MONTELUKAST 4 mg Chewable Tablets

Зміст інструкції

1. MONTELUKAST PENSA 5 mg chewable tablets
   1. WHAT IS MONTELUKAST PENSA 5 MG AND WHAT IS IT USED FOR
2. MONTELUKAST PENSA also helps to prevent airway narrowing induced
   1. WHAT YOU NEED TO KNOW BEFORE TAKING MONTELUKAST PENSA 5 MG
   2. HOW TO TAKE MONTELUKAST PENSA 5 MG
3. MONTELUKAST PENSA may only be effective against your asthma or your child's asthma if
   1. POSSIBLE SIDE EFFECTS
   2. HOW TO STORE MONTELUKAST PENSA 5 MG
   3. PACKAGE CONTENTS AND OTHER INFORMATION
4. MONTELUKAST PENSA 4 mg chewable tablets
   1. WHAT IS MONTELUKAST PENSA 4 MG AND WHAT IS IT USED FOR
5. MONTELUKAST PENSA also helps to prevent airway narrowing induced
   1. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD TAKES MONTELUKAST PENSA 4 MG
6. MONTELUKAST PENSA does not appear to impair the ability to drive vehicles or to
   1. HOW TO GIVE MONTELUKAST PENSA 4 MG
   2. POSSIBLE SIDE EFFECTS
   3. HOW TO STORE MONTELUKAST PENSA 4 MG
   4. PACKAGE CONTENTS AND OTHER INFORMATION
7. MONTELUKAST PENSA 10 mg film-coated tablets
   1. WHAT IS MONTELUKAST PENSA 10 MG AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING MONTELUKAST PENSA 10 MG
   3. HOW TO TAKE MONTELUKAST PENSA 10 MG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MONTELUKAST PENSA 10 MG
   6. PACKAGE CONTENTS AND OTHER INFORMATION

MONTELUKAST PENSA 5 mg chewable tablets

Generic medicine

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 others. It could be harmful even if their symptoms are the same as yours or your child's.
• If any side effects occur, tell your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. WHAT IS MONTELUKAST PENSA 5 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 to control it.
Your doctor has prescribed MONTELUKAST PENSA for the treatment of asthma, to prevent asthma symptoms during the day and night.
MONTELUKAST PENSA is used for the treatment of patients aged 6-14 years who are not adequately controlled with their medications and need additional medications.
MONTELUKAST PENSA can also be used as an alternative treatment to inhaled corticosteroids for patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and who have shown they are unable to use inhaled corticosteroids.

MONTELUKAST PENSA also helps to prevent airway narrowing induced

by physical exercise.
The doctor will determine how to use MONTELUKAST PENSA depending on the symptoms and severity
of your or 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 of the airways worsens and improves in response to various conditions.
• sensitive airways react to many things, such as cigarette smoke, pollen, cold air or exercise.
• swelling (inflammation) of the airways. Asthma symptoms include: coughing, wheezing, and chest tightness.

2. WHAT YOU NEED TO KNOW BEFORE TAKING MONTELUKAST PENSA 5 MG

Do not take MONTELUKAST PENSA:

• 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 MONTELUKAST PENSA 5 mg

• If your asthma or breathing gets worse, contact your doctor immediately.
• MONTELUKAST PENSA by mouth should not be used to treat acute asthma attacks. If attacks occur, follow the instructions given to you or your child by your doctor. Always keep your child's emergency inhaled medicines for asthma attacks with you.
• It is important that you or your child take all asthma medicines prescribed by your doctor. MONTELUKAST PENSA should not be used instead of other asthma medicines that your doctor has prescribed for you or your child.
• Every patient taking asthma medicines should be aware that if they experience a combination of symptoms such as flu-like symptoms, tingling or numbness of arms or legs, worsening of lung symptoms and/or skin rash, they should consult a doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called 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, you should consult your child’s doctor.

