Singulair

PACKAGE LEAFLET

Package leaflet: information for the user

Singulair 10 mg film-coated tablets

montelukast
Please read this entire 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 only. Do not pass it on to other people, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Singulair is and what it is used for

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

• Singulair 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.
• Singulair also prevents exercise-induced narrowing of the airways.
• In asthmatic patients for whom Singulair is indicated for asthma, Singulair may provide relief from symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Singulair based on your symptoms and the severity of your asthma.
What asthma is
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.
• Airway sensitivity to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
• Swelling (inflammation) of the airways. Symptoms of asthma include: coughing, shortness of breath, and chest tightness.

What seasonal allergies are
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, nasal itching; sneezing; red, swollen, itchy eyes, and tearing.

2. What you need to know before taking Singulair

Tell your doctor about any medical conditions you currently have or have had in the past, and about any allergies.

Do not take Singulair

• 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 Singulair

• If your asthma or breathing worsens, contact your doctor immediately.
• Singulair for oral use must not be used to treat acute asthma attacks. If you experience an asthma attack, 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. Singulair must not be used instead of other asthma medications prescribed by your doctor.
• Patients taking asthma medications should be aware that if they develop 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 must consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Neuropsychiatric events (such as 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 while taking 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 Singulair
Tell 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 action of Singulair, or Singulair may interfere with the action of other medicines.
Tell your doctor if you are taking the following medicines before starting Singulair:

• 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)

Singulair with food and drink
Singulair 10 mg film-coated tablet can 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 Singulair.

Pregnancy
Your doctor will decide whether you can take Singulair under these circumstances.

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

Driving and using machines
No effects of Singulair 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 with Singulair may affect the ability to drive and use machinery.

Singulair 10 mg film-coated tablets contain lactose and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor 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 Singulair

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 Singulair tablet daily as prescribed by your doctor.
• The tablet should be taken even if you do not have symptoms or are experiencing an acute asthma attack.

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

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

If you forget to take Singulair
Try to take Singulair as prescribed. However, if you forget to take a tablet, continue taking the medicine as normally scheduled.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Singulair
Treatment with Singulair will only be effective against asthma if you continue taking it. It is important to keep taking Singulair for the entire duration prescribed by your doctor. It will help you control your asthma.

If you have any questions 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 Singulair 10 mg film-coated tablets, the side effects considered related to Singulair most commonly reported (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 Singulair 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 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 observed 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 feeling, restlessness
• dizziness, somnolence (drowsiness), tingling/numbness
• nosebleed
• dry mouth, digestive disorders
• bruising, pruritus (itching), urticaria (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 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Singulair

• 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 Singulair 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 Singulair and contents of the pack
The 10 mg Singulair tablets are beige-colored, square-shaped, with rounded edges, film-coated, smooth on one side and imprinted with "117" on the other.
Blister packs in sizes: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140, 200 tablets.
Unit-dose blister packs (single dose) in packs of: 49x1, 50x1 and 56x1 tablets.
Not all pack sizes may be marketed.

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

Manufacturers
Merck Sharp & Dohme B.V.
Waarderweg 39
Haarlem 2031BN
The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Vianex S.A.
Plant A 12 Km National Road Athens-Lamia
Metamorfossi 144 51
Greece
Vianex S.A.
Plant B 15 Km Marathonos Avenue
Pallini, Attiki, 153 51
Greece

This medicinal product is authorized in the European Economic Area countries under the
following names:
Austria, Belgium, Denmark, Finland, France, Greece, Spain, Sweden, Germany, Ireland, Italy,
Luxembourg, The Netherlands, Portugal
Singulair

Package leaflet: Information for the user

Singulair 5 mg chewable tablets

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

• 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, as it could be harmful.
• If you or your child 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 Singulair is and what it is used for
2. What you need to know before taking Singulair
3. How to take Singulair
4. Possible side effects
5. How to store Singulair
6. Contents of the pack and other information

1. What Singulair is and what it is used for

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

• Singulair is used for the treatment of pediatric patients aged 6 to 14 years whose asthma is not adequately controlled with their current medications and who require additional therapy.
• Singulair 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 been shown unable to use inhaled corticosteroids.
• Singulair also prevents exercise-induced narrowing of the airways.

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

• 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 taking Singulair

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

• if you or your child 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 you or your child takes Singulair.

