM and what is it used for
   2. What you need to know before using ACIDO BORICO AFOM
   3. How to use ACIDO BORICO AFOM
   4. Possible side effects
   5. How to store ACIDO BORICO AFOM
   6. Contents of the pack and other information
2. ACIDO BORICO AFOM 3% ointment
   1. What is ACIDO BORICO AFOM and what is it used for
   2. What you need to know before using ACIDO BORICO AFOM
   3. How to use ACIDO BORICO AFOM
   4. Possible side effects
   5. How to store ACIDO BORICO AFOM
   6. Package Contents and Other Information

ACIDO BORICO AFOM 3% cutaneous solution

Acido borico

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.
• See a doctor if you do not feel better or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What is ACIDO BORICO AFOM and what is it used for

ACIDO BORICO AFOM contains the active ingredient boric acid, which belongs to a group of medicines
called antiseptics and disinfectants that work by slowing down or preventing the growth of bacteria.
This medicine is indicated for:

• disinfecting minor burns and irritated or chapped skin areas;
• reducing swelling caused by fluid accumulation (decongestant);
• treating an inflammatory skin disease (acne).

Consult your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

2. What you need to know before using ACIDO BORICO AFOM

Do not use ACIDO BORICO AFOM

• if you are allergic to boric acid or to any of the other ingredients of this medicine (listed in section 6);
• if you have very extensive skin lesions;
• if the person who needs to use this medicine is less than 3 years old (See section “Children”).

Warnings and precautions
Consult your doctor or pharmacist before using ACIDO BORICO AFOM.
This medicine should not be applied to the eyes.
Keep this medicine out of the reach of children, as, if ingested, it can even cause death
(See section “If you use more ACIDO BORICO AFOM than you should”).
Avoid applying the product for prolonged periods of time and at excessive doses, to very
extensive areas of skin or to wounds (damaged skin), as toxic effects may occur (See section “Possible
undesirable effects”).

Children
The use of this medicine is contraindicated in children under 3 years of age.

Other medicines and ACIDO BORICO AFOM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only in cases of actual need and
under the supervision of your doctor.

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

3. How to use ACIDO BORICO AFOM

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine is for external use only and should be applied only when actually needed.
Adults and children over 3 years of age:
Apply the product 1-2 times a day to the inflamed areas.
The medicine can be used for cracked, irritated or dry skin, abrasions, skin irritations (dermatitis) caused by diapers, mild burns, sunburns or windburns
and insect bites.
Do not mix the medicine with solutions containing: tannins; polyvinyl alcohol; hydroxides; alkaline carbonates; glycerol. In this case, a product more acidic than boric acid itself (glyceroboric acid) may form.

If you use more ACIDO BORICO AFOM than you should
The risk of acute poisoning is rare if the medicine is only applied to the skin, as boric acid does not pass through the skin. Absorption of the medicine, in toxic quantities, can occur if
you ingest the medicine, if you inhale it, or if you have skin lesions. Following the use of large quantities of
boric acid on wounds or sores, cases of poisoning and death have occurred, especially in children. The parts of the body most affected by lesions and bleeding are the skin, kidneys, stomach, intestines,
brain and lungs.
In case of boric acid poisoning, the following symptoms may occur: vomiting, diarrhea, pain in
various areas of the body (visceral pain), skin irritation (erythema followed by desquamation),
increased brain activity (CNS stimulation) followed by: depression, restlessness, headache
(cephalalgia), increased levels of acidic substances in the blood (metabolic acidosis), severe alterations in the levels
of salts and fluids in the blood (electrolyte imbalances), alterations in body temperature, kidney disorders
accompanied by reduced urine output (oliguria), bluish discoloration of the skin (cyanosis),
delirium, deep state of unconsciousness (coma), severe circulatory problems (shock) and death.
In case of chronic poisoning, the following symptoms may occur: loss of appetite (anorexia),
confusion, debility, skin irritation (dermatitis), menstrual disorders, reduction in the number of
red blood cells (anemia), convulsions and hair loss (alopecia).
The doctor will establish the most appropriate therapy based on the severity of the symptoms.
In case of accidental ingestion/intake of ACIDO BORICO AFOM, contact your doctor or go
immediately to the nearest hospital.

If you forget to use ACIDO BORICO AFOM
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following inappropriate use of the medicine (systemic route) or application of boric acid to
wounds and lesions, the following side effects may occur:

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

• skin irritations (dermatitis, skin rashes), hair loss (alopecia);
• nausea, vomiting, diarrhoea;
• loss of appetite (anorexia);
• menstrual cycle disturbances;
• decreased number of red blood cells in the blood (anaemia);
• weakness;
• confusion;
• convulsions.

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 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 ACIDO BORICO AFOM

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The expiry
date refers to the last day of that month.
Store at a temperature below 25°C and in a tightly closed container to protect the medicine from
light .
Do not dispose of any medicine in 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 ACIDO BORICO AFOM 3% cutaneous solution contains

• The active ingredient is boric acid. 100 ml of solution contains 3 g of boric acid.
• The other component is purified water.

Description of the appearance and contents of the pack
Bottle of 200 ml or 500 ml of cutaneous solution.

