Brokast: detailed information

Patient Information Leaflet

BROKAST 10 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 or your child only. Do not give it to others, even if their symptoms are the same as yours or your child's, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What BROKAST is and what it is used for
What you need to know before taking BROKAST
How to take BROKAST
Possible side effects
How to store BROKAST
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 and also cause allergic symptoms.
By blocking leukotrienes, BROKAST improves asthma symptoms and helps control asthma, as well as improving 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 at night.

BROKAST is used to treat patients whose asthma is not adequately controlled with their current medications and who require additional therapy.
BROKAST also prevents exercise-induced narrowing of the airways.
In asthmatic patients for whom BROKAST is indicated for asthma, BROKAST may provide relief from symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use BROKAST based on your symptoms and the severity of your asthma.
What is asthma?
Asthma is a long-term condition.
Asthma involves:

Difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers.
Airway sensitivity to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
Swelling (inflammation) of the airways.

Asthma symptoms include: coughing, shortness of breath, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also called hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grass, and weeds. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose, itchy nose, sneezing, red, swollen, itchy eyes, and tearing.

2. What you should know before taking BROKAST

Inform your doctor of any illness you currently have or have had in the past, and of any allergies.
Do not take BROKAST

If you are allergic (hypersensitive) to montelukast 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 BROKAST

if your asthma or breathing worsens, contact your doctor immediately.
BROKAST for oral use must not be used to treat acute asthma attacks. If you experience an attack, follow your doctor's instructions. Always carry your emergency inhaled medication for asthma attacks.
It is important that you, or your child, take all asthma medications prescribed by your doctor. BROKAST must not be used instead of other asthma medications prescribed by your doctor.
Patients taking anti-asthma medications should be aware that if they experience a combination of symptoms such as flu-like symptoms, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness, they must consult their doctor.
Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Neuropsychiatric events (e.g. changes in behaviour and mood, depression and suicidal thoughts) have been
reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while
taking montelukast, you must contact your doctor.
Children and adolescents
Do not give this medicine to children under 15 years of age.
For children aged 2 to 5 years, BROKAST 4 mg chewable tablets are available.
For children aged 6 to 14 years, BROKAST 5 mg chewable tablets are available.
Other medicines and BROKAST
Inform your doctor if you are taking or have recently taken any other medicines, including those without
prescription.
Some medicines may interfere with the action of BROKAST, or BROKAST may interfere with the action of other
medicines.
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 certain other infections).
Gemfibrozil (used to treat high levels of lipids in plasma).

BROKAST with food and drink
BROKAST 10 mg may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will decide whether you can take BROKAST under these circumstances.
Breastfeeding
It is not known whether BROKAST passes 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 or operate machinery are expected.
However, individual responses to medicines may vary. Some adverse effects (such as dizziness and drowsiness)
reported very rarely with BROKAST may affect the ability to drive and use machinery.
BROKAST 10 mg film-coated tablets contain lactose and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
3. How to take BROKAST
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your
doctor or pharmacist.

You should take only one tablet of BROKAST per day as prescribed by your doctor.
The tablet should be taken even if you have no symptoms or are experiencing an acute asthma attack.
Take the tablet by mouth.

Use in adults aged 15 years and older:
The recommended dose is one 10 mg tablet taken once daily in the evening. BROKAST 10 mg may be taken with or
without food. If you are taking BROKAST, make sure you do not take other products containing the same active
substance, montelukast.
If you take more BROKAST than you should
Contact your doctor immediately. In most reports of overdose, no adverse effects were observed. The most
frequently reported symptoms in cases of overdose in adults and children include abdominal pain, drowsiness,
thirst, headache, vomiting and hyperactivity.
If you forget to take BROKAST
Try to take BROKAST as prescribed. However, if you forget to take a tablet, continue taking the medicine as
usual. Do not take a double dose to make up for the forgotten tablet.
If you stop taking BROKAST
Treatment with BROKAST is effective against asthma only if you continue taking it. It is important to continue
taking BROKAST for as long as your doctor has prescribed it. It will help you control your asthma.
If you have any doubts about using BROKAST, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, BROKAST may cause side effects, although not everybody gets them.
In clinical studies with montelukast 10 mg film-coated tablets, the side effects considered related to drug use most commonly reported (may affect up to 1 in 10 people) were:

Abdominal pain
Headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active drug).

Serious side effects
Contact your doctor immediately if you experience any of the following side effects, which may be serious and for which you may require urgent medical treatment.

