Elunkast

PACKAGE LEAFLET: INFORMATION FOR THE USER

ELUNKAST 4 mg chewable tablets

Montelukast
Generic medicine
Read this leaflet carefully before taking this medicine.

• 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 personally or for your child. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours or your child's.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. Contents of this leaflet:
  1. What ELUNKAST is and what it is used for
  2. Before taking ELUNKAST
  3. How to take ELUNKAST
  4. Possible side effects
  5. How to store ELUNKAST
  6. Further information

1. WHAT ELUNKAST IS AND WHAT IT IS USED FOR

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

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

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

• Difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers.

Page 1 of 5

• 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. BEFORE TAKING ELUNKAST

Tell the doctor about any illness currently present or experienced in the past, as well as any allergies.
Do not give ELUNKAST to your child

• if he/she is allergic (hypersensitive) to montelukast or to any of the excipients in ELUNKAST (see
  6. OTHER INFORMATION).

Take special care with ELUNKAST

• if asthma or breathing worsens, contact the doctor immediately.
• Oral ELUNKAST must not be used to treat acute asthma attacks. If an attack occurs, follow the 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. ELUNKAST must not be used instead of other asthma medications prescribed for your child and/or abruptly substituted for inhaled or oral corticosteroids.
• If your child is taking anti-asthma medications, be aware that if he/she develops 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.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen asthma.
• Your child must continue taking ELUNKAST 4 mg chewable tablets even when asthma is under control, as well as during periods of worsening asthma.

Use in children
For children aged 2 to 5 years, ELUNKAST 4 mg chewable tablets are available.
For children aged 6 to 14 years, ELUNKAST 5 mg chewable tablets are available.
The efficacy and safety of ELUNKAST 4 mg chewable tablets have not been established in children under 2 years of age.
For children who have difficulty taking a chewable tablet, granule formulations are available.
The ELUNKAST 4 mg chewable tablet formulation is not recommended for children under 2 years of age.

Use of ELUNKAST with other medicines
Some medicines may interfere with the action of ELUNKAST, or ELUNKAST may interfere with the action of other medicines.
Page 2 of 5
Inform the doctor or pharmacist if your child is taking or has recently taken any other medicines, including those not requiring a prescription.
Tell the doctor if your child is taking the following medicines before starting ELUNKAST:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy).
• Rifampicin (used to treat tuberculosis and certain other infections).
• Gemfibrozil (used to lower blood fat levels – lipids – for example triglycerides).

Use of ELUNKAST with food and drink
ELUNKAST 4 mg chewable tablets should 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 ELUNKAST 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.
Use during pregnancy
If you are pregnant or planning to become pregnant, consult your doctor before taking ELUNKAST. Your doctor will decide whether or not you can take ELUNKAST under these circumstances.
Use during breastfeeding
It is not known whether ELUNKAST is excreted in human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking ELUNKAST.

Driving and using machines
This section does not apply to ELUNKAST 4 mg chewable tablets, as they are intended for use in children aged 2 to 5 years; however, the following information refers to the active substance, montelukast.
No effects on the ability to drive vehicles or operate machinery are expected.
However, individual responses to medicines may vary. Some adverse effects (such as dizziness and somnolence), which have been reported very rarely with ELUNKAST, may affect the ability to drive vehicles and operate machinery.

Important information on some excipients of ELUNKAST
ELUNKAST chewable tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare inherited metabolic disorder), note that the chewable tablet contains phenylalanine.

3. HOW TO TAKE ELUNKAST

• This medicine should be administered to the child under the supervision of an adult.
• The child must take only one ELUNKAST tablet per day as prescribed by the doctor.

Page 3 of 5

• The tablet should be taken even if your child has no symptoms or is experiencing an acute asthma attack.
• Always give ELUNKAST exactly as instructed by the doctor. If you have any doubts, consult your doctor or pharmacist.
• Administer the tablet by mouth.

For children aged 2 to 5 years
One 4 mg chewable tablet to be taken daily in the evening. ELUNKAST 4 mg chewable tablets must not be taken immediately before or after meals. The tablet should be taken at least 1 hour before or 2 hours after meals.
If your child is taking ELUNKAST, make sure they do not take other products containing the same active substance, montelukast.

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

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

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

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, ELUNKAST can cause side effects, although not everyone experiences them.

In clinical studies with montelukast 4 mg chewable tablets, the most commonly reported side effects considered related to montelukast (occurring in at least 1 in 100 patients and in fewer than 1 in 10 treated pediatric patients) were:

• abdominal pain
• thirst

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

• headache

Page 4 of 5
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).

The frequency of the possible side effects listed below is defined using the following convention:

Very common (affects at least 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects fewer than 1 in 10,000 people)

In addition, the following side effects have been reported during post-marketing use of the medicine:

• upper respiratory tract infection (very common)
• increased tendency to bleeding (rare)
• allergic reactions including rash (common), swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing (uncommon)
• changes in behaviour and mood: sleep disturbances including nightmares, insomnia, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression (uncommon); tremor (rare); hallucinations, disorientation, suicidal thoughts and behaviour (suicidal ideation) (very rare)
• dizziness, drowsiness, tingling, reduced sensation, seizures (uncommon)
• palpitations (rare)
• nosebleeds (uncommon)
• diarrhoea, nausea, vomiting (common); dry mouth, digestive disorders (uncommon)
• increased levels of certain liver function parameters such as serum transaminases (ALT, AST) (common)
• hepatitis (liver inflammation; generally liver problems such as hepatic eosinophilic infiltration and cholestatic, hepatocellular, and/or mixed-type liver injury) (very rare)
• bruising, itching, urticaria (uncommon), subcutaneous swelling (angioedema) (rare), painful red swellings of the subcutaneous tissue, most commonly on the front of the legs (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); feeling tired/fatigue, malaise, swelling (uncommon)

During treatment of asthmatic patients with montelukast, a combination of symptoms has been reported in very rare cases, including flu-like symptoms, tingling or numbness in the arms or legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome). If you experience one or more of these symptoms, you must stop taking this medicine and contact your doctor immediately.

Reporting of side effects

Page 5 of 5

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: www.agenziafarmaco.gov.it/it/responsabili.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ELUNKAST

Keep ELUNKAST out of the reach and sight of children.
Do not use ELUNKAST after the expiry date stated on the label with the six numbers following the word EXP.
The first two numbers indicate the month; the last four indicate the year. The expiry date refers to the last day of the month.
Store below 25°C in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What ELUNKAST contains

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

Description of the appearance of ELUNKAST and contents of the pack

Carton pack containing 28 tablets: 4 blisters of 7 tablets each.
Marketing Authorization Holder
PIAM Farmaceutici S.p.A. – Via Padre G. Semeria, 5 – 16131 Genova
Responsible manufacturer for batch release
Adamed Sp. z o.o.
Pienków 149
05-152 Czosnów, Poland
This patient information leaflet was last approved on
Page 6 of 5

INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

ELUNKAST 5 mg Chewable Tablets

Montelukast
Generic medicine
Please read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. This medicine may be harmful to other people, even if their symptoms are the same as yours or your child's.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What ELUNKAST is and what it is used for
2. Before taking ELUNKAST
3. How to take ELUNKAST
4. Possible side effects
5. How to store ELUNKAST
6. Further information

1. WHAT ELUNKAST IS AND WHAT IT IS USED FOR

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

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

Your doctor will determine how to use ELUNKAST 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.

Page 1 of 5

• 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. BEFORE TAKING ELUNKAST

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

• if he/she is allergic (hypersensitive) to montelukast or to any of the excipients of ELUNKAST (see
  6. OTHER INFORMATION).

Take special care with ELUNKAST

• if asthma or breathing worsens, contact your doctor immediately.
• Oral ELUNKAST must not be used to treat acute asthma attacks. If attacks occur, follow your doctor's instructions. Always keep your child’s emergency inhaled medication for asthma attacks readily available.
• It is important that your child takes all asthma medications prescribed by the doctor. ELUNKAST must not be used instead of other asthma medications prescribed for your child and/or abruptly substituted for inhaled or oral corticosteroids.
• If your child takes anti-asthma medications, be aware that if he/she experiences a combination of symptoms such as flu-like symptoms, tingling or reduced sensation in arms or legs, worsening of lung symptoms and/or skin redness, you should consult the doctor.
• Acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) should not be taken if they worsen asthma.
• Your child must continue taking ELUNKAST 5 mg chewable tablets even when asthma is under control, as well as during periods of worsening asthma.

