Patient Information Leaflet: Information for the User

BORIC ACID NA 30 mg/ml Cutaneous Solution

Boric Acid
Read this leaflet carefully before using 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 you.

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, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after a few days.

Contents of this leaflet:

What ACIDO BORICO NA is and what it is used for
What you need to know before using ACIDO BORICO NA
How to use ACIDO BORICO NA
Possible side effects
How to store ACIDO BORICO NA
Package contents and other information

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

ACIDO BORICO NA contains the active substance 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 areas of irritated or chapped skin;
reducing swelling caused by fluid accumulation (decongestant);
treating an inflammatory skin condition (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 NA

Do not use ACIDO BORICO NA

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;
in children under 3 years of age (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before using ACIDO BORICO NA.
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.
Avoid applying the product for prolonged periods and in excessive doses, over large areas of skin or on wounds (damaged skin), as toxic effects due to accumulation of the medicine 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 NA
Inform 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, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only when strictly necessary and under medical supervision.
Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.
ACIDO BORICO NA 30 mg/ml cutaneous solution contains parahydroxybenzoates
These may cause allergic reactions (including delayed reactions).

3. How to use ACIDO BORICO NA

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:
Apply the product 1–2 times a day to inflamed areas.
The medicine may be used in case of chapped, irritated or dry skin, abrasions, mild burns, sunburn (solar burns) or windburn, and insect bites.
Children over 3 years of age:
Apply the product 1–2 times a day to inflamed areas.
The medicine may be used in case of chapped, irritated or dry skin, skin irritations (dermatitis) caused by diapers, mild burns, sunburn (solar burns) or windburn, and insect bites.
Do not mix this medicine with solutions containing: tannins; polyvinyl alcohol; hydroxides; alkaline carbonates; glycerol (in this case, a product more acidic than boric acid itself may form (glyceroboric acid)).
If you use more ACIDO BORICO NA than you should
The risk of acute intoxication is rare when the medicine is applied only to the skin, as absorption through intact skin is minimal. 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 body parts 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 parts of the body (visceral pain), skin irritation (cutaneous erythema followed by desquamation), increased brain activity (stimulation of the CNS), 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), convulsions, alterations in body temperature, kidney disorders accompanied by reduced urine output (oliguria), bluish discoloration of the skin (cyanosis), delirium, deep unconsciousness (coma), severe circulatory problems (cardiocirculatory shock), and death.
In case 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 (anemia), convulsions, and hair loss (alopecia).
The doctor will determine the most appropriate treatment depending on the severity of symptoms.
In case of accidental ingestion/ingestion of ACIDO BORICO NA, contact your doctor or go immediately to the nearest hospital.
If you forget to use ACIDO BORICO NA
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

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 following inappropriate use of the medicine (systemic route) or application of boric acid on wounds and skin lesions:

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

skin irritation (dermatitis, 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.

Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects

If you experience any side effects, 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 NA

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 "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 NA 30 mg/ml cutaneous solution contains

The active substance is boric acid. 1 ml of solution contains 30 mg of boric acid.
The other components are purified water and methyl p-hydroxybenzoate.

Description of the appearance and contents of the pack
500 ml bottle of cutaneous solution.
Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l. – Via Carlo Porta, 49 – 20064 Gorgonzola (MI).
Manufacturer
AEFFE FARMACEUTICI Srl – Via Torino, 448 – Brandizzo (TO)