Montelukast Pensa: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST PENSA 5 mg chewable tablets

Equivalent medicine
Please read this leaflet carefully before 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. Never give it to other people. It may be harmful even if their symptoms are the same as yours or those of your child.
If any side effects occur, inform your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

What MONTELUKAST PENSA 5 mg is and what it is used for
What you need to know before taking MONTELUKAST PENSA 5 mg
How to take MONTELUKAST PENSA 5 mg
Possible side effects
How to store MONTELUKAST PENSA 5 mg
Contents of the pack and other information

1. WHAT MONTELUKAST PENSA 5 MG IS AND WHAT IT IS USED FOR

MONTELUKAST PENSA is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, MONTELUKAST PENSA improves asthma symptoms and helps control the condition.
Your doctor has prescribed MONTELUKAST PENSA for the treatment of asthma, to prevent asthma symptoms during both day and night.
MONTELUKAST PENSA is used to treat patients aged 6 to 14 years who are not adequately controlled with their current medications and require additional therapy.
MONTELUKAST PENSA may also be used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and who have been shown unable to use inhaled corticosteroids.
MONTELUKAST PENSA also helps prevent exercise-induced narrowing of the airways.
Your doctor will determine how to use MONTELUKAST PENSA based on the symptoms and severity of asthma in you or your child.

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

Breathing difficulties caused by narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
Sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or physical exercise.
Swelling (inflammation) of the airways. Asthma symptoms include coughing, wheezing, and chest tightness.

2. WHAT YOU SHOULD KNOW BEFORE TAKING MONTELUKAST PENSA 5 MG

Do not take MONTELUKAST PENSA:

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

Warnings and Precautions
Talk to your doctor or pharmacist before taking MONTELUKAST PENSA 5 mg

If your asthma or your child’s asthma or breathing worsens, contact your doctor immediately.
MONTELUKAST PENSA oral tablets must not be used to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you or your child. Always keep your child’s emergency inhaled medication available for asthma attacks.
It is important that you or your child take all asthma medications prescribed by the doctor. MONTELUKAST PENSA must not be used instead of other asthma medications prescribed for you or your child.
Every patient taking asthma medications should know that if they experience a combination of symptoms such as flu-like symptoms, tingling or numbness in arms or legs, worsening of lung symptoms and/or skin redness, they 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 they worsen your asthma.
Patients should be aware that various neuropsychiatric events (e.g., changes in behavior and mood) have been reported in adults, adolescents, and children treated with MONTELUKAST PENSA (see section 4). If you or your child develops these symptoms during treatment with MONTELUKAST PENSA, consult your child’s doctor.

Children
For children aged 2 to 5 years, MONTELUKAST PENSA 4 mg chewable tablets are available.
For children aged 6 to 14 years, MONTELUKAST PENSA 5 mg chewable tablets are available.
Other medicines and MONTELUKAST PENSA
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or plan to take any other medicines.
Some medicines may interfere with the action of MONTELUKAST PENSA, or MONTELUKAST PENSA may interfere with the action of other medicines.
Tell your doctor if you or your child are taking the following medicines before starting MONTELUKAST PENSA:

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

MONTELUKAST PENSA with food, drinks and alcohol
MONTELUKAST PENSA 5 mg chewable tablets must not be taken immediately before or after meals; they should be taken at least 1 hour before or 2 hours after eating.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Use during pregnancy
Your doctor will assess whether it is appropriate to take MONTELUKAST PENSA during pregnancy.
Use during breastfeeding
It is not known whether MONTELUKAST PENSA passes into breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking MONTELUKAST PENSA.
Driving and using machines
MONTELUKAST PENSA is not expected to impair the ability to drive vehicles or operate machinery. However, individual responses to medicines may vary. Some adverse effects (such as dizziness and drowsiness), which have been reported very rarely with MONTELUKAST PENSA, may affect the ability to drive and use machinery.
This medicinal product contains aspartame, a source of phenylalanine. It may be harmful for people with phenylketonuria.

