Sopulmin

Package leaflet: Information for the user

SOPULMIN Children 100 mg suppositories

Sobrerol
Please read this leaflet carefully before using this medicine because 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 to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if 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 substance sobrerol, which belongs to a group of medicines called mucolytics,
which reduce the viscosity of mucus, liquefying it and facilitating its elimination.
SOPULMIN is indicated to help remove excess mucus and phlegm in acute and
chronic respiratory tract disorders.
Consult your doctor if your child does not feel better or feels worse after a short period.
The duration of treatment must 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 substance 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 seizures;
• if your child has recently had an anorectal injury.

Warnings and precautions
Talk to your child's doctor or pharmacist before using SOPULMIN.
Exercise special caution:

• 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 (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 the risks of neuropsychological disturbances and rectal burns.
• Do not administer doses higher than those recommended to avoid an increased risk of adverse reactions to the medicine and disorders associated with overdose.
• The medicine is flammable; keep away from 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 occlusion.
The ability to clear bronchial mucus is limited in this age group due to the characteristics of the respiratory tract.
Other medicines and SOPULMIN
Inform your child's doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Do not administer SOPULMIN suppositories to your child if they are 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 exactly as stated in this leaflet or as directed 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 as follows:
SOPULMIN Bambini 100 mg suppositories
Children over 30 months of age: the recommended dose is 1–2 suppositories per day.
Due to the presence of sobrerol, there is a risk of seizures in children and infants if the recommended doses are not observed.
If you use more SOPULMIN than you should
No cases of overdose are known.
In case of accidental ingestion/absorption of an excessive dose of SOPULMIN, inform your doctor immediately or go to the nearest hospital.
If you forget to use SOPULMIN
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult the doctor treating your child or your pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

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

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 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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, undamaged packaging, stored correctly.
Suppositories must be stored at a temperature not exceeding 30°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 SOPULMIN contains
SOPULMIN Children's Suppositories

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

Description of the appearance of SOPULMIN and contents of the pack
Each pack of SOPULMIN Children's Suppositories contains 10 suppositories.
Marketing Authorization 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

Patient Information Leaflet

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

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.

• 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.
• Contact your doctor if you do not notice improvement 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 taking 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 SOPULMIN is and what it is used for

SOPULMIN contains the active substance sobrerol, which belongs to a group of medicines called mucolytics,
which reduce the viscosity of mucus, making it more fluid and easier to eliminate. SOPULMIN is indicated
to help remove excess mucus and phlegm in acute and chronic respiratory tract 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 taking SOPULMIN

Do not take SOPULMIN

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is under 30 months of age (see Children);
• if you have phenylketonuria (high levels of phenylalanine in the blood), only regarding the use of the oral solution granules.
• In children with a history of epilepsy or febrile seizures.

Take special care:

• 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 risks associated with the accumulation of terpene derivatives in the body, including the brain, and particularly due to the risk of neuropsychological disturbances.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOPULMIN.
For those engaged in sports activities, SOPULMIN syrup contains ethyl alcohol and may lead to positive results in anti-doping tests.

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

Other medicines and SOPULMIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use SOPULMIN if you are 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
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During the first three months of pregnancy, use this medicine only if clearly needed and under direct medical supervision. There are no known contraindications during breastfeeding.

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

SOPULMIN oral solution granules contain 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 disorder causing accumulation of phenylalanine due to the body's inability to metabolize 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 been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, consult 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 intolerance to certain sugars, contact them before taking this medicine.
It contains 12.6 g of sucrose per dose (2 tablespoons). This should be considered in individuals with diabetes mellitus. It may be harmful to teeth.
This medicine contains 46.8 mg of sodium (a main component of table salt) per dose. This corresponds to 2.34% of the maximum recommended daily dietary intake for an adult.
This medicine contains propyl and methyl parahydroxybenzoate.
They may cause allergic reactions.
This medicine contains 25 mg of alcohol (ethanol) per pediatric dose (13 g of syrup), equivalent to 10 g of ethanol in 200 ml (0.05 g/ml). The amount in one 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) per adult dose, equivalent to 10 g of ethanol in 200 ml (0.05 g/ml). The amount in one 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 does not appear to have an effect on adults and adolescents, and its effects in children are not clearly evident. Some effects may occur in very young children, for example drowsiness.
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 are alcohol-dependent, talk to your doctor before taking this medicine.

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

SOPULMIN Syrup contains benzyl alcohol (present in caramel flavoring)
This medicine contains a flavoring which itself contains benzyl alcohol.
Benzyl alcohol may cause allergic reactions.