• If asthma or breathing worsens, contact your doctor immediately.
• Singulair 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 the doctor. Singulair must not be used as a substitute for 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 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 known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen 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 6 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 Singulair
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 action of Singulair, or Singulair may interfere with the action of other medicines.
Tell your doctor if you or your child is taking the following medicines before starting Singulair:

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

Singulair with food and drink
Singulair 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
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking Singulair.
Pregnancy
Your doctor will determine whether you can take Singulair under these circumstances.
Breastfeeding
It is not known whether Singulair passes into human milk. If you are breastfeeding or planning to breastfeed, you must consult your doctor before taking Singulair.
Driving and using machines
No effects of Singulair on the ability to drive or operate machinery are expected. However, individual responses to medicines may vary. Some adverse effects (such as dizziness and somnolence) reported with Singulair may affect the ability to drive and operate machinery.
Singulair 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 properly eliminate it.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".
This medicine contains up to 0.45 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, 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, because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take Singulair

Take this medicine exactly as your doctor or pharmacist has told you. If
you are unsure, consult your doctor or pharmacist.

• You or your child must take only one Singulair chewable tablet per day as prescribed by your doctor.
• The tablet must be taken even if you or your child has no symptoms or is experiencing an acute asthma attack.

For children aged 6 to 14 years:
The recommended dose is one 5 mg chewable tablet to be taken once daily in the evening.
If you or your child is taking Singulair, 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.
Singulair 5 mg chewable tablets should not be taken immediately before or after food; they should be taken at least 1 hour before or 2 hours after meals.

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

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

If you or your child stops treatment with Singulair
Treatment with Singulair will only be effective against asthma if you or your child continues to take it. It is important to continue taking Singulair for as long as your doctor has prescribed it. It will help control your 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 Singulair 5 mg chewable tablets, the side effects considered related to Singulair most commonly reported (may affect up to 1 in 10 people) were:

• headache

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

• abdominal pain.

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

Serious side effects
Talk 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 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 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) 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
• 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, 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, 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 can help provide more information on the safety of this medicine.

5. How to store Singulair

• 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 Singulair contains

• The active substance is montelukast. Each chewable tablet contains sodium montelukast 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 Singulair and contents of the pack
Singulair 5 mg chewable tablets are pink, round, biconvex, smooth on one side and engraved with 275 on the other.
Blister packs in pack sizes of: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140, 200 tablets.
Blister packs (unit 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 2031BN
The Netherlands

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

Vianex S.A.
Plant A 12 Km National Road Athens-Lamia
Metamorfossi 144 51
Greece

Vianex S.A.
Plant B 15 Km Marathonos Avenue
Pallini, Attiki, 153 51
Greece

This medicinal product is authorised in the European Economic Area countries with the following names:
Austria, Belgium, Denmark, Finland, France, Greece, Spain, Sweden, Germany, Ireland, Italy, Luxembourg, The Netherlands, Portugal:
Singulair

Package leaflet: Information for the user

Singulair 4 mg chewable tablets

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

• 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 your child only. Do not give it to others, even if their symptoms are the same as your child's, because it could be harmful.
• If your child experiences any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Singulair is and what it is used for

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

• Singulair is used to treat patients aged 2 to 5 years whose asthma is not adequately controlled with their current medications and who require additional therapy.
• Singulair 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.
• Singulair also prevents exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use Singulair based on your child’s symptoms and the severity of their asthma.
What asthma is
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 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 should know before your child takes Singulair

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

• If your child's asthma or breathing worsens, contact your doctor immediately.
• Singulair 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 child’s emergency inhaled medication for asthma attacks with you.
• It is important that your child takes all asthma medications prescribed by the doctor. Singulair must not be used instead of other asthma medicines prescribed for your child.
• If your child takes anti-asthma medicines, you should know that if he or 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 must 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 or her asthma.

Neuropsychiatric events (e.g. 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 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 Singulair
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 how Singulair works, or Singulair may interfere with how your child’s other medicines work.
Tell your doctor if your child is taking any of the following medicines before starting Singulair:

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

Singulair with food and drink
Singulair 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 does not apply because Singulair 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 Singulair 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 Singulair on driving and using machines are expected. Individual responses to medicines may, however, vary. Some side effects (such as dizziness and drowsiness) reported with Singulair may affect the ability to drive and use machines.
Singulair 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 or your child has phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate 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 0.36 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you or your child has liver or kidney disease.
This is because large amounts of benzyl alcohol may accumulate in the body and cause unwanted effects (such as metabolic acidosis).

3. How to take Singulair

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

• This medicine should be administered to your child under adult supervision. For children who have difficulty taking a chewable tablet, a granule formulation is available.
• Your child must take only one Singulair chewable 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.

For children aged 2 to 5 years:
The recommended dose is one 4 mg chewable tablet taken once daily in the evening.
If your child is taking Singulair, 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.
Singulair 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 eating.

If your child takes more Singulair than prescribed
Contact your child's doctor immediately.
In most reports of overdose, no adverse effects were observed. 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 Singulair to your child
Try to give Singulair to your child as prescribed. However, if you forget to give a chewable tablet, continue giving the medicine as normally scheduled.
Do not give your child a double dose to make up for the missed tablet.