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

Other medicines and MONTELUKAST PENSA
Tell your doctor or pharmacist if you or your child are taking, have recently taken or are planning to take any other medicines.
Some medicines can interfere with the way MONTELUKAST PENSA works or MONTELUKAST PENSA can interfere with the way other medicines work.
Tell your doctor if you or your child are taking the following medicines before starting to take MONTELUKAST PENSA:

• phenobarbital (for the treatment of epilepsy)
• phenytoin (for the treatment of epilepsy)
• rifampicin (for the treatment of tuberculosis and some other infections)

MONTELUKAST PENSA with food, drinks and alcohol
MONTELUKAST PENSA 5 mg chewable tablets should not be taken immediately before or after meals; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy, breastfeeding and fertility
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.

Use during pregnancy
The doctor will assess whether it is possible to take MONTELUKAST PENSA during this period.

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

Driving and operating machinery
It is not expected that MONTELUKAST PENSA will impair the ability to drive vehicles or operate machinery. Individual responses to medicines may however vary. Some undesirable 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 5 MG

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

• You or your child should take only one tablet of MONTELUKAST PENSA 5 mg a day as prescribed by your doctor.
• The tablet should be taken, even if you or your child no longer have symptoms or are having an acute asthma attack.
• take the tablet by mouth

For children from 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 should not be taken immediately before or after meals; it should be taken at least 1 hour before or 2 hours after meals.
If you or your child are taking MONTELUKAST PENSA, make sure he/she does not take other medicines that contain the same active substance, montelukast.

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

If you take more MONTELUKAST PENSA than you should
Consult your doctor immediately.
There have been no adverse effects in most cases of overdose. The symptoms most frequently reported 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 it has been prescribed to you. If, however, you forget to take or to give a tablet to your child, continue to take the medicine according to the usual dosage. Do not take a double dose to make up for a forgotten one.

If you stop taking MONTELUKAST PENSA

MONTELUKAST PENSA may only be effective against your asthma or your child's asthma if

he/she continues to take it. It is important to continue taking MONTELUKAST PENSA for
as long as your doctor has prescribed it. It will help to control your or your child's
asthma.
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
experiences them.
In clinical studies with montelukast 4 mg chewable tablets, the most
commonly reported side effects (occur in at least 1 in 100 patients and less than 1 in 10 patients
pediatric patients treated) associated with montelukast were:

• Abdominal pain
• thirst

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

• headache

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

• upper respiratory tract infections (very common)
• increased tendency to bleed (rare)
• allergic reactions including skin rashes, swelling of face, lips, tongue and/or throat which can cause difficulty in breathing or swallowing (uncommon)
• changes in behavior and mood [altered dream activity including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive behavior or hostility, depression (uncommon), tremor (rare), hallucinations, disorientation, suicidal thoughts and behaviors, stuttering (in very rare cases)]
• dizziness, drowsiness, pins and needles/numbness, convulsions (uncommon)
• palpitations (rare)
• nosebleeds (uncommon)
• diarrhea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
• hepatitis (liver inflammation) (very rare)
• skin rash (common); bruising, itching, hives (uncommon); swellings of the subcutaneous tissue of reddish color mainly on the shins (erythema nodosum), severe skin reactions (erythema multiforme) that can occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); fatigue, feeling unwell, swelling (uncommon)

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

Reporting of side effects
If you get any side effect, even if not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/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 MONTELUKAST PENSA 5 MG

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage temperature.
Store in the original package to protect the product from light and moisture.
Do not use this medicine after the expiry date which is 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. PACKAGE CONTENTS AND OTHER INFORMATION

What MONTELUKAST PENSA contains
The active ingredient is: montelukast. Each tablet contains 5 mg of montelukast (as the 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 corn), artificial flavour, triacetin, benzyl
alcohol].

Description of the appearance of MONTELUKAST PENSA and package contents
The chewable tablets of MONTELUKAST PENSA 5 mg are pink and biconvex,
with "M5" imprinted on one side.
The chewable tablets are available in blisters containing 14, 28 and 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

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 denominations:
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 tablet

MONTELUKAST PENSA 4 mg chewable tablets

Generic medicine

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 only for you. Never give it to others. It could be harmful even if their symptoms are the same as yours.
• If any side effects occur, tell your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. WHAT IS MONTELUKAST PENSA 4 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 to control it.
Your doctor has prescribed MONTELUKAST PENSA for the treatment of your child's asthma, to prevent asthma symptoms during the day and night.
MONTELUKAST PENSA is used for the treatment of patients from 2 to 5 years of age who are not adequately controlled with their medications and need additional medications.
MONTELUKAST PENSA can also be used as an alternative treatment to inhaled corticosteroids for patients from 2 to 5 years of age who have not recently taken oral corticosteroids for asthma and who have shown they are unable to use inhaled corticosteroids.

