Boric acid Sella

Patient Information Leaflet: Instructions for the User

BORIC ACID SELLA 3% Cutaneous Solution

Boric Acid
Please 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 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 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 improvement or if you notice worsening of symptoms after a few days.

Contents of this leaflet:

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

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

ACIDO BORICO SELLA contains boric acid, which belongs to a group of medicines called antiseptics and disinfectants. These medicines work by slowing down or preventing the growth of bacteria.
This medicine is indicated, in adults and children over 3 years of age, for:

• disinfecting minor burns and irritated or chapped skin areas;
• reducing swelling caused by blood accumulation (decongestant);
• treating an inflammatory skin 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 SELLA

Do not use ACIDO BORICO SELLA

• 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;

This medicine must not be used in children under 3 years of age (See section “Children”).
Warnings and precautions
Talk to your doctor or pharmacist before using ACIDO BORICO SELLA.
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 SELLA 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 SELLA
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 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 affect the ability to drive or operate machinery.
ACIDO BORICO SELLA contains benzalkonium chloride
50 ml of this medicine contains 0.1 mg of benzalkonium chloride. Benzalkonium chloride may irritate the skin. If you are breastfeeding, do not apply this medicine on the breast, as the infant may ingest it through breast milk.

3. How to use ACIDO BORICO SELLA

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.
Adults and children over 3 years of age:
Apply the product 1–2 times daily to the affected areas.
Do not mix the medicine with solutions containing:

• tannins;
• polyvinyl alcohol;
• hydroxides;
• alkali carbonates;
• glycerol. In this case, a product more acidic than boric acid itself (glyceroboric acid) may form.

Method of administration This medicine is for external use only and should be applied only when actually needed.
If you use more ACIDO BORICO SELLA than you should
The risk of acute intoxication is rare when the medicine is applied only to the skin, as boric acid does not pass through intact skin. However, following the use of large amounts of boric acid on wounds or ulcers, cases of poisoning and death—especially in children—have been reported.
Symptoms of boric acid poisoning may include: vomiting, diarrhoea, pain in various parts of the body (visceral pain), skin irritation (desquamative cutaneous erythema), increased brain activity (central nervous system stimulation) followed by: depression, restlessness, headache (cephalaea), increased levels of acidic substances in the blood (metabolic acidosis), severe disturbances in electrolyte and fluid balance (hydroelectrolytic imbalances), disturbances in body temperature regulation, kidney disorders accompanied by reduced urine output (oliguria), bluish discoloration of the skin (cyanosis), delirium, seizures, 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 the symptoms.
In case of accidental ingestion/ingestion of ACIDO BORICO SELLA, contact your doctor or go immediately to the nearest hospital.
If you forget to use ACIDO BORICO SELLA
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 everybody will experience them.
Following inappropriate use of the medicine (systemic route) or application of boric acid on wounds and lesions, and after prolonged use, 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);
• menstrual cycle disturbances;
• 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 SELLA

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 this medicine in its original packaging and protect it 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 SELLA contains

• The active substance is boric acid. 100 g of solution contain 3 g of boric acid.
• The other components are: benzalkonium chloride, purified water.

Description of the appearance of ACIDO BORICO SELLA and contents of the pack
ACIDO BORICO SELLA 3% cutaneous solution is available in a 500 ml bottle.
Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l. - Via Vicenza, 67 - 36015 Schio (VI) - Italy