Monkasta

Package leaflet: Information for the user

Monkasta 4 mg chewable tablets

For children from 2 to 5 years
Montelukast
Equivalent medicine
Read this leaflet carefully before starting to administer 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 for your child only. Never give it to other people, even if their symptoms are the same as your child's, because it could be dangerous.
• If your child experiences any side effect, including those not listed in this leaflet, consult a 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 Monkasta is and what it is used for

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

• Monkasta is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with asthma medications and require additional therapy.
• Monkasta 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 have shown inability to use inhaled corticosteroids.
• Monkasta also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

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

• difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers.
• 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 should know before your child takes Monkasta

Inform the doctor about any medical condition or allergy your child currently has or has had in the past.
Do not give Monkasta to your child:

• If your child is allergic to montelukast or to any of the excipients in 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 worsens, inform the doctor immediately.
• Oral Monkasta is NOT indicated for the treatment of acute asthma attacks. If an attack occurs, follow exactly the instructions the doctor has given you for your child. Always carry the emergency inhaled medicine for your child's asthma attacks.
• It is important that your child takes all asthma medicines prescribed by the doctor. Monkasta must not replace other asthma medicines prescribed for your child.
• If your child is taking asthma medicines, be careful and consult the doctor if your child develops a combination of symptoms such as flu-like symptoms, tingling or numbness in arms and legs, worsening of lung symptoms and/or rash.
• 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 his/her 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
Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may affect the action of Monkasta, or Monkasta may affect how other medicines work in your child.
Inform the 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 drinks
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 eating.
Pregnancy and breastfeeding
This subsection is not relevant for Monkasta 4 mg chewable tablets, as they are indicated for use in children aged 2 to 5 years.
Driving and using machines
This subsection is not relevant for Monkasta 4 mg chewable tablets, as they are indicated for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.
Monkasta is considered not to affect the ability to drive vehicles or operate machinery. However, individual responses to treatment may vary. Some adverse effects (such as dizziness and drowsiness) reported with Monkasta may affect the ability of some patients to drive or use machinery.
Monkasta contains aspartame
It contains a source of phenylalanine. It may be harmful for children with phenylketonuria.

3. How to take Monkasta

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

• This medicine should be given to children under the supervision of an adult. For children who have difficulty taking chewable tablets, an oral granule formulation is available.
• Your child should take only one Monkasta chewable tablet once daily as prescribed by your doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.

Use in children aged 2 to 5 years:
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 other medicines containing the same active substance, montelukast.
This medicine is for oral use.
Monkasta 4 mg chewable tablets should not be taken immediately with food; they should be taken at least 1 hour before or 2 hours after food.

If your child takes more Monkasta than they should
Contact your child’s doctor immediately.
In most cases of overdose, no adverse effects have been reported. The most commonly reported symptoms in cases of 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 prescribed schedule of one chewable tablet once daily. Do not give a double dose to make up for the missed dose.

If your child stops taking Monkasta
Monkasta can only treat your child’s asthma if they continue taking it.
It is important that your child continues to take Monkasta for the entire duration prescribed by their doctor. This will help control your child’s asthma.

If you have any questions about the use of this medicine, consult your child’s doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not 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 and less than 1 in 10 pediatric patients treated), considered to be related to montelukast treatment, were:

• abdominal pain,
• thirst.

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

• headache.

These were usually mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (a tablet containing no active ingredient).

The frequency of the 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)

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

• 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)
• behavioural and mood-related changes [abnormal dreams, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression (uncommon); tremor, attention disorders, memory loss (rare); hallucinations, disorientation, suicidal thoughts and actions (very rare)]
• dizziness, drowsiness, tingling/numbness, seizures (uncommon)
• palpitations (rare)
• nosebleeds (uncommon), swelling (inflammation) of the lungs (very rare)
• diarrhoea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
• hepatitis (inflammation of the liver) (very rare)
• rash (common), bruising, itching, urticaria (uncommon); soft red nodules under the skin, mainly on the shins (erythema nodosum), severe skin reactions (erythema multiforme), which may occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); weakness/tiredness, 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 illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or rash (Churg-Strauss syndrome). You must inform your doctor immediately if your child develops one or more of these symptoms (see section 2).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 stated on the blister and on the carton 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 via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Monkasta chewable tablets contain

• The active substance is montelukast. Each chewable tablet contains 4 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 glyceryl triacetate (E1518)) and magnesium stearate (see section 2).