3. HOW TO TAKE MONTELUKAST PENSA 5 MG

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 must take only one tablet of MONTELUKAST PENSA daily, as prescribed by the doctor.
The tablet must be taken even if you or your child no longer have symptoms or are experiencing an acute asthma attack.
Take the tablet by mouth.

For children aged 6 to 14 years:
One chewable tablet of MONTELUKAST PENSA 5 mg should be taken every day in the evening. MONTELUKAST PENSA 5 mg chewable tablets must not be taken immediately before or after meals; they must be taken at least 1 hour before or 2 hours after meals.
If you or your child are taking MONTELUKAST PENSA, make sure that he/she does not take other medicines containing the same active substance, montelukast.

Use in children:
4 mg chewable tablets are available for children aged 2 to 5 years.
5 mg chewable tablets are available for children aged 6 to 14 years.

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

If you forget to take MONTELUKAST PENSA
Try to take MONTELUKAST PENSA as prescribed. However, if you forget to take it or forget to give it to your child, continue taking the medicine as normally scheduled. Do not take a double dose to make up for the missed dose.

If you stop taking MONTELUKAST PENSA
MONTELUKAST PENSA can be effective against your or your child's asthma only if taken regularly. It is important to continue taking MONTELUKAST PENSA for the entire duration prescribed by the doctor. It will help control your or your child's asthma.

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

4. POSSIBLE ADVERSE REACTIONS

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

Abdominal pain
Thirst

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

Headache

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

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

Upper respiratory tract infections (very common)
Increased tendency to bleeding (rare)
Allergic reactions including skin rashes, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing (uncommon)
Changes in behaviour and mood [including changes in dream activity such as nightmares, difficulty falling asleep, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression (uncommon), tremor (rare), hallucinations, disorientation, suicidal thoughts and behaviours, stuttering (in very rare cases)]
Dizziness, drowsiness, pins and needles/numbness, seizures (uncommon)
Palpitations (rare)
Nosebleeds (uncommon)
Diarrhoea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
Hepatitis (inflammation of the liver) (very rare)
Rash (common); bruising, itching, urticaria (uncommon); red, tender 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); fatigue, feeling unwell, swelling (uncommon)

During treatment of asthmatic patients with montelukast, a combination of symptoms such as a flu-like illness, tingling or numbness in the arms or legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) has been reported in very rare cases. Please report immediately to your doctor if you or your child experience one or more of these symptoms.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MONTELUKAST PENSA 5 MG

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature conditions.
Store in the original packaging to protect the product from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What MONTELUKAST PENSA contains
The active substance is: montelukast. Each tablet contains 5 mg of montelukast (as sodium salt).
The other ingredients are: microcrystalline cellulose, mannitol (E-421), sodium croscarmellose,
aspartame (E-951), red iron oxide (E172), magnesium stearate (E-572), cherry flavour [starch of maltodextrin, modified food (waxy maize), artificial flavour, triacetin, benzyl alcohol].

Description of the appearance of MONTELUKAST PENSA and pack sizes
The 5 mg chewable tablets of MONTELUKAST PENSA are pink, biconvex tablets, marked with "M5" on one side.
The chewable tablets are available in blisters containing 14, 28 or 98 chewable tablets.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Marketing Authorisation Holder
Pensa Pharma S.p.A
Via Ippolito Rosellini 12,
20124 Milano
Italy

MANUFACTURER
Idifarma Desarrollo Farmaceutico, S.L.
Polígono Mocholí, C/ Noáin, Nº 1,
Noáin, 31110 Navarra
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
IT: MONTELUKAST PENSA 5 mg chewable tablets
PT: MONTELUCASTE PENSA 5 mg chewable tablets
ES: MONTELUKAST PENSA 5 mg chewable tablets EFG
IE: MONTELUKAST PENSA 5 mg chewable tablets
SE: MONTELUKAST PENSA 5 mg chewable tablets

