Sobrefri

Package leaflet: Information for the user

SOBREFRI 40 mg/5 ml single-dose syrup, 40 mg/5 ml syrup

Sobrerol
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take 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 have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

1. What Sobrefri is and what it is used for

The active substance of Sobrefri is sobrerol, a mucolytic agent.
This medicinal product is used as a fluidifier of bronchial secretions in the treatment of respiratory conditions characterized by dense, viscous hypersecretion.
The duration of treatment must not exceed 3 days.

2. What you need to know before taking SOBREFRI

Do not take SOBREFRI

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

Warnings and precautions
Talk to your doctor or pharmacist before taking SOBREFRI.
Take special care:
This medicine contains sobrerol, which in excessive doses may cause neurological disorders such as
seizures in infants 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 risk of neuropsychological disturbances.
Do not exceed the recommended doses to avoid an increased risk of adverse drug reactions and symptoms associated with overdose.
Children
Do not use Sobrepin in children under 30 months of age, as 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 SOBREFRI
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Sobrepin if you are 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
SOBREFRI does not affect the ability to drive or operate machinery.
SOBREFRI 40 mg/5 ml syrup contains maltitol, sodium and hydroxybenzoates
Maltitol
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this
medicine. It may have a mild laxative effect. The caloric value of maltitol is 2.3 kcal/g.
Sodium
This medicine contains 26.74 mg of sodium (main component of table salt) per 20 ml.
This corresponds to 1.3% of the maximum recommended daily dietary intake for an adult.
Parabens
The multidose syrup also contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may
cause allergic reactions (including delayed-type reactions).

3. How to take SOBREFRI

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults
10-20 ml twice daily.
Use in children over 30 months
10 ml twice daily.
Use the markings on the dosing syringe as a reference.
Warning: Do not exceed the recommended doses.
Use only for short treatment periods.
Consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.
Due to the presence of sobrerol and in cases where recommended doses are not observed, there may be a risk of seizures in children and infants.
If you take more SOBREFRI than you should
No cases of overdose have been reported.
In case of accidental ingestion or intake of an excessive dose of SOBREFRI, inform 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.
If you forget to take SOBREFRI
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects at unknown frequency (frequency cannot be estimated from the available data):

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

Following the instructions provided in the leaflet reduces the risk of side effects.
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 via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store SOBREFRI

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. The expiry date applies to the product in its original, undamaged packaging stored correctly.
The shelf life after first opening the bottle is 28 days (record the date of first opening in the designated space on the carton).
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 SOBREFRI contains
SOBREFRI 40 mg/5 ml single-dose syrup
One single-dose container:

• the active substance is: sobrerol 40 mg;
• the other components are: maltisorb (maltitol 75%), glycerol 98%, monosodium phosphate, sodium hydroxide, water for injections.

SOBREFRI 40 mg/5 ml 200 ml syrup
5 ml:

• the active substance is: sobrerol 40 mg;
• the other components are: maltisorb (maltitol 75%), glycerol 98%, monosodium phosphate, sodium hydroxide, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, water for injections.

Description of the appearance of SOBREFRI and package contents
SOBREFRI 40 mg/5 ml is presented as a syrup.
Package sizes are 20 single-dose containers and one 200 ml bottle.
Marketing Authorization Holder
Pharm@idea S.r.l. – Via del Commercio 5 – 25039 Travagliato (Brescia)
Manufacturer:
Genetic S.p.A., Contrada Canfora, Fisciano (SA)
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