MONKASTA 4 mg Chewable Tablet

Зміст інструкції

1. Monkasta 4 mg chewable tablets
   1. What is Monkasta and what is it used for
   2. What you need to know before your child takes Monkasta
   3. How to take Monkasta
   4. Possible side effects
   5. How to store Monkasta
   6. Package contents and other information
2. Monkasta 5 mg chewable tablets
   1. What is Monkasta and what is it used for
   2. What you need to know before taking Monkasta
   3. How to take Monkasta
   4. Possible side effects
   5. How to store Monkasta
   6. Package Contents and Other Information
   7. What is Monkasta and what it is used for
   8. Possible side effects
   9. How to store Monkasta
   10. Contents of the pack and other information

Monkasta 4 mg chewable tablets

For children from 2 to 5 years
Montelukast
Generic medicine

Read this leaflet carefully before starting to give this medicine to your child
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 only for your child. Never give it to other people, even if they have the same symptoms as your child, as it could be dangerous.
• If your child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Monkasta and what is it used for

What is Monkasta
Monkasta is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Monkasta works
Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes,
Monkasta relieves asthma symptoms and helps to control asthma.

When should Monkasta be used
Your doctor has prescribed Monkasta for the treatment of your child's asthma and to prevent symptoms
of asthma during the day and night.

• Monkasta is used for the treatment of patients from 2 to 5 years of age who are not adequately controlled with asthma medications and require additional therapy.
• Monkasta can also be used as an alternative treatment to inhaled corticosteroids in patients from 2 to 5 years of age who have recently not taken oral corticosteroids for asthma and have shown they cannot take inhaled corticosteroids.
• Monkasta also helps to prevent the narrowing of the airways caused by exercise in patients 2 years of age and older.

Your doctor will determine how to use Monkasta based on the symptoms and 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. This narrowing gets worse and better in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) in the wall of the airways.

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

2. What you need to know before your child takes Monkasta

Inform your doctor of any medical problems or allergies your child has now or has had in the past.

Do not give Monkasta to your child:

• If your child is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before giving Monkasta to your child:

• If your child’s asthma or breathing gets worse, tell your doctor immediately.
• Monkasta oral NOTis indicated for the treatment of acute asthma attacks. If an attack occurs, follow exactly the instructions your doctor has given for your child. Always carry your child’s emergency inhaler for asthma attacks with you.
• It is important that your child takes all asthma medicines prescribed by their doctor. Monkasta should not be substituted for other asthma medicines that the doctor has prescribed for your child.
• If your child is taking medicines for asthma, they should be careful that, if they develop a combination of symptoms such as flu-like symptoms, tingling or numbness of arms and legs, worsening of lung symptoms and/or rash, they should consult a doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen their asthma.

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 the age range.

Other medicines and Monkasta
Tell 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 can affect the action of Monkasta or Monkasta can affect the way other medicines act on your child.
Tell your doctor if your child is taking any of the following medicines before starting Monkasta:

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

Monkasta with food and drink
Monkasta 4 mg chewable tablets should not be taken at the same time as food; it should be taken at least one hour before or two hours after food.

Pregnancy and breastfeeding
This sub-paragraph is not relevant to Monkasta 4 mg chewable tablets as their use is indicated in children from 2 to 5 years of age.

Driving and using machines
This sub-paragraph is not relevant to Monkasta 4 mg chewable tablets as their use is indicated in children from 2 to 5 years of age, however, the following information relates to the active ingredient, montelukast.
Monkasta is not thought to affect the ability to drive or operate machinery. However, individual responses to treatment may vary. Some undesirable effects (such as dizziness and drowsiness) that have been reported with Monkasta may affect the ability of some patients to drive or use machines.

Monkasta contains aspartame
Contains a source of phenylalanine. May be harmful to children with phenylketonuria.

3. How to take Monkasta

Give this medicine to your child following the instructions of the doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.

• This medicine must be administered to children under the supervision of an adult. For children who have problems taking chewable tablets, an oral formulation in granules is available.
• Your child should take only one chewable Monkasta tablet once a day as prescribed by your doctor.
• It should be taken even when your child has no symptoms or if they have an acute asthma attack.