Uncommon: may affect up to 1 in 100 people

Allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing
Changes in behaviour and mood: agitation including aggressive behaviour or hostility, depression
Seizure

Rare: may affect up to 1 in 1,000 people

Increased tendency to bleed
Tremor
Palpitations

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

A combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
Low platelet count in the blood
Changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
Fluid accumulation (inflammation) in the lungs
Severe skin reactions (erythema multiforme) that may occur without warning
Inflammation of the liver (hepatitis)

Other side effects during post-marketing use of the medicine

Very common: may affect more than 1 in 10 people

Upper respiratory tract infection

Common: may affect up to 1 in 10 people

Diarrhoea, nausea, vomiting
Skin rash
Fever
Elevated liver enzymes

Uncommon: may affect up to 1 in 100 people

Changes in behaviour and mood: dream abnormalities including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness
Dizziness, drowsiness, tingling/numbness
Nosebleeds
Dry mouth, digestive disturbances
Bruising, itching, urticaria
Joint or muscle pain, muscle cramps
Involuntary loss of urine during sleep in children
Weakness/tiredness, malaise, swelling

Rare: may affect up to 1 in 1,000 people

Changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements

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

Painful, red-coloured swellings of the subcutaneous tissue, usually located on the front of the legs (erythema nodosum)
Changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Ask your doctor or pharmacist for further information about side effects. Tell your doctor or pharmacist about any side effect not listed above or if any symptom worsens.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects may help provide more information on the safety of this medicine.

5. How to store BROKAST

Keep BROKAST out of the sight and reach of children.
Do not use BROKAST after the expiry date stated on the label following the word EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the month.
Store below 30°C in the original packaging to protect from light and moisture.
Do not dispose of medicines 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 BROKAST contains

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

Tablet core: Microcrystalline cellulose, monohydrate lactose, sodium croscarmellose,
hydroxypropylcellulose, magnesium stearate.
Coating: Hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Description of the appearance of BROKAST and packaging contents
Carton pack containing 28 tablets: 4 blisters with 7 tablets each.
Marketing Authorization Holder
AGIPS FARMACEUTICI S.r.l. – Via AMENDOLA n. 4 – 16035 Rapallo
Responsible manufacturer for batch release
ADAMED PHARMA S.A. ul. Marszalka Jòzefa Pilsudskiego 5, 95-200 Pabianice, Poland

Patient Information Leaflet

BROKAST 4 mg chewable tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 or your child only. Do not give it to others, even if their symptoms are the same as yours or your child's, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What BROKAST is and what it is used for
What you need to know before taking BROKAST
How to take BROKAST
Possible side effects
How to store BROKAST
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 control the condition.
Your doctor has prescribed BROKAST for the treatment of asthma, to prevent asthma symptoms both during the day and at night.

BROKAST is used to treat patients whose asthma is not adequately controlled with their current medications and who require additional therapy.
BROKAST may also be used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and who have been shown unable to use inhaled corticosteroids.
BROKAST also prevents exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use BROKAST based on your child's symptoms and the severity of their asthma.
What is asthma?
Asthma is a long-term condition.
Asthma involves:

Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
Airway sensitivity to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
Swelling (inflammation) of the airways.

Asthma symptoms include: coughing, shortness of breath, and chest tightness.

2. What you need to know before taking BROKAST

Inform your doctor of any current or past medical conditions and any allergies.
Do not take or give BROKAST to your child

if he/she is allergic (hypersensitive) to montelukast or to 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 asthma or breathing worsens, contact your doctor immediately.
BROKAST for oral use must not be used to treat acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always keep your child’s emergency inhaled medication for asthma attacks with you.
It is important that your child takes all asthma medications prescribed by the doctor. BROKAST must not be used instead of other asthma medications prescribed for your child.
If your child takes anti-asthma medicines, you should know that if he/she experiences a combination of symptoms such as flu-like symptoms, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness, you must consult the doctor.
Acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) must not be taken if they worsen asthma.

Neuropsychiatric events (e.g. changes in behaviour and mood, depression and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you experience these symptoms while taking montelukast, contact your doctor.
Children and adolescents
Do not give this medicine to children under 2 years of age.
For children aged 2 to 5 years, BROKAST 4 mg chewable tablets are available.
For children aged 6 to 14 years, BROKAST 5 mg chewable tablets are available.
Other medicines and BROKAST
Some medicines may interfere with the action of BROKAST, or BROKAST may interfere with the action of other medicines.
Inform your doctor if your child is taking or has recently taken any other medicines, including those not requiring a prescription.
Tell your doctor if your child is taking the following medicines before starting BROKAST:

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

BROKAST with food and drink
BROKAST 4 mg chewable tablets must 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 intended for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.
Pregnancy
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
It is not known whether BROKAST passes 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 or operate machinery are expected.
However, individual responses to medicines may vary. Some very rare side effects (such as dizziness and drowsiness) reported with BROKAST may affect the ability to drive and operate machinery.
BROKAST 4 mg chewable tablets contain aspartame and sodium
This medicine contains 0.0674 mmol of aspartame per 4 mg tablet. Aspartame is a source of phenylalanine. It may be harmful if your child has phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take BROKAST

Give this medicine to your child exactly as directed by the doctor or
pharmacist. If you have any doubts, consult the doctor or pharmacist.

