BRONCOVALEAS 2 mg /5 Ml Syrop

Treść ulotki

1. Broncovaleas 2 mg/5 ml syrup
   1. What is Broncovaleas syrup and what is it used for
   2. What you need to know before you take Broncovaleas syrup
   3. How to take Broncovaleas syrup
   4. Possible side effects
   5. How to store Broncovaleas syrup
   6. Contents of the pack and other information
2. Broncovaleas 100 micrograms/spray
   1. What is Broncovaleas pressurized suspension for inhalation and what it is used for
   2. What you need to know before using Broncovaleas pressurised suspension for inhalation
   3. How to use Broncovaleas pressurized suspension for inhalation
   4. Possible side effects
   5. How to store Broncovaleas pressurised suspension for inhalation
   6. Contents of the pack and other information
3. Broncovaleas 5mg/ml solution for nebulisation
   1. What is Broncovaleas solution for nebulization and what it is used for
   2. What you need to know before using Broncovaleas solution for nebulization
   3. How to use Broncovaleas solution for nebulization
4. Broncovaleas solution for nebulization is only for inhalation use, and must be used only
   1. Possible side effects
   2. How to store Broncovaleas solution for nebulization
   3. Contents of the pack and other information

Broncovaleas 2 mg/5 ml syrup

Salbutamol

Read this leaflet carefully before taking 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Broncovaleas syrup and what is it used for

Broncovaleas syrup contains the active ingredient salbutamol, which belongs to a group of
medicines called bronchodilators. Salbutamol helps the airways to remain open,
facilitating the passage of air.
This medicine is used in the treatment of breathing difficulties caused by bronchial asthma and/or
obstructive bronchopathies with an asthmatic component.

2. What you need to know before you take Broncovaleas syrup

Do not take Broncovaleas syrup

• if you are allergic to salbutamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Broncovaleas syrup.
Tell your doctor if you suffer from serious heart disease and if you experience chest pain (angina)
in the region behind the sternum before starting therapy with Broncovaleas syrup.
If you suffer from severe or unstable asthma, Broncovaleas syrup should not be the only or the main
therapeutic treatment.
Severe asthma requires regular medical check-ups, including tests that monitor lung function.
In patients with severe asthma, the doctor may prescribe the maximum recommended doses of
inhaled and/or oral steroids.
If you notice the need to use medicines more frequently to control asthma symptoms,
consult your doctor because this may indicate a worsening of asthma and may
therefore require different treatment (see section “how to use Broncovaleas”).

Pay particular attention with this medicine:

• if you notice a worsening of asthma during treatment; in this case, contact your doctor immediately, as a sudden worsening of asthma is potentially life-threatening and your doctor will consider the possibility of increasing the dose or starting treatment with corticosteroids (anti-inflammatory drugs);
• if you have serious heart problems, such as coronary artery disease (blood vessels that carry blood to the heart), fast and irregular heartbeat (tachyarrhythmia) or severe heart failure, if you experience chest pain or a worsening of heart disease symptoms during treatment, as the use of Broncovaleas syrup may increase the risk of insufficient oxygenation of the heart muscle (myocardial ischemia);
• if you suffer from any of the conditions listed below, as in this case you should use Broncovaleas syrup only if absolutely necessary: heart artery disease (coronary artery disease), irregular heartbeat (arrhythmias), high blood pressure (hypertension), a disease of the optic nerve called glaucoma, excessive production of thyroid hormones (hyperthyroidism), pheochromocytoma, a rare tumor of the adrenal gland, enlarged prostate (prostatic hypertrophy), diabetes.

Broncovaleas syrup may cause reversible changes in certain metabolic parameters such as
for example, an increase in blood sugar levels (hyperglycemia) that diabetic patients may not
always be able to balance without changing ongoing diabetic therapy. In some cases, a complication of diabetes called ketoacidosis has been reported, which manifests with rapid weight loss, nausea or vomiting. The simultaneous administration of other medicines for asthma
(glucocorticoids) can worsen this effect.
Furthermore, this medicine can lead to a reduction in blood potassium levels (hypokalemia),
especially if taken at the same time as other medicines for the treatment of asthma (such as
xanthine derivatives or steroids) or medicines to increase urine production (diuretics), or if
you suffer from a lack of oxygen in the body (hypoxia). In this case, your doctor will
recommend that you regularly undergo blood tests to check potassium levels.

For those who engage in sports:the use of the medicine without therapeutic necessity constitutes doping
and may still result in positive doping tests.

Other medicines and Broncovaleas syrup
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
Normally, bronchodilator medicines such as the beta-agonist salbutamol and antihypertensive medicines such as the non-selective beta-blocker propranolol should not be prescribed
at the same time.

Pregnancy, breastfeeding and fertility
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.
There is limited knowledge regarding use during pregnancy, therefore Broncovaleas should only be used if the doctor considers it absolutely necessary.
Breastfeeding
Since salbutamol probably passes into breast milk, it is not recommended for use
in breastfeeding mothers unless the doctor considers it absolutely necessary.
It is not known whether salbutamol present in breast milk can cause harmful effects to the fetus.

Driving and using machines
No effects on the ability to drive vehicles and use machines have been reported.

Broncovaleas syrup contains para-hydroxybenzoates (parabens), sucrose, azorubine
(E122) and ethanol
The medicine contains methyl parahydroxybenzoate and ethyl parahydroxybenzoate which may cause
allergic reactions (even delayed).
This medicine contains sucrose. The amount of sucrose is equal to 7.7 g per 10
ml dose of medicine. To be taken into consideration in people affected by diabetes mellitus.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
This medicine contains the colorant E122 azorubine which may cause allergic reactions.
This medicine contains 7.6 mg of alcohol (ethanol), contained in the cherry flavor, in a dose of
10 ml (1 measuring spoon) of Broncovaleas syrup. The amount of ethanol contained in 10 ml of this
medicine is equivalent to 0.2 ml of beer or 0.1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Broncovaleas syrup

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The doctor will be able to establish what is the most appropriate dose for you.

Adults: The effective doses of Broncovaleas syrup must be determined individually, starting
from the lowest doses of half a measuring cup (5 ml), twice a day, up to a maximum of 1 measuring cup
(10 ml), twice a day.

Use in children and adolescents under 12 years of age
Children from 3 to 6 years: one quarter - half a measuring cup (2.5 ml - 5 ml), twice a day.
Children from 6 to 12 years: half a measuring cup (5 ml), twice a day.
Over 12 years: adult dosage.
Since adverse effects may occur at high doses, the dosage and frequency of
administrations must be varied only as indicated by the doctor.

If you take more Broncovaleas syrup than you should
In case of accidental ingestion/intake of an excessive dose of Broncovaleas syrup,
immediately inform your doctor or go to the nearest hospital.
The main signs and symptoms resulting from an excessive dose (overdose) may be:
agitation, tremors, palpitations (tachycardia), restlessness, reduction of potassium levels in the
blood (hypokalemia) and accumulation of lactic acid in the body (lactic acidosis).
Furthermore, particularly in children, nausea, vomiting and increased levels of
blood sugar (hyperglycemia) have been reported following intake of an excessive dose of salbutamol for
oral use.
The specific antidote in case of accidental overdose consists of medicines with an action
opposite to that of Broncovaleas syrup (cardioselective beta-blockers). These medicines should
however be taken with caution because, in sensitive subjects, they can cause severe crises of
bronchospasm (narrowing of the bronchi, causing difficulty breathing).

If you forget to take Broncovaleas syrup
Do not take a double dose to make up for a missed dose.

If you stop taking Broncovaleas syrup
Do not stop taking this medicine without consulting your doctor.
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.

Very common(may affect more than 1 in 10 people)

• tremor.

Common(may affect up to 1 in 10 people)

• headache;
• increased heart rate (tachycardia);
• palpitations;
• muscle cramps.

Rare(may affect up to 1 in 1,000 people)

• decreased levels of potassium in the blood (hypokalaemia);
• irregular heartbeat (cardiac arrhythmia), including atrial fibrillation (cardiac arrhythmia originating from the atria of the heart), supraventricular tachycardia (fast rhythm originating above the ventricle) and extrasystole (heartbeat that occurs earlier than expected);
• dilation of skin blood vessels (peripheral vasodilation).