MONTELUKAST PENSA also helps to prevent airway narrowing induced

by physical exercise in patients 2 years of age or older.
Your doctor will determine how to use MONTELUKAST PENSA depending 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 of the airways worsens and improves in response to various conditions.
• sensitive airways react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the airways. The symptoms of asthma include: coughing, wheezing, and chest tightness.

2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD TAKES MONTELUKAST PENSA 4 MG

Do not give 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 giving MONTELUKAST PENSA 4 mg

• If your child's asthma or breathing gets worse, contact your doctor immediately.
• MONTELUKAST PENSA by mouth should not be used to treat acute asthma attacks. If attacks occur, follow the instructions your doctor has given for your child. Always keep your child's emergency inhaler medicine with you for asthma attacks.
• It is important that your child takes all the asthma medicines prescribed by the doctor. MONTELUKAST PENSA should not be used instead of other asthma medicines that the doctor has prescribed for your child.
• If your child is taking asthma medicines, you should know that if they experience a combination of symptoms such as flu-like syndrome, tingling or numbness of arms or legs, worsening of lung symptoms and/or skin redness, they should consult a doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if their asthma worsens.
• 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 your child develops these symptoms during treatment with
MONTELUKAST PENSA, you should consult your child's doctor.

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

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

• phenobarbital (for the treatment of epilepsy)
• phenytoin (for the treatment of epilepsy)
• rifampicin (for the treatment of 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; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy, breastfeeding and fertility
This section does not concern MONTELUKAST PENSA 4 mg as its use is intended for
children from 2 to 5 years of age. However, the information below concerns the active
ingredient, montelukast.
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.

Use during pregnancy
The doctor will assess whether it is possible to take MONTELUKAST PENSA during this period.

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

Driving and operating machinery
This section does not concern MONTELUKAST PENSA 4 mg as its use is intended for
children from 2 to 5 years of age. However, the information below concerns the active
ingredient, montelukast.

MONTELUKAST PENSA does not appear to impair the ability to drive vehicles or to

operate machinery. However, individual responses to medicines may vary. Some
undesirable effects (such as dizziness and drowsiness) that have been reported very rarely
with MONTELUKAST PENSA may affect the ability to drive vehicles and operate
machinery.

This medicinal productcontains aspartame, a source of phenylalanine. It may be
dangerous for people suffering from phenylketonuria.

3. HOW TO GIVE MONTELUKAST PENSA 4 MG

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

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

For children from 2 to 5 years:
One chewable MONTELUKAST PENSA 4 mg tablet should be taken every day
in the evening. MONTELUKAST PENSA 4 mg chewable tablets should not be taken
immediately before or after meals; it should be taken at least 1 hour before or 2 hours after
meals.
If your child is taking MONTELUKAST PENSA, make sure he does not take other
medicines that contain the same active ingredient, montelukast.

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

If your child takes more MONTELUKAST PENSA than they should
Consult your doctor immediately.
There have been no adverse effects in most cases of overdose. The symptoms
reported most frequently with 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 it has been prescribed to you. However,
if you forget to have your child take a tablet, continue to have him take the
medicine according to the usual dosage. Do not give him a double dose to
make up for the missed one.