Use in children from 2 to 5 years of age:
The recommended dose is one 4 mg chewable tablet to be taken in the evening.
If your child is taking Monkasta, make sure they do not take any other medicines that contain the same active ingredient, montelukast.
This medicine is for oral use.
Monkasta chewable tablets 4 mg should not be taken immediately with food; it should be taken at least 1 hour before or two hours after food.

If your child takes more Monkasta than they should
Contact your child's doctor immediately to inform them.
No adverse effects have been reported in most cases of overdose. The symptoms most frequently observed in overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting and hyperactivity.

If you forget to give Monkasta to your child
Try to give Monkasta as prescribed. However, if your child misses a dose, continue with the usual prescription of one chewable tablet once a day. Do not give a double dose to compensate for the missed dose.

If your child stops treatment with Monkasta
Monkasta can treat your child's asthma only if they continue to take it.
It is important that your child continues to take Monkasta for the entire time it has been prescribed by your doctor. This will help to control your child's asthma.
If you have any doubts about the use of this medicine, ask your child's doctor or pharmacist.

4. Possible side effects

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

• abdominal pain,
• thirst.

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

• headache.

These were usually mild and occurred more frequently in patients treated with
montelukast compared to placebo (a tablet that does not contain any active ingredient).
The frequency of possible side effects listed below is defined using the following
convention:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
In addition, the following side effects have been reported during the post-marketing of this medicine:

• upper respiratory tract infection (very common)
• increased tendency to bleeding (rare)
• allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing (uncommon)
• behaviour and mood changes [abnormal dreams, including nightmares, problems with sleeping, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive or hostile behaviour, depression (uncommon); tremor, attention disturbances, memory loss (rare); hallucinations, disorientation, suicidal thoughts and actions (very rare)]
• dizziness, drowsiness, pins and needles/numbness, convulsions (uncommon)
• palpitations (rare)
• nosebleed (uncommon), lung inflammation (very rare)
• diarrhoea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
• hepatitis (liver inflammation) (very rare)
• skin rash (common), bruising, itching, hives (uncommon); soft, red lumps under the skin mainly on the shins (erythema nodosum), severe skin reactions (erythema multiforme), which can occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); weakness/fatigue, feeling unwell, swelling (uncommon).

In asthmatic patients treated with montelukast, very rare cases of a combination of
symptoms have been reported, such as flu-like symptoms, pins and needles or numbness of arms and legs, worsening
of lung symptoms and/or rash (Churg-Strauss syndrome). You should tell your doctor immediately if your
child develops one or more of these symptoms (see section 2).

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/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Monkasta

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 and the box after EXP. The
expiry date refers to the last day of the month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in 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 Monkasta chewable tablets contain

• The active ingredient is montelukast. Each chewable tablet contains 4 mg of montelukast (as montelukast sodium).
• The excipients are: mannitol (E421), microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose aspartame (E951), red iron oxide (E172), cherry flavour (also contains glycerol triacetate (E1518)) and magnesium stearate (see section 2).

Description of the appearance of Monkasta chewable tablets and package contents
Pink, marbled, round, slightly biconvex tablets with bevelled edges and 4 inscribed on one side.
Boxes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 or 200 chewable tablets are available
in blisters.

Marketing Authorisation Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA POLSKA Sp. z.o.o., 02-235 Warszawa, Równoległa 5, Poland
TAD Pharma GmbH , Heinz-Lohmann-Straße 5, 27472 Cuxhaven , Germany

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

Monkasta 5 mg chewable tablets

For children from 6 to 14 years
Montelukast

Generic medicine
Read this leaflet carefully before you or your child start 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 only for you or your child. Never give it to other people, even if they have the same symptoms as you or your child, as it could be dangerous.
• If your child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Monkasta and what is it used for

What is Monkasta
Monkasta is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Monkasta works
Leukotrienes cause narrowing and swelling of the lungs. By blocking leukotrienes, Monkasta
improves asthma symptoms and helps to control asthma.

When should Monkasta be used
Your doctor has prescribed Monkasta for the treatment of asthma and to prevent asthma symptoms during
the day and night.

• Monkasta is used for the treatment of pediatric patients from 6 to 14 years of age who are not adequately controlled on their current therapy and need additional therapy.
• Monkasta can also be used as an alternative treatment to inhaled corticosteroids for patients from 6 to 14 years of age who have recently not been on oral corticosteroids for asthma and have shown they cannot take inhaled corticosteroids.
• Monkasta also helps to prevent narrowing of the airways caused by exercise.

