Sobrepin

Package leaflet: Information for the user

Sobrepin 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 told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact 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 Sobrepin is and what it is used for
2. What you need to know before taking Sobrepin
3. How to take Sobrepin
4. Possible side effects
5. How to store Sobrepin
6. Contents of the pack and other information

1. What Sobrepin is and what it is used for

The active substance of Sobrepin is sobrerol, a mucolytic agent. This medicinal product is used as a fluidifier of bronchial secretions in the treatment of respiratory disorders characterised by dense and viscous hypersecretion.
The duration of treatment should not exceed 3 days.

2. What you should know before taking Sobrepin

Do not take Sobrepin

• 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 Sobrepin.
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 accumulation of terpene derivatives in the body, including the brain, and particularly the risk of neuropsychological disturbances.
Do not administer doses higher than those recommended to avoid an increased risk of adverse drug reactions and overdose-related disorders.
This product is flammable; keep away from flames.

Children
Do not use Sobrepin in children under 30 months of age, as mucolytic agents may cause bronchial obstruction (the ability to clear bronchial mucus in children under 30 months is limited due to characteristics of their respiratory tract).

Other medicines and Sobrepin
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 using 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 or while breastfeeding.

Driving and using machines
Sobrepin does not affect the ability to drive or operate machinery.

Sobrepin contains sucrose, ethanol, and parabens

Sucrose
Children
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Adults
Contains 6 g of sucrose (sugar) per 20 ml of this medicine. This should also be taken into account in patients with diabetes mellitus.

Ethanol
Children
This medicine contains 500 mg of alcohol (ethanol) per pediatric dose unit. The amount in 10 ml of this medicine is equivalent to less than 13 ml of beer or 5 ml of wine.

Adults
This medicine contains 1 g of alcohol (ethanol) per adult dose unit. The amount in 20 ml of this medicine is equivalent to less than 25 ml of beer or 10 ml of wine.

Parabens
This medicine contains parabens (methyl p-hydroxybenzoate and propyl p-hydroxybenzoate) which may cause allergic reactions (including delayed reactions).

3. How to take Sobrepin

Take this medicine exactly as stated in this leaflet or as directed 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 repeatedly or if you notice any recent changes in their characteristics.
Due to the presence of sobrerol and in cases where patients do not follow the recommended doses, there may be a risk of seizures in children and infants.
If you take more Sobrepin than you should
No cases of overdose have been reported.
In case of accidental ingestion or intake of an excessive dose of Sobrepin, 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects at unknown frequency (frequency cannot be estimated from the available data):

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

Following the instructions in this 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 can also report side effects directly via the national reporting system: 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, correctly stored.
Shelf life after first opening: 6 months.
Store the medicine at a temperature not exceeding 25°C.
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 Sobrepin Contains

• The active substance is: sobrerol. 100 ml of syrup contain 0.8 g of sobrerol.
• The other components are: sucrose, glycerol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, monosodium phosphate, saccharin, sodium hydroxide, ethanol, caramel (E150), raspberry flavour, crème caramel flavour, cherry brandy flavour, purified water.

Description of the Appearance of Sobrepin and Contents of the Package
Sobrepin is presented as a syrup.
The package contains 1 bottle of 200 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharm@idea S.r.l. – Via del Commercio 5 – 25039 Travagliato (Brescia) - Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Cortemaggiore (Piacenza) – Via Martiri delle Foibe 1

This patient information leaflet has been updated

Patient Information Leaflet: Information for the user

Sobrepin 300 mg granules

sobrerol
Please read this leaflet carefully before 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 to do.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, consult your pharmacist.
• 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:

7. What Sobrepin is and what it is used for
8. What you need to know before taking Sobrepin
9. How to take Sobrepin
10. Possible side effects
11. How to store Sobrepin
12. Contents of the pack and other information

1. What Sobrepin is and what it is used for

The active substance of Sobrepin is sobrerol, a mucolytic agent.
This medicine is used in adults as a liquefying agent for bronchial secretions in the treatment of respiratory disorders characterised by dense, viscous hypersecretion.
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

Do not take Sobrepin:

• 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").
• if you are under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sobrepin.
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 risks of neuropsychological disturbances.
Do not take higher doses than those recommended to avoid an increased risk of adverse drug reactions and
symptoms associated with overdose.
Children
Do not use Sobrepin in children or adolescents under 18 years of age (see "Do not take Sobrepin").
Other medicines and Sobrepin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
Do not use Sobrepin 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
Sobrepin does not affect the ability to drive vehicles or operate machinery.
Sobrepin contains aspartame, sorbitol and colouring E110
This medicine contains 10 mg of aspartame per dose. Aspartame is a source of phenylalanine. It may be
harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation because the body cannot properly eliminate it.
This medicine contains sorbitol. Sorbitol is a source of fructose. If your doctor has told you that you (or
the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a
rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
This dye contains colouring E110 which may cause you allergic reactions.

3. How to take Sobrepin

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults: 2 sachets per day
Dissolve the contents of one sachet in half a glass of water.
Warning: Do not exceed the recommended doses.
Use only for short treatment periods.
Consult your doctor if symptoms recur repeatedly or if you notice any recent change in their characteristics.
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 than you should
Cases of overdose have not been reported.
In case of accidental ingestion or intake of an excessive dose of Sobrepin, inform your doctor immediately or go to the nearest hospital.
If you have any questions 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 everyone gets them.
Side effects at unknown frequency (frequency cannot be estimated from the available data):

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

Following the instructions in this 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 can also report side effects directly via the national reporting system: 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original unopened packaging, properly stored.
Do not store the medicine at temperatures above 25°C.
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 contains:

• The active substance is: sobrerol 300 mg. One sachet of 3 g granules contains 300 mg of sobrerol.
• Other components are: mandarin flavour, lemon flavour, orange flavour, citric acid, sodium saccharin, aspartame, polysorbate 20, E110, sorbitol.

Description of the appearance of Sobrepin and contents of the pack
Sobrepin 300 mg granules is an oral solution granulate.
Pack sizes are 24 and 60 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharm@idea S.r.l. – Via del Commercio 5 – 25039 Travagliato (BS)
Manufacturer
Doppel Farmaceutici S.r.l. - Quinto de’ Stampi-Rozzano (MI) - Via Volturno 48.