Use in children and adolescents
For children aged 2 to 5 years, ELUNKAST 4 mg chewable tablets are available.
For children aged 6 to 14 years, ELUNKAST 5 mg chewable tablets are available.
The efficacy and safety of ELUNKAST chewable tablets have not been established in children under
2 years of age.
Use of ELUNKAST with other medicines
Some medicines may interfere with the action of ELUNKAST, or ELUNKAST may interfere with the
action of other medicines.
Inform your doctor or pharmacist if your child is taking or has recently taken any
other medicines, including those obtained without a prescription.
Tell your doctor if your child is taking any of the following medicines before starting
ELUNKAST:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy). Page 2 of 5
• Rifampicin (used to treat tuberculosis and certain other infections).
• Gemfibrozil (used to lower blood lipid levels, such as triglycerides).

Use of ELUNKAST with food and drink
ELUNKAST 5 mg chewable tablets should 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
ELUNKAST 5 mg chewable tablets are intended for use in children aged 6 to 14 years. The
following information, however, refers to the active substance, montelukast.
Use during pregnancy
If you are a woman who is pregnant or planning to become pregnant, consult your doctor before taking
ELUNKAST. Your doctor will determine whether you can or cannot take ELUNKAST under these circumstances.
Use during breastfeeding
It is not known whether ELUNKAST is excreted in human milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking ELUNKAST.
Driving and operating machinery
No effects on the ability to drive vehicles or operate machinery are expected.
Individual responses to medicines may, however, vary. Some adverse reactions (such as dizziness and
drowsiness) reported very rarely with ELUNKAST may affect the ability to drive vehicles and operate machinery.
Important information about some excipients of ELUNKAST
ELUNKAST chewable tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare inherited metabolic disorder), note that the chewable tablet contains phenylalanine.

3. HOW TO TAKE ELUNKAST

• This medicine should be administered to the child under the supervision of an adult.
• The child must take only one ELUNKAST 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.
• Always ensure ELUNKAST is taken exactly as instructed by the doctor. If you have any doubts, consult your doctor or pharmacist.
• The tablet should be taken by mouth.

For children aged 6 to 14 years
One 5 mg chewable tablet to be taken once daily in the evening. ELUNKAST 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.
If your child is taking ELUNKAST, make sure they do not take other products containing the same active substance, montelukast.
Page 3 of 5

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

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

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ELUNKAST may cause adverse reactions, although not everybody experiences them.
In clinical studies with montelukast 4 mg chewable tablets, the most commonly reported adverse reactions considered related to montelukast (occurring in at least 1 in 100 patients and less than 1 in 10 patients among treated pediatric patients) were:

• abdominal pain
• thirst

Additionally, the following adverse reaction has been reported in clinical studies with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache

These adverse reactions were usually mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active substance).
The frequency of the possible adverse reactions listed below is defined using the following convention:
Very common (affects at least 1 in 10 people)
Common (affects from 1 to 10 in 100 people)
Uncommon (affects from 1 to 10 in 1,000 people)
Rare (affects from 1 to 10 in 10,000 people)
Very rare (affects fewer than 1 in 10,000 people)
Page 4 of 5

Furthermore, the following adverse reactions have been reported during post-marketing use of the medicine:

• upper respiratory tract infection (very common)
• increased tendency to bleeding (rare)
• allergic reactions including rash (common), swelling of the face, lips, tongue and/or throat, which may cause breathing or swallowing difficulties (uncommon)
• changes in behaviour and mood: changes in dreams, including nightmares, insomnia, sleepwalking, irritability, feelings of anxiety, restlessness, agitation including aggressive behaviour or hostility, depression (uncommon); tremor (rare); hallucinations, disorientation, suicidal thoughts and behaviour (suicidal ideation) (very rare)
• dizziness, somnolence, paraesthesia, reduced sensation, seizures (uncommon)
• palpitations (rare)
• nosebleeds (uncommon)
• diarrhoea, nausea, vomiting (common); dry mouth, digestive disorders (uncommon)
• increased levels of certain liver function parameters, such as serum transaminases (ALT, AST) (common)
• hepatitis (liver inflammation; generally liver problems such as hepatic eosinophilic infiltration and cholestatic, hepatocellular, and/or mixed-type liver injury) (very rare)
• bruising, pruritus, urticaria (uncommon), subcutaneous tissue swelling (angioedema) (rare), painful red subcutaneous swellings upon pressure, most commonly on the anterior surface of the legs (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); feeling of tiredness/fatigue, malaise, swelling (uncommon)

