BROKAST 4 mg Chewable Tablet

Зміст інструкції

1. BROKAST 4 mg chewable tablets
   1. What BROKAST is and what it is used for
   2. What you need to know before you take BROKAST
   3. How to take BROKAST
   4. Possible side effects
   5. How to store BROKAST
   6. Contents of the pack and other information
2. BROKAST 5 mg chewable tablets
   1. What is BROKAST and what is it used for
   2. What you need to know before taking BROKAST
   3. How to take BROKAST
   4. Possible side effects
   5. How to store BROKAST
   6. Contents of the pack and other information
3. BROKAST 10 mg film-coated tablets
   1. What is BROKAST and what is it used for
   2. What you need to know before taking BROKAST
   3. How to take BROKAST
   4. Possible side effects
   5. How to store BROKAST
   6. Contents of the pack and other information

BROKAST 4 mg chewable tablets

Equivalent medicine

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 only for you or for your child. Do not give it to other people, even if their symptoms are the same as yours or your child's, as it could be dangerous.
• If any undesirable effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What BROKAST is and what it is used for

BROKAST is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, BROKAST improves asthma symptoms and helps to control it.
Your doctor has prescribed BROKAST for the treatment of asthma, to prevent asthma symptoms both during the day and during the night.

• BROKAST is used for the treatment of patients who are not adequately controlled with their medications and need additional drugs.
• BROKAST can also be used as an alternative treatment to inhaled corticosteroids for patients between 2 and 5 years of age who have not recently taken oral corticosteroids for asthma and who have shown an inability to use inhaled corticosteroids.
• BROKAST also prevents the narrowing of the airways induced by exercise in patients 2 years of age and older.

The doctor will determine how to use BROKAST depending on the symptoms and severity of your child's asthma.

What is asthma?
Asthma is a long-term illness.
Asthma includes:

• Difficulty breathing due to narrowing of the airways. The narrowing of the airways worsens and improves in response to various conditions.
• Airways that react to many irritating stimuli, such as cigarette smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the airways.

The symptoms of asthma include: cough, shortness of breath, and a feeling of tightness in the chest.

2. What you need to know before you take BROKAST

Tell the doctor about any existing or past illnesses and any allergies.

Do not give or allow your child to take BROKAST

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

Warnings and precautions
Talk to your doctor or pharmacist before using BROKAST

• If your asthma or breathing gets worse, contact your doctor immediately.
• BROKAST by mouth should not be used to treat acute asthma attacks. If attacks occur, follow your doctor's instructions. Always keep your child's emergency inhaler medication with you for asthma attacks.
• It is important that your child takes all asthma medications prescribed by the doctor. BROKAST should not be used instead of other asthma medications that the doctor has prescribed for your child.
• If your child takes asthma medications, you should know that if they experience a combination of symptoms such as flu-like syndrome, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin redness, they should consult a doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if asthma worsens.

Patients should be aware that various neuropsychiatric events (e.g., changes in behavior and
mood) have been reported in adults, adolescents and children treated with BROKAST (see section
4). If you or your child develops these symptoms during treatment with BROKAST, you should consult your child's
doctor.

Children and adolescents
For children from 2 to 5 years, BROKAST 4 mg chewable tablets are available.
For children from 6 to 14 years, BROKAST 5 mg chewable tablets are available.

Other medicines and BROKAST
Some medicines can interfere with the way BROKAST works, or BROKAST can interfere with the
way other medicines work.
Tell the doctor if your child is taking or has recently taken any other medicines, including
those available without a prescription.
Tell the doctor if your child is taking the following medicines before starting to take BROKAST:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy).
• Rifampicin (used to treat tuberculosis and some other infections).

BROKAST with food and drink
BROKAST 4 mg chewable tablets should not be taken immediately before or after meals. It should be
taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding
This section is not applicable because BROKAST 4 mg chewable tablets are to be used in children aged
between 2 and 5 years. The information below, however, refers to the active ingredient, montelukast.

Pregnancy
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 taking this medicine.

Breastfeeding
It is not known whether BROKAST can pass into human milk. If you are breastfeeding or intend to breastfeed, you should consult
your doctor before taking BROKAST.