Your doctor will determine how to use Monkasta based on the symptoms and severity of your asthma or
that of your child.

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

• difficulty breathing due to narrowing of the airways. This narrowing gets worse and

improves in response to various conditions.

• airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) inside the airways.

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

2. What you need to know before taking Monkasta

Tell your doctor about any medical problems or allergies that you or your child currently have or have had in the past.

Do not take Monkasta

• If you or your child are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking or giving Monkasta to your child.

• If your asthma or breathing gets worse, tell your doctor immediately.
• Monkasta oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow exactly the instructions given to you or your child by your doctor. Always carry your reliever inhaler for asthma attacks with you.
• It is important that you or your child take all medicines prescribed by your doctor. Monkasta should not be used instead of other asthma medicines that your doctor has prescribed for you or your child.
• Any patient taking medicines for asthma should be aware of developing a combination of symptoms such as flu-like symptoms, tingling or numbness of the arms and legs, worsening of lung symptoms and/or rash, and should consult a doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen your asthma.

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 the age range.

Other medicines and Monkasta
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines, including those available without a prescription.
Some medicines can affect the action of Monkasta or Monkasta can affect the way other medicines act on your child.
Tell your doctor if your child is taking any of the following medicines before starting Monkasta:

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

Monkasta with food
Monkasta 5 mg chewable tablets should not be taken at the same time as food; it should be taken at least one hour before or two hours after food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Your doctor will check if you can take Monkasta during this period.

Breastfeeding
It is not known whether Monkasta is excreted in breast milk. You should consult your doctor before taking Monkasta if you are breastfeeding or intend to breastfeed.

Driving and using machines
It is believed that Monkasta does not affect the ability to drive or operate machinery. However, individual responses to treatment may vary. Some undesirable effects (such as dizziness or drowsiness) that have been reported very rarely with montelukast may affect the ability of some patients to drive or use machines.

Monkasta contains aspartame
Contains a source of phenylalanine. May be harmful to children with phenylketonuria.

3. How to take Monkasta

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

• You or your child should only take one Monkasta tablet once a day as prescribed by your doctor.
• It should be taken even when you or your child have no symptoms or are having an acute asthma attack.

Use in children from 6 to 14 years of age:
The recommended dose is one chewable 5 mg tablet per day to be taken in the evening.
If you or your child are taking Monkasta, make sure that neither you nor your child take other
medicines that contain the same active ingredient, montelukast.
This medicine is for oral use.
The tablets should be chewed before being swallowed.
Monkasta 5 mg chewable tablets should not be taken with food; it should be taken
at least 1 hour before or 2 hours after food.

If you or your child takes more Monkasta than you should
Contact your doctor immediately to inform them.
No adverse effects have been reported in most cases of overdose. The symptoms
most frequently observed in cases of overdose in adults and children include abdominal pain,
drowsiness, thirst, headache, vomiting and hyperactivity.

If you forget to take Monkasta or to give Monkasta to your child
Try to take Monkasta as prescribed. However, if you or your child miss a dose, continue with
the usual prescription of one chewable tablet once a day. Do not take a double dose to
make up for the missed dose.

If you or your child stop taking Monkasta
Monkasta can treat your asthma and that of your child only if you or your child continue to
take it.
It is important that you continue to take Monkasta for the entire time it has been prescribed by your doctor. This
will help to control your asthma or that of your child.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
In clinical studies with montelukast 5 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 in 100 patients and in less than 1 in 10 pediatric patients treated) considered to be associated with treatment with montelukast were:

• headache. In addition, in clinical studies with montelukast 10 mg film-coated tablets, the following side effects were reported:
• abdominal pain.