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

Use in children from 2 to 5 years of age
The recommended dose is one 4 mg chewable tablet to be taken once daily in the 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 containing the same active substance,
montelukast.

If your child takes more BROKAST than they should
Contact your doctor immediately. In most reported cases of overdose, no adverse effects occurred. The most
commonly reported symptoms associated with overdose 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 prescribed. However, if you forget to give a tablet, continue giving the medicine as
normally scheduled. Do not give a double dose to make up for the missed tablet.

If your child stops treatment with BROKAST
Treatment with BROKAST can be effective against asthma only if your child continues taking it. It is important
to keep taking BROKAST for as long as the doctor has prescribed it. This will help control your child's asthma.

If you have any questions about the use of BROKAST, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, BROKAST may cause side effects, although not everyone gets them.
In clinical studies with montelukast 4 mg chewable tablets, the most commonly reported side effects considered related to
montelukast (which may affect up to 1 in 10 people) were:

abdominal pain
thirst

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

headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active ingredient).

Serious side effects
Speak to your doctor immediately if you notice any of the following side effects in your child, which
may be serious and for which your child may require urgent medical treatment.

Uncommon: may affect up to 1 in 100 people

allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing
changes in behaviour and mood: agitation including aggressive behaviour or hostility, depression
seizure

Rare: may affect up to 1 in 1,000 people

increased tendency to bleeding
tremor
palpitations

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

a group of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
low platelet count in the blood
changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
accumulation of fluid (inflammation) in the lungs
severe skin reactions (erythema multiforme) which may occur without warning
inflammation of the liver (hepatitis)

Other side effects during post-marketing use of the medicine

Very common: may affect more than 1 in 10 people

upper respiratory tract infection

Common: may affect up to 1 in 10 people

diarrhoea, nausea, vomiting
rash
fever
elevated liver enzymes

Uncommon: may affect up to 1 in 100 people

changes in behaviour and mood: dream abnormalities including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness
dizziness, drowsiness, tingling/numbness
nose bleeds
dry mouth, digestive disturbances
bruising, itching, urticaria
joint or muscle pain, muscle cramps
involuntary loss of urine during sleep in children
weakness/feeling tired, malaise, swelling

Rare: may affect up to 1 in 1,000 people

changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements

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

painful red swellings under the skin, usually located on the front of the legs (erythema nodosum)
changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Ask your doctor or pharmacist for further information about side effects. Inform your doctor or pharmacist if you experience any side effects not listed above, or if any symptom persists or worsens.

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 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 the sight and reach of children.
Do not use BROKAST after the expiry date stated on the label following the word EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the month.
Store below 25°C in the original packaging to protect from light and moisture.
Do not dispose of medicines 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 BROKAST contains

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

Description of the appearance of BROKAST and pack contents
Carton pack containing 28 tablets: 4 blisters with 7 tablets each.
Marketing Authorization Holder
AGIPS FARMACEUTICI S.r.l. – Via AMENDOLA n. 4 – 16035 Rapallo
Responsible manufacturer for batch release
ADAMED PHARMA S.A., ul. Marszalka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland

Package leaflet: information for the patient

BROKAST 5 mg chewable tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 or your child only. Do not give it to other people, even if their symptoms are the same as yours or your child's, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What BROKAST is and what it is used for
What you need to know before taking BROKAST
How to take BROKAST
Possible side effects
How to store BROKAST
Contents of the pack and other information

2. What BROKAST is and what it is used for

BROKAST is used to treat patients whose asthma is not adequately controlled with their current medications and who require additional therapy.
BROKAST may also be used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and who have shown inability to use inhaled corticosteroids.
BROKAST also prevents exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use BROKAST based on your child's symptoms and the severity of their asthma.
What is asthma?
Asthma is a long-term disease.
Asthma involves:

Difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers.
Airway hyperresponsiveness to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
Swelling (inflammation) of the airways.

Symptoms of asthma include: cough, shortness of breath, and chest tightness.

2. What you should know before taking BROKAST

Inform your doctor about any current or past medical conditions and any allergies.
Do not give BROKAST to your child

if he/she is allergic (hypersensitive) to montelukast or to any of the other ingredients of this medicine (listed in section 6).

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

if asthma or breathing worsens, contact your doctor immediately.
BROKAST for oral use must not be used to treat acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always keep your child's emergency inhaled asthma medication with you.
It is important that your child takes all asthma medications prescribed by the doctor. BROKAST must not be used instead of other asthma medicines prescribed for your child.
If your child is taking asthma medications, you should know that if he/she experiences a combination of symptoms such as flu-like symptoms, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness, you must consult the doctor.
Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also called non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen asthma.

Neuropsychiatric events (for example, changes in behaviour and mood, depression and suicidal
thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If such
symptoms develop while taking montelukast, contact your doctor.
Children and adolescents
Do not give this medicine to children under 6 years of age.
For children aged 2 to 5 years, BROKAST 4 mg chewable tablets are available.
For children aged 6 to 14 years, BROKAST 5 mg chewable tablets are available.
Other medicines and BROKAST
Some medicines may interfere with the action of BROKAST, or BROKAST may interfere with the action of other medicines.
Inform your doctor if your child is taking or has recently taken any other medicines, including those not requiring a prescription.
Tell your doctor if your child is taking the following medicines before starting 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. However, the following information refers to the active substance, montelukast.
Pregnancy
If you are pregnant, think 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 passes into human milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking BROKAST.
Driving and using machines
No effects on the ability to drive or use machines are expected.
However, individual responses to medicines may vary. Some adverse effects (such as dizziness and drowsiness), which have been reported very rarely with BROKAST, may affect the ability to drive or use machines.
BROKAST 5 mg chewable tablets contain aspartame and sodium.
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 causing accumulation of phenylalanine due to the body's inability to properly metabolize it.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take BROKAST

Give this medicine to your child exactly as instructed by the doctor or
pharmacist.

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

Use in children and adolescents aged 6 to 14 years
The recommended dose is one 5 mg chewable tablet taken once daily in the 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 containing the same active substance, montelukast.
If your child takes more BROKAST than they should
Contact your doctor immediately. In most reported cases of overdose, no adverse effects occurred. The most commonly reported symptoms with overdose 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 prescribed. However, if you forget to give a dose, continue giving the medicine as normally scheduled. Do not give a double dose to make up for the missed tablet.
If your child stops treatment with BROKAST
Treatment with BROKAST can only be effective against asthma if your child continues taking it. It is important to continue taking BROKAST for as long as the doctor has prescribed it. This will help control your child's asthma.
If you have any doubts about how to use BROKAST, consult 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 5 mg chewable tablets, the most commonly reported side effects considered related to montelukast (which may affect up to 1 in 10 people) were:

abdominal pain
thirst

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

headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active substance).

Serious side effects
Speak to your doctor immediately if you notice any of the following side effects, which may be serious and for which you or your child may need urgent medical treatment.

Uncommon: may affect up to 1 in 100 people

allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing
changes in behaviour and mood: agitation including aggressive behaviour or hostility, depression
seizure (convulsion)

Rare: may affect up to 1 in 1,000 people

increased tendency to bleed
tremor
palpitations

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

a combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
low platelet count in the blood
changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
fluid accumulation (inflammation) in the lungs
severe skin reactions (erythema multiforme) which may occur without warning
inflammation of the liver (hepatitis)

Other side effects reported during commercial use of the medicine

Very common: may affect more than 1 in 10 people

upper respiratory tract infection

Common: may affect up to 1 in 10 people

diarrhoea, nausea, vomiting
rash
fever
elevated liver enzymes

Uncommon: may affect up to 1 in 100 people

changes in behaviour and mood: dream abnormalities, including nightmares, insomnia, sleepwalking, irritability, anxious feelings, restlessness
dizziness, drowsiness, tingling/numbness
nosebleeds
dry mouth, digestive disturbances
bruising, itching, urticaria
joint or muscle pain, muscle cramps
involuntary loss of urine during sleep in children
weakness/tiredness, malaise, swelling

Rare: may affect up to 1 in 1,000 people

changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements

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

painful red swellings under the skin, usually located on the front of the legs (erythema nodosum)
changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Ask your doctor or pharmacist for further information about side effects. Tell your doctor or pharmacist about any side effects not listed above or if any symptoms persist or worsen.

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 the sight and reach of children.
Do not use BROKAST after the expiry date stated on the label following the word EXP. 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 below 25°C in the original packaging to protect from light and moisture.
Do not dispose of medicines via 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 substance is montelukast. Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.
The other ingredients (excipients) are: Mannitol (E421), microcrystalline cellulose, sodium croscarmellose, red iron oxide (E172), hydroxypropylcellulose, cherry flavour (also contains glycerol triacetate (E1518)), aspartame (E951) and magnesium stearate.

Description of the appearance of BROKAST and contents of the pack
Carton pack containing 28 tablets: 4 blisters with 7 tablets each.
Marketing Authorization Holder
AGIPS FARMACEUTICI S.r.l. – Via Amendola n. 4 – 16035 Rapallo
Responsible manufacturer for batch release
ADAMED PHARMA S.A. ul. Marszalka Jòzefa Pilsudskiego 5, 95-200 Pabianice, Poland