Lukasm

PACKAGE LEAFLET

Package leaflet: Information for the user

Lukasm 10 mg film-coated tablets

montelukast
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lukasm is and what it is used for

What Lukasm is
Lukasm is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Lukasm works
Leukotrienes cause narrowing and swelling of the airways in the lungs and also trigger allergic symptoms. By blocking leukotrienes, Lukasm improves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever and seasonal allergic rhinitis).
When Lukasm should be used
Your doctor has prescribed Lukasm for the treatment of asthma, to prevent asthma symptoms both during the day and at night.

• Lukasm is used for the treatment of adults and adolescents 15 years of age and older whose asthma is not adequately controlled with their current medications and who require additional therapy.
• Lukasm also prevents exercise-induced narrowing of the airways.
• In asthmatic patients for whom Lukasm is indicated for asthma, Lukasm may provide relief from symptoms of seasonal allergic rhinitis.

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

• 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. 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 Lukasm

Inform your doctor about any current or past medical conditions and any allergies you may have.
Do not take Lukasm

• if you are allergic 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 Lukasm

• If your asthma or breathing worsens, contact your doctor immediately.
• Lukasm for oral use must not be used to treat acute asthma attacks. If an asthma attack occurs, follow your doctor's instructions. Always keep your emergency inhaled asthma medication with you.
• It is important that you, or your child, take all asthma medications prescribed by your doctor. Lukasm must not be used instead of other asthma medications prescribed for you by your doctor.
• Patients taking asthma medications should be aware that if they experience a combination of symptoms such as flu-like symptoms, tingling or numbness in the arms or legs, worsening of lung symptoms, and/or skin redness, they should 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.

Various neuropsychiatric events (e.g. changes in behavior and mood, depression and suicidal
ideation) have been reported in patients of all ages treated with montelukast (see section 4). If you
develop these symptoms during treatment with montelukast, you must consult your doctor.
Children and adolescents
Do not give this medicine to children under 15 years of age.
Different formulations of this medicine are available for pediatric patients under 18 years of age, depending on age group.
Other medicines and Lukasm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may interfere with the way Lukasm works, or Lukasm may interfere with the way other medicines work.
Tell your doctor if you are taking any of the following medicines before starting Lukasm:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections)
• gemfibrozil (used to treat high plasma lipid levels).

Lukasm with food and drinks
Lukasm 10 mg film-coated tablet can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking Lukasm.
Pregnancy
Your doctor will decide whether you can take Lukasm under these circumstances.
Breastfeeding
It is not known whether Lukasm passes into human milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Lukasm.
Driving and operating machinery
Lukasm is not expected to affect your ability to drive or operate machinery. However, individual responses to medicines may vary. Some adverse effects (such as dizziness and drowsiness) reported with Lukasm may affect your ability to drive or operate machinery.
Lukasm 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 Lukasm

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 Lukasm tablet daily as prescribed by your doctor.
• You must take the tablet even if you have no symptoms or are experiencing an acute asthma attack.

For adults and adolescents aged 15 years and above:
The recommended dose is one 10 mg tablet taken once daily in the evening.
If you are taking Lukasm, make sure you do not take other products containing the same active substance, montelukast.
This medicine is for oral use.
You may take Lukasm 10 mg with or without food.

If you take more Lukasm than you should
Contact your doctor immediately.
In most reported cases of overdose, no adverse effects were observed. The most frequently reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Lukasm
Try to take Lukasm as prescribed. However, if you forget to take a tablet, continue taking the medicine as usual at your regular dose.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Lukasm
Treatment with Lukasm is effective against asthma only if you continue taking it. It is important to keep taking Lukasm for as long as your doctor has prescribed it. It will help you control your asthma.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical studies with montelukast 10 mg film-coated tablets, the most commonly reported side effects considered related to montelukast (may affect up to 1 in 10 people) were:

• abdominal pain
• headache

These side effects were usually mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet without active ingredient).

