Boric acid Zeta

Boric Acid Zeta

Package Leaflet

Zeta Farmaceutici S.p.A.

Package leaflet: Information for the user

BORIC ACID ZETA 3% cutaneous solution, ointment

Boric acid
Please 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.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after a few days.

Contents of this leaflet:

1. What ACIDO BORICO ZETA is and what it is used for
2. What you need to know before using ACIDO BORICO ZETA
3. How to use ACIDO BORICO ZETA
4. Possible side effects
5. How to store ACIDO BORICO ZETA
6. Package contents and other information

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

ACIDO BORICO ZETA 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 areas of skin;
• 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 a worsening of symptoms after a few days.

2. What you need to know before using BORIC ACID ZETA

Do not use BORIC ACID ZETA

• 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 BORIC ACID ZETA.
Boric Acid Zeta

Package Leaflet

Zeta Farmaceutici S.p.A.
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 ZETA 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 ZETA
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are 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 or operate machinery.
ACIDO BORICO ZETA 3% cutaneous solution contains sodium benzoate, parahydroxybenzoates, and
propylene glycol
This medicine contains:

• sodium benzoate, which may cause slight irritation of the skin, eyes, and mucous membranes;
• parahydroxybenzoates, which may cause allergic reactions (including delayed reactions);
• propylene glycol, which may cause skin irritation.

3. How to use BORIC ACID ZETA

Use this medicine exactly as described 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.

Boric Acid Zeta

Package Leaflet

Zeta Farmaceutici S.p.A.
The medicine is for external use only and should be applied only when strictly necessary.
If you use more ACIDO BORICO ZETA 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 the skin. However, following the use of large amounts of boric acid on wounds or ulcers, cases of poisoning and even death—particularly in children—have been reported.
In case of boric acid poisoning, the following symptoms may occur: vomiting, diarrhoea, pain in various parts of the body (visceral pain), skin irritation (erythematous desquamative skin rash), increased brain activity (CNS 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), alterations in body temperature, kidney disorders accompanied by reduced urine output (oliguria), bluish discoloration of the skin (cyanosis), delirium, convulsions, 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), convulsions, and hair loss (alopecia).
In case of accidental ingestion/ingestion of ACIDO BORICO ZETA, contact your doctor or go immediately to the nearest hospital.
The doctor will determine the most appropriate treatment based on the severity of the symptoms.
If you forget to use ACIDO BORICO ZETA
Do not use a double dose to make up for the missed 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 everyone will experience them.
Following inappropriate use of the medicine (systemic route) or application of boric acid to wounds and lesions, or prolonged use, the following side effects may occur:
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);
• menstrual cycle disturbances;
• reduction in the number of red blood cells in the blood (anaemia);
• weakness;
• confusion;
• seizures.

Following the instructions provided in the leaflet reduces the risk of side effects.
Reporting of side effects
Acido borico Zeta

Package Leaflet

Zeta Farmaceutici S.p.A.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACIDO BORICO ZETA

Keep this medicine out of 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 ZETA 3% cutaneous solution contains

• The active substance is boric acid. 100 g of solution contain 3 g of boric acid.
• The other components are: sodium benzoate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide, propylene glycol, purified water.

What ACIDO BORICO ZETA 3% ointment contains

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

Description of the appearance and contents of the pack
ACIDO BORICO ZETA 3% cutaneous solution is available in a 500 ml bottle.
ACIDO BORICO ZETA 3% ointment is available in
a 30 g tube.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zeta Farmaceutici S.p.A. Via Mentana, 38 – 36100 Vicenza-Italy
Manufacturer
Zeta Farmaceutici S.p.A. Via Galvani, 10 – 36066 Sandrigo (VI)-Italy