Very rare(may affect up to 1 in 10,000 people)

• hypersensitivity reactions including: rapid swelling of the skin and mucous membranes (angioedema), urticaria, difficulty breathing due to narrowing of the bronchi (bronchospasm), reduced blood pressure (hypotension), loss of consciousness (collapse);
• hyperactivity;
• insufficient oxygenation of the heart muscle (myocardial ischemia);
• feeling of muscle tension.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
https://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 Broncovaleas syrup

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 refers to the
product in intact packaging, correctly stored.
Store at a temperature below 25°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 Broncovaleas syrup contains

• The active ingredient is salbutamol. 5 ml of syrup contain 2 mg of salbutamol (corresponding to 2.41 mg of salbutamol sulfate).
• The other ingredients are: sucrose, methylparahydroxybenzoate, ethylparahydroxybenzoate, cherry aroma (contains ethanol), azorubine dye E 122, purified water.

Description of the appearance of Broncovaleas syrup and contents of the pack
Broncovaleas syrup is presented as a syrup.
The pack of Broncovaleas syrup contains a 120 ml bottle of syrup.

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 - 20143 Milan

Manufacturer
VALEAS S.p.A. - Chemical and Pharmaceutical Industry - Via Vallisneri, 10 - 20133 Milan
Lachifarma S.r.l. Salento Chemical Pharmaceutical Laboratory - S.S. 16 – Industrial Area 73010
Zollino (LE)

Broncovaleas 100 micrograms/spray

pressurized suspension for inhalation
Salbutamol

Read this leaflet carefully before you start to use 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Broncovaleas pressurized suspension for inhalation and what it is used for

Broncovaleas pressurized suspension for inhalation contains the active ingredient salbutamol, which
belongs to a group of medicines called bronchodilators. Salbutamol helps the airways to
remain open, facilitating the passage of air.
This medicine is used in the treatment of breathing difficulties caused by bronchial asthma and/or
in obstructive bronchopathies with an asthmatic component.

2. What you need to know before using Broncovaleas pressurised suspension for inhalation

Do not use Broncovaleas pressurised suspension for inhalation

• if you are allergic to salbutamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Broncovaleas pressurised suspension for
inhalation.
Tell your doctor if you have serious heart conditions and if you experience chest pain (angina)
in the region behind the sternum, before starting therapy with Broncovaleas pressurised
suspension.
If you have severe or unstable asthma, Broncovaleas pressurised suspension for inhalation should not
be the only or main therapeutic treatment.
Severe asthma requires regular medical monitoring, including tests that check lung function.
In patients with severe asthma, your doctor may prescribe the maximum recommended doses of
inhaled and/or oral steroids.
If you notice that you need to use your medicines more frequently to control your asthma symptoms,
see your doctor because this may indicate a worsening of your asthma and you may therefore need
different treatment (see section “how to use Broncovaleas”).
During treatment with medicines administered by inhalation, shortly after inhalation, you may
experience increased breathlessness due to excessive constriction of the airways
(paradoxical bronchospasm) (see section “Possible side effects”).
If this occurs, immediately stop therapy with Broncovaleas
pressurised suspension for inhalation and immediately consult your doctor to establish an
alternative treatment.

Pay particular attention with this medicine:

• if you notice a worsening of your asthma during treatment; in this case, consult your doctor immediately, as a sudden worsening of asthma is potentially life-threatening and your doctor will consider increasing the dose or starting treatment with corticosteroids (anti-inflammatory drugs);
• if you have serious heart problems, such as coronary artery disease (blood vessels that carry blood to the heart), fast and irregular heartbeat (tachyarrhythmia) or severe heart failure, if you experience chest pain or a worsening of heart disease symptoms during treatment, as the use of Broncovaleas pressurised suspension for inhalation may increase the risk of insufficient oxygenation of the heart muscle (myocardial ischemia);
• if you suffer from any of the following conditions, as in this case you should only use Broncovaleas pressurised suspension for inhalation if absolutely necessary: heart artery diseases (coronary artery disease), irregular heartbeat (arrhythmias), high blood pressure (hypertension), a disease of the optic nerve called glaucoma, excessive production of thyroid hormones (hyperthyroidism), pheochromocytoma, a rare tumor of the adrenal gland, enlarged prostate (prostatic hypertrophy), diabetes.

