Boric acid Afom

Package leaflet: Information for the user

BORIC ACID AFOM 3% cutaneous solution

Boric acid
Read this leaflet carefully before you use this medicine because it contains important information for you.
Always 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 any improvement or if you experience worsening of symptoms 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 ACIDO BORICO AFOM is and what it is used for

ACIDO BORICO AFOM contains the active substance acidum boricum, 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 areas of irritated or chapped skin;
• reducing swelling caused by fluid accumulation (decongestant);
• treating a skin inflammatory condition (acne).

Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms 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 using this medicine is under 3 years of age (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before using ACIDO BORICO AFOM.
This medicine must not be applied to the eyes.
Keep the medicine out of the reach of children, as ingestion may even result in death
(See section “If you use more ACIDO BORICO AFOM than you should”).
Avoid applying the product for prolonged periods and in excessive doses, over very large areas of skin or on wounds (damaged skin), as toxic effects may occur (See section “Possible side 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, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only when clearly needed and under medical supervision.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use BORIC ACID AFOM

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.
This medicine is for external use only and should be applied only when necessary.
Adults and children over 3 years of age:
Apply the product 1–2 times a day to the affected areas.
This 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 this medicine with solutions containing: tannins; polyvinyl alcohol; hydroxides; alkali carbonates; glycerol. In such cases, a substance more acidic than boric acid itself (glyceroboric acid) may form.
If you use more BORIC ACID AFOM than you should
The risk of acute poisoning is rare when the medicine is applied only to the skin, as boric acid does not pass through intact skin. However, absorption of the medicine in toxic amounts may occur if the medicine is ingested, inhaled, or applied to damaged skin. Cases of poisoning and death, particularly in children, have occurred following the use of large amounts of boric acid on wounds or ulcers. The organs most commonly affected include the skin, kidneys, stomach, intestines, brain, and lungs.
Symptoms of boric acid poisoning may include: vomiting, diarrhoea, pain in various parts of the body (visceral pain), skin irritation (cutaneous erythema followed by desquamation), increased brain activity (central nervous system stimulation) followed by: depression, restlessness, headache (cephalalgia), increased levels of acidic substances in the blood (metabolic acidosis), severe disturbances in electrolyte and fluid balance (hydroelectrolytic imbalances), changes in body temperature, kidney disorders accompanied by reduced urine output (oliguria), bluish discoloration of the skin (cyanosis), delirium, deep unconsciousness (coma), severe circulatory problems (shock), and death.
In cases of chronic poisoning, the following symptoms may occur: loss of appetite (anorexia), confusion, weakness, skin irritation (dermatitis), menstrual disorders, reduced number of red blood cells in the blood (anaemia), seizures, and hair loss (alopecia).
The doctor will determine the most appropriate treatment depending on the severity of symptoms.
In case of accidental ingestion/absorption of BORIC ACID AFOM, contact your doctor or go immediately to the nearest hospital.
If you forget to use BORIC ACID AFOM
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use 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 on wounds and lesions, the following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

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

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 ACIDO BORICO AFOM

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 "Exp.". The expiry date refers to the last day of that month.
Store below 25°C and keep the container tightly closed to protect the medicine 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 ACIDO BORICO AFOM 3% cutaneous solution contains

• The active substance is boric acid. 100 ml of solution contain 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 Authorization Holder
AEFFE FARMACEUTICI Srl – Via Carlo Porta, 49 – 20064 Gorgonzola (Milan)
Responsible Manufacturer for Batch Release
AEFFE FARMACEUTICI Srl – Via Torino, 448 – Brandizzo (TO)
Marketing Authorization Holder and Distributor:
Montefarmaco OTC Spa
Via IV Novembre, 92 – 20021 Bollate (MI)

Package leaflet: information for the user

ACIDO BORICO AFOM 3% ointment

Boric acid
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 directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if 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 ACIDO BORICO AFOM is and what it is used for

ACIDO BORICO AFOM contains the active substance acidum borici, 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 areas of irritated or cracked skin;
• 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 you notice worsening of symptoms 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 using this medicine is under 3 years of age (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before using ACIDO BORICO AFOM.
This medicine must not be applied to the eyes.
Keep the medicine out of the reach of children, as ingestion may even result in death
(See section “If you use more ACIDO BORICO AFOM than you should”).
Avoid applying the product for prolonged periods and in excessive doses, over large areas of skin or on wounds (damaged skin), as toxic effects may occur (See section “Possible side 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, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if clearly needed and under medical supervision.

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

3. How to use ACIDO BORICO AFOM

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.
This 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 daily to the affected areas.
The medicine can be used in cases of cracked, irritated, or dry skin, abrasions, skin irritations (dermatitis) caused by diapers, mild burns, sunburns (solar burns) or windburns, and insect bites.

If you use more ACIDO BORICO AFOM than you should
The risk of acute poisoning is rare when the medicine is applied only to the skin, as boric acid does not pass through intact skin. However, absorption of the medicine in toxic amounts may occur if the product is ingested, inhaled, or applied to broken or damaged skin. Cases of poisoning and death, especially in children, have occurred following the use of large amounts of boric acid on wounds or ulcers. Organs most commonly affected include the skin, kidneys, stomach, intestines, brain, and lungs.

Symptoms of boric acid poisoning may include: vomiting, diarrhea, pain in various parts of the body (visceral pain), skin irritation (cutaneous erythema followed by desquamation), increased brain activity (CNS stimulation) followed by: depression, restlessness, headache (cephalalgia), increased levels of acid in the blood (metabolic acidosis), severe disturbances in the body's fluid and electrolyte balance (hydroelectrolytic imbalances), changes in body temperature, kidney disorders accompanied by reduced urine output (oliguria), bluish discoloration of the skin (cyanosis), delirium, deep unconsciousness (coma), severe circulatory problems (shock), and death.

Symptoms of chronic poisoning may include: loss of appetite (anorexia), confusion, weakness, skin irritation (dermatitis), menstrual disorders, reduced number of red blood cells (anemia), seizures, and hair loss (alopecia).

The doctor will determine the most appropriate treatment depending on the severity of symptoms.
In case of accidental ingestion or 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 the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur following inappropriate use of the medicine (systemic route) or application of boric acid on wounds and lesions:
Frequency not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult 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 BORIC ACID AFOM

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 “Exp.”. The expiry date refers to the last day of that month.
Store below 25°C and keep the container tightly closed to protect the medicine 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 ACIDO BORICO AFOM 3% ointment contains

• The active substance is boric acid. 100 g of ointment contain 3 g of boric acid.
• The other component is white vaseline.

Description of the appearance and contents of the pack
30 g tube or 1000 g jar.
Marketing Authorization Holder
AEFFE FARMACEUTICI Srl – Via Carlo Porta, 49 – 20064 Gorgonzola (Milan)
Responsible Manufacturer for Batch Release
Pharmaceutical Industry NOVA ARGENTIA S.r.l. – Via G. Pascoli, 1 – Gorgonzola (MI)
Zeta Farmaceutici S.p.A. - Via Galvani, 10 – 36066 Sandrigo (VI) – Italy
Sole Distributor:
Montefarmaco OTC Spa
Via IV Novembre, 92 – 20021 Bollate (MI)