If your child stops taking Singulair
Treatment with Singulair is effective against asthma only if he/she continues taking it.
It is important for your child to continue taking Singulair 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 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 Singulair 4 mg chewable tablets, the side effects considered related to Singulair 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 Singulair 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 Singulair 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 bleed
• tremor
• palpitations

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

• a group of symptoms including 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) that may occur without warning
• inflammation of the liver (hepatitis)

Other side effects during the medicine’s commercial use
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 (sleepiness), tingling/numbness
• nosebleed
• dry mouth, digestive disorders
• bruising, pruritus (itching), urticaria (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, subcutaneous swellings, tender to pressure, 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 Singulair

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the 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 required. This will help protect the environment.

6. Package contents and other information

What Singulair contains

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

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

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

Manufacturers
Merck Sharp & Dohme B.V.
Waarderweg 39
Haarlem 2031 BN
The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Vianex S.A.
Plant A 12 Km National Road Athens-Lamia
Metamorfossi 144 51
Greece
Vianex S.A.
Plant B 15 Km Marathonos Avenue
Pallini, Attiki, 153 51
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden
Singulair

Package leaflet: information for the user

Singulair 4 mg granules

montelukast
Read this leaflet carefully before giving this medicine to your child
because it contains important information.

• 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 your child only. Do not give it to others, even if their symptoms are the same as your child’s, because it could be harmful.
• If your child experiences any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Singulair is and what it is used for

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

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

Your doctor will determine how to use Singulair 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. 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 should know before your child takes Singulair

Inform your doctor about any illness currently present or previously experienced, and any allergies your child may have.
Do not give Singulair 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 giving Singulair to your child.

• If your child's asthma or breathing worsens, contact your doctor immediately.
• Singulair 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. Singulair must not be used instead of other asthma medications prescribed by your doctor for your child.
• If your child is taking asthma medicines, 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 medicines (also called non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen asthma.

Neuropsychiatric events (e.g. changes in behaviour and mood, depression and suicidal
ideation) 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 6 months of age.
Different formulations of this medicine are available for pediatric patients under 18 years of age, based on age groups.
Other medicines and Singulair
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 Singulair, or Singulair may interfere with the action of other medicines your child is taking.
Tell your doctor if your child is taking any of the following medicines before starting Singulair:

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

Singulair with food and drinks
Singulair granules can be taken regardless of meals.
Pregnancy and breastfeeding
This section does not apply because Singulair 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 Singulair 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.
No effects of Singulair on driving and using machines are expected. Individual responses to medicines may, however, vary. Some adverse effects (such as dizziness and drowsiness) reported with Singulair may affect the ability to drive and use machinery.
Singulair contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially “sodium-free”.

3. How to take Singulair

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 should be given to your child under adult supervision. Your child must take Singulair 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 Singulair 4 mg granules to be taken once daily in the evening.
If your child is taking Singulair, make sure they do not take any other products containing the same active substance, montelukast.

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

• Do not open the sachet until ready to use.
• Singulair granules may 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 Singulair granules sachet with one spoonful of soft, cold or room-temperature food, making sure the dose is completely mixed with the food. Ensure that your child takes the entire mixture immediately (within 15 minutes). IMPORTANT: Do not store the granule/food mixture for later use.
• Singulair granules must not be dissolved in liquids. However, liquids may be taken after administration of Singulair granules.
• Singulair granules may be taken regardless of meals.

If your child takes more Singulair than they should
Contact your child's 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 Singulair to your child
Try to give Singulair to your child as prescribed. However, if you forget to give a dose, continue with the next dose at the usual time.
Do not give your child a double dose to make up for the missed sachet.

If your child stops taking Singulair
Treatment with Singulair will only be effective against your child's asthma if they continue taking it.
It is important to keep giving Singulair for as long as the doctor has prescribed it. It will help control your child's asthma.

If you have any questions about the use of 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 Singulair 4 mg granules, the side effects considered related to Singulair that were most commonly reported (may affect up to 1 in 10 people) were:

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

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

• abdominal pain
• headache
• thirst

These side effects were generally mild and occurred more frequently in patients treated with Singulair than in those treated with placebo (a tablet without any 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 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 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 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, feeling anxious, restlessness
• dizziness, somnolence, 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

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 Singulair

• 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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Singulair contains

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

Description of the appearance of Singulair and contents of the pack
Singulair 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 Roma
Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39, Haarlem, The Netherlands
This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Latvia, Luxembourg, Norway, The Netherlands, Poland, Portugal, Slovak Republic, Romania, Slovenia, Spain, Sweden
Singulair