Sobrefluid

Patient Information Leaflet: Information for the User

Sobrefluid Adults 200 mg Suppositories

sobrerol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use 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 need more information or advice, consult your doctor or 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 you experience worsening of symptoms after 3 days.

Contents of this leaflet:

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

1. What Sobrefluid is and what it is used for

The active substance of Sobrefluid is sobrerol, a mucolytic agent.
This medicinal product is indicated in adults to help remove excess mucus in acute and chronic respiratory tract disorders.
The duration of treatment should not exceed three days.

2. What you need to know before using Sobrefluid

Do not use Sobrefluid

• 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 individuals under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Sobrefluid.
Exercise particular caution:
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 in order to avoid an increased risk of adverse drug reactions and overdose-related disorders.
The product is flammable; keep away from flames.
Children
Do not use Sobrepin in children or adolescents under 18 years of age (see section "Do not use Sobrepin").
Other medicines and Sobrefluid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Sobrefluid 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
Sobrefluid does not affect the ability to drive or operate machinery.

3. How to use Sobrefluid

Use 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.
The recommended dose is 1-2 suppositories per day.
If you use more Sobrefluid than you should
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 infants.
In case of accidental overdose, 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 (hypersensitivity) reactions 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 can 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 Sobrefluid:

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.
Do not store above 25°C.
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 Sobrefluid contains

• The active substance is sobrerol. Each suppository contains 200 mg of sobrerol.
• The other components are solid semisynthetic glycerides.

Description of the appearance of Sobrefluid and contents of the pack
Sobrefluid for adults is available as suppositories.
The pack contains 10 suppositories.

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

Package leaflet: Information for the user

Sobrefluid children 100 mg suppositories

sobrerolo
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Always use 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 need more information or advice, consult your doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

1. What Sobrefluid 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.
The duration of treatment must not exceed 3 days.

2. What you need to know before using Sobrefluid

Do not use Sobrefluid

• 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;
• in children with a recent history of anorectal injury.

Warnings and precautions
Talk to your doctor or pharmacist before using Sobrefluid.
Exercise particular caution:
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 administer doses higher than those recommended to avoid an increased risk of adverse drug reactions and disorders associated with overdose.
The product is flammable; keep away from flames.
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 Sobrefluid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Sobrefluid when also taking other products (medicinal or cosmetic) containing terpene derivatives (e.g. camphor, cineole, niaouli, wild thyme, _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.

3. How to use Sobrefluid

Use 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.
The recommended dose is 1-2 suppositories per day for children over 30 months of age.
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 use more Sobrefluid than you should
In case of accidental ingestion of an excessive dose of Sobrefluid, inform your doctor immediately or go to the nearest hospital.
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 will experience them.
Side effects occurring at frequency not known (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.

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 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 Sobrefluid

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.
Do not store above 25°C.
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 Sobrefluid contains

• The active substance is sobrerol. Each suppository contains 100 mg of sobrerol.
• The other components are semi-synthetic solid glycerides.

Description of the appearance of Sobrefluid and contents of the pack
Sobrefluid pediatric is available in the form of suppositories.
The pack contains 10 suppositories.

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

Package leaflet: Information for the user

Sobrefluid 60 mg/4 ml solution for injection for intramuscular use ADULTS

Sobrerol
Please read this leaflet carefully before using this medicine as 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 you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sobrefluid 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 using Sobrefluid

Do not use Sobrefluid

• 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 individuals under 18 years of age.

Important: this formulation of the medicine, injectable solution for intramuscular use,
must be used only in adults.
Warnings and precautions
Talk to your doctor or pharmacist before using Sobrefluid.
Exercise particular caution:
Do not extend treatment beyond 3 days due to the risks associated with the accumulation of terpenic derivatives in
the body, including the brain, and particularly the risk of neuropsychological disorders.
Do not administer doses higher than those recommended in order to avoid an increased risk of adverse drug reactions and disorders associated with overdose.
Children
Do not use Sobrepin in children or adolescents under 18 years of age (see "Do not use Sobrepin").
Other medicines and Sobrefluid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not use Sobrefluid when also taking other products (medicinal or cosmetic) containing terpenic
derivatives (e.g. camphor, cineole, niaouli, wild thyme, 20 terpineol, terpina, 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
Sobrefluid does not affect the ability to drive vehicles or operate machinery.
Sobrefluid contains benzoic acid and sodium benzoate
This medicine contains 0.03 mg of benzoic acid per dose.
This medicine contains 90 mg of sodium benzoate per dose.

