ELUNKAST 4 mg Tabletka Do Żucia

Treść ulotki

1. ELUNKAST 4 mg chewable tablets
   1. WHAT IS ELUNKAST 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. OTHER INFORMATION
2. ELUNKAST 5 mg chewable tablets
   1. WHAT IS ELUNKAST 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. OTHER INFORMATION
3. ELUNKAST 10 mg film-coated tablets
   1. WHAT IS ELUNKAST AND WHAT IS IT USED FOR
   2. BEFORE TAKING ELUNKAST
   3. HOW TO TAKE ELUNKAST
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ELUNKAST
   6. OTHER INFORMATION

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 anyone else. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours or your child's.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell 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 IS ELUNKAST 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 to control it.
Your doctor has prescribed ELUNKAST for the treatment of asthma, to prevent asthma symptoms both
during the day and during the night.

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

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

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

• Difficulty breathing due to narrowing of the airways. The narrowing of the airways gets worse and better in response to various conditions.

Page 1of 5

• Airways that react to many irritating stimuli, such as cigarette smoke, pollen, cold air or exercise.
• Swelling (inflammation) of the airways.

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

2. BEFORE TAKING ELUNKAST

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

Do not give ELUNKAST to your child

• if they are allergic (hypersensitive) to montelukast or any of the excipients of ELUNKAST (see
• 6. FURTHER INFORMATION).

Take particular care with ELUNKAST

• if your child's asthma or breathing gets worse, contact your doctor immediately.
• ELUNKAST by mouth should not be used to treat acute asthma attacks. If attacks occur, follow your doctor's instructions. Always keep your child's emergency inhaler medication with you for asthma attacks.
• It is important that your child takes all asthma medications prescribed by the doctor. ELUNKAST should not be used instead of other asthma medications that the doctor has prescribed for your child and/or suddenly replace inhaled or oral corticosteroids.
• If your child takes asthma medications, they should know that if they experience a combination of symptoms such as flu-like syndrome, tingling or numbness in the arms or legs, worsening lung symptoms and/or skin redness, they should consult a doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if asthma worsens.
• Your child should continue to take ELUNKAST 4 mg chewable tablets even when asthma is under control, as well as during periods of worsening asthma.

Use in children
For children from 2 to 5 years, ELUNKAST 4 mg chewable tablets are available.
For children from 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, granular 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 functioning of ELUNKAST, or ELUNKAST may interfere with the functioning of other medicines.
Page 2of 5
Inform your doctor or pharmacist if your child is taking or has recently taken any other medicine, including those without a prescription.
Tell your doctor if your child is taking the following medicines before starting to take ELUNKAST:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy).
• Rifampicin (used to treat tuberculosis and some other infections).
• Gemfibrozil (used to lower lipid levels - fats - in the blood, for example triglycerides).

Use of ELUNKAST with food and drinks
ELUNKAST 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 paragraph is not applicable because ELUNKAST 4 mg chewable tablets are intended for use in children aged 2 to 5 years. The following information, however, refers to the active ingredient, montelukast.

Use in pregnancy
If you are a pregnant woman or planning to become pregnant, you should consult your doctor before taking ELUNKAST. The doctor will determine whether you can or cannot take ELUNKAST under these circumstances.

Use during breastfeeding
It is not known whether ELUNKAST can be excreted in human milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking ELUNKAST.

Driving and using machines
This paragraph is not applicable to ELUNKAST 4 mg chewable tablets because it is intended for use in children aged 2 to 5 years; the following information, however, refers to the active ingredient, montelukast.
No effects on the ability to drive vehicles and use machines are expected.
Individual responses to medicines may vary. Some undesirable effects (such as dizziness and drowsiness) that have been reported very rarely with ELUNKAST may affect the ability to drive vehicles and use machines.

