SOBREPIN AEROSOL

Patient Information Leaflet: Information for the User

SOBREPIN AEROSOL 40 mg/3 ml nebulizer solution

Sobrerol
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 need more information or advice, consult 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

1. What SOBREPIN AEROSOL is and what it is used for

The active substance of Sobrefluid is sobrerol, a mucolytic agent.
This medicinal product is indicated to facilitate the removal of excess mucus in 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 SOBREPIN AEROSOL

Do not use SOBREPIN AEROSOL

• 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 during 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 using SOBREPIN AEROSOL.
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 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, 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 SOBREPIN AEROSOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not use Sobrefluid if you are also taking other products (medicines or cosmetics) containing terpene derivatives (e.g. camphor, cineole, niaouli, wild thyme, 20 terpineol, terpinol, 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
SOBREPIN AEROSOL does not impair the ability to drive or operate machinery.

3. How to use SOBREPIN AEROSOL

Use 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 per inhalation or aerosolized tubal catheterization,
administered 1 or 2 times daily.
Due to the presence of sobrerol, and in cases where patients do not adhere to the recommended doses,
there may be a risk of seizures in children and newborns.
If you take more SOBREPIN AEROSOL than you should
Cases of overdose have not been reported.
In case of accidental ingestion/overdose of Sobrefluid, contact your doctor immediately or go to the nearest hospital.
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 everybody will experience them.
Side effects occurring at unknown 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 upper airways);
• gastric disturbances (stomach discomfort);
• nausea.

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 through 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 SOBREPIN AEROSOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What SOBREPIN AEROSOL contains

• The active substance is sobrerol. One single-dose container of 3 ml contains 40 mg of sobrerol.
• The other components are: sodium chloride, water for injections.

Description of the appearance of SOBREPIN AEROSOL and contents of the pack
Sobrepin aerosol is a solution for nebulization.
The pack contains 10 single-dose containers of 3 ml each.
Marketing Authorization Holder
Euromed Pharma S.r.l. – Via Artemisia Gentileschi, 26 - 810126 Naples
Manufacturer:
Genetic S.p.A., Contrada Canfora, Fisciano (SA)
This leaflet was last updated on