3. How to take SOPULMIN

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.
Unless otherwise prescribed by a doctor, the recommended dosage, method and frequency of administration are as follows:
SOPULMIN 40 mg/5 ml syrup
Adults: The recommended dose is 1–2 tablespoons twice daily.
Children over 30 months of age: The recommended dose is 2 teaspoons twice daily.
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 daily.
If you take more SOPULMIN than you should
There are no known cases of overdose.
In case of accidental ingestion or overdose of SOPULMIN, contact your doctor immediately or go to the nearest hospital.
If you forget to take SOPULMIN
Do not take a double dose to make up for the missed dose.
If you have any questions 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.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

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

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 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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
The stated expiry date applies to the product stored in its original, undamaged packaging and kept under recommended storage conditions.
No special storage precautions are required for the syrup and sachets.
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 SOPULMIN contains
SOPULMIN 40 mg/5 ml syrup

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

SOPULMIN Adults 300 mg oral solution granules

• The active substance is sobrerol. Each sachet contains 300 mg of sobrerol.
• The other components are: mandarin flavour, lemon flavour, orange flavour, 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 oral solution granules 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 oral solution granules
Doppel Farmaceutici S.r.l. - Via Volturno, 48-Quinto Dè Stampi –20089 Rozzano (MI) - Italy

Package leaflet: Information for the user

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

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 have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 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 substance sobrerol, which belongs to a group of medicines called mucolytics,
which reduce the viscosity of mucus, making it more fluid and facilitating its elimination.
SOPULMIN is indicated to help remove excess mucus and phlegm in acute and
chronic respiratory tract disorders.

2. What you need to know before using SOPULMIN

Do not use SOPULMIN

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

Exercise special caution:

• 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 in particular the risk of neuropsychological disorders.

Warnings and precautions
Talk to your doctor or pharmacist before using SOPULMIN.
Other medicines and SOPULMIN
Inform 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 (medicinal or cosmetic) containing terpene derivatives
(e.g. camphor, cineole, niaouli, wild thyme, 20 terpineol, terpinen, 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 may be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor or pharmacist before using this medicine.
During the first three months of pregnancy, use this medicine only when strictly necessary and under direct medical supervision. There are no known contraindications during breastfeeding.
Driving and using machines
SOPULMIN does not impair the ability to drive or operate machinery.
SOPULMIN injectable solution contains benzoic 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 exactly as directed 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 as follows.

SOPULMIN Adults 60 mg/4 ml injectable solution
Adults: The recommended dose is 1–2 vials per day by intramuscular injection.

If you use more SOPULMIN than you should
There are no known cases of overdose.
If you are concerned that you may have been given too high a dose of SOPULMIN, contact your doctor immediately or go to the nearest hospital.

If you forget to use SOPULMIN
Do not use a double dose to make up for a forgotten dose.
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.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

• stomach disturbances and nausea;
• bronchial obstruction (airway blockage).

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 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 stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, undamaged packaging and stored correctly.
Vials for injectable solution must be stored in a dry place at room temperature.
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 SOPULMIN contains
SOPULMIN Adults 60 mg/4 ml injectable solution

• The active substance is sobrerol. Each vial contains 60 mg of sobrerol.
• The other components are: sodium benzoate, benzoic acid, water for injectable preparations.

Description of the appearance of SOPULMIN and contents of the pack
Each pack of SOPULMIN injectable solution contains 10 vials of 4 ml.
Marketing Authorization Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan - Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - Quinto De' Stampi – 20089 Rozzano (MI) - Italy

Package leaflet: information for the user

SOPULMIN 40 mg/3 ml nebulizer solution

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.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the 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 improvement or if you experience worsening of symptoms 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 substance sobrerol, which belongs to a group of medicines called mucolytics,
which reduce the viscosity of mucus, making it more fluid and facilitating its elimination. SOPULMIN is indicated
to help remove excess mucus and phlegm in acute and chronic respiratory tract disorders.
Consult your doctor if you do not feel better or 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 substance or to any of the other ingredients of this medicine (listed in section 6).
• In children with a history of epilepsy or febrile seizures.

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 risks associated with accumulation of terpene derivatives in the body, including the brain, and particularly due to risks of neuropsychological disturbances.

Warnings and precautions
Talk to 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 (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
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During the first three months of pregnancy, use this medicine only when strictly necessary and under direct medical supervision. There are no known contraindications during breastfeeding.
Driving and operating machinery
SOPULMIN does not affect the ability to drive vehicles or operate machinery.
SOPULMIN nebulizing 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 may cause local irritation.
Sodium benzoate and benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to use SOPULMIN

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.
Unless otherwise prescribed by a physician, the recommended dosage, method, and frequency of administration are as follows:
SOPULMIN 40 mg/3 ml nebulising solution
The recommended dose is 1 vial of solution for nebulisation per inhalation via mask or nasal catheter, once or twice daily.
If you use more SOPULMIN than you should
No cases of overdose are known.
In case of accidental ingestion/overdose of SOPULMIN, contact your doctor immediately 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 questions 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 everyone experiences them.
The following side effects may occur:
Not known (frequency cannot be estimated from available data)

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

Reporting of side effects
If you experience any side effects, 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 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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, undamaged packaging, correctly stored.
The vials for nebulizer solution must be stored in a dry place at room temperature.
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 SOPULMIN contains
SOPULMIN 40 mg/3 ml nebulising solution

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

Description of the appearance of SOPULMIN and contents of the pack
Each pack of SOPULMIN nebulising solution contains 10 vials of 3 ml.
Marketing Authorization Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan - Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - Quinto de' Stampi – 20089 Rozzano (MI) - Italy