If you stop your child's treatment with MONTELUKAST PENSA
MONTELUKAST PENSA may only be effective against your child's asthma if
he continues to take it. It is important to continue taking MONTELUKAST PENSA for the entire
time that the doctor has prescribed it. It will help control your child's asthma.
If you have any doubts about the use of this medicine, consult 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 4 mg chewable tablets, the most
commonly reported side effects (occur in at least 1 in 100 patients and less than 1 in 10 patients
pediatric treated) associated with montelukast were:

• Abdominal pain
• thirst Furthermore, the following side effect has been 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 compared to placebo (a pill that does not contain any medicine). The frequency of possible side effects listed below is defined according to the following convention: Very common (affect at least 1 in 10 patients) Common (affect 1 to 10 patients per 100) Uncommon (affect 1 to 10 patients per 1,000) Rare (affect 1 to 10 patients per 10,000) Very rare (affect less than 1 in 10,000 patients)

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

• upper respiratory tract infections (very common)
• increased tendency to bleeding (rare)
• allergic reactions including skin rashes, swelling of face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing (uncommon)
• changes in behaviour and mood [including altered dreaming including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, 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, convulsions (uncommon)
• palpitations (rare)
• nosebleed (uncommon)
• diarrhoea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
• hepatitis (liver inflammation) (very rare)
• skin rash (common); bruising, itching, hives (uncommon); red, painful 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); fatigue, feeling unwell, swelling (uncommon)

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

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 MONTELUKAST PENSA 4 MG

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

6. PACKAGE CONTENTS AND OTHER INFORMATION

What MONTELUKAST PENSA contains
The active ingredient is: montelukast. Each tablet contains 4 mg of montelukast (as the 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 (cerous maize), artificial flavour, triacetin, benzyl
alcohol].

Description of the appearance of MONTELUKAST PENSA and contents of the pack
MONTELUKAST PENSA 4 mg chewable tablets are pink and biconvex,
with "M4" imprinted on one side.
The chewable tablets are available in blisters containing 14, 28 and 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 Milan

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 denominations:
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 tablet

MONTELUKAST PENSA 10 mg film-coated tablets

Generic medicine

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. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in

Contents of this leaflet:

• 1. What MONTELUKAST PENSA 10 mg is and what it is used for
• 2. What you need to know before you take MONTELUKAST PENSA 10 mg
• 3. How to take MONTELUKAST PENSA 10 mg
• 4. Possible side effects
• 5. How to store MONTELUKAST PENSA 10 mg
• 6. 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 with symptoms of seasonal allergy (also known as hay fever or allergic rhinitis).
Your doctor has prescribed MONTELUKAST PENSA for the treatment of asthma, to prevent asthma symptoms during the day and night.
MONTELUKAST PENSA is used for the treatment of adults and adolescents 15 years of age and older who are not adequately controlled with their medications and need additional medications.
In these asthmatic patients for whom MONTELUKAST PENSA is indicated for asthma, MONTELUKAST PENSA can also be used to relieve symptoms of seasonal allergic rhinitis.
MONTELUKAST PENSA also prevents narrowing of the airways induced by physical exercise.
The doctor will determine how to use MONTELUKAST PENSA depending 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 of the airways gets worse and better in response to various conditions.
• sensitive airways react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the airways. Asthma symptoms include: coughing, wheezing, and chest tightness.

2. WHAT YOU NEED TO KNOW BEFORE TAKING MONTELUKAST PENSA 10 MG

Do not take MONTELUKAST PENSA :

• if you are allergic to montelukast or any of the other ingredients 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 gets worse, contact your doctor immediately.
• MONTELUKAST PENSA should not be used to treat acute asthma attacks. If you experience attacks, follow the instructions given to you by your doctor. Always keep your emergency reliever inhaler with you for asthma attacks.
• It is important that you take all asthma medicines prescribed by your doctor. MONTELUKAST PENSA should not be used instead of other asthma medicines that your doctor has prescribed.
• Every patient taking asthma medicines should be aware that if they experience a combination of symptoms such as flu-like symptoms, tingling or numbness of arms or legs, worsening of lung symptoms and/or skin rash, they should consult a doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your 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 you develop these symptoms while taking MONTELUKAST PENSA, you should consult your doctor.

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

Other medicines and MONTELUKAST PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.
Some medicines can interfere with the way MONTELUKAST PENSA works or MONTELUKAST PENSA can interfere with the way other medicines work.
Tell your doctor if you are taking the following medicines before starting to take MONTELUKAST PENSA:

• phenobarbital (for the treatment of epilepsy)
• phenytoin (for the treatment of epilepsy)
• rifampicin (for the treatment of tuberculosis and some 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, 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.