These were usually mild and occurred more frequently in patients treated with
montelukast compared to placebo (a tablet that does not contain any active ingredient).
The frequency of possible side effects listed below is defined using the following
convention:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from available data)
In addition, the following side effects have been reported during the marketing of this medicine:

• upper respiratory tract infection (very common)
• increased tendency to bleeding (rare)
• allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing (uncommon)
• behaviour and mood changes [abnormal dreams, including nightmares, problems sleeping, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive or hostile behaviour, depression (uncommon); tremor, attention disturbances, memory loss (rare); hallucinations, disorientation, suicidal thoughts and behaviour (very rare)]
• dizziness, drowsiness, pins and needles/numbness, convulsions (uncommon)
• palpitations (rare)
• nosebleed (uncommon), lung inflammation (very rare)
• diarrhoea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
• hepatitis (liver inflammation) (very rare)
• skin rash (common); bruising, itching, hives (uncommon); soft, red bumps under the skin mainly on the shins (erythema nodosum), severe skin reactions (erythema multiforme), which can occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); weakness/fatigue, feeling unwell, swelling (uncommon). In asthmatic patients treated with montelukast, very rare cases have been reported of a combination of symptoms such as flu-like symptoms, pins and needles or numbness of arms and legs, worsening of lung symptoms and/or rash (Churg-Strauss syndrome). You should tell your doctor immediately if you or your child develop one or more of these symptoms (see section 2).

Reporting of side effects
If your child gets any side effect, talk to your doctor or pharmacist. You can also report side effects directly through the
national reporting system www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Monkasta

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 and the package after EXP. The
expiry date refers to the last day of the month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in 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 Monkasta chewable tablets contain

• The active ingredient is montelukast. Each chewable tablet contains 5 mg of montelukast (as montelukast sodium).
• The excipients are: mannitol (E421), microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose aspartame (E951), red iron oxide (E172), cherry flavour (also contains glycerol triacetate (E1518)) and magnesium stearate (see section 2).

Description of the appearance of Monkasta chewable tablets and package contents
Pink, marbled, round, slightly biconvex tablets with beveled edges and 5 inscribed on one side.
Available in boxes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 or 200 chewable tablets
in blisters.

Marketing Authorisation Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA POLSKA Sp. z.o.o., 02-235 Warszawa, Równoległa 5, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:

Monkasta10 mg film-coated tablets
For adults and adolescents 15 years and older
Montelukast
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

2. What is Monkasta and what it is used for

What is Monkasta
The active ingredient of Monkasta 10 mg tablets is montelukast, a leukotriene receptor antagonist.

How Monkasta works
Leukotrienes cause narrowing of the airways and inflammation in the lungs and also cause allergy symptoms.
By blocking leukotrienes, Monkasta reduces allergy symptoms of seasonal allergy (also known as
hay fever or seasonal allergic rhinitis).

When should Monkasta be used
Your doctor has prescribed Monkasta for the treatment of asthma and to prevent asthma symptoms during
the day and night.

• Monkasta is used for the treatment of adults and adolescents aged 15 years and older, who are not adequately controlled with medicines and need additional therapy.
• Monkasta also helps prevent narrowing of the airways caused by exercise.
• In patients in whom Monkasta is indicated for asthma, Monkasta may also provide relief for seasonal allergic rhinitis. Your doctor will determine how to use Monkasta based on your symptoms and the severity of your asthma.

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

• difficulty breathing due to narrowing of the airways. This narrowing gets worse and improves in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or

exercise.

• swelling (inflammation) inside the airways.

Asthma symptoms include: coughing, wheezing, and chest tightness.

What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic reaction often caused by pollen in the air from trees and grasses. Symptoms of seasonal allergies usually include a runny, itchy, stuffy nose, sneezing, swollen, red, watery, and itchy eyes.

• 4. What you need to know before you take MonkastaTell your doctor about any medical problems or allergies you have or have had in the past.

Do not take Monkasta:

• if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Monkasta.

• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral Monkasta is notindicated for the treatment of acute asthma attacks. If you have an attack, follow exactly the instructions your doctor has given you. Always carry your emergency inhaler for asthma attacks with you.
• It is important that you and your child take all the asthma medicines prescribed by your doctor. Monkasta should not be substituted for other asthma medicines your doctor has prescribed.
• Any patient being treated with asthma medicines should be careful that, if they develop a combination of symptoms such as flu-like symptoms, tingling or numbness of arms and legs, worsening of lung symptoms and/or rash, they should consult a doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen your asthma.

Children
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 the age range.