Driving and operating machinery
No effects on the ability to drive and operate machinery are expected.
Individual responses to medicines can however vary. Some undesirable effects (such as dizziness and drowsiness)
that have been reported very rarely with BROKAST may affect the ability to drive and
operate machinery.

BROKAST 4 mgchewable tablets contains aspartame
This medicine contains 0.0674 per 4 mg tablet. Aspartame is a source of phenylalanine. It may be
harmful if your child has phenylketonuria, a rare genetic disorder that causes a buildup of
phenylalanine because the body cannot properly process it.

3. How to take BROKAST

Give this medicine to your child following the doctor's or pharmacist's instructions exactly. If you have any doubts, consult your doctor or pharmacist.

• This medicine should be administered to the child under the supervision of an adult.
• The child should take only one BROKAST tablet a day as prescribed by the doctor.
• The tablet should be taken even if your child has no symptoms or is having an acute asthma attack.
• Give the tablet by mouth.

Use in children from 2 to 5 years
The recommended dose is one 4 mg chewable tablet to be taken every evening. BROKAST 4 mg
chewable tablets should not be taken immediately before or after meals. It should be taken at least 1 hour
before or 2 hours after meals.
If your child is taking BROKAST, make sure they do not take other products that contain the same
active substance, montelukast.

If your child takes more BROKASTthan they should
Consult your doctor immediately. In the majority of overdosage reports, no adverse effects
have been reported. The symptoms most frequently reported with overdosage in adults and children
include abdominal pain, drowsiness, thirst, headache, vomiting and hyperactivity.

If you forget to give BROKAST to your child
Try to give BROKAST as it was prescribed. However, if you forget to give a tablet,
continue to give the medicine according to the usual dosage. Do not give a double dose to make up for the
missed tablet.

If your child stops taking BROKAST
Treatment with BROKAST may only be effective against asthma if your child continues to take it. It is
important to continue taking BROKAST for as long as your doctor has prescribed it. It will help to
control your child's asthma.
If you have any doubts about the use of BROKAST, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, BROKAST can cause side effects, although not everybody gets them.
In clinical studies with montelukast 4 mg chewable tablets, the side effects considered related to
montelukast reported most commonly (occur in at least 1 in 100 patients and less than 1 in 10 patients
pediatric treated) were:

• abdominal pain
• thirst

In addition, the following side effect has been reported in clinical studies with montelukast 10 mg film-coated
tablets and 5 mg chewable tablets:

• headache

These side effects were usually mild and occurred more frequently in patients
treated with montelukast compared to those treated with placebo (a tablet that does not contain medicinal substance).
The frequency of possible side effects listed below is defined using the following convention:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known: the frequency cannot be estimated from the available data
In addition, the following side effects have been reported with post-marketing use of the medicine:

• upper respiratory tract infection (Very common)
• increased tendency to bleeding (Rare)
• allergic reactions including skin rash, swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing (Uncommon)
• changes in behaviour and mood [dream disturbances, including nightmares, insomnia, sleepwalking, irritability, feeling of anxiety, restlessness, agitation including aggressive or hostile behaviour, depression (Uncommon); tremor (Rare); hallucinations, suicidal thoughts and behaviour (Very rare)]
• dizziness, drowsiness, pins and needles, convulsions (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth, digestive disturbances (Uncommon)
• hepatitis (liver inflammation) (Very rare)
• bruising, itching, hives (Uncommon), painful, red skin lumps usually on the front of the legs (erythema nodosum) (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); feeling tired, unwell, swelling (Uncommon)
• stammering (Very rare)

During treatment of asthmatic patients with montelukast, a very rare complex of
symptoms has been reported, including flu-like symptoms, pins and needles or numbness in the arms or legs, worsening of
lung symptoms and/or rash (Churg-Strauss syndrome). If one or more of
these symptoms occur, the patient should stop taking the medicine and contact their doctor immediately.
Ask your doctor or pharmacist for further information about side effects. Report any side effects to your doctor or
pharmacist, even if they are not listed in this leaflet or if any symptom persists or gets worse.
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 BROKAST

Keep BROKAST out of sight and reach of children.
Do not use BROKAST after the expiry date indicated on the label with the six numbers after the word SCAD. The first
two numbers indicate the month; the last four indicate the year. The expiry date refers to the last day
of the month.
Store at a temperature not exceeding 25°C in the original packaging to protect it from light and humidity.
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 BROKAST contains

• The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The excipients are: Mannitol (E421), microcrystalline cellulose, sodium croscarmellose, red iron oxide (E172), hydroxypropylcellulose, cherry flavour (also contains triacetin (E1518)), aspartame (E951) and magnesium stearate.