Broncovaleas pressurised suspension for inhalation may cause reversible changes in
some metabolic parameters such as, for example, increased blood sugar levels
(hyperglycemia) that diabetic patients are not always able to balance without changing their ongoing diabetic therapy. In some cases, a complication of diabetes called
ketoacidosis has been reported, which manifests with rapid weight loss, nausea or vomiting. Co-administration of other medicines for asthma (glucocorticoids) may worsen this effect.
Furthermore, this medicine can lead to a reduction in blood potassium levels (hypokalaemia),
especially if taken at the same time as other medicines for the treatment of asthma (such as
xanthine derivatives or steroids) or medicines to increase urine production (diuretics), or if
you suffer from a lack of oxygen in the body (hypoxia). In this case, your doctor will
recommend that you have regular blood tests to check your potassium levels.

For athletes:the use of the medicine without therapeutic need constitutes doping
and may still result in a positive doping test.

Other medicines and Broncovaleas pressurised suspension for inhalation
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Normally, bronchodilator medicines such as the beta2-agonist salbutamol and antihypertensive medicines such as the non-selective beta-blocker propranolol should not be prescribed
at the same time.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
There is limited knowledge regarding use during pregnancy, therefore you should only use
Broncovaleas if your doctor considers it absolutely necessary.
Breastfeeding
Since salbutamol probably passes into breast milk, it is not recommended for use
in breastfeeding mothers unless your doctor considers it absolutely necessary.
It is not known whether salbutamol in breast milk can cause harmful effects to the fetus.

Driving and using machines
No effects on the ability to drive and operate machines have been reported.

Broncovaleas suspension contains ethanol
This medicine contains 6.908 mg of ethyl alcohol (ethanol) per dose (spray). The amount of
ethanol contained in 1 spray of this medicine is equivalent to 0.2 ml of beer or 0.1 ml of
wine. The small amount of alcohol in this medicine will not produce significant effects.

3. How to use Broncovaleas pressurized suspension for inhalation

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.

The recommended doses are:

Adults: 2 puffs, 3-6 times a day.
If you know the times when a respiratory (bronchospastic) crisis may occur, try to use
the medicine about half an hour before the presumed onset.

Use in children
The dose must be proportionally reduced in relation to age and the severity of the syndrome in
progress. Children should use Broncovaleas pressurized suspension for inhalation only
under the direct supervision of an adult, strictly adhering to the prescribed dose.
Administer a maximum of 2 puffs of pressurized suspension at a time and allow
at least 4 hours before repeating the treatment.

Warning: Excessive use of Broncovaleas pressurized suspension for inhalation may be
dangerous.
Shake well before use.
Keep the mouthpiece and valve always clean. Wash the mouthpiece frequently with lukewarm water.
Protect the mouthpiece from dust.

Instructions for use:

• 1. Remove the cap from the mouthpiece.

• 2. Hold the inhaler with your thumb and index finger, without pressing the canister. Shake vigorously.

• 3. Place the mouthpiece between your lips.

• 4. Exhale deeply, blowing directly into the mouthpiece.

• 5. Take a slow, deep breath while simultaneously pressing the index finger on the bottom of the canister once, to coincide the delivery of the medicine with the beginning of the inspiration itself.
• 6. Hold your breath for as long as possible. Remove the mouthpiece from your lips and exhale slowly.
• 7. Wait at least one minute before performing the next inhalation of the medicine. Follow the procedures described in points 2, 3, 4, 5 and 6.

• 8. Replace the cap on the mouthpiece.

Broncovaleas pressurized suspension for inhalation should be used as needed rather than
regularly.
If asthma is active (e.g., frequent symptoms or exacerbations, such as shortness of breath that makes
it difficult to speak, eat, or sleep, cough, wheezing, chest tightness, or
limitation of physical abilities), you should immediately inform your doctor, who may start or
increase a medicine to control asthma, such as an inhaled corticosteroid.
Inform your doctor as soon as possible if the medicine does not seem to work as well as usual
(e.g., if higher doses are needed to relieve breathing problems or if the inhaler
does not provide relief for at least 3 hours), as asthma may worsen and another
medicine may be needed.
If you use Broncovaleas pressurized suspension more than twice a week to treat
asthma symptoms, excluding use as a preventative measure before exercise, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening
of asthma) that can lead to serious complications and can be life-threatening or
even fatal. You should contact your doctor as soon as possible to review your asthma treatment.
If you are using a medicine to treat lung inflammation daily, such as an
“inhaled corticosteroid”, it is important to continue using it regularly, even if you
feel better.

If you use more Broncovaleas pressurized suspension for inhalation than you should
In case of ingestion/accidental intake of an excessive dose of Broncovaleas pressurized suspension
for inhalation, immediately inform your doctor or go to the nearest hospital.
The main signs and symptoms resulting from an overdose may be:
agitation, tremors, palpitations (tachycardia), restlessness, reduced potassium levels in
the blood (hypokalemia) and accumulation of lactic acid in the body (lactic acidosis).
The specific antidote in case of accidental overdose consists of medicines with an action
opposite to that of Broncovaleas pressurized suspension for inhalation (cardioselective beta-blockers).
These medicines should still be taken with caution because, in sensitive subjects, they can cause serious crises of bronchospasm (narrowing of the bronchi, causing
difficulty breathing).
Following an overdose of salbutamol, the doctor may request a check of potassium levels
in the blood and lactate levels. Monitoring of lactate levels in the blood may be indicated for the risk of excessive accumulation of the same (metabolic acidosis) in
particular if the need to breathe more frequently (tachypnea) persists or worsens, due to
inadequate breathing (dyspnea).

If you forget to use Broncovaleas pressurized suspension for inhalation
Do not use a double dose to make up for a missed dose.

If you stop using Broncovaleas pressurized suspension for inhalation
Do not stop using this medicine without consulting your doctor.
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.

Very common(may affect more than 1 in 10 people)

• tremor.

Common(may affect up to 1 in 10 people)

• headache;
• increased heart rate (tachycardia);
• palpitations;
• muscle cramps.

Uncommon(may affect up to 1 in 100 people)

• irritation of the mouth and throat.

Rare(may affect up to 1 in 1,000 people)

• reduction of potassium levels in the blood (hypokalaemia);
• irregular heartbeat (cardiac arrhythmia), including atrial fibrillation (cardiac arrhythmia originating from the atria of the heart), supraventricular tachycardia (fast rhythm originating above the ventricle) and extrasystole (heartbeat that occurs earlier than expected);
• dilation of blood vessels in the skin (peripheral vasodilation).

Very rare(may affect up to 1 in 10,000 people)

• hypersensitivity reactions including: rapid swelling of the skin and mucous membranes (angioedema), urticaria, difficulty breathing due to narrowing of the bronchi (bronchospasm), reduced blood pressure (hypotension) loss of consciousness (collapse);
• hyperactivity;
• insufficient oxygenation of the heart muscle (myocardial ischemia);
• severe difficulty breathing caused by exaggerated constriction of the bronchi following inhalation of the bronchodilator medicine (paradoxical bronchospasm) (see “Warnings and precautions”);
• feeling of muscle tension.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system at: https://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 Broncovaleas pressurised suspension for inhalation

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 refers to the
product in intact packaging, correctly stored.
Store at a temperature below 25°C.
The pressurised container must not be punctured and must not be brought – even if empty –
near sources of heat, exposed to direct sunlight or frozen.
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 Broncovaleas pressurised suspension for inhalation contains

• The active ingredient is salbutamol. One pressurised container contains 20 mg of salbutamol (corresponding to 24.1 mg of salbutamol sulfate).
• The other ingredients are: oleic acid, ethanol, norflurane.

Description of the appearance of Broncovaleas pressurised suspension for inhalation and content of the pack
Broncovaleas is presented as a pressurised suspension for inhalation.
The product does not contain substances harmful to the stratospheric ozone layer.
The pack of Broncovaleas pressurised suspension for inhalation contains a pressurised container
for 200 sprays of 100 micrograms.