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 your baby or intend to breastfeed, consult your doctor before taking MONTELUKAST PENSA.

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

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

3. HOW TO TAKE MONTELUKAST PENSA 10 MG

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

• You must take only one tablet of MONTELUKAST PENSA a day as prescribed by your doctor.
• The tablet must be taken, even if you no longer have symptoms or are having an acute asthma attack.
• take the tablet by mouth

For adults 15 years and over:
One film-coated tablet of MONTELUKAST PENSA 10 mg must 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 are not taking other medicines
that contain the same active substance, montelukast.

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

If you take more MONTELUKAST PENSA than you should
Consult your doctor immediately.
There have been no adverse effects in most cases of overdose. The symptoms
reported most frequently 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 it has been prescribed to you. If, however, you forget
to take a dose, continue to take the medicine according to the usual dosage. Do not
take a double dose to make up for a forgotten one.

If you stop taking MONTELUKAST PENSA
MONTELUKAST PENSA may only be effective against asthma if you continue to take it. It is
important to continue taking MONTELUKAST PENSA for as long as your doctor has
prescribed it. It will help to control your asthma.
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 everybody gets them.
In clinical studies with montelukast 4 mg chewable tablets, the most
commonly reported side effects (occur in at least 1 in 100 patients and less than 1 in 10 patients
pediatric treated) associated with montelukast were:

• Abdominal pain
• thirst

In addition, the following adverse reaction has been 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 compared to placebo (a pill that does not contain any medicine).
The frequency of possible side effects listed below is defined according to the
following convention:
Very common (affect at least 1 in 10 patients)
Common (affect 1 to 10 patients in 100)
Uncommon (affect 1 to 10 patients in 1,000)
Rare (affect 1 to 10 patients in 10,000)
Very rare (affect less than 1 in 10,000 patients)
In addition, with the commercial use of the medicine, the following effects
undesirable have been reported:

• upper respiratory tract infections (very common)
• increased tendency to bleeding (rare)
• allergic reactions including skin rashes, swelling of face, lips, tongue and/or throat which can cause difficulty breathing or swallowing (uncommon)
• changes in behavior and mood [altered dream activity including nightmares, problems 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, pins and needles/numbness, seizures (uncommon)
• palpitations (rare)
• nosebleeds (uncommon)
• diarrhea, nausea, vomiting (common); dry mouth, indigestion (uncommon)
• hepatitis (liver inflammation) (very rare)
• skin rash (common); bruising, itching, hives (uncommon); swellings of the subcutaneous tissue of reddish color mainly on the shins (erythema nodosum), severe epidermal reactions (erythema multiforme) that can occur without warning (very rare)
• joint or muscle pain, muscle cramps (uncommon)
• fever (common); fatigue, feeling unwell, swelling (uncommon)

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

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 MONTELUKAST PENSA 10 MG

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage temperature.
Store in the original package to protect the product from light and moisture.
Do not use this medicine after the expiry date which is 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. PACKAGE CONTENTS AND OTHER INFORMATION

What MONTELUKAST PENSA contains
The active ingredient is: montelukast. Each tablet contains 10 mg of montelukast (as the sodium salt).
The excipients are:

Core:Microcrystalline cellulose, lactose monohydrate ,sodium croscarmellose, magnesium
stearate (E-572)

Coating:Polyvinyl Alcohol- partially hydrolyzed ,talc ,titanium dioxide (E-171) ,
macrogol/PEG3350 ,yellow iron oxide (E-172) ,red iron oxide (E-172).

Description of the appearance of MONTELUKAST PENSA and package contents
The film-coated tablets of MONTELUKAST PENSA 10 mg are peach-colored and
biconvex, with "M10" imprinted on one side.
The film-coated tablets are available in blisters containing 14, 28 and 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 Milan

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 denominations:
IT: MONTELUKAST PENSA 10 mg film-coated tablets
PT: MONTELUCASTE PENSA 10 mg comprimidos revestidos por película
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