Serious side effects
Talk to your doctor immediately if you experience any of the following side effects, which may be serious and for which you 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 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 blood
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of 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, anxiety, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleed
• 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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
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 Lukasm

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister after 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 that month.
• Store in the original packaging to protect the medicine from light and moisture.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lukasm contains

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
• The other components are: microcrystalline cellulose, lactose monohydrate (89.3 mg), croscarmellose sodium, hypromellose (E463), and magnesium stearate. Coating: hypromellose, hypromellose (E463), titanium dioxide (E171), red and yellow iron oxide (E172), carnauba wax.

Description of the appearance of Lukasm and package contents
Lukasm 10 mg tablets are beige-colored, square-shaped, with rounded edges, film-coated, marked with "117" on one side.
Blister packs in packages containing 28 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Italy

Manufacturer
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Package leaflet: information for the user

Lukasm 5 mg chewable tablets

montelukast
Please read this leaflet carefully before taking this medicine, as it contains important information for you or your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms appear identical to yours or your child's, as it could be harmful.
• If you or your child experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lukasm is and what it is used for

What Lukasm is
Lukasm is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Lukasm works
Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking
leukotrienes, Lukasm improves asthma symptoms and helps control the condition.
When Lukasm should be used
Your doctor has prescribed Lukasm for the treatment of asthma, to prevent asthma symptoms both during the
day and at night.

• Lukasm is used to treat pediatric patients aged 6 to 14 years who are not adequately controlled with their current medications and who require additional therapy.
• Lukasm 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.
• Lukasm also prevents exercise-induced narrowing of the airways.

Your doctor will determine how to use Lukasm based on your symptoms and the severity of 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.
• Airways that react 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 Lukasm

Tell your doctor about any current or past medical conditions and about any allergies you may have.
Do not take Lukasm

• if you or your child is allergic 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 you or your child takes Lukasm.

• If asthma or breathing worsens, contact your doctor immediately.
• Lukasm for oral use must not be used to treat acute asthma attacks. If attacks occur, follow your doctor's instructions. Always keep your emergency inhaled asthma medication with you.
• It is important that you or your child take all asthma medications prescribed by your doctor. Lukasm must not be used instead of other asthma medications prescribed for you or your child.
• 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 should consult their doctor.
• Acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) must not be taken if they worsen asthma.

Neuropsychiatric events (such as changes in behaviour and mood, depression and suicidal
ideation) have been reported in patients of all ages treated with montelukast (see section 4). If you
develop these symptoms during treatment with montelukast, you must consult your doctor.
Children and adolescents
Do not give this medicine to children under 6 years of age.
Different formulations of this medicine are available for pediatric patients under 18 years of age, based on age group.
Other medicines and Lukasm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may interfere with the way Lukasm works, or Lukasm may interfere with the way other medicines work.
Tell your doctor if you or your child is taking any of the following medicines before starting Lukasm:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections).

Lukasm with food and drink
Lukasm 5 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
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking Lukasm.
Pregnancy
Your doctor will decide whether you can take Lukasm under these circumstances.
Breastfeeding
It is not known whether Lukasm passes into human breast milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Lukasm.
Driving and using machines
No effects of Lukasm on the ability to drive or operate machinery are expected. However, individual responses to medicines may vary. Some side effects (such as dizziness and drowsiness) reported with Lukasm may affect the ability to drive and use machinery.
Lukasm 5 mg chewable tablets contain aspartame, sodium and benzyl alcohol
This medicine contains 1.5 mg of aspartame per 5 mg chewable tablet, equivalent to 0.842 mg of phenylalanine. Aspartame is a source of phenylalanine. It may be harmful if you or your child has phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".
This medicine contains up to 0.45 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you or your child has liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take Lukasm

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

• You or your child must take only one Lukasm chewable tablet per day as prescribed by the doctor.
• The tablet must be taken even if you or your child do not have symptoms or are experiencing an acute asthma attack.

For children aged 6 to 14 years:
The recommended dose is one 5 mg chewable tablet taken once daily in the evening.
If you or your child is taking Lukasm, make sure not to take other products containing the same active substance, montelukast.
This medicine is for oral use.
The tablets must be chewed before swallowing.
Lukasm 5 mg chewable tablets must not be taken immediately before or after meals; they should be taken at least 1 hour before or 2 hours after meals.

