Package leaflet: Information for the user

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

1. What ACIDO BORICO MARCO VITI is and what it is used for

ACIDO BORICO MARCO VITI 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 worsening of symptoms after a few days.

2. What you need to know before using ACIDO BORICO MARCO VITI

Do not use ACIDO BORICO MARCO VITI

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 MARCO VITI.
This medicine must not be applied to the eyes.
Keep this medicine out of the reach of children, as ingestion may even result in death.
(See section “If you use more ACIDO BORICO MARCO VITI than you should”).
Avoid applying the product for prolonged periods and in excessive doses, over large skin areas 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 MARCO VITI
Inform your doctor or pharmacist if you are currently 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, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if strictly necessary and under medical supervision.

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

ACIDO BORICO MARCO VITI 3% cutaneous solution contains sodium benzoate, parahydroxybenzoates and propylene glycol
This medicine contains:

sodium benzoate, which may cause slight irritation to 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 MARCO VITI

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 such cases, a product more acidic than boric acid itself (glyceroboric acid) may form. This medicine is for external use only and should be applied only when strictly necessary.

If you use more BORIC ACID MARCO VITI 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 (erythematous cutaneous desquamation), 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), disturbances in body temperature, kidney disorders accompanied by reduced urine excretion (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).
In case of accidental ingestion/ingestion of BORIC ACID MARCO VITI, contact your doctor or go immediately to the nearest hospital.
Your doctor will determine the most appropriate treatment based on the severity of symptoms.
If you forget to use BORIC ACID MARCO VITI
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 experiences 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);
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 effect, including those not listed in this leaflet, talk to 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 MARCO VITI

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.
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 no longer required. This will help protect the environment.

6. Package contents and other information

What ACIDO BORICO MARCO VITI 3% cutaneous solution contains

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

What ACIDO BORICO MARCO VITI 3% ointment contains

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

Description of the appearance of ACIDO BORICO MARCO VITI and contents of the package
ACIDO BORICO MARCO VITI 3% cutaneous solution is available in 200 ml or 500 ml bottles.
ACIDO BORICO MARCO VITI 3% ointment is available in 30 g tubes or 50 g boxes.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A., Via Mentana, 38 – 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A., Via Galvani, 10 – 36066 Sandrigo