Other medicines and Monkasta
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 can affect the action of Monkasta, or Monkasta can affect the way other medicines act.
Tell your doctor if you are taking the following medicines before starting treatment with Monkasta:

• phenobarbital (used to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and some other infections),
• gemfibrozil (used to treat high levels of lipids in the blood)

Monkasta with food
Monkasta 10 mg can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The doctor will assess whether you can take Monkasta during this period.
Breastfeeding
It is not known whether montelukast passes into breast milk. You should consult your doctor before taking
Monkasta if you are breastfeeding or intend to breastfeed.

Driving and using machines
Monkasta is not thought to affect your ability to drive or operate machinery. However, individual responses to treatment can vary. Some undesirable effects (such as dizziness and drowsiness) that have occurred with Monkasta may affect the ability of some patients to drive or use
machines.

Monkasta contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicine.

• 5. How to take MonkastaAlways take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
• You must take only one Monkasta tablet once a day, as prescribed by your doctor.
• You should take it even when you do not have symptoms or are having an acute asthma attack.

For adults and adolescents 15 years of age and over:
The recommended dose is one 10 mg tablet once a day, taken in the evening.
If you are taking Monkasta, you should be sure you are not taking it together with other products that contain the
same active ingredient, montelukast.
This medicine is for oral use.
You can take Monkasta 10 mg with or without food.

If you take more Monkasta than you should
Contact your doctor or pharmacist for advice immediately.
Adverse effects have not been reported in most reports of overdose. The most common symptoms reported with overdose in adults and children included abdominal pain,
drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Monkasta
Try to take Monkasta as prescribed. However, if you miss a dose, continue with the next dose as usual, once a day. Do not take a double dose to make up for a missed dose.

If you stop taking Monkasta
Monkasta can only treat your asthma if you continue to take it.
It is important that you continue to take Monkasta for as long as your doctor has prescribed it. This
will help to control your asthma.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
In clinical studies with montelukast 10 mg film-coated tablets, the side effects most
commonly considered related to montelukast (which occurred in at least 1 in 100 patients and in less
than 1 in 10 treated patients) were:

• abdominal pain
• headache.

These were usually mild and occurred more frequently in patients treated with montelukast
compared to placebo (tablets that do not contain any medicine).
The frequency of possible side effects listed below is defined using the following
convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
In addition, the following side effects have been reported during the marketing of this medicine:

• upper respiratory tract infection (very common)
• increased tendency to bleed (rare)
• allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty
  breathing or swallowing (uncommon)
• behaviour and mood changes [abnormal dreams, including nightmares, problems with sleeping, sleep
  walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility,
  depression (uncommon); tremor, attention disturbances, memory loss (rare); hallucinations,
  disorientation, suicidal thoughts and actions (very rare)]
• dizziness, drowsiness, pins and needles/numbness, convulsions (uncommon)
• palpitations (rare)
• nosebleed (uncommon), lung inflammation (pneumonitis) (very rare)
• diarrhoea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
• hepatitis (liver inflammation) (very rare)
• skin rash (common); bruising, itching, hives (uncommon); soft, red lumps under the skin mainly on the
  shins (erythema nodosum), severe skin reactions (erythema multiforme), which can occur without
  warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); weakness/fatigue, feeling unwell, swelling (uncommon). In asthmatic patients treated
  with montelukast, very rare cases have been reported of a combination of symptoms such as flu-like
  symptoms, pins and needles or numbness of the arms and legs, worsening of lung symptoms and/or rash
  (Churg-Strauss syndrome). If you experience one or more of these symptoms, you should inform your
  doctor immediately (see section 2).

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/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Monkasta

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 and the carton after EXP. The
expiry date refers to the last day of the month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Monkasta contains

• The active ingredient is montelukast. Each film-coated tablet contains 10 mg of montelukast (as montelukast sodium).
• The excipients are: lactose monohydrate, powdered cellulose, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate in the tablet core and hypromellose, titanium dioxide (E171), talc, propylene glycol, iron oxide red (E172) and iron oxide yellow (E172) in the coating.

Description of the appearance of Monkasta and contents of the pack
The film-coated tablets are apricot-colored, round, slightly biconvex with beveled edges.
Boxes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 or 200 film-coated tablets are available
in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA Polska Sp. z.o.o., 02-235 Warszawa, Równoległa 5, Poland
TAD Pharma GmbH , Heinz-Lohmann-Straße 5 , 27472 Cuxhaven , Germany

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorised in the Member States of the European Economic Area with the following
names: