Brunac

Italy
Brand name Brunac
Form solution, eye
Active substance / Dosage
ACETYLCYSTEINE
Prescription type Non-prescription – not available over the counter
ATC code
S01XA08
Registration number 024593
Manufacturer BRUSCHETTINI S.R.L.
Brunac solution, eye

Table of Contents

Package leaflet: Information for the user

BRUNAC 5% eye drops, solution

Acetylcysteine
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 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 adverse reactions occur, 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 experience worsening of symptoms after a few days.

Contents of this leaflet:

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

1. What BRUNAC is and what it is used for

BRUNAC contains the active substance acetylcysteine.
This medicinal product is indicated for the treatment of:

  • corneal ulcers;
  • keratopathies of various etiologies;
  • corneal diseases caused by altered tear secretion.

Consult your doctor if you do not feel better or feel worse after a few days.

2. What you should know before using BRUNAC

Do not use BRUNAC

  • if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions

Consult your doctor or pharmacist before using BRUNAC.
The unpleasant (sulfurous) odour you may notice when opening the bottle is a characteristic of the active substance and does not indicate that the medicine has deteriorated.
Children and adolescents
This medicine is not intended for use in pediatric patients, except when strictly necessary and under close medical supervision.
Other medicines and BRUNAC
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.
If necessary, your doctor may combine BRUNAC treatment with other eye medications (medicines containing antibiotics or other active substances).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
The effects of this medicine on the ability to drive vehicles or operate machinery are unknown.
BRUNAC contains benzalkonium chloride
This medicine contains 0.1 mg of benzalkonium chloride per 1 ml, equivalent to 0.00307 mg per drop.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (damage to the transparent outer layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak to your doctor.
BRUNAC contains phosphate buffer
This medicine contains 40 mg of phosphate buffer in 1 ml, equivalent to 1.228 mg of phosphate buffer per drop. If you have severe damage to the outer transparent layer of the eye (cornea), phosphates may very rarely cause opaque corneal deposits due to calcium accumulation during treatment.

3. How to use BRUNAC

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.
The recommended dose is 1-2 drops, to be instilled into the lower part of the eye (conjunctival sac), 3-4 times daily, depending on the judgment of the doctor or pharmacist.
The duration of treatment will be determined by the doctor or pharmacist, according to the severity of symptoms.
Tear off the aluminium seal and open the bottle.
Open the sachet inside the package, remove the dropper and attach it to the bottle.

Three orange line drawings show hands opening a medicine bottle and pouring its contents drop by drop

If you use more BRUNAC than you should
Cases of overdose are not known.
If you ingest or take an excessive amount of this medicine, contact your doctor or the nearest hospital immediately.
If you forget to use BRUNAC
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.
The following side effect may occur:
Frequency not known (frequency cannot be estimated from the available data)

  • Temporary and reversible eye irritation.

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 BRUNAC

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 the medicine in its container tightly closed, at a temperature not exceeding 30°C.
After opening, the medicine should be stored in the refrigerator (2°C-8°C) and used within 15 days.
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 BRUNAC contains

  • The active substance is acetylcysteine. 100 ml of solution contain 5 g of acetylcysteine.
  • The other components are: dibasic sodium phosphate, benzalkonium chloride, polyvinylpyrrolidone, dithiothreitol, sodium edetate, sodium hydroxide q.s. to pH 6.5, purified water.

Description of the appearance of BRUNAC and contents of the pack
5 ml bottle with dropper in sterile pouch.
Marketing Authorization Holder
Bruschettini S.r.l. - Via Isonzo, 6 – Genoa – Italy.
Manufacturer
BRUSCHETTINI S.r.l., manufacturing site located in Genoa (Italy), Via Isonzo, 6