Marketing Authorisation Holder
AEFFE FARMACEUTICI Srl – via Carlo Porta, 49 – 20064 Gorgonzola (Milan)

Responsible Manufacturer for Batch Release
AEFFE FARMACEUTICI Srl – Via Torino, 448 – Brandizzo (TO)

Sales distributor:
Montefarmaco OTC Spa
Via IV Novembre, 92 – 20021 Bollate (MI)

ACIDO BORICO AFOM 3% ointment

Acido borico

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.
• See a doctor if you do not feel better or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What is ACIDO BORICO AFOM and what is it used for

ACIDO BORICO AFOM contains the active ingredient boric acid, which belongs to a group of medicines
called antiseptics and disinfectants that work by slowing down or preventing the growth of bacteria.
This medicine is indicated for:

• disinfecting minor burns and irritated or cracked skin areas;
• reducing swelling caused by fluid accumulation (decongestant);
• treating an inflammatory skin disease (acne).

Consult your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

2. What you need to know before using ACIDO BORICO AFOM

Do not use ACIDO BORICO AFOM

• if you are allergic to boric acid or any of the other ingredients of this medicine (listed in section 6);
• if you have very extensive skin lesions;
• if the person who needs to use this medicine is less than 3 years old (See section “Children”).

Warnings and precautions
Consult your doctor or pharmacist before using ACIDO BORICO AFOM.
This medicine should not be applied to the eyes.
Keep the medicine out of the reach of children, as, if ingested, it can even cause death
(See section “If you use more ACIDO BORICO AFOM than you should”).
Avoid applying the product for prolonged periods of time and at excessive doses, to very
extensive areas of skin or to wounds (damaged skin), as toxic effects may occur (See section “Possible
undesirable effects”).

Children
The use of this medicine is contraindicated in children under 3 years of age.

Other medicines and ACIDO BORICO AFOM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only in cases of actual need and
under the supervision of your doctor.

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

3. How to use ACIDO BORICO AFOM

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine is for external use only and should only be applied if actually needed.
Adults and children over 3 years of age:
Apply the product 1-2 times a day to the inflamed areas.
The medicine can be used for cracked, irritated or dry skin, abrasions, skin irritations (dermatitis) caused by diapers, mild burns, sunburns or windburns and insect bites.

If you use more ACIDO BORICO AFOM than you should
The risk of acute poisoning is rare if the medicine is only applied to the skin, as boric acid does not pass through the skin. Absorption of the medicine, in toxic quantities, can occur if you ingest the medicine, if you inhale it or if you have skin lesions. Following the use of large quantities of boric acid on wounds or sores, cases of poisoning and death have occurred, especially in children. The parts of the body most affected by lesions and bleeding are the skin, kidneys, stomach, intestines, brain and lungs.
In case of boric acid poisoning, the following symptoms may occur: vomiting, diarrhea, pain in various areas of the body (visceral pain), skin irritation (erythema followed by desquamation), increased brain activity (stimulation of the CNS) followed by: depression, restlessness, headache, increased levels of acidic substances in the blood (metabolic acidosis), severe alterations in the levels of salts and fluids in the blood (hydro-saline imbalances), alterations in body temperature, kidney disorders accompanied by reduced urine output (oliguria), bluish discoloration of the skin (cyanosis), delirium, deep state of unconsciousness (coma), severe circulatory problem (shock) and death.
In case of chronic poisoning, the following symptoms may occur: loss of appetite (anorexia), confusion, debility, skin irritation (dermatitis), menstrual disorders, reduction in the number of red blood cells (anemia), convulsions and hair loss (alopecia).
The doctor will establish the most appropriate therapy based on the severity of the symptoms.
In case of accidental ingestion/intake of ACIDO BORICO AFOM, contact your doctor or go immediately to the nearest hospital.

If you forget to use ACIDO BORICO AFOM
Do not use a double dose to make up for a missed dose.
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 gets them.
Following inappropriate use of the medicine (systemic route) or application of boric acid to
wounds and lesions, the following side effects may occur:

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

• skin irritations (dermatitis, skin rashes), hair loss (alopecia);
• nausea, vomiting, diarrhoea;
• loss of appetite (anorexia);
• menstrual cycle disorders;
• reduction in the number of red blood cells (anaemia);
• weakness;
• confusion;
• convulsions.

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 ACIDO BORICO AFOM

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The expiry
date refers to the last day of that month.
Store at a temperature below 25°C and in a well-closed container to protect the medicine from
light .
Do not dispose of any medicine in 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 ACIDO BORICO AFOM 3% ointment contains

• The active ingredient is boric acid. 100 g of ointment contains 3 g of boric acid.
• The other component is white petrolatum.

Description of the appearance and package contents
Tube of 30 g or jar of 1000 g.

Marketing Authorisation Holder
AEFFE FARMACEUTICI Srl – via Carlo Porta, 49 – 20064 Gorgonzola (Milan)

Manufacturer Responsible for Batch Release
Industria farmaceutica NOVA ARGENTIA S.r.l. – Via G. Pascoli, 1 – Gorgonzola (MI)
Zeta Farmaceutici S.p.A. - Via Galvani, 10 – 36066 Sandrigo (VI) – Italy

Sales Concessionaire:
Montefarmaco OTC Spa
Via IV Novembre, 92 – 20021 Bollate (MI)