During treatment of asthmatic patients with montelukast, a combination of symptoms has been reported in very rare cases, including a flu-like illness, tingling or numbness in the arms or legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome). If the patient experiences one or more of these symptoms, they must stop taking the medicine and contact their doctor immediately.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ELUNKAST

Keep ELUNKAST out of the reach and sight of children.
Do not use ELUNKAST after the expiry date stated on the label with the six numbers following the word EXP.
The first two numbers indicate the month; the last four indicate the year. The expiry date refers to the last day of the month.
Page 5 of 5
Store at a temperature not exceeding 25°C in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What ELUNKAST contains

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

Description of the appearance of ELUNKAST and contents of the pack
Carton pack containing 28 tablets: 4 blisters with 7 tablets each.
Marketing Authorization Holder
PIAM Farmaceutici S.p.A. – Via Padre G. Semeria, 5 – 16131 Genova
Manufacturer responsible for batch release
Adamed Sp. z o.o.
Pienków 149
05-152 Czosnów, Poland
This leaflet was last approved on
Page 6 of 5

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

ELUNKAST 10 mg film-coated tablets

Montelukast
Generic medicine
Read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What ELUNKAST is and what it is used for
2. Before taking ELUNKAST
3. How to take ELUNKAST
4. Possible side effects
5. How to store ELUNKAST
6. Further information

1. WHAT ELUNKAST IS AND WHAT IT IS USED FOR

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

• ELUNKAST is used to treat patients whose asthma is not adequately controlled with their current medications and who require additional therapy.
• ELUNKAST also prevents exercise-induced narrowing of the airways.
• In asthmatic patients for whom ELUNKAST is indicated for asthma, it may also provide relief from symptoms of seasonal allergic rhinitis. Your doctor will determine how to use ELUNKAST 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. 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. Page 1 of 5

Symptoms of asthma 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. BEFORE TAKING ELUNKAST

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

• If you are allergic (hypersensitive) to montelukast or to any of the excipients of ELUNKAST (see 6. OTHER INFORMATION).

Take special care with ELUNKAST

• If your asthma or breathing worsens, contact your doctor immediately.
• Oral ELUNKAST must not be used to treat acute asthma attacks. If an 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. ELUNKAST must not be used instead of other asthma medications prescribed for you or your child, nor should it be abruptly substituted for inhaled or oral corticosteroids.
• 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 pulmonary symptoms and/or skin redness, they must consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma. ELUNKAST 10 mg film-coated tablets must not be used concomitantly with other products containing the same active substance, montelukast.
• If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
• You or your child must continue to take ELUNKAST 10 mg chewable tablets even when asthma is under control, as well as during periods of worsening asthma.

Use in children and adolescents
ELUNKAST 10 mg film-coated tablets are not recommended for use in children and adolescents under 15 years of age.
For children aged 2 to 5 years, ELUNKAST 4 mg chewable tablets are available.
For children aged 6 to 14 years, ELUNKAST 5 mg chewable tablets are available.

Use of ELUNKAST with other medicines
Some medicines may interfere with the action of ELUNKAST, or ELUNKAST may interfere with the action of other medicines.
Page 2 of 5
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Tell your doctor if you are taking the following medicines before starting ELUNKAST:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy).
• Rifampicin (used to treat tuberculosis and certain other infections).
• Gemfibrozil (used to lower blood lipid levels, such as triglycerides).

Use of ELUNKAST with food and drinks
ELUNKAST 10 mg film-coated tablets can be taken with or without food.

Pregnancy and breastfeeding
Use during pregnancy
If you are pregnant or planning to become pregnant, consult your doctor before taking ELUNKAST. Your doctor will decide whether or not you may take ELUNKAST under these circumstances.
Use during breastfeeding
It is not known whether ELUNKAST is excreted in human milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking ELUNKAST.