Description of the appearance of BROKAST and contents of the pack
Pack of 28 tablets: 4 blisters of 7 tablets each.

Marketing Authorisation Holder
AGIPS FARMACEUTICI S.r.l. – Via AMENDOLA n. 4 – 16035 Rapallo

Manufacturer responsible for batch release
ADAMED PHARMA S.A. ul. Marszalka Jòzefa Pilsudskiego 5, 95-200 Pabianice, Poland

BROKAST 5 mg chewable tablets

Generic medicine

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 only for you or for your child. Do not give it to other people, even if their symptoms are the same as yours or your child's, as it could be dangerous.
• If any undesirable effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

2. What is BROKAST and what is it used for

BROKAST is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, BROKAST improves asthma symptoms and helps to control it.
Your doctor has prescribed BROKAST for the treatment of asthma, to prevent asthma symptoms both during the day and during the night.

• BROKAST is used for the treatment of patients who are not adequately controlled with their medications and need additional drugs.
• BROKAST can also be used as an alternative treatment to inhaled corticosteroids for patients from 6 to 14 years of age who have not recently taken oral corticosteroids for asthma and who have shown an inability to use inhaled corticosteroids.
• BROKAST also prevents airway narrowing induced by exercise in patients 2 years of age and older.

The doctor will determine how to use BROKAST depending on the symptoms and severity of your child's asthma.

What is asthma?
Asthma is a long-term illness.
Asthma includes:

• Difficulty breathing due to narrowing of the airways. The narrowing of the airways worsens and improves in response to various conditions.
• Airways that react to many irritant stimuli, such as cigarette smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the airways.

Asthma symptoms include: cough, shortness of breath, and a feeling of tightness in the chest.

2. What you need to know before taking BROKAST

Inform your doctor about any existing or past illnesses and any allergies.

Do not give BROKAST to your child

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

Warnings and precautions
Talk to your doctor or pharmacist before taking BROKAST

• if your asthma or breathing gets worse, contact your doctor immediately.
• BROKAST by mouth should not be used to treat acute asthma attacks. If attacks occur, follow your doctor's instructions. Always keep your child's emergency inhaled medication with you for asthma attacks.
• It is important that your child takes all asthma medications prescribed by the doctor. BROKAST should not be used instead of other asthma medications that your doctor has prescribed for your child.
• If your child is taking asthma medications, you should know that if they experience a combination of symptoms such as flu-like syndrome, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin redness, they should consult a doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if your asthma gets worse.

Patients should be aware that various neuropsychiatric events (e.g., changes in behavior and mood) have been reported in adults, adolescents and children treated with BROKAST (see section 4). If you or your child develops these symptoms during treatment with BROKAST, you should consult your child's doctor.

Children and adolescents
BROKAST 4 mg chewable tablets are available for children from 2 to 5 years of age.
BROKAST 5 mg chewable tablets are available for children from 6 to 14 years of age.

Other medicines and BROKAST
Some medicines can interfere with the way BROKAST works, or BROKAST can interfere with the way other medicines work.
Tell your doctor if your child is taking or has recently taken any other medicines, including those available without a prescription.
Tell your doctor if your child is taking the following medicines before starting to take BROKAST:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy).
• Rifampicin (used to treat tuberculosis and some other infections).

BROKAST with food and drink
BROKAST 5 mg chewable tablets should not be taken immediately before or after meals. It should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding
BROKAST 5 mg chewable tablets are intended for use in children aged 6 to 14 years. The information that follows, however, refers to the active ingredient, montelukast.

Pregnancy
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding
It is not known whether BROKAST can pass into breast milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking BROKAST.

Driving and operating machinery
No effects on the ability to drive and operate machinery are expected.
Individual responses to medicines can vary, however. Some undesirable effects (such as dizziness and drowsiness) that have been reported very rarely with BROKAST may affect the ability to drive and operate machinery.