This patient information leaflet was last approved on

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST PENSA 4 mg chewable tablets

Equivalent medicine
Please read this entire leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to other people. It may be harmful even if their symptoms are the same as those of your child.
If you experience any side effects, inform your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

What MONTELUKAST PENSA 4 mg is and what it is used for
What you need to know before taking MONTELUKAST PENSA 4 mg
How to take MONTELUKAST PENSA 4 mg
Possible side effects
How to store MONTELUKAST PENSA 4 mg
Contents of the pack and other information

1. WHAT MONTELUKAST PENSA 4 MG IS AND WHAT IT IS USED FOR

Your doctor has prescribed MONTELUKAST PENSA for the treatment of your child's asthma to prevent asthma symptoms during both day and night.

MONTELUKAST PENSA is used to treat patients aged 2 to 5 years who are not adequately controlled with their current medications and require additional therapy.

MONTELUKAST PENSA may also be used as an alternative treatment to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and who have shown inability to use inhaled corticosteroids.

MONTELUKAST PENSA also helps prevent exercise-induced narrowing of the airways in patients 2 years of age and older.

Your doctor will determine how to use MONTELUKAST PENSA based on your child's symptoms and the severity of their asthma.

What is asthma?
Asthma is a long-term disease.

Asthma includes:

breathing difficulties due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
sensitive airways that react to many factors, such as cigarette smoke, pollen, cold air, or physical exercise.
swelling (inflammation) of the airways. Asthma symptoms include coughing, wheezing, and chest tightness.

2. WHAT YOU SHOULD KNOW BEFORE TAKING MONTELUKAST PENSA 4 MG

Do not take MONTELUKAST PENSA:

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

Warnings and Precautions
Talk to your doctor or pharmacist before taking MONTELUKAST PENSA 4 mg

If your child's asthma or breathing worsens, contact your doctor immediately.
MONTELUKAST PENSA oral tablets must not be used to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep your child’s emergency inhaled medication available for asthma attacks.
It is important that your child takes all asthma medications prescribed by the doctor. MONTELUKAST PENSA must not be used instead of other asthma medications prescribed by your doctor for your child.
If your child is taking asthma medications, you should know that if they experience a combination of symptoms such as flu-like symptoms, tingling or numbness in arms or legs, worsening of lung symptoms and/or skin redness, you should consult the doctor.
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 their asthma.
Patients should be aware that various neuropsychiatric events (e.g., changes in behaviour and mood) have been reported in adults, adolescents and children treated with MONTELUKAST PENSA (see section 4). If your child develops these symptoms while taking MONTELUKAST PENSA, you must consult your child’s doctor.

Children
For children aged 2 to 5 years, MONTELUKAST PENSA 4 mg chewable tablets are available.
For children aged 6 to 14 years, MONTELUKAST PENSA 5 mg chewable tablets are available.

Other medicines and MONTELUKAST PENSA
Inform your doctor or pharmacist if your child is currently taking, has recently taken or intends to take any other medicines.
Some medicines may interfere with the action of MONTELUKAST PENSA, or MONTELUKAST PENSA may interfere with the action of other medicines.
Tell your doctor if your child is taking any of the following medicines before starting MONTELUKAST PENSA:

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

MONTELUKAST PENSA with food, drinks and alcohol
MONTELUKAST PENSA 4 mg chewable tablets should not be taken immediately before or after meals; they should be taken at least 1 hour before or 2 hours after eating.

Pregnancy, breastfeeding and fertility
This section does not apply to MONTELUKAST PENSA 4 mg, as this formulation is intended for children aged 2 to 5 years. However, the information below refers to the active substance, montelukast.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Use during pregnancy
Your doctor will assess whether it is possible to take MONTELUKAST PENSA during pregnancy.

Use during breastfeeding
It is not known whether MONTELUKAST PENSA passes into breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking MONTELUKAST PENSA.