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

3. HOW TO TAKE ELUNKAST

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

Page 3of 5

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

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

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

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

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

4. POSSIBLE SIDE EFFECTS

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

• abdominal pain
• thirst

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

• headache

Page 4of 5
These side effects were usually mild and occurred more frequently in
patients treated with montelukast compared to those treated with placebo (a tablet that does not contain
medicinal substance).
The frequency of the possible side effects listed below is defined using the following
convention:
Very common (affects at least 1 in 10 people)
Common (affects from 1 to 10 people in 100)
Uncommon (affects from 1 to 10 people in 1,000)
Rare (affects from 1 to 10 people in 10,000)
Very rare (affects less than 1 in 10,000 people)
In addition, the following side effects have been reported with post-marketing use of the medicine:

• upper respiratory tract infection (very common)
• increased tendency to bleeding (rare)
• allergic reactions including skin rash (common), swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing (uncommon)
• changes in behaviour and mood: altered dreams, including nightmares, insomnia, sleepwalking, irritability, feeling of 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, decreased sensitivity, convulsions (uncommon)
• palpitations (rare)
• nosebleed (uncommon)
• diarrhoea, nausea, vomiting (common); dry mouth, digestive disturbances (Uncommon)
• increase in liver enzymes, such as serum transaminases (ALT, AST) (common)
• hepatitis (liver inflammation; in general liver problems such as eosinophilic infiltration of the liver and cholestatic, hepatocellular and/or mixed hepatic damage) (very rare)
• bruising, itching, hives (uncommon), swelling of the subcutaneous tissue (angioedema) (rare), painful, red, tender lumps under the skin, most commonly located on the front of the legs (erythema nodosum) severe skin reactions (erythema multiforme) that can occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); feeling tired/fatigued, unwell, swelling (uncommon)

During the treatment of asthmatic patients with montelukast, a
complex of symptoms such as flu-like illness, tingling or numbness in the arms or legs,
worsening of pulmonary symptoms and/or rash has been reported very rarely (Churg-Strauss syndrome). If
one or more of these symptoms occur, the patient should stop taking the medicine and contact
their doctor immediately.
Reporting of side effects
Page 5of 5
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: 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 indicated on the label with the six numbers after 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 at a temperature not exceeding 25°C in the original packaging to protect it from light and
humidity.
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 ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast. The excipients are: Mannitol (E421), microcrystalline cellulose, sodium croscarmellose, red iron oxide (E172), hydroxypropylcellulose, cherry flavour (also contains triacetin (E1518)), aspartame (E951) and magnesium stearate. Description of the appearance of ELUNKAST and contents of the pack

Pack of 28 tablets: 4 blisters of 7 tablets each.

Marketing Authorisation 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
Page 6of 5

ELUNKAST 5 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 anyone else. Indeed, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours or your child's.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell 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 IS ELUNKAST 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 to control it.
Your doctor has prescribed ELUNKAST for the treatment of asthma, to prevent asthma symptoms both
during the day and during the night.

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

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

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

• Difficulty breathing due to narrowing of the airways. The narrowing of the airways gets worse and improves in response to various conditions.

Page 1of 5

• Airways that react to many irritating stimuli, such as cigarette smoke, pollen, cold air or exercise.
• Swelling (inflammation) of the airways.

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

2. BEFORE TAKING ELUNKAST

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

Do not give ELUNKAST to your child

• if they are allergic (hypersensitive) to montelukast or any of the excipients of ELUNKAST (see
• 6. FURTHER INFORMATION).

Take special care with ELUNKAST

• if your child's asthma or breathing gets worse, contact your doctor immediately.
• ELUNKAST taken orally should not be used to treat acute asthma attacks. If attacks occur, follow your doctor's instructions. Always keep your child's emergency inhaled medication with you for asthma attacks.
• It is important that your child takes all asthma medications prescribed by the doctor. ELUNKAST should not be used instead of other asthma medications that the doctor has prescribed for your child and/or suddenly replace inhaled or oral corticosteroids.
• If your child takes asthma medications, you should be aware that if they experience a combination of symptoms such as flu-like syndrome, tingling or decreased sensation in the arms or legs, worsening of lung symptoms and/or skin redness, they should consult a doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if asthma worsens.
• Your child should continue to take ELUNKAST 5 mg chewable tablets even when asthma is under control, as well as during periods of worsening asthma.