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

Package leaflet: Information for the user

Monkasta 5 mg chewable tablets

For children aged 6 to 14 years
Montelukast
Generic medicine
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Never give it to others, even if their symptoms are the same as yours or your child's, because it could be harmful.
• If your child experiences any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Monkasta is and what it is 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. Contents of the pack and other information

1. What Monkasta is and what it is used for

What Monkasta is
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 improves asthma symptoms and helps control asthma.
When Monkasta should be used
Your doctor has prescribed Monkasta for the treatment of asthma and to prevent asthma symptoms during both day and night.

• Monkasta is used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled on their current therapy and require additional treatment.
• Monkasta may also be used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and who have shown inability to use inhaled corticosteroids.
• Monkasta also helps prevent exercise-induced narrowing of the airways.

Your doctor will determine how to use Monkasta based on the symptoms and severity of asthma in you or your child.
What is asthma?
Asthma is a long-term (chronic) disease.
Asthma includes:

• difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers.
• sensitive airways that react to many factors, 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

Inform your doctor of any medical condition or allergy 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 to any of the excipients 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 or your child’s asthma or breathing worsens, inform your doctor immediately.
• Oral Monkasta is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow exactly the instructions given by your doctor for you or your child. Always carry your emergency inhaled medicine for asthma attacks.
• It is important that you or your child take all the medicines prescribed by your doctor. Monkasta must not be used instead of other asthma medications prescribed by your doctor for you or your child.
• Every patient taking asthma medications should be cautious if they develop a combination of symptoms such as flu-like symptoms, tingling or numbness in arms and legs, worsening of lung symptoms and/or rash, and should consult their doctor.
• You or your child must 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
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines, including those without a prescription.
Some medicines may affect the action of Monkasta, or Monkasta may affect how other medicines work in your child.
Inform 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 and food
Monkasta 5 mg chewable tablets must not be taken at the same time as food; it should be taken at least one hour before or two hours after eating.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will determine whether you can take Monkasta during this time.
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
Monkasta is considered not to affect the ability to drive or operate machinery. However, individual responses to treatment may vary. Some adverse effects (such as dizziness or drowsiness), which have been reported very rarely with montelukast, may affect the ability of some patients to drive or use machinery.
Monkasta contains aspartame
It is a source of phenylalanine. It may be harmful for children with phenylketonuria.

3. How to take Monkasta

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

• You or your child should take only one tablet of Monkasta once daily as prescribed by the doctor.
• It should be taken even when you or your child do not have symptoms or are experiencing an acute asthma attack.

Use in children aged 6 to 14 years:
The recommended dose is one 5 mg chewable tablet daily, taken in the evening.
If you or your child are taking Monkasta, make sure that neither you nor your child take any other
medicines containing the same active substance, montelukast.
This medicine is for oral use.
The tablets must be chewed before swallowing.
Monkasta 5 mg chewable tablets must not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

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

If you or your child forget to take Monkasta or forget 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 prescribed regimen of one chewable tablet once daily. Do not take a double dose to make up for the missed dose.

If you or your child stop taking Monkasta
Monkasta can only control your asthma or your child's asthma if you or your child continue taking it.
It is important that you continue taking Monkasta for the entire duration prescribed by your doctor. This will help control your asthma or your child's asthma.
If you have any questions about how to use 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 less than 1 in 10 pediatric patients treated), considered related to montelukast treatment, were:

• headache.

Additionally, 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 than in those receiving placebo (a tablet containing no active ingredient).

The frequency of the 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)

Furthermore, the following side effects have been reported during post-marketing use 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 in breathing or swallowing (uncommon)
• behavioural and mood-related changes [abnormal dreams, including nightmares, trouble sleeping, sleepwalking, irritability, anxious feelings, restlessness, agitation including aggressive behaviour or hostility, depression (uncommon); tremor, attention disorders, memory loss (rare); hallucinations, disorientation, suicidal thoughts and actions (very rare)]
• dizziness, drowsiness, tingling/numbness, seizures (uncommon)
• palpitations (rare)
• nosebleeds (uncommon), swelling (inflammation) of the lungs (very rare)
• diarrhoea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
• hepatitis (inflammation of the liver) (very rare)
• rash (common); bruising, itching, urticaria (uncommon); soft red lumps under the skin, mainly on the shins (erythema nodosum), severe skin reactions (erythema multiforme), which may occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); weakness/tiredness, 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 illness, tingling or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome). You must inform 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 experiences any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system: 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 stated on the blister and the carton 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Monkasta chewable tablets contain

• The active substance is montelukast. Each chewable tablet contains 5 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 glyceryl 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 the number 5 inscribed on one side.
Boxes containing 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 or 200 chewable tablets in blisters are available.

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:

Package leaflet: Information for the user

Monkasta 10 mg film-coated tablets
For adults and adolescents from 15 years of age
Montelukast
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of this leaflet:

1. What Monkasta is and what it is 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. Contents of the pack and other information

2. What Monkasta is and what it is used for

What Monkasta is
The active substance 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 symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When Monkasta should 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 other medications and require additional therapy.
• Monkasta also helps prevent narrowing of the airways caused by exercise.
• In patients for whom Monkasta is indicated for asthma, Monkasta may also provide relief from seasonal allergic rhinitis. Your doctor will determine how to use Monkasta based on your symptoms and severity of asthma.

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

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

exercise.

• swelling (inflammation) inside the airways.

Symptoms of asthma include: coughing, shortness of breath, 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 airborne pollen from trees and grasses. Symptoms of seasonal allergies usually include a blocked, runny, itchy nose, sneezing, and puffy, red, watery, itchy eyes.

4. What you need to know before taking Monkasta
   Tell your doctor about any medical problems or allergies you currently have or have had in the past.

Do not take Monkasta:

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

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

• If your asthma or breathing worsens, inform your doctor immediately.
• Oral Monkasta is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow exactly the instructions your doctor has given you. Always carry your emergency inhaled medication for asthma attacks.
• It is important that you and your child take all asthma medications prescribed by your doctor. Monkasta should not replace any other asthma medications prescribed by your doctor.
• Any patient being treated with asthma medications should be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or rash, they must consult their 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 age group.
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 may affect the action of Monkasta, or Monkasta may affect how other medicines work.
Inform 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 plasma).

Monkasta with food
Monkasta 10 mg can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will assess whether you can take Monkasta during this period.
Breastfeeding
It is not known whether montelukast passes into breast milk. You must consult your doctor before taking Monkasta if you are breastfeeding or intend to breastfeed.
Driving and using machines
Monkasta is not considered to affect the ability to drive or use machines. However, individual responses to treatment may vary. Some side 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 your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

5. How to take Monkasta
   Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

• You should take only one Monkasta tablet once daily, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years and older:
The recommended dose is one 10 mg tablet once daily, taken in the evening.
If you are taking Monkasta, make sure you do not take it together with other products containing the same active substance, montelukast.
This medicine is for oral use.
You may take Monkasta 10 mg with or without food.
If you take more Monkasta than you should
Contact your doctor or pharmacist immediately for advice.
No adverse effects have been reported in most overdose reports. The most commonly reported symptoms in cases of overdose in adults and children include 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, take your next dose as usual, once daily. Do not take a double dose to make up for the missed dose.
If you stop taking Monkasta
Monkasta can only treat your asthma if you continue taking it.
It is important that you continue to take Monkasta for as long as your doctor has prescribed it. This will help control your asthma.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• abdominal pain
• headache.

These were usually mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (tablets containing no active ingredient).
The frequency of the 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

Additionally, the following side effects have been reported during post-marketing use 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 in breathing or swallowing (uncommon)
• behavioural and mood-related changes [abnormal dreams, including nightmares, sleep problems, sleepwalking, irritability, feelings of anxiety, restlessness, agitation including aggressive behaviour or hostility, depression (uncommon); tremor, attention disorders, memory loss (rare); hallucinations, disorientation, suicidal thoughts and actions (very rare)]
• dizziness, drowsiness, tingling/numbness, seizures (uncommon)
• palpitations (rare)
• nosebleeds (uncommon), swelling (inflammation) of the lungs (very rare)
• diarrhoea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
• hepatitis (liver inflammation) (very rare)
• rash (common); bruising, itching, urticaria (uncommon); soft, red nodules under the skin, mainly on the shins (erythema nodosum), severe skin reactions (erythema multiforme), which may occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); weakness/tiredness, feeling unwell, swelling (uncommon).

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness in the arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported. If you experience one or more of these symptoms, you must inform your doctor immediately (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 stated on the blister and carton after EXP.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Monkasta contains

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

Description of the appearance of Monkasta and pack sizes
The film-coated tablets are apricot-coloured, round, slightly biconvex, with bevelled edges.
Available in packs of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 or 200 film-coated tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names: