SOPULMIN 40 mg /5 Ml Syrup

Зміст інструкції

1. SOPULMIN Bambini 100 mg suppositories
   1. What SOPULMIN is and what it is used for
   2. What you need to know before using SOPULMIN
   3. How to use SOPULMIN
   4. Possible side effects
   5. How to store SOPULMIN
   6. Contents of the pack and other information
2. SOPULMIN 40 mg/5 ml syrup, Adults 300 mg granules for oral solution
   1. What is SOPULMIN and what is it used for
   2. What you need to know before taking SOPULMIN
   3. How to take SOPULMIN
   4. Possible side effects
   5. How to store SOPULMIN
   6. Contents of the pack and other information
3. SOPULMIN Adulti 60 mg/4 ml injectable solution for intramuscular use
   1. What SOPULMIN is and what it is used for
   2. What you need to know before using SOPULMIN
   3. How to use SOPULMIN
   4. Possible side effects
   5. How to store SOPULMIN
   6. Contents of the pack and other information
4. SOPULMIN 40 mg/3 ml solution for nebulization
   1. What SOPULMIN is and what it is used for
   2. What you need to know before using SOPULMIN
   3. How to use SOPULMIN
   4. Possible side effects
   5. How to store SOPULMIN
   6. Contents of the pack and other information

SOPULMIN Bambini 100 mg suppositories

Sobrerolo

Read this leaflet carefully before using this medicine as it contains important
information for your child.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not get better or if your symptoms worsen after 3 days

Contents of this leaflet:

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

1. What SOPULMIN is and what it is used for

SOPULMIN contains the active ingredient sobrerol, which belongs to a group of medicines called mucolytics,
which decrease the viscosity of mucus, fluidifying it and facilitating its elimination.
SOPULMIN is indicated to facilitate the removal of excess mucus and phlegm in acute and
chronic conditions of the respiratory tract.
Consult your doctor if your child does not feel better or if they feel worse after a short period.
The duration of treatment should not exceed 3 days.

2. What you need to know before using SOPULMIN

Do not use SOPULMIN

• if your child is allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• in children under 30 months of age;
• if your child has a history of epilepsy or febrile convulsions;
• if your child has a recent history of anorectal injury.

Warnings and precautions
Consult the doctor treating your child or your pharmacist before using SOPULMIN.

Pay particular attention:

• This medicine contains sobrerol which, in excessive doses, can induce neurological disorders such as convulsions in newborns and children.
• Do not prolong treatment for more than 3 days due to the risks associated with the accumulation of terpene derivatives (e.g. camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol and essential oils of pine needles, eucalyptus and turpentine) in the body, including the brain, and particularly due to the risks of neuropsychological disorders and rectal burns.
• Do not administer doses higher than those recommended to avoid a greater risk of adverse reactions to the medicine and disorders associated with overdose.
• The medicine is flammable, do not approach flames.

Pregnancy and breastfeeding
Do not use during pregnancy and breastfeeding.

Children
Do not use SOPULMIN in children under 30 months of age as it may cause bronchial obstruction.
The ability to eliminate bronchial mucus is limited in this age group due to the characteristics
of the respiratory tract.

Other medicines and SOPULMIN
Inform the doctor treating your child or your pharmacist if you are taking, have recently taken or might
take any other medicines.
Do not administer SOPULMIN suppositories to your child when also taking other products (medicines or
cosmetics) 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).

3. How to use SOPULMIN

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by a doctor, the recommended dosage, method and frequency of administration are
reported below.

SOPULMIN Children 100 mg suppositories
Children over 30 months of age:the recommended dose is 1-2 suppositories per day.
Due to the presence of sobrerol and in case of patients who do not follow the recommended doses, there may be a
risk of convulsions in children and infants.

If you use more SOPULMIN than you should
No cases of overdose are known.
In case of accidental ingestion/intake of an excessive dose of SOPULMIN, immediately notify your
doctor or go to the nearest hospital.

If you forget to use SOPULMIN
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult the doctor treating your child or the
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Not known(the frequency of which cannot be estimated from available data)

• stomach discomfort and nausea;
• bronchial obstruction (bronchial blockage).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 SOPULMIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad”.
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
The suppositories must be stored at a temperature not exceeding 30° C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SOPULMIN contains
SOPULMIN Children suppositories

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

Description of the appearance of SOPULMIN and contents of the pack
Each pack of SOPULMIN children suppositories contains 10 suppositories.

Marketing Authorisation Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan- Italy

Manufacturer
Doppel Farmaceutici S.r.l.–Via Martiri delle Foibe, 1–29016 Cortemaggiore (PC) - Italy

SOPULMIN 40 mg/5 ml syrup, Adults 300 mg granules for oral solution

Sobrerolo

Read this leaflet carefully before taking this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if you feel worse after 3 days.
• Contents of this leaflet:
• 1. What SOPULMIN is and what it is used for
• 2. What you need to know before you take SOPULMIN
• 3. How to take SOPULMIN
• 4. Possible side effects
• 5. How to store SOPULMIN
• 6. Contents of the pack and other information

1. What is SOPULMIN and what is it used for

SOPULMIN contains the active ingredient sobrerol, which belongs to a group of drugs called mucolytics,
which decrease the viscosity of mucus, making it more fluid and facilitating its elimination. SOPULMIN is indicated
to facilitate the removal of excess mucus and phlegm in acute and chronic conditions of the
respiratory tract.
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 SOPULMIN

Do not take SOPULMIN

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if the patient's age is less than 30 months (See Children);
• if you suffer from phenylketonuria (high levels of phenylalanine in the blood), only for the use of the oral solution granules.
• In children with a history of epilepsy or febrile convulsions

Pay particular attention:

• This medicine contains sobrerol which, in excessive doses, can induce neurological disorders such as convulsions in newborns and children.
• Do not prolong treatment for more than 3 days due to the risks associated with the accumulation of terpenic derivatives in the body, including the brain, and in particular for the risks of neuropsychological disorders

Warnings and precautions
Consult your doctor or pharmacist before taking SOPULMIN.
For those who engage in sports, SOPULMIN syrup contains ethyl alcohol and may determine positivity to doping
tests.

Children
Do not use SOPULMIN in children under the age of 30 months as it may cause bronchial obstruction.
The ability to eliminate bronchial mucus is limited in this age group due to the characteristics
of the respiratory tract.

Other medicines and SOPULMIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not use SOPULMIN when taking other products (medicines or cosmetics) containing terpenic derivatives
(e.g. camphor, cineole, niaouli, wild thyme, 20 terpineol, terpine, 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
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
During the first three months of pregnancy, use the medicine only when absolutely necessary under the direct control of
the doctor. No contraindications are known during breastfeeding.

Driving and operating machinery
SOPULMIN does not alter the ability to drive vehicles or operate machinery.

SOPULMIN oral solution granules contains sorbitol, aspartame, sodium and E110
This medicine contains 10 mg of aspartame per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic
disease that causes a build-up of phenylalanine because the body cannot dispose of it properly.
This medicine contains 2304 mg of sorbitol per sachet.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have a
diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot
metabolize fructose, talk to your doctor before taking this medicine
This medicine contains E 110
It may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially ‘sodium-free’.

SOPULMIN syrup contains sucrose, propyl and methyl parahydroxybenzoate, ethyl alcohol, sodium and
propylene glycol
This medicine contains sucrose, if your doctor has diagnosed you with an intolerance to certain sugars, contact
them before taking this medicine.
Contains 12.6 g of sucrose per dose (2 tablespoons). To be taken into consideration in people affected by diabetes
mellitus. It may be harmful to teeth
This medicine contains 46.8 mg of sodium (the main component of table salt) per dose. This
is equivalent to 2.34 % of the recommended daily intake with the diet of an adult .
This medicine contains propyl and methyl parahydroxybenzoate
They may cause allergic reactions.
This medicine contains 25 mg of alcohol (ethanol) in each dose for children (13 g of syrup) which is
equivalent to 10 g of ethanol in 200 ml (0.05 g/ml). The amount in a dose of this medicine is equivalent to
less than 0.7 ml of beer or 0.3 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains 2.1 g of alcohol (ethanol) in each dose for adults which is equivalent to 10 g of ethanol in
200 ml (0.05 g/ml). The amount in a dose of this medicine is equivalent to less than 54 ml of beer or 23 ml
of wine.
The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents and its effects in
children are not evident. Some effects may occur in young children, for example feeling
sleepy.
The alcohol in this medicine may alter the effects of other medicines.
Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breastfeeding, talk
to your doctor or pharmacist before taking this medicine. If you have an alcohol dependence, talk to
your doctor before taking this medicine.

Sopulmin Syrup contains propylene glycol (contained in both raspberry and caramel flavour)
This medicine contains 12.11 mg of propylene glycol per dose (2 tablespoons), corresponding to 0.288 mg/ml.

Sopulmin Syrup contains benzyl alcohol (contained in caramel flavour)
This medicine contains a flavour in turn containing benzyl alcohol.
Benzyl alcohol may cause allergic reactions.

3. How to take SOPULMIN

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dosage, method of administration and frequency are
indicated below.

SOPULMIN 40 mg/5 ml syrup
Adults:the recommended dose is 1-2 tablespoons 2 times a day.

Children over 30 months of age:the recommended dose is 2 teaspoons 2 times a day.

SOPULMIN Adults 300 mg granules for oral solution
Adults:the recommended dose is 2 sachets per day. Dissolve the contents of one sachet in half a glass of
water and take twice a day.

If you take more SOPULMIN than you should
No cases of overdose are known.
In case of accidental ingestion/intake of an excessive dose of SOPULMIN, immediately notify your
doctor or go to the nearest hospital.

If you forget to take SOPULMIN
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Not known(the frequency of which cannot be estimated from available data)

• stomach discomfort and nausea;
• bronchial obstruction (bronchial occlusion).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 SOPULMIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
The syrup and sachets have no particular precautions for storage.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SOPULMIN contains
SOPULMIN 40mg/5 ml syrup

• The active ingredient is sobrerol. Each 100 ml of syrup contains 0.80 g of sobrerol
• The other ingredients are: sucrose, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, sodium phosphate monobasic, glycerin, caramel (E 150), saccharin, ethyl alcohol, raspberry aroma (contains: propylene glycol, crème caramel aroma (contains: benzyl alcohol and propylene glycol), cherry brandy aroma), sodium hydroxide, purified water.

SOPULMIN Adults 300 mg granules for oral solution

• The active ingredient is sobrerol. Each sachet contains 300 mg of sobrerol.
• The other ingredients are :mandarin aroma, lemon aroma, orange aroma, citric acid, sodium saccharin, aspartame, polysorbate 20, E 110, sorbitol.

Description of the appearance of SOPULMIN and contents of the pack
Each pack of SOPULMIN syrup contains a 200 ml bottle.
Each pack of SOPULMIN granules for oral solution contains 20 sachets of 300 mg.

Marketing Authorisation Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan - Italy

Manufacturer
SOPULMIN 40 mg/5 ml syrup
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1–29016 Cortemaggiore (PC) - Italy

SOPULMIN Adults 300 mg granules for oral solution
Doppel Farmaceutici S.r.l. - Via Volturno, 48-Quinto Dè Stampi –20089 Rozzano (MI) - Italy

SOPULMIN Adulti 60 mg/4 ml injectable solution for intramuscular use

Overleaf
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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SOPULMIN is and what it is used for

SOPULMIN contains the active ingredient sobrerol, which belongs to a group of drugs called mucolytics,
which decrease the viscosity of mucus, fluidifying it and facilitating its elimination.
SOPULMIN is indicated to facilitate the removal of excess mucus and phlegm in acute and
chronic respiratory tract conditions.

2. What you need to know before using SOPULMIN

Do not use SOPULMIN

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• In children with a history of epilepsy or febrile convulsions

Take special care:

• This medicine contains sobrerol which, in excessive doses, can induce neurological disorders such as convulsions in newborns and children
• Do not prolong the treatment for more than 3 days due to the risks associated with the accumulation of terpene derivatives in the body, including the brain, and in particular for the risks of neuropsychological disorders

Warnings and precautions
Consult your doctor or pharmacist before using SOPULMIN.

Other medicines and SOPULMIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not use SOPULMIN 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
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before using this medicine.
During the first three months of pregnancy, use the medicine only in cases of actual need under direct
medical supervision. No contraindications are known during breastfeeding

Driving and operating machinery
SOPULMIN does not alter the ability to drive vehicles or operate machinery.

SOPULMIN injectable solution containsbenzoic acid/sodium benzoate

• This medicine contains 90.03 mg of sodium benzoate and benzoic acid per vial equivalent to 22.5 mg/ml and 0.008 mg/ml respectively.

This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.

3. How to use SOPULMIN

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist
Unless otherwise prescribed by your doctor, the recommended dosage, method and frequency of administration are
reported below.

SOPULMIN Adults 60 mg/4 ml injectable solution
Adults:the recommended dose is 1-2 vials per day by intramuscular route.