If you or your child takes more Lukasm than you should
Contact your doctor immediately.
In most reports of overdose, no adverse effects were observed. The most frequently reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you or your child forgets to take Lukasm or forgets to give it to your child
Try to take Lukasm as prescribed. However, if you or your child forgets to take a chewable tablet, continue taking the medicine as normally scheduled.
Do not take a double dose to make up for the forgotten tablet.

If you or your child stops treatment with Lukasm
Treatment with Lukasm can only be effective against asthma if you or your child continues taking it. It is important to continue taking Lukasm for the entire duration prescribed by the doctor.
It will help control your asthma or your child's asthma.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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:

• headache

Additionally, the following side effect was reported in clinical studies with montelukast 10 mg film-coated tablets:

• abdominal pain.

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

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 blood
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of 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, hives
• 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, most commonly on the front of the legs (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

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 Lukasm

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack after 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 that month.
• Store in the original packaging to protect the medicine from light and moisture.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lukasm contains

• The active substance is montelukast. Each chewable tablet contains montelukast sodium equivalent to 5 mg of montelukast.
• The other components are: mannitol (E 421), microcrystalline cellulose, hypromellose (E 463), red iron oxide (E 172), sodium croscarmellose, cherry flavour containing benzyl alcohol (E 1519), aspartame (E 951) and magnesium stearate.

Description of the appearance of Lukasm and package contents
Lukasm 5 mg chewable tablets are pink, round, biconvex, with "275" imprinted on one side.
Blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy

Manufacturer
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg, Belgium

Package leaflet: information for the user

Lukasm 4 mg chewable tablets

montelukast
Please read this leaflet carefully before giving this medicine to your child, as it contains
important information.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if their symptoms are the same as your child's, as it could be harmful.
• If your child experiences any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lukasm is and what it is used for

What Lukasm is
Lukasm is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Lukasm works
Leukotrienes cause narrowing and swelling of the airways in the lungs. Blocking leukotrienes improves asthma symptoms and helps control the condition.
When Lukasm should be used
Your doctor has prescribed Lukasm for the treatment of your child's asthma to prevent asthma symptoms both during the day and at night.

• Lukasm is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medications and who require additional therapy.
• Lukasm 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 shown inability to use inhaled corticosteroids;
• Lukasm also prevents exercise-induced narrowing of the airways in patients aged 2 years and older.

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

• Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
• Airway hyperreactivity 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 should know before your child takes Lukasm

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

• if he/she is allergic 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 Lukasm to your child.

• If your child's asthma or breathing worsens, contact your doctor immediately.
• Lukasm 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 available for asthma attacks.
• It is important that your child takes all asthma medications prescribed by the doctor. Lukasm must not be used as a substitute for other asthma medications prescribed for your child.
• If your child is taking anti-asthma medications, you should know that if he/she experiences a combination of symptoms such as flu-like symptoms, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin redness, you should consult the doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen his/her asthma.

Neuropsychiatric events (such as 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 occur during treatment with montelukast, consult your
doctor.
Children and adolescents
Do not give this medicine to children under 2 years of age.
Different formulations of this medicine are available for pediatric patients under 18 years of age, depending on age group.
Other medicines and Lukasm
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may interfere with the action of Lukasm, or Lukasm may interfere with the action of your child’s other medicines.
Tell your doctor if your child is taking any of the following medicines before starting Lukasm:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections).

Lukasm with food and drink
Lukasm 4 mg chewable tablets must not be taken immediately before or after meals; they should be taken at least 1 hour before or 2 hours after meals.
Pregnancy and breastfeeding
This section does not apply because Lukasm 4 mg chewable tablets are intended for use in children aged 2 to 5 years.
Driving and using machines
This section does not apply because Lukasm 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.
No effects of Lukasm on driving and using machines are expected. Individual responses to medicines may vary, however. Some adverse effects (such as dizziness and drowsiness) reported with Lukasm may affect the ability to drive and use machinery.
Lukasm 4 mg chewable tablets contain aspartame, sodium and benzyl alcohol
This medicine contains 1.2 mg of aspartame per 4 mg chewable tablet, equivalent to 0.674 mg of phenylalanine. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate in the body due to inability to properly metabolize it.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".
This medicine contains up to 0.36 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you or your child have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take Lukasm

Give this medicine to your child exactly as instructed 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. For children who have difficulty taking a chewable tablet, a granular formulation is available.
• Your child must take only one chewable tablet of Lukasm 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.