Use in children and adolescents
ELUNKAST 4 mg chewable tablets are available for children from 2 to 5 years of age.
ELUNKAST 5 mg chewable tablets are available for children from 6 to 14 years of age.
The efficacy and safety of Elunkast chewable tablets have not been established in children under the age of
2 years.

Use of ELUNKAST with other medicines
Some medicines can interfere with the functioning of ELUNKAST, or ELUNKAST can interfere with the
functioning of other medicines.
Tell your doctor or pharmacist if your child is taking or has recently taken any
other medicines, including those without a prescription.
Tell your doctor if your child is taking the following medicines before starting to take
ELUNKAST:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy). Page 2of 5
• Rifampicin (used to treat tuberculosis and some other infections).
• Gemfibrozil (used to lower the level of fats - lipids - in the blood, for example triglycerides).

Use of ELUNKAST with food and drink
ELUNKAST 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
ELUNKAST 5 mg chewable tablets should be used in children between the ages of 6 and 14 years. The
information that follows, however, refers to the active ingredient, montelukast.

Use during pregnancy
If you are a pregnant woman or planning to become pregnant, you should consult your doctor before taking
ELUNKAST. The doctor will determine whether you can or cannot take ELUNKAST under these circumstances.

Use during breastfeeding
It is not known whether ELUNKAST can be excreted in human milk. If you are breastfeeding or intend to breastfeed,
consult your doctor before taking ELUNKAST.

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

Important information about some of the excipients in ELUNKAST
ELUNKAST chewable tablets contains aspartame, a source of phenylalanine. If your child is
affected by phenylketonuria (a rare inherited metabolic disorder), please note that the
chewable tablet contains phenylalanine.

3. HOW TO TAKE ELUNKAST

• This medicine must be administered to the child under the supervision of an adult.
• The child must take only one ELUNKAST tablet a day as prescribed by the doctor.
• The tablet must be taken even if your child has no symptoms or is having an acute asthma attack.
• Always give ELUNKAST following exactly the doctor's instructions. If you have any doubts, consult your doctor or pharmacist.
• Give the tablet by mouth.

For children from 6 to 14 years
One chewable tablet of 5 mg to be taken every day in the evening. ELUNKAST 5 mg chewable tablets
should not be taken immediately before or after meals. It must 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 that contain the
same active ingredient, montelukast.
Page 3of 5

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

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

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

4. POSSIBLE SIDE EFFECTS

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

• abdominal pain
• thirst

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

• headache

These side effects were usually mild and occurred more frequently in
patients treated with montelukast compared to those treated with placebo (a tablet that does not contain
medicinal substance).
The frequency of possible side effects listed below is defined using the following
convention:
Very common (affects at least 1 in 10 users)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 in 10,000 users)
Page 4of 5
In addition, the following side effects have been reported with post-marketing use of the medicine:

• upper respiratory tract infection (very common)
• increased tendency to bleeding (rare)
• allergic reactions including skin rash (common), swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing (uncommon)
• changes in behaviour and mood: altered dreams including nightmares, insomnia, sleepwalking, irritability, feeling of anxiety, restlessness, agitation including aggressive or hostile behaviour, depression (uncommon); tremor (rare); hallucinations, disorientation, suicidal thoughts and behaviour (propensity to suicide) (very rare)
• dizziness, somnolence, tingling, decreased sensitivity, convulsions (uncommon)
• palpitations (rare)
• nosebleed (uncommon)
• diarrhoea, nausea, vomiting (common); dry mouth, digestive disorders (uncommon)
• increase in liver function tests such as serum transaminases (ALT, AST) levels (common)
• hepatitis (liver inflammation; in general liver problems such as eosinophilic infiltration of the liver and cholestatic, hepatocellular, and/or mixed liver damage) (very rare)
• bruising, itching, hives (uncommon), swelling of the subcutaneous tissue (angioedema) (rare), painful, red skin lumps that usually occur on the front of the legs (erythema nodosum) severe skin reactions (erythema multiforme) which can occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); feeling tired/fatigued, unwell, swelling (uncommon)