If you use more SOPULMIN than you should
No cases of overdose are known.
If you are concerned that you have been given an excessive dose of SOPULMIN, immediately inform your doctor or go to the nearest hospital.

If you forget to use SOPULMIN
Do not use a double dose to make up for a 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.
The following side effects may occur:

Not known(the frequency of which cannot be estimated from available data)

• stomach discomfort and nausea;
• bronchial obstruction (bronchial blockage).

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, please tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at 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 SOPULMIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad”.
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
The vials for injectable solution must be stored in a dry place and at room temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SOPULMIN contains
SOPULMIN Adults 60 mg/4 ml injectable solution

• The active ingredient is sobrerol. Each vial contains 60 mg of sobrerol.
• The other ingredients are: sodium benzoate, benzoic acid, water for injections

Description of the appearance of SOPULMIN and contents of the pack
Each pack of SOPULMIN injectable solution contains 10 vials of 4 ml.

Marketing Authorisation Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan - Italy

Manufacturer
Doppel Farmaceutici S.r.l.-Via Volturno, 48-Quinto Dè Stampi –20089 Rozzano (MI) - Italy

SOPULMIN 40 mg/3 ml solution for nebulization

Sobrerolo
Read this 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
told you to do.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days
• Contents of this leaflet:
• 1. What SOPULMIN is and what it is used for
• 2. What you need to know before using SOPULMIN
• 3. How to use SOPULMIN
• 4. Possible side effects
• 5. How to store SOPULMIN
• 6. Contents of the pack and other information

1. What SOPULMIN is and what it is used for

SOPULMIN contains the active ingredient sobrerol, which belongs to a group of drugs called mucolytics,
which decrease the viscosity of mucus, making it more fluid and facilitating its elimination. SOPULMIN is indicated
to facilitate the removal of excess mucus and phlegm in acute and chronic respiratory conditions.
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 SOPULMIN

Do not use SOPULMIN

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• In children with a history of epilepsy or febrile convulsions.

Take special care:

• This medicine contains sobrerol which, in excessive doses, can induce neurological disorders such as convulsions in newborns and children
• Do not prolong treatment for more than 3 days due to the risks associated with the accumulation of terpene derivatives in the body, including the brain, and in particular for the risks of neuropsychological disorders.

Warnings and precautions
Consult your doctor or pharmacist before using SOPULMIN.

Other medicines and SOPULMIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not use SOPULMIN when 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
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before using this medicine.
During the first three months of pregnancy, use the medicine only when absolutely necessary under direct
medical supervision. No contraindications are known during breastfeeding.

Driving and operating machinery
SOPULMIN does not impair the ability to drive vehicles or operate machinery.

SOPULMIN nebulizer solution contains benzoic acid/sodium benzoate
This medicine contains 60.02 mg of sodium benzoate and benzoic acid per vial equivalent to
22 mg/ml and 0.007 mg/ml respectively.
Sodium benzoate and benzoic acid can cause local irritation.
Sodium benzoate and benzoic acid can increase jaundice (yellowing of the skin and eyes) in newborns
(up to 4 weeks of age).

3. How to use SOPULMIN

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dosage, method and frequency of administration are
reported below:

SOPULMIN 40 mg/3 ml solution for nebulization
The recommended dose is 1 vial of solution for aerosol for each inhalation with a mask or through
nasal catheter for 1 or 2 applications per day.

If you use more SOPULMIN than you should
No cases of overdose are known.
In case of ingestion/accidental intake of an excessive dose of SOPULMIN, immediately notify your
doctor or go to the nearest hospital.

If you forget to use SOPULMIN
Do not use 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.
The following side effects may occur:

Not known(the frequency of which cannot be estimated from available data)

• stomach discomfort and nausea;
• bronchial obstruction (bronchial occlusion).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 SOPULMIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad”.
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
The vials for nebulization solution must be stored in a dry place and at room temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SOPULMIN contains
SOPULMIN 40 mg/3 ml solution for nebulisation

• The active ingredient is sobrerol. Each vial contains 40 mg of sobrerol.
• The other ingredients are: sodium benzoate, benzoic acid, water for injections

Description of the appearance of SOPULMIN and contents of the pack
Each pack of SOPULMIN solution for nebulisation contains 10 vials of 3 ml.

Marketing Authorisation Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan - Italy

Manufacturer
Doppel Farmaceutici S.r.l.-Via Volturno, 48-Quinto Dè Stampi –20089 Rozzano (MI) - Italy