Bornilyene

Package leaflet: Information for the user

BORNILENE 30 mg/ml oral mucosa spray suspension

Xibornol
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BORNILENE is and what it is used for

BORNILENE is a medicinal product with disinfectant properties, which acts, in combination with other medicinal products,
against infections of the throat, mouth and gums.
BORNILENE is used, in combination with other medicinal products:

• for the treatment of infections and inflammations of the throat (e.g. pharyngitis, laryngitis, rhinopharyngitis, acute and chronic tonsillitis);
• for oral hygiene and disinfection of the mouth and gums before and after surgical procedures or dental treatments.

2. What you need to know before using BORNILENE

Do not use BORNILENE

• if you are allergic to xibornol or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using BORNILENE.
In particular, inform your doctor if you suffer from allergic asthma.
Other medicines and BORNILENE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use BORNILENE during pregnancy and breastfeeding unless recommended by your doctor.
Driving and using machines
The use of BORNILENE does not affect the ability to drive or operate machinery.
BORNILENE contains ethanol and castor oil
This medicine contains 6 mg of alcohol (ethanol) per dose, equivalent to 30 mg/ml. The amount of ethanol per dose is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
BORNILENE contains castor oil: it may cause local skin reactions.

3. How to use BORNILENE

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
4 to 6 pharyngeal spray administrations per day at regular intervals.
Instructions for use

1. Lift the spray nozzle (Figure 1):

Figure 1

2. Before each use, SHAKE THE BOTTLE VIGOROUSLY to obtain a fluid consistency of the product inside, and SPRAY IMMEDIATELY AFTER SHAKING. For first-time use, PRESS THE CAP AT LEAST THREE TIMES until the product comes out, to prime the high-precision pump (Figure 2):

Figure 2

3. Direct the spray towards the affected area, keeping the bottle in an upright position (Figure 3):

Figure 3
AFTER EACH USE, IMMEDIATELY WIPE OFF any product drops on the outside or on the tip of the spray nozzle.
DO NOT rinse the spray nozzle with water after use.
If you use more BORNILENE than you should
In case of accidental ingestion or overdose of BORNILENE oral mucosa spray, contact your doctor immediately or go to the nearest hospital.
If you forget to use BORNILENE
Do not use a double dose to make up for the missed dose.
If you stop using BORNILENE
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
To date, no side effects have been reported.

Reporting of side effects
If you experience any side effect, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: 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 BORNILENE

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the packaging after "Expiry". The expiry date refers to the last day of that month.
After first opening the bottle, the medicine remains valid for 3 months (record the date of first opening in the designated space on the carton).
After this period, any remaining medicine must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What BORNILENE contains

• The active substance in 100 ml of suspension is xibornol 3 g.
• The other components are: glycerol, ethanol 96% v/v, polyoxylated castor oil (see section “BORNILENE contains ethanol and castor oil”), microcrystalline cellulose and sodium carmellose, 30% simethicone emulsion, clathrated menthol, ammonium glycyrrhizinate, chlorobutanol hemihydrate, sodium saccharin, clathrated citral, anhydrous colloidal silica, potassium sorbate, purified water.

Description of the appearance of BORNILENE and contents of the pack
BORNILENE is a spray suspension for oral mucosa (30 ml) supplied in an amber glass bottle equipped with a nebulizer.
Marketing Authorization Holder
Abiogen Pharma S.p.A.
Via Meucci 36 - Ospedaletto - Pisa
Manufacturer
Abiogen Pharma S.p.A. - Via Meucci 36 – Ospedaletto - Pisa