For children aged 2 to 5 years:
The recommended dose is one 4 mg chewable tablet to be taken once daily in the evening.
If your child is taking Lukasm, make sure he/she does not take other medicines containing the same active substance, montelukast.
This medicine is for oral use.
The tablets must be chewed before swallowing.
Lukasm 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 takes more Lukasm than prescribed
Contact your child’s doctor immediately.
In most reported cases of overdose, no adverse effects were observed. The most frequently reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to give Lukasm to your child
Try to give Lukasm to your child as prescribed. However, if you forget to give a chewable tablet, continue giving the medicine as usual at the next scheduled dose.
Do not give your child a double dose to make up for the missed tablet.

If your child stops taking Lukasm
Treatment with Lukasm can be effective against asthma only if your child continues taking it.
It is important for your child to continue taking Lukasm for the entire duration prescribed by the doctor. It will help control your child’s asthma.
If you have any questions about using this medicine, consult your child’s doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

In clinical studies with montelukast 4 mg chewable tablets, the side effects considered related to montelukast most commonly reported (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 usually 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 in your child, which may be serious and for which 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 bleeding
• 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
• swelling (inflammation) of 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
• nosebleed
• 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, tender to touch, most commonly located on the front of the legs (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

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 Lukasm

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister after 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 that month.
• Store in the original packaging to protect the medicine from light and moisture.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lukasm contains

• The active substance is montelukast. Each chewable tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other components are: mannitol (E 421), microcrystalline cellulose, hypromellose (E 463), red iron oxide (E 172), sodium croscarmellose, cherry flavour containing benzyl alcohol (E 1519), aspartame (E 951) and magnesium stearate.

Description of the appearance of Lukasm and package contents
Lukasm 4 mg chewable tablets are pink, oval-shaped, biconvex tablets, with "711" imprinted on one side.
Blister packs in pack sizes of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
Blister packs (single dose) in pack sizes of: 49x1, 50x1 and 56x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
Haarlem, The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Package leaflet: information for the user

Lukasm 4 mg granulate

montelukast
Please read this leaflet carefully before giving this medicine to your child, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if their symptoms are the same as your child's, as it could be harmful.
• If your child experiences any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lukasm is and what it is used for

What Lukasm is
Lukasm is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Lukasm works
Leukotrienes cause narrowing and swelling of the airways in the lungs. Blocking leukotrienes improves asthma symptoms and helps control the condition.
When Lukasm should be used
Your doctor has prescribed Lukasm for the treatment of your child's asthma to prevent asthma symptoms both during the day and at night.

• Lukasm is used for the treatment of patients aged 6 months to 5 years whose asthma is not adequately controlled with their current medications and who require additional therapy.
• Lukasm 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 shown inability to use inhaled corticosteroids.
• Lukasm also prevents exercise-induced narrowing of the airways in patients aged 2 years and older.

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

• Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
• Airways that react 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 should know before your child takes Lukasm

Inform your doctor about any current or past medical conditions and any allergies your child may have.

Do not give Lukasm to your child

• if he or she is allergic 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 administering Lukasm to your child.

• If your child's asthma or breathing worsens, contact your doctor immediately.
• Lukasm 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 for asthma attacks.
• It is important that your child takes all asthma medications prescribed by the doctor. Lukasm must not be used instead of other asthma medications prescribed for your child.
• If your child takes asthma medications, be aware that if he or 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 should consult the doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen asthma.