During treatment of asthmatic patients with montelukast, a
complex of symptoms resembling influenza, tingling or numbness in the arms or legs,
worsening of pulmonary symptoms and/or rash has been reported very rarely (Churg-Strauss syndrome). If
one or more of these symptoms occur, the patient should stop taking the medicine and contact
their doctor immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 indicated on the label with the six numbers after 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 5of 5
Store at a temperature not exceeding 25°C in the original packaging to protect it from light and
humidity.
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 ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 5 mg of montelukast. The excipients are: Mannitol (E421), microcrystalline cellulose, sodium croscarmellose, red iron oxide (E172), hydroxypropylcellulose, cherry flavour (also contains triacetin (E1518)), aspartame (E951) and magnesium stearate.

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

Marketing Authorisation 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
Page 6of 5

ELUNKAST 10 mg film-coated tablets

Montelukast
Generic medicine
Read this leaflet carefully before you start 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. Indeed, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist. Contents of this leaflet:
• 1. What ELUNKAST is and what it is used for
• 2. Before you take ELUNKAST
• 3. How to take ELUNKAST
• 4. Possible side effects
• 5. How to store ELUNKAST
• 6. Further information

1. WHAT IS ELUNKAST AND WHAT IS IT 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 cause allergic symptoms. Blocking leukotrienes improves the symptoms of asthma and helps to control it
and improves the symptoms of seasonal allergies (also known as hay fever and seasonal allergic rhinitis).
The doctor has prescribed ELUNKAST for the treatment of asthma, to prevent asthma symptoms both
during the day and during the night.

• ELUNKAST is used for the treatment of patients who are not adequately controlled with their medications and need additional medications.
• ELUNKAST also prevents the narrowing of the airways induced by exercise.
• In asthmatic patients where ELUNKAST is indicated for asthma, ELUNKAST may provide relief from the symptoms of seasonal allergic rhinitis. The doctor will determine how to use ELUNKAST depending on the symptoms and the severity of asthma. What is asthma?

Asthma is a long-term illness.
Asthma includes:

• Difficulty breathing due to narrowing of the airways. The narrowing of the airways worsens and improves in response to various conditions.
• Airways that react to many irritating stimuli, such as cigarette smoke, pollen, cold air or exercise.
• Swelling (inflammation) of the airways. Page 1of 5

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

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

2. BEFORE TAKING ELUNKAST

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

Do not take ELUNKAST

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

Take particular care with ELUNKAST

• if your asthma or breathing worsens, contact your doctor immediately.
• ELUNKAST taken orally should not be used to treat acute asthma attacks. If attacks occur, follow your doctor's instructions. Always keep your emergency inhaled medication for asthma attacks with you.
• It is important that you, or your child, take all asthma medications prescribed by your doctor. ELUNKAST should not be used in place of other asthma medications that your doctor has prescribed for you or your child and/or suddenly replace inhaled or oral corticosteroids.
• Patients taking asthma medications should be aware that if they experience a combination of symptoms such as flu-like syndrome, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin redness, they should consult a doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if your asthma worsens. 10 mg film-coated tablets should not be used in conjunction with otherproducts containing the same active ingredient, montelukast.
• If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine
• You or your child should 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 from 2 to 5 years, ELUNKAST 4 mg chewable tablets are available.
For children from 6 to 14 years, ELUNKAST 5 mg chewable tablets are available.