BROKAST 5 mgchewable tablets contains aspartame.
This medicine contains 0.842 mg of aspartame per 5 mg tablet. Aspartame is a source of phenylalanine. It may be harmful if your child has phenylketonuria, a rare genetic disorder that causes phenylalanine to build up because the body cannot process it properly.

3. How to take BROKAST

Always give this medicine to your child exactly as your doctor or pharmacist has instructed.

• This medicine must be administered to the child under the supervision of an adult.
• The child should only take one BROKAST tablet a day as prescribed by the doctor.
• The tablet must be taken even if your child has no symptoms or is having an acute asthma attack.
• Give the tablet by mouth.

Use in children and adolescents from 6 to 14 years
The recommended dose is one chewable 5 mg tablet to be taken every evening. BROKAST 5 mg
chewable tablets should not be taken immediately before or after meals. It should be taken at least 1 hour
before or 2 hours after meals. If your child is taking BROKAST, make sure they do not take other products
that contain the same active ingredient, montelukast.

If your child takes more BROKASTthan they should
Consult your doctor immediately. In the majority of overdosage reports, no adverse effects
have been reported. The symptoms most frequently reported with overdosage in adults and children
include abdominal pain, drowsiness, thirst, headache, vomiting and hyperactivity.

If you forget to give BROKAST to your child
Try to give BROKAST as it was prescribed. However, if you forget to give a tablet,
continue to give the medicine according to the usual dosage. Do not give a double dose to make up for the
forgotten tablet.

If your child stops treatment with BROKAST
Treatment with BROKAST may only be effective against asthma if your child continues to take it. It is
important to continue taking BROKAST for as long as your doctor has prescribed it. This will help to
control your child’s asthma.
If you have any questions about the use of BROKAST, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, BROKAST can cause side effects, although not everybody gets them.
In clinical studies with montelukast 4 mg chewable tablets, the side effects considered related to
montelukast reported most commonly (occur in at least 1 in 100 patients and less than 1 in 10 patients
pediatric treated) were:

• abdominal pain
• thirst

In addition, the following side effect has been reported in clinical studies with montelukast 10 mg film-coated
tablets and 5 mg chewable tablets:

• headache

These side effects were usually mild and occurred more frequently in patients
treated with montelukast compared to those treated with placebo (a tablet that does not contain medicinal substance).
The frequency of the possible side effects listed below is defined using the following convention:
Very common (may affect at least 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known: the frequency cannot be estimated from the available data
In addition, the following side effects have been reported with post-marketing use of the medicine:

• upper respiratory tract infection (Very common)
• increased tendency to bleed (Rare)
• allergic reactions including skin rash, swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing (Uncommon)
• changes in behaviour and mood [dream disturbances, including nightmares, insomnia, sleepwalking, irritability, feeling of anxiety, restlessness, agitation including aggressive or hostile behaviour, depression (Uncommon); tremor (Rare); hallucinations, suicidal thoughts and behaviour (Very rare)]
• dizziness, somnolence, paraesthesia, convulsions (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth, digestive disturbances (Uncommon)
• hepatitis (liver inflammation) (Very rare)
• bruising, pruritus, urticaria (Uncommon), painful, red tender lumps under the skin most commonly on the front of the legs (erythema nodosum) (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); feeling tired, unwell, swelling (Uncommon)
• stammering (Very rare)

During treatment of asthmatic patients with montelukast, a complex of
symptoms such as flu-like illness, tingling or numbness in the arms or legs, worsening of
lung symptoms and/or rash has been reported in very rare cases (Churg-Strauss syndrome). The patient should stop taking the medicine and contact their doctor immediately if one or more of
these symptoms occur.
Ask your doctor or pharmacist for further information about side effects. Report any side effects not listed in this leaflet or if any symptom persists or worsens to your doctor or
pharmacist. 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 BROKAST

Keep BROKAST out of sight and reach of children.
Do not use BROKAST after the expiry date indicated on the label with the six numbers after the word SCAD. The first
two numbers indicate the month; the last four indicate the year. The expiry date refers to the last day
of the month.
Store at a temperature not exceeding 25°C in the original packaging to protect it from light and humidity.
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 BROKAST contains

• The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.
• The excipients are: Mannitol (E421), microcrystalline cellulose, sodium croscarmellose, red iron oxide (E172), hydroxypropylcellulose, cherry flavour (also contains triacetin (E1518)), aspartame (E951) and magnesium stearate.

Description of the appearance of BROKAST and contents of the pack
Pack of 28 tablets: 4 blisters of 7 tablets each.

Marketing Authorisation Holder
AGIPS FARMACEUTICI S.r.l. – Via Amendola n. 4 – 16035 Rapallo

Manufacturer responsible for batch release
ADAMED PHARMA S.A. ul. Marszalka Jòzefa Pilsudskiego 5, 95-200 Pabianice, Poland

BROKAST 10 mg film-coated tablets

Generic medicine

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 only for you or for your child. Do not give it to other people, even if their symptoms are the same as yours or your child's, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is BROKAST and what is it used for

BROKAST is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and also cause allergic symptoms. Blocking leukotrienes improves asthma symptoms and helps to control it and improves the symptoms of seasonal allergies (also known as hay fever and seasonal allergic rhinitis).
Your doctor has prescribed BROKAST for the treatment of asthma, to prevent asthma symptoms both during the day and during the night.

• BROKAST is used for the treatment of patients who are not adequately controlled with their medications and need additional medications.
• BROKAST also prevents the narrowing of the airways induced by exercise.
• In asthmatic patients in whom BROKAST is indicated for asthma, BROKAST may provide relief from the symptoms of seasonal allergic rhinitis.

The doctor will determine how to use BROKAST depending on the symptoms and the severity of asthma.

What is asthma?
Asthma is a long-term illness.
Asthma includes:

• Difficulty breathing due to narrowing of the airways. The narrowing of the airways worsens and improves in response to various conditions.
• Airways that react to many irritating stimuli, such as cigarette smoke, pollen, cold air or exercise.
• Swelling (inflammation) of the airways.

The symptoms of asthma include: cough, shortness of breath and a feeling of tightness in the chest.

What are seasonal allergies?
Seasonal allergies (also called hay fever or seasonal allergic rhinitis) are allergic reactions often
caused by pollen in the air that comes from trees, grass and seeds. Typical symptoms of seasonal allergies may include: stuffy nose, cold, itchy nose, sneezing, red, swollen, itchy and
watery eyes.

2. What you need to know before taking BROKAST

Inform your doctor about any existing or past medical conditions and any allergies.

Do not take BROKAST

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

Warnings and precautions
Talk to your doctor or pharmacist before taking BROKAST

• if your asthma or breathing gets worse, contact your doctor immediately.
• BROKAST taken orally should not be used to treat acute asthma attacks. If attacks occur, follow your doctor's instructions. Always keep your emergency inhaler medication for asthma attacks with you.
• It is important that you, or your child, take all asthma medications prescribed by your doctor. BROKAST should not be used in place of other asthma medications that your doctor has prescribed for you.
• Patients taking asthma medications should be aware that if they experience a combination of symptoms such as flu-like syndrome, tingling or decreased sensitivity in the arms or legs, worsening of lung symptoms and/or skin redness, they should consult a doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if your asthma worsens.

Patients should be aware that various neuropsychiatric events (e.g., changes in behavior and mood) have been reported in adults, adolescents and children treated with BROKAST (see section 4). If you or your child develops these symptoms during treatment with BROKAST, you should consult your child's doctor.

Children and adolescents
BROKAST 4 mg chewable tablets are available for children from 2 to 5 years of age.
BROKAST 5 mg chewable tablets are available for children from 6 to 14 years of age.

Other medicines and BROKAST
Tell your doctor if you are taking or have recently taken any other medicines, including those available without a prescription.
Some medicines can interfere with the way BROKAST works, or BROKAST can interfere with the way other medicines work.
Tell your doctor if you are taking the following medicines before starting to take BROKAST:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy).
• Rifampicin (used to treat tuberculosis and some other infections).

BROKAST with food and drink
BROKAST 10 mg can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding
It is not known whether BROKAST can pass into human milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking BROKAST.

Driving and using machines
No effects on the ability to drive and use machines are expected.
However, individual responses to medicines may vary. Some undesirable effects (such as dizziness and drowsiness) that have been reported very rarely with BROKAST may affect the ability to drive and use machines.

BROKAST 10 mgfilm-coated tablets contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take BROKAST

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

• You must take only one BROKAST tablet a day as prescribed by your doctor.
• The tablet must be taken even if you do not have symptoms or have an acute asthma attack.
• Take the tablet by mouth.

Use in adults aged 15 years and over:
The recommended dose is one 10 mg tablet to be taken every evening. BROKAST 10 mg can be
taken with or without food. If you are taking BROKAST, make sure you do not take other products that
contain the same active ingredient, montelukast.

If you take more BROKASTthan you should
Consult your doctor immediately. In the majority of overdosage reports, no adverse effects
have been reported. The symptoms most frequently reported with overdosage in adults and children
include abdominal pain, drowsiness, thirst, headache, vomiting and hyperactivity.

If you forget to take BROKAST
Try to take BROKAST as it has been prescribed. However, if you forget to take a tablet, continue to
take the medicine according to the usual dosage. Do not take a double dose to make up for a missed
tablet.

If you stop taking BROKAST
Treatment with BROKAST may only be effective against asthma if you continue to take it. It is important
to continue taking BROKAST for as long as your doctor has prescribed it. It will help to control your asthma.
If you have any questions about the use of BROKAST, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, BROKAST can cause side effects, although not everybody gets them.
In clinical studies with montelukast 10 mg film-coated tablets, adverse reactions considered related
to the use of the drug reported most commonly (occurring in at least 1 patient in 100 and less than 1
patient in 10) were:

• Abdominal pain
• Headache

These side effects were normally mild and occurred more frequently in patients
treated with montelukast compared to those treated with placebo (a tablet that does not contain medicine).
The frequency of possible side effects listed below is defined using the following convention:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 1,000 people)
Rare (may affect up to 1 in 10,000 people)
Very rare (may affect less than 1 in 10,000 people)
Not known: the frequency cannot be estimated from the available data
In addition, the following side effects have been reported with post-marketing use of the medicine:

• upper respiratory tract infection (Very common)
• increased tendency to bleeding (Rare)
• allergic reactions including skin rash, swelling of the face, lips, tongue and/or throat which can cause difficulty breathing or swallowing (Uncommon)
• changes in behaviour and mood [dream disturbances, including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive or hostile behaviour, depression (Uncommon); tremor (Rare); hallucinations, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles, convulsions (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth, digestive disturbances (Uncommon)
• hepatitis (liver inflammation) (Very rare)
• bruising, itching, hives (Uncommon), painful, red skin lumps usually on the front of the lower legs (erythema nodosum) (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); feeling tired, unwell, swelling (Uncommon)
• stuttering (Very rare)

During treatment of asthmatic patients with montelukast, a complex of
symptoms such as flu-like illness, pins and needles or numbness in the arms or legs, worsening of
lung symptoms and/or rash has been reported very rarely (Churg-Strauss syndrome). If one or more of
these symptoms occur, the patient should stop taking the medicine and contact their doctor immediately.
Ask your doctor or pharmacist for further information about side effects. Report any side effects not listed above to your doctor or
pharmacist, or if any symptom worsens.
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 BROKAST

Keep BROKAST out of sight and reach of children.
Do not use BROKAST after the expiry date indicated on the label with the six numbers after the word SCAD. The first
two numbers indicate the month; the last four indicate the year. The expiry date refers to the last day
of the month.
Store at a temperature not exceeding 30°C in the original packaging to protect it from light and humidity.
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 BROKAST contains

• The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
• The excipients are:

Tablet core: Microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,
hydroxypropylcellulose, magnesium stearate.
Coating: Hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), iron
oxide red (E172), iron oxide black (E172).

Description of the appearance of BROKAST and contents of the pack
Pack of 28 tablets: 4 blisters of 7 tablets each.

Marketing authorisation holder
AGIPS FARMACEUTICI S.r.l. – Via AMENDOLA n. 4 – 16035 Rapallo

Manufacturer responsible for batch release
ADAMED PHARMA S.A. ul. Marszalka Jòzefa Pilsudskiego 5, 95-200 Pabianice, Poland