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 - 20143 Milano

Manufacturer
VALEAS S.p.A. - Chemical and Pharmaceutical Industry - Via Vallisneri, 10 - 20133 Milano

Broncovaleas 5mg/ml solution for nebulisation

Salbutamol

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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Broncovaleas solution for nebulization and what it is used for

Broncovaleas solution for nebulization contains the active ingredient salbutamol, which belongs to
a group of medicines called bronchodilators. Salbutamol helps the airways to remain
open, facilitating the passage of air.
This medicine is used in the treatment of breathing difficulties caused by bronchospasm
(narrowing of the bronchi) in patients over 2 years of age, suffering from reversible obstructive
airway diseases and acute attacks of bronchospasm.

2. What you need to know before using Broncovaleas solution for nebulization

Do not use Broncovaleas solution for nebulization

• if you are allergic to salbutamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Broncovaleas solution for nebulization.
Tell your doctor if you have serious heart disease and if you experience chest pain (angina)
in the region behind the sternum before starting therapy with Broncovaleas solution for nebulization.
If you have severe or unstable asthma, Broncovaleas solution for nebulization should not be
the only or main therapeutic treatment.
Severe asthma requires regular medical monitoring, including tests that check lung function.
In patients with severe asthma, your doctor may prescribe the maximum recommended doses of
inhaled and/or oral steroids.
If you notice that you need to use your medicines more frequently to control your asthma symptoms,
see your doctor because this may indicate a worsening of your asthma and you may therefore
need different treatment (see section “how to use Broncovaleas”).
During treatment with medicines administered by inhalation, shortly after inhalation, you may
experience increased breathlessness due to excessive constriction of the bronchi
(paradoxical bronchospasm) (see section “Possible side effects”).
If this occurs, immediately stop therapy with Broncovaleas
solution for nebulization and immediately consult your doctor to establish alternative
treatment.

Pay particular attention with this medicine:

• if you notice a worsening of your asthma during treatment; in this case, consult your doctor immediately, as a sudden worsening of asthma is potentially life-threatening and your doctor will consider the possibility of increasing the dose or starting treatment with corticosteroids (anti-inflammatory drugs);
• if you have serious heart problems, such as alteration of the coronary arteries (blood vessels that carry blood to the heart) (ischemic heart disease), fast and irregular heartbeat (tachyarrhythmia) or severe heart failure, if you experience chest pain or a worsening of heart disease symptoms during treatment, as the use of Broncovaleas solution for nebulization may increase the risk of insufficient oxygenation of the heart muscle (myocardial ischemia);
• if you are undergoing concomitant treatment with anticholinergic medicines (e.g. ipratropium bromide) administered by nebulization, due to the risk of an eye disease called acute angle-closure glaucoma (see “Other medicines and Broncovaleas solution for nebulization”). Follow the instructions for correct administration of the medicine and avoid contact of the solution or spray with the eyes.
• if you have any of the following conditions, as in this case you should use Broncovaleas solution for nebulization only if absolutely necessary: heart artery diseases (coronary artery disease), irregular heartbeat (arrhythmias), high blood pressure (hypertension), an eye disease called glaucoma, excessive production of thyroid hormones (hyperthyroidism), pheochromocytoma, a rare tumor of the adrenal gland, enlarged prostate (prostatic hypertrophy), diabetes.

Broncovaleas solution for nebulization may cause reversible changes in some metabolic parameters
such as, for example, an increase in blood sugar levels (hyperglycemia) that patients with diabetes
are not always able to balance without changing ongoing diabetic therapy.
In some cases, a complication of diabetes called ketoacidosis has been reported, which manifests
with rapid weight loss, nausea or vomiting. The simultaneous administration of other medicines
for asthma (glucocorticoids) may worsen this effect.
High therapeutic doses of Broncovaleas solution for nebulization can cause an accumulation of
lactate in the body (lactic acidosis), especially if you are being treated for an asthma exacerbation
(see section “Possible side effects”).
Increased lactate levels can cause difficulty breathing (dyspnea) and very rapid breathing
(compensatory hyperventilation) which could be mistakenly interpreted as
a sign of asthma treatment failure and lead to inappropriate intensification of
treatment with short-acting bronchodilator medicines (beta-agonists). In this
situation, your doctor will recommend that you undergo blood tests to check lactate levels to avoid the accumulation of an excessive amount (metabolic acidosis).
In addition, this medicine can lead to a reduction in blood potassium levels (hypokalemia),
especially if taken at the same time as other medicines for the treatment of asthma (such as
xanthine derivatives or steroids) or medicines to increase urine production (diuretics), or if
you suffer from a lack of oxygen in the body (hypoxia). In this case, your doctor will
recommend that you undergo regular blood tests to check potassium levels.

For athletes:the use of the medicine without therapeutic need constitutes doping
and may in any case result in a positive doping test.

Other medicines and Broncovaleas solution for nebulization
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Normally, bronchodilator medicines such as the beta-agonist salbutamol and antihypertensive medicines such as the non-selective beta-blocker propranolol should not be prescribed
at the same time.

Pregnancy, breastfeeding and fertility
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. There is
limited knowledge regarding use during pregnancy, therefore you should use
Broncovaleas only if your doctor considers it absolutely necessary.
Breastfeeding
As salbutamol probably passes into breast milk, it is not recommended for use in
breastfeeding mothers unless your doctor considers it absolutely necessary.
It is not known whether salbutamol present in breast milk can cause harmful effects to the fetus.

Driving and operating machinery
No effects on the ability to drive and operate machinery have been reported.

Broncovaleas solution for nebulization contains para-hydroxybenzoates (parabens)
The medicine contains methyl parahydroxybenzoate, ethyl parahydroxybenzoate and butyl
parahydroxybenzoate which may cause allergic reactions (including delayed reactions) and exceptionally
bronchospasm (narrowing of the bronchi and difficulty breathing).

3. How to use Broncovaleas solution for nebulization

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

Broncovaleas solution for nebulization is only for inhalation use, and must be used only

through a suitable nebulizer.
The solution must not be swallowed or injected.
Salbutamol has a duration of action of 4 to 6 hours in most patients.

Correlation n° drops - ml – mg
The recommended doses are:

Adults, adolescents and children over 12 years
2.5 mg of salbutamol administered three or four times a day by nebulization. A frequency
of administration greater than 4 times a day or doses higher than 2.5 mg is not recommended.
To administer 2.5 mg of salbutamol, dilute 0.5 ml of Broncovaleas solution with 2.5 ml
of sterile saline solution. The flow rate of the inhaler should be adjusted to
administer the dose within a time of 5 to 15 minutes.
Since adverse effects may occur at high doses, the dosage and frequency of
administrations must be varied only as directed by your doctor.
Renew the solution contained in the nebulizer ampoule at least once a day.

Use in children and adolescents from 2 to 12 years
Caution: considering the risk of overdose due to incorrect administration in
children, follow the dosage prescribed by your doctor, paying particular attention to the
correspondence: “drops - ml – mg”.
The initial dosage should be based on body weight (0.1 to 0.15 mg/kg per dose), with subsequent
titration to achieve the desired clinical response.
The dose should never exceed 2.5 mg three or four times a day by nebulization (read
the following table carefully).

Instructions for use
To prevent the bottle from being easily opened, a dropper has been used for which opening requires the movement indicated below:

• To open the bottle, simultaneously press on the dropper ring and twist it counterclockwise.
• To close the bottle, screw the ring tightly clockwise. To ensure that the safety mechanism has engaged correctly, rotate the ring counterclockwise without pressing and verify that the bottle cannot be opened.

Broncovaleas solution for nebulization should be used as needed rather than regularly.
If asthma is active (e.g., frequent symptoms or exacerbations, such as shortness of breath that makes
it difficult to speak, eat, or sleep, cough, wheezing, tightness in the chest, or
limitation of physical abilities), you should immediately inform your doctor, who may start or
increase a medicine to control asthma, such as an inhaled corticosteroid.
Inform your doctor as soon as possible if the medicine does not seem to work as well as usual
(e.g., if higher doses are needed to relieve breathing problems or if the inhaler
does not provide relief for at least 3 hours), as asthma may worsen and another
medicine may be needed.
If you use Broncovaleas solution for nebulization more than twice a week to treat asthma symptoms,
excluding use as a preventative measure before exercise, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening of asthma) that
can lead to serious complications and can be life-threatening or even fatal.
You should contact your doctor as soon as possible to review your asthma treatment.
If you are using a medicine to treat lung inflammation on a daily basis, such as an
“inhaled corticosteroid”, it is important to continue using it regularly, even if you
feel better.