Driving and using machines
This section does not apply to MONTELUKAST PENSA 4 mg, as this formulation is intended for children aged 2 to 5 years. However, the information below refers to the active substance, montelukast.
MONTELUKAST PENSA does not appear to impair the ability to drive vehicles or operate machinery. However, individual responses to medicines may vary. Some adverse effects (such as dizziness and drowsiness), which have been reported very rarely with MONTELUKAST PENSA, may affect the ability to drive vehicles and operate machinery.

This medicinal product contains aspartame, a source of phenylalanine. It may be harmful for people with phenylketonuria.

3. HOW TO TAKE MONTELUKAST PENSA 4 MG

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

Your child should take only one tablet of MONTELUKAST PENSA daily, as prescribed by the doctor.
The tablet should be taken even if your child no longer has symptoms or during an acute asthma attack.
take the tablet by mouth

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

Use in children:
4 mg chewable tablets are available for children aged 2 to 5 years.
5 mg chewable tablets are available for children aged 6 to 14 years.

If your child takes more MONTELUKAST PENSA than prescribed
Contact your doctor immediately.
In most cases of overdose, no adverse effects have been reported. The most commonly reported symptoms of overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to give MONTELUKAST PENSA to your child
Try to give MONTELUKAST PENSA to your child as prescribed. However, if you forget to give a dose, continue giving the medicine as usual. Do not give a double dose to make up for the missed dose.

If you stop your child's treatment with MONTELUKAST PENSA
MONTELUKAST PENSA can be effective against your child's asthma only if taken regularly. It is important to continue taking MONTELUKAST PENSA for as long as the doctor has prescribed it. This will help control your child's asthma.

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

4. POSSIBLE ADVERSE REACTIONS

Abdominal pain
Thirst

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

Headache

These were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill containing no active drug). The frequency categories for the possible adverse reactions listed below are defined as follows:
Very common (affects at least 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects fewer than 1 in 10,000 people)

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

Upper respiratory tract infections (very common)
Increased tendency to bleeding (rare)
Allergic reactions including skin rash, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing (uncommon)
Changes in behavior and mood [including changes in dreaming activity such as nightmares, difficulty falling asleep, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behavior or hostility, depression (uncommon), tremor (rare), hallucinations, disorientation, suicidal thoughts and behaviors, stuttering (in very rare cases)]
Dizziness, drowsiness, prickling or tingling sensations/numbness, seizures (uncommon)
Palpitations (rare)
Nosebleeds (uncommon)
Diarrhea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
Hepatitis (inflammation of the liver) (very rare)
Skin rash (common); bruising, itching, urticaria (uncommon); red, painful swellings under the skin mainly on the shins (erythema nodosum), severe skin reactions (Stevens-Johnson syndrome, erythema multiforme) which may occur without warning (very rare)
Joint or muscle pain, muscle cramps (uncommon)
Fever (common); fatigue, feeling unwell, swelling (uncommon)

During treatment of asthmatic patients with montelukast, a combination of symptoms such as a flu-like illness, tingling or numbness in the arms or legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) has been reported in very rare cases.
Please inform your doctor immediately if your child experiences one or more of these symptoms.

Reporting of adverse reactions
If you notice any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MONTELUKAST PENSA 4 MG

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the product from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What MONTELUKAST PENSA contains
The active substance is: montelukast. Each tablet contains 4 mg of montelukast (as sodium salt).
The excipients are: microcrystalline cellulose, mannitol (E-421), sodium croscarmellose,
aspartame (E-951), red iron oxide (E172), magnesium stearate (E-572), cherry flavour [maltodextrin starch, modified food (waxy maize), artificial flavour, triacetin, benzyl alcohol].

Description of the appearance of MONTELUKAST PENSA and packaging contents
The 4 mg chewable tablets of MONTELUKAST PENSA are pink, biconvex tablets, marked with "M4" on one side.
The chewable tablets are available in blisters containing 14, 28 or 98 chewable tablets.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Marketing Authorisation Holder
Pensa Pharma S.p.A
Via Ippolito Rosellini 12,
20124 Milano
Italy

MANUFACTURER
Idifarma Desarrollo Farmaceutico, S.L.
Polígono Mocholí, C/ Noáin, Nº 1,
Noáin, 31110 Navarra
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
IT: MONTELUKAST PENSA 4 mg chewable tablets
PT: MONTELUCASTE PENSA 4 mg chewable tablets
ES: MONTELUKAST PENSA 4 mg chewable tablets EFG
IE: MONTELUKAST PENSA 4 mg chewable tablets
SE: MONTELUKAST PENSA 4 mg chewable tablets

This patient information leaflet was last approved on

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST PENSA 10 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What MONTELUKAST PENSA 10 mg is and what it is used for
What you need to know before taking MONTELUKAST PENSA 10 mg
How to take MONTELUKAST PENSA 10 mg
Possible side effects
How to store MONTELUKAST PENSA 10 mg
Contents of the pack and other information

1. WHAT IS MONTELUKAST PENSA 10 MG AND WHAT IS IT USED FOR

MONTELUKAST PENSA is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, MONTELUKAST PENSA improves asthma symptoms and helps relieve symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed MONTELUKAST PENSA for the treatment of asthma, to prevent asthma symptoms during both day and night.
MONTELUKAST PENSA is used for the treatment of adults and adolescents 15 years of age and older whose asthma is not adequately controlled with their current medications and who require additional therapy.
In these asthmatic patients for whom MONTELUKAST PENSA is indicated for asthma, MONTELUKAST PENSA may also be used to relieve symptoms of seasonal allergic rhinitis.
MONTELUKAST PENSA also prevents exercise-induced narrowing of the airways.
Your doctor will determine how you should use MONTELUKAST PENSA based on your symptoms and the severity of your asthma.

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

breathing difficulties caused by narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
sensitive airways that react to many factors, such as cigarette smoke, pollen, cold air, or physical exercise.
swelling (inflammation) of the airways. Asthma symptoms include coughing, wheezing, and chest tightness.

2. WHAT YOU SHOULD KNOW BEFORE TAKING MONTELUKAST PENSA 10 MG

Do not take MONTELUKAST PENSA:

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

Warnings and Precautions
Talk to your doctor or pharmacist before taking MONTELUKAST PENSA 10 mg.

If your asthma or breathing worsens, contact your doctor immediately.
MONTELUKAST PENSA must not be used to treat acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor. Always keep your emergency inhaled asthma medication with you.
It is important that you take all asthma medications prescribed by your doctor. MONTELUKAST PENSA must not be used instead of other asthma medicines prescribed by your doctor.
Any patient taking asthma medications should be aware that if they experience a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms and/or skin redness, they should consult their doctor.
Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
Patients should be aware that various neuropsychiatric events (for example, changes in behavior and mood) have been reported in adults, adolescents and children treated with MONTELUKAST PENSA (see section 4). If you develop these symptoms while taking MONTELUKAST PENSA, you should consult your doctor.

Children
For children aged 2 to 5 years, MONTELUKAST PENSA 4 mg chewable tablets are available.
For children aged 6 to 14 years, MONTELUKAST PENSA 5 mg chewable tablets are available.

Other medicines and MONTELUKAST PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines.
Some medicines may interfere with the action of MONTELUKAST PENSA, or MONTELUKAST PENSA may interfere with the action of other medicines.
Tell your doctor if you are taking any of the following medicines before starting MONTELUKAST PENSA:

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

MONTELUKAST PENSA with food, drinks and alcohol
MONTELUKAST PENSA 10 mg film-coated tablets can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Use during pregnancy
Your doctor will assess whether it is possible to take MONTELUKAST PENSA during this period.
Use during breastfeeding
It is not known whether MONTELUKAST PENSA passes into breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking MONTELUKAST PENSA.

Driving and using machines
MONTELUKAST PENSA is not expected to impair the ability to drive vehicles or operate machinery. However, individual responses to medicines may vary. Some very rare side effects (such as dizziness and drowsiness) reported with MONTELUKAST PENSA may affect the ability to drive and use machinery.

This medicinal product contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. HOW TO TAKE MONTELUKAST PENSA 10 MG

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

You should take only one tablet of MONTELUKAST PENSA daily, as prescribed by your doctor.
The tablet should be taken even if you no longer have symptoms or during an acute asthma attack.
Take the tablet by mouth.

For adults from 15 years of age and older:
One film-coated tablet of MONTELUKAST PENSA 10 mg should be taken every day in the evening. MONTELUKAST PENSA 10 mg film-coated tablets can be taken with or without food.
If you are taking MONTELUKAST PENSA, make sure you do not take other medicines containing the same active substance, montelukast.

Use in children:
Chewable 4 mg tablets are available for children aged 2 to 5 years.
Chewable 5 mg tablets are available for children aged 6 to 14 years.

If you take more MONTELUKAST PENSA than you should
Contact your 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 take MONTELUKAST PENSA
Try to take MONTELUKAST PENSA as prescribed. However, if you forget to take a dose, continue taking the medicine as usual. Do not take a double dose to make up for the missed one.

If you stop taking MONTELUKAST PENSA
MONTELUKAST PENSA is effective against asthma only if you continue taking it. It is important to continue taking MONTELUKAST PENSA for as long as your doctor has prescribed it. It will help you control your asthma.

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

4. POSSIBLE ADVERSE EFFECTS

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

Abdominal pain
Thirst

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

Headache

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

Additionally, the following adverse effects have been reported during post-marketing use of the medicine:

Upper respiratory tract infections (very common)
Increased tendency to bleeding (rare)
Allergic reactions including skin rashes, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing (uncommon)
Changes in behaviour and mood [changes in dream activity including nightmares, difficulty falling asleep, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression (uncommon), tremor (rare), hallucinations, disorientation, suicidal thoughts and behaviours, stuttering (in very rare cases)]
Dizziness, drowsiness, sensation of pins and needles/numbness, seizures (uncommon)
Palpitations (rare)
Nosebleeds (uncommon)
Diarrhoea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
Hepatitis (inflammation of the liver) (very rare)
Skin rash (common); bruising, itching, urticaria (uncommon); red swellings 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); fatigue, feeling unwell, swelling (uncommon)

During treatment of asthmatic patients with montelukast, a combination 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. Please inform your doctor immediately if you experience one or more of these symptoms.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MONTELUKAST PENSA 10 MG

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the product from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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. PACK CONTENTS AND OTHER INFORMATION

What MONTELUKAST PENSA contains
The active substance is: montelukast. Each tablet contains 10 mg of montelukast (as sodium salt).
The excipients are:
Core: Microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, magnesium stearate (E-572)
Coating: Partially hydrolysed polyvinyl alcohol, talc, titanium dioxide (E-171), macrogol/PEG 3350, yellow iron oxide (E-172), red iron oxide (E-172).

Description of the appearance of MONTELUKAST PENSA and pack contents
The 10 mg film-coated tablets of MONTELUKAST PENSA are peach-coloured and biconvex, marked "M10" on one side.
The film-coated tablets are available in blisters containing 14, 28 or 98 film-coated tablets.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Marketing authorisation holder
Pensa Pharma S.p.A
Via Ippolito Rosellini 12,
20124 Milano, Italy

MANUFACTURER
Idifarma Desarrollo Farmacéutico, S.L.
Polígono Mocholí, C/ Noáin, Nº 1,
Noáin, 31110 Navarra, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
IT: MONTELUKAST PENSA 10 mg film-coated tablets
PT: MONTELUCASTE PENSA 10 mg film-coated tablets
ES: MONTELUKAST PENSA 10 mg comprimidos recubiertos con película EFG
IE: MONTELUKAST PENSA 10 mg film-coated tablets
SE: MONTELUKAST PENSA 10 mg filmdragerad tablett

This patient information leaflet was last approved on