Patient Information Leaflet: Information for the User

SOBILON 40 mg/3 ml nebulising solution

Sobrerol
Equivalent medicine
Please read all of this leaflet carefully before taking 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 other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What SOBILON is and what it is used for
What you need to know before taking SOBILON
How to take SOBILON
Possible side effects
How to store SOBILON
Contents of the pack and other information

1. What SOBILON is and what it is used for

SOBILON contains the active substance sobrerol, a mucolytic agent that liquefies mucus and facilitates its elimination.
SOBILON is indicated for the treatment of acute and chronic respiratory tract disorders.
Consult your doctor if you do not feel better or feel worse after 3 days.

2. What you need to know before taking SOBILON

Do not take SOBILON

if you are allergic to sobrerol or to any of the other ingredients of this medicine (listed in section 6).
if you are pregnant or breastfeeding. (see "Pregnancy and breastfeeding").
in children under 30 months of age.
in children with a history of epilepsy or febrile seizures.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOBILON.
Exercise particular caution
This medicine contains sobrerol which, in excessive doses, may cause neurological disorders such as
seizures in newborns and children.
Do not extend treatment beyond 3 days due to the risks associated with the accumulation of terpene derivatives in
the body, including the brain, and in particular the risk of neuropsychological disturbances.
Do not administer doses higher than those recommended to avoid an increased risk of adverse drug reactions and symptoms associated with overdose.
Children
This product must not be used in children under 30 months of age, since mucolytics may cause bronchial occlusion (the ability to clear bronchial mucus in children under 30 months is limited due to the characteristics of their respiratory tract).
Other medicines and SOBILON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not use SOBILON when also taking other products (medicinal or cosmetic) containing terpene derivatives
(e.g. camphor, cineole, niaouli, wild thyme, 20 terpineol, terpin, citral, menthol and essential oils of pine needles, eucalyptus and turpentine), regardless of the route of administration (oral, rectal,
cutaneous or pulmonary).
Pregnancy and breastfeeding
Do not use during pregnancy and while breastfeeding.
Driving and using machines
SOBILON does not impair the ability to drive vehicles or use machinery.

3. How to take SOBILON

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
1 single-dose container for each inhalation or aerosolized tubal catheterization (nasal insufflations directed
towards the ear), for 1 or 2 applications per day.
Due to the presence of sobrerol, and in cases of patients not adhering to the recommended doses, there may
be a risk of seizures in children and newborns.
If you take more SOBILON than you should
In case of accidental ingestion/overdose of SOBILON, contact your doctor immediately or go to the nearest hospital.
If you forget to take SOBILON
Do not take 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 experiences them.
Side effects with unknown frequency (frequency cannot be determined from the available data):

allergic reactions (hypersensitivity) presenting as itching, skin rash, urticaria, oedema, and dyspnoea;
bronchial obstruction (temporary narrowing of the airways);
gastric disturbances (stomach discomfort);
nausea.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://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 SOBILON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What SOBILON contains

The active substance is sobrerol. The other components are: sodium chloride, water for injections.

Description of the appearance of SOBILON and contents of the pack
Nebuliser solution.
Pack containing 10 single-dose containers of 3 ml each.
Marketing Authorisation Holder
Genetic S.p.A., Via G. Della Monica n. 26, Castel San Giorgio (SA)
MANUFACTURER
Genetic S.p.A., Contrada Canfora, Fisciano (SA)
This leaflet was last updated on