Neuropsychiatric events (such as changes in behaviour and mood, depression and suicidal
ideation) have been reported in patients of all ages treated with montelukast (see section 4). If
these symptoms develop during treatment with montelukast, consult your doctor.
Children and adolescents
Do not administer this medicine to children under 6 months of age.
Different formulations of this medicine are available for pediatric patients under 18 years of age, depending on age group.
Other medicines and Lukasm
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may interfere with the way Lukasm works, or Lukasm may interfere with the way other medicines work.
Tell your doctor if your child is taking any of the following medicines before starting Lukasm:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections).

Lukasm with food and drink
Lukasm granules can be taken regardless of meals.
Pregnancy and breastfeeding
This section does not apply because Lukasm 4 mg granules are intended for use in children aged between 6 months and 5 years.
Driving and using machines
This section does not apply because Lukasm 4 mg granules are intended for use in children aged between 6 months and 5 years. However, the following information refers to the active substance, montelukast.
Lukasm is not expected to affect driving or operating machinery. Individual responses to medicines may vary, however. Some adverse effects (such as dizziness and drowsiness) reported with Lukasm may affect the ability to drive and use machinery.
Lukasm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially "sodium-free".

3. How to take Lukasm

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

• This medicine must be given to your child under adult supervision. Your child must take Lukasm every evening.
• The medicine should be taken even if your child has no symptoms or is experiencing an acute asthma attack.

For children from 6 months to 5 years of age:
The recommended dose is one sachet of Lukasm 4 mg granules to be taken once daily in the evening.
If your child is taking Lukasm, make sure they do not take any other products containing the same
active substance, montelukast.

How should I give Lukasm granules to my child?
This medicine is for oral use.

• Do not open the sachet until you are ready to use it.
• Lukasm granules can be given either:
• Directly into the mouth
• OR mixed with one spoonful of soft food, cold or at room temperature (for example, apple puree, ice cream, carrot and rice puree).
• Mix the entire contents of the Lukasm granules with one spoonful of soft food, cold or at room temperature, making sure the dose is completely mixed with the food. Ensure that your child takes the entire contents of the spoon immediately (within 15 minutes) containing the mixture of granules and food. IMPORTANT: do not store the granule/food mixture for later use.
• Lukasm granules must not be dissolved in liquids. However, liquids may be taken after administration of Lukasm granules.
• Lukasm granules may be taken regardless of meals.

If your child takes more Lukasm than they should
Contact your child's doctor immediately.
In most reported cases of overdose, no adverse effects occurred. The most frequently reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to give Lukasm to your child
Try to give Lukasm to your child as prescribed. However, if you forget to give a dose, continue giving the medicine as normally scheduled.
Do not give your child a double dose to make up for the missed sachet.

If your child stops taking Lukasm
Treatment with Lukasm can only be effective against your child's asthma if they continue taking it.
It is important to continue giving Lukasm for as long as the doctor has prescribed it. This will help control your child's asthma.
If you have any doubts about using this medicine, consult your child's doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical studies with montelukast 4 mg granules, the side effects considered related to montelukast most commonly reported (may affect up to 1 in 10 people) were:

• diarrhoea
• hyperactivity
• asthma
• itching and scaly skin
• rash

In addition, the following side effects were reported in clinical studies with montelukast 10 mg film-coated tablets, 5 mg or 4 mg chewable tablets:

• abdominal pain
• headache
• thirst

These side effects were usually 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 in your child, which may be serious and for which 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 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 the arms and legs, worsening of lung symptoms and/or rash (Churg-Strauss syndrome) (see section 2)
• low platelet count in the blood
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) which may occur without warning
• inflammation of the liver (hepatitis)

Other side effects 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, feeling anxious, restlessness
• dizziness, somnolence, paraesthesia/numbness
• nosebleeds
• 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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Lukasm

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the sachet after 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 that month.
• Do not store above 25°C. Store in the original packaging to protect the medicine from light and moisture.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lukasm contains

• The active substance is montelukast. Each sachet of granules contains sodium montelukast equivalent to 4 mg of montelukast.
• The other components are: mannitol (E 421), hypromellose (E 463), and magnesium stearate.

Description of the appearance of Lukasm and the contents of the pack
Lukasm 4 mg granules, white granules.
Pack sizes: 7, 20, 28 and 30 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
Haarlem, The Netherlands