Use of ELUNKAST with other medicines
Some medicines may interfere with the functioning of ELUNKAST, or ELUNKAST may interfere with the
functioning of other medicines.
Page 2of 5
Inform your doctor or pharmacist if you are taking or have recently taken or may take
any other medicine, including those available without a prescription.
Tell your doctor if you are taking the following medicines before starting to take ELUNKAST:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy).
• Rifampicin (used to treat tuberculosis and some other infections).
• Gemfibrozil (used to lower the level of fats - lipids - in the blood, for example triglycerides)

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

Pregnancy and breastfeeding

Use in pregnancy
If you are a pregnant woman or planning to become pregnant, you should consult your doctor before taking
ELUNKAST. The doctor will determine whether you can or cannot take ELUNKAST under these circumstances.

Use during breastfeeding
It is not known whether ELUNKAST can be 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 vehicles and operate machinery are expected.
Individual responses to medicines may vary, however. Some undesirable effects (such as dizziness and
drowsiness) that have been reported very rarely with ELUNKAST may affect the ability to
drive vehicles and operate machinery.

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

3. HOW TO TAKE ELUNKAST

• You must take only one ELUNKAST tablet a day as prescribed by your doctor.
• The tablet must be taken even if you do not have symptoms or are having an acute asthma attack.
• Always take ELUNKAST following exactly your doctor's instructions. If you have any doubts, consult your doctor or pharmacist.
• Take the tablet by mouth.

For adults and adolescents 15 years and over:
One 10 mg tablet to be taken every evening. ELUNKAST 10 mg can be taken with
meals or away from meals. If you are taking ELUNKAST, make sure you do not take other products that
contain the same active substance, montelukast.

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

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

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

4. POSSIBLE SIDE EFFECTS

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

• Abdominal pain
• Headache

These side effects were usually mild and occurred more frequently in
patients treated with montelukast compared to those treated with placebo (a tablet that does not contain
active substance).
The frequency of possible side effects listed below is defined using the following
convention:
Very common (affects at least 1 in 10 users)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 in 10,000)
In addition, the following side effects have been reported with the post-marketing use of the medicine:

• upper respiratory tract infection (very common)
• increased tendency to bleeding (rare)
• allergic reactions including skin rash (common), swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing (uncommon)
• changes in behaviour and mood: altered dreams, including nightmares, insomnia, sleepwalking, irritability, feeling of anxiety, restlessness, agitation including behaviour

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aggressive or hostility, depression (uncommon); tremor (rare); hallucinations, disorientation,
suicidal thoughts and behaviour (very rare)

• dizziness, somnolence, paraesthesia, decreased sensitivity, convulsions (uncommon)
• palpitations (rare)
• nosebleed (uncommon)
• diarrhoea, nausea, vomiting (common); dry mouth, digestive disturbances (uncommon)
• increased levels of some values that indicate liver function, such as serum levels of transaminases (ALT, AST) (common)
• hepatitis (liver inflammation, generally liver problems such as eosinophilic infiltration at the hepatic level and cholestatic, hepatocellular, and mixed hepatic damage) (very rare) (very rare)
• bruising, pruritus, urticaria (uncommon), swelling of the subcutaneous tissue (angioedema) (rare), subcutaneous tissue swellings of reddish colour painful to the pressure located more commonly on the anterior surface of the legs (erythema nodosum) (very rare), severe skin reactions (erythema multiforme) that can occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); feeling tired/fatigue, malaise, swelling (uncommon)

During the treatment of asthmatic patients with montelukast, a
complex of symptoms such as flu-like illness, tingling or numbness in the arms or legs,
worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) has been reported in very rare cases. If the patient
experiences one or more of these symptoms, they should stop taking the medicine and contact
their doctor immediately.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 indicated on the label with the six numbers after the word SCAD.
The first two numbers indicate the month; the last four indicate the year. The expiry date refers to
the last day of the month.
Store at a temperature not exceeding 30°C in the original packaging to protect it from light and
humidity.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

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What ELUNKAST contains

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

Coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172),
red iron oxide (E172), black iron oxide (E172).

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

Marketing Authorisation Holder
PIAM Farmaceutici S.p.A. – Via Padre G. Semeria, 5 – 16131 Genova

Manufacturer
Adamed Sp. z o.o.
Pienków 149
05-152 Czosnów, Poland
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