Driving and using machines
No effects on the ability to drive or operate machinery are expected.
However, individual responses to medicines may vary. Some adverse effects (such as dizziness and drowsiness), which have been reported very rarely with ELUNKAST, may affect the ability to drive and operate machinery.

Important information about some excipients of ELUNKAST
ELUNKAST 10 mg film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE ELUNKAST

• You should take only one ELUNKAST 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.
• Always take ELUNKAST exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• Take the tablet by mouth.

For adults and adolescents aged 15 years and over:
One 10 mg tablet to be taken every evening. ELUNKAST 10 mg may be taken with food or on an empty stomach. If you are taking ELUNKAST, make sure you do not take other products containing the same active substance, montelukast.

If you take more ELUNKAST than you should
Page 3 of 5
Contact your doctor immediately. In most reported cases of overdose, no adverse effects were observed. 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 take ELUNKAST
Try to take ELUNKAST 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 missed tablet.

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

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ELUNKAST may cause adverse reactions, although not everyone experiences them.
In clinical studies with montelukast 10 mg film-coated tablets, the most commonly reported adverse reactions considered related to the use of the drug (occurring in at least 1 patient in 100 and in fewer than 1 patient in 10) were:

• Abdominal pain
• Headache

These adverse reactions were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active substance).
The frequency of the possible adverse reactions listed below is defined using the following convention:
Very common (affects at least 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects fewer than 1 in 10,000 people)

In addition, the following adverse reactions have been reported during post-marketing use of the medicine:

• Upper respiratory tract infection (very common)
• Increased tendency to bleeding (rare)
• Allergic reactions including rash (common), swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing (uncommon)
• Changes in behaviour and mood: sleep disturbances, including nightmares, insomnia, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression (uncommon); tremor (rare); hallucinations, disorientation, suicidal thoughts and behaviour (suicidal ideation) (very rare)
• Dizziness, drowsiness, tingling sensations, reduced sensation, seizures (uncommon)
• Palpitations (rare)
• Nosebleeds (uncommon)
• Diarrhoea, nausea, vomiting (common); dry mouth, digestive disorders (uncommon)
• Increased levels of certain liver function parameters, such as serum transaminases (ALT, AST) (common)
• Hepatitis (inflammation of the liver, generally liver problems such as hepatic eosinophilic infiltration and cholestatic, hepatocellular or mixed-type liver injury) (very rare)
• Bruising, itching, urticaria (uncommon), subcutaneous tissue swelling (angioedema) (rare), painful red swellings of the subcutaneous tissue usually located on the front surface of the legs (erythema nodosum) (very rare), severe skin reactions (erythema multiforme) which may occur without warning (very rare)
• Joint or muscle pain, muscle cramps (uncommon)
• Fever (common); feeling of tiredness/fatigue, malaise, swelling (uncommon)

During treatment of asthmatic patients with montelukast, a combination of symptoms including a flu-like illness, tingling or numbness in the arms or legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) has been reported in very rare cases. If a patient experiences one or more of these symptoms, they must stop taking the medicine and contact their doctor immediately.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
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5. HOW TO STORE ELUNKAST

Keep ELUNKAST out of the reach and sight of children.
Do not use ELUNKAST after the expiry date stated on the label with the six numbers following the word EXP.
The first two numbers indicate the month; the last four indicate the year. The expiry date refers to the last day of the month.
Store below 30°C in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. OTHER INFORMATION

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What ELUNKAST contains

• The active substance is montelukast. Each tablet contains sodium montelukast equivalent to 10 mg of montelukast.
• The excipients are: Tablet core: microcrystalline cellulose, monohydrate lactose, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate.

Coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172),
red iron oxide (E172), black iron oxide (E172).
Description of the appearance of ELUNKAST and pack contents
Box containing 28 tablets: 4 blisters with 7 tablets each.
Marketing Authorization Holder
PIAM Farmaceutici S.p.A. – Via Padre G. Semeria, 5 – 16131 Genoa, Italy
Manufacturer
Adamed Sp. z o.o.
Pienków 149
05-152 Czosnów, Poland
This patient information leaflet was last approved on
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