3. How to use Sobrefluid

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 1-2 vials per day for intramuscular injection.

If you use more Sobrefluid than you should.
No cases of overdose have been reported.
In case of accidental ingestion/over-administration of an excessive dose of Sobrefluid, inform your doctor immediately or go to the nearest hospital.
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 unknown frequency (frequency cannot be estimated from the available data):

• allergic reactions (hypersensitivity) manifesting as itching, 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 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 Sobrefluid

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.
This medicine does not require any special storage conditions.
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 Sobrefluid contains

• The active substance is sobrerol. One 4 ml vial contains 60 mg of sobrerol.
• The other components are: sodium benzoate, benzoic acid, water for injections.

Description of the appearance of Sobrefluid and contents of the pack
Sobrefluid is a solution for intramuscular injection supplied in vials.
The pack contains 10 vials of 4 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. - Quinto Dé Stampi-Rozzano (MI) - Via Volturno 48

Package leaflet: Information for the user

Sobrefluid 40mg/3ml nebulizer solution

sobrerol
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or 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 Sobrefluid is and what it is used for
2. What you need to know before using Sobrefluid
3. How to use Sobrefluid
4. Possible side effects
5. How to store Sobrefluid
6. Contents of the pack and other information

1. What Sobrefluid is and what it is used for

The active substance of Sobrefluid is sobrerol, a mucolytic.
This medicine 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 using Sobrefluid

Do not use Sobrefluid

• 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 using Sobrefluid.
Take special care with:
This medicine contains sobrerol, which in excessive doses may cause neurological disorders such as
seizures in neonates 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 administer doses higher than those recommended to avoid an increased risk of adverse drug reactions and symptoms related to overdose.
Children
This product must not be used in children under 30 months of age, as mucolytic agents may induce bronchial occlusion (the ability to clear bronchial mucus is limited in children under 30 months due to the characteristics of their respiratory tract).
Other medicines and Sobrefluid
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Sobrefluid when also taking other products (medicines or cosmetics) containing terpene derivatives (e.g. camphor, cineole, niaouli, wild thyme, 20-terpinenol, 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
Sobrefluid does not affect the ability to drive or operate machinery.
Sobrefluid contains sodium benzoate
This medicine contains 60 mg of sodium benzoate per dose. Sodium benzoate may increase jaundice in neonates up to 4 weeks of age.
Sobrefluid contains benzoic acid
This medicine contains 0.02 mg of benzoic acid per dose. Sodium benzoate may increase jaundice in neonates up to 4 weeks of age.

3. How to use Sobrefluid

Use 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.
The recommended dose is 1 vial for each inhalation or aerosolized tubar catheterization, once or twice daily.

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 use more Sobrefluid than you should
Cases of overdose have not been reported.
In case of accidental ingestion/absorption of an excessive dose of Sobrefluid, 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 everybody will experience them.
Side effects occurring 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 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 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 Sobrefluid

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.
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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Sobrefluid contains

• The active substance is sobrerol. One 3 ml vial contains 40 mg of sobrerol.
• The other components are: sodium benzoate, benzoic acid, water for injections.

Description of the appearance of Sobrefluid and contents of the pack
Sobrefluid is a solution for nebulization.
The pack contains 10 vials of 3 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharm@idea S.r.l. – Via del Commercio 5 – 25039 Travagliato (Brescia) - Italy
Manufacturer
Doppel Farmaceutici S.r.l. Quinto de’ Stampi-Rozzano (MI) - Via Volturno 48