Package leaflet: Information for the user

REPUSOX 40 mg/3 ml nebulising solution

Sobrerol
Equivalent medicine
Please read 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What REPUSOX is and what it is used for

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

2. What you need to know before taking REPUSOX

Do not take REPUSOX

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 REPUSOX.
Take special care
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 particularly the risks of neuropsychological disturbances.
Do not administer doses higher than those recommended to avoid an increased risk of adverse drug reactions and disorders associated with overdose.
Children
This product must not be used in children under 30 months of age, as mucolytics may induce 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 REPUSOX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Repusox when also taking other products (medicines or cosmetics) 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
REPUSOX does not impair the ability to drive vehicles or operate machinery.

3. How to take REPUSOX

Take this medicine exactly as instructed 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 aerosolized inhalation or tubaric catheterization (nasal insufflations directed
toward 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 REPUSOX than you should
In case of accidental ingestion/overdose of REPUSOX, immediately inform your doctor or go to the nearest hospital.
If you forget to take REPUSOX
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 everybody gets them.
Side effects with not known frequency (frequency cannot be estimated from the available data):

allergic reactions (hypersensitivity) manifesting 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 effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can 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 REPUSOX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 no longer required. This will help protect the environment.

6. Package contents and other information

What REPUSOX contains

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

Description of the appearance of REPUSOX and package contents
Nebulizer solution.
Pack containing 10 single-dose containers of 3 ml each.
Marketing Authorization Holder
Genetic S.p.A., Via G. Della Monica n. 26, Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A., Contrada Canfora, Fisciano (SA)
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