If you use more Broncovaleas solution for nebulization than you should
In case of ingestion/accidental intake of an excessive dose of Broncovaleas solution for
nebulization, immediately inform your doctor or go to the nearest hospital.
The main signs and symptoms resulting from an overdose (overdosage) may be:
agitation, tremors, palpitations (tachycardia), restlessness, decreased potassium levels in
the blood (hypokalemia) and accumulation of lactic acid in the body (lactic acidosis).
The specific antidote in case of accidental overdose consists of medicines with an action
opposite to that of Broncovaleas solution for nebulization (cardioselective beta-blockers). These
medicines should still be taken with caution because, in sensitive subjects, they can cause
severe bronchospasm (narrowing of the bronchi, causing difficulty breathing).
Following an overdose of salbutamol, the doctor may request a check of potassium levels in the blood and those of lactate. Monitoring of lactate levels in the blood may be indicated for the risk of accumulation of excessive amounts of the same (metabolic acidosis) in
particular if the need to breathe more frequently (tachypnea) persists or worsens, due to
inadequate breathing (dyspnea).

If you forget to use Broncovaleas solution for nebulization
Do not use a double dose to make up for the missed dose.

If you stop using Broncovaleas solution for nebulization
Do not stop using this medicine without consulting your doctor.
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.

Very common(may affect more than 1 in 10 people)

• tremor.

Common(may affect up to 1 in 10 people)

• headache;
• increased heart rate (tachycardia);
• palpitations;
• muscle cramps.

Uncommon(may affect up to 1 in 100 people)

• irritation of the mouth and throat.

Rare(may affect up to 1 in 1,000 people)

• reduction of potassium levels in the blood (hypokalaemia);
• irregular heartbeat (cardiac arrhythmia), including atrial fibrillation (cardiac arrhythmia originating from the atria of the heart), supraventricular tachycardia (fast rhythm originating above the ventricle) and extrasystole (heartbeat that occurs earlier than expected);
• dilation of skin blood vessels (peripheral vasodilation).

Very rare(may affect up to 1 in 10,000 people)

• hypersensitivity reactions including: rapid swelling of the skin and mucous membranes (angioedema), urticaria, difficulty breathing due to narrowing of the bronchi (bronchospasm),
• reduction of blood pressure (hypotension) loss of consciousness (collapse);
• hyperactivity;
• insufficient oxygenation of the heart muscle (myocardial ischemia);
• severe difficulty breathing caused by exaggerated constriction of the bronchi following inhalation of the bronchodilator medicine (paradoxical bronchospasm) (see “Warnings and precautions”);
• feeling of muscle tension.

Frequency not known(the frequency cannot be estimated from the available data)

• accumulation of lactic acid in the body (lactic acidosis) (see “Warnings and precautions”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system at: https://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 Broncovaleas solution for nebulization

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 refers to the
product in intact packaging, correctly stored.
Do not use Broncovaleas solution for nebulization after 3 months have passed since the first opening of the
bottle.
Store at a temperature below 25°C.
Store in the original packaging to protect the medicine from light.
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 Broncovaleas solution for nebulisation contains

• The active ingredient is salbutamol. 100 ml of solution contains 500 mg of salbutamol (corresponding to 600 mg of salbutamol sulfate).
• The other ingredients are: methyl parahydroxybenzoate(E218), ethyl parahydroxybenzoate(E214), butyl parahydroxybenzoate, sodium chloride, sulfuric acid sol 1N, purified water.

Description of the appearance of Broncovaleas solution for nebulisation and contents of the pack
Broncovaleas is presented as a solution for nebulisation.
The pack of Broncovaleas solution for nebulisation contains an amber bottle of 15 ml.

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 - 20143 Milan

Manufacturer
VALEAS S.p.A. - Chemical and Pharmaceutical Industry - Via Vallisneri, 10 - 20133 Milan
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)
Lachifarma S.r.l. Salento Chemical Pharmaceutical Laboratory - S.S. 16 Industrial Area -73010
Zollino (LE)