PACKAGE LEAFLET: Information for the user

MONTEGEN 10 mg film-coated tablets

montelukast
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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Montegen is and what it is used for

What Montegen is
Montegen contains the active substance montelukast, a leukotriene receptor antagonist.
How Montegen works
Leukotrienes are substances that cause the narrowing and swelling of the airways in the lungs and also trigger allergic symptoms. Montegen works by blocking the interaction of leukotrienes with their receptors, thereby relieving asthma symptoms, helping to control asthma, and improving symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When Montegen should be used
Your doctor has prescribed Montegen 10 mg film-coated tablets for the treatment of asthma, to prevent asthma symptoms both during the day and at night.
Montegen 10 mg film-coated tablets are used to treat adults and adolescents aged 15 years and older whose asthma is not adequately controlled with their current medication and who require additional therapy.
Montegen 10 mg film-coated tablets also prevent exercise-induced narrowing of the airways.
Montegen 10 mg film-coated tablets may also provide relief from symptoms of seasonal allergic rhinitis in patients for whom Montegen is indicated for asthma.
Your doctor will determine how you should take Montegen 10 mg film-coated tablets based on your symptoms and the severity of your asthma.
What is asthma?
Asthma is a long-term condition.
The characteristics of asthma are:

difficulty breathing due to narrowing of the airways, which worsens and improves in response to various conditions;
airways that react to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise;
swelling (inflammation) of the airways.

Symptoms of asthma include cough, shortness of breath, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include a blocked or runny nose, nasal itching, sneezing, and red, swollen, itchy, and watery eyes.

2. What you need to know before taking Montegen

Inform your doctor of any medical conditions you currently have or have had in the past, and of any allergies.
Do not take Montegen

if you 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 Montegen 10 mg film-coated tablets.
Exercise particular caution with Montegen:

if your asthma or breathing worsens; in this case, contact your doctor immediately;
do not use Montegen to treat acute asthma attacks. If you experience an acute asthma attack, follow the instructions provided by your doctor. Make sure you always have your prescribed inhaled emergency medication available for asthma attacks;
it is important that you continue taking all asthma medications prescribed by your doctor. Montegen does not replace other asthma medications prescribed by your doctor;
consult your doctor if you are taking asthma medications and develop a combination of symptoms such as flu-like symptoms, tingling or reduced sensation in the arms or legs, worsening of lung symptoms, and/or skin redness;
do not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these cause your asthma to worsen.

Children and adolescents
Montegen 10 mg film-coated tablets must not be given to children and adolescents under 15 years of age.
Different formulations of this medicine are available for pediatric patients under 18 years of age, based on age group.
Other medicines and Montegen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect how Montegen works, or Montegen may affect how other medicines work.
Inform your doctor or pharmacist if you are taking the following medicines before starting Montegen 10 mg film-coated tablets:

phenobarbital (used to treat epilepsy);
phenytoin (used to treat epilepsy);
rifampicin (used to treat tuberculosis and certain other infections);
gemfibrozil (used to treat high levels of lipids in plasma).

Montegen with food and drink
Montegen 10 mg film-coated tablets can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether or not you can take Montegen in this case.
Breastfeeding
It is not known whether Montegen passes into breast milk. If you are breastfeeding or intend to breastfeed your baby, consult your doctor before taking Montegen.
Driving and using machines
No effects of Montegen 10 mg film-coated tablets on the ability to drive vehicles or operate machinery are expected. However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and drowsiness) reported after taking Montegen may affect the ability to drive vehicles and operate machinery; therefore, exercise appropriate caution in such circumstances.
Montegen 10 mg film-coated tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Montegen

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

For adults and adolescents aged 15 years and older
The recommended dose for adults and adolescents aged 15 years and older is one 10 mg tablet daily, taken in the evening with or without food.
Take only one Montegen tablet per day, orally, even when you have no symptoms or during an acute asthma attack, as prescribed by your doctor.
If you are already taking Montegen, make sure you do not simultaneously take other medicines containing the same active substance (montelukast).

If you take more Montegen than you should
Contact your doctor immediately.
In most reports of overdose, no adverse effects were observed. The most commonly reported symptoms following overdose in adults and children include: abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Montegen
Take Montegen 10 mg film-coated tablets as prescribed by your doctor. However, if you forget to take a tablet, continue treatment with Montegen according to the usual schedule (one tablet per day).
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Montegen
Treatment with Montegen is effective against asthma only if taken continuously. It is important that you continue taking Montegen 10 mg film-coated tablets for the entire duration of treatment as prescribed by your doctor, as this will help control your asthma.

If you have any questions 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 everyone experiences them.
The side effects considered related to the use of Montegen 10 mg film-coated tablets, most commonly reported during clinical studies (may affect up to 1 in 10 people), were:

abdominal pain;
headache.

If you notice any of the following serious side effects, stop using Montegen and contact a doctor immediately:
Uncommon (may affect up to 1 in 100 people)

allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing;
changes in behaviour and mood: agitation including aggressive behaviour or hostility, depression;
seizures.

Rare (may affect up to 1 in 1,000 people)

increased tendency to bleed;
tremor;
awareness of heartbeat (palpitations).

Very rare (may affect up to 1 in 10,000 people)

a group of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2);
low platelet count in the blood;
changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions;
swelling (inflammation) of the lungs;
severe skin reactions (erythema multiforme) which may occur without warning;
inflammation of the liver (hepatitis).

Additionally, the following side effects have been reported following marketing of the product:
Very common (may affect more than 1 in 10 people)

upper respiratory tract infection.

Common (may affect up to 1 in 10 people)

diarrhoea, nausea, vomiting;
fever;
rash;
increased transaminase levels in the blood.

Uncommon (may affect up to 1 in 100 people)

changes in behaviour and mood: changes in dreams, including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness;
dizziness, drowsiness, tingling;
nosebleed;
dry mouth, digestive problems;
bruising, itching, urticaria;
joint or muscle pain, muscle cramps;
involuntary loss of urine during sleep in children;
weakness/tiredness, malaise, swelling.

Rare (may affect up to 1 in 1,000 people)
changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements.
Very rare (may affect up to 1 in 10,000 people)

red, painful lumps under the skin, most commonly located on the front of the legs (erythema nodosum).

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 Montegen

Keep Montegen out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after the word "EXP". The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Montegen contains

The active substance is montelukast. Each film-coated tablet contains montelukast sodium equivalent to 10 mg of montelukast.
The other ingredients are: microcrystalline cellulose, monohydrate lactose (89.3 mg), sodium croscarmellose, hypromellose (E463), and magnesium stearate. Coating: hypromellose, hypromellose (E463), titanium dioxide (E171), red and yellow iron oxides (E172), carnauba wax.

Description of the appearance of Montegen and contents of the pack
Montegen film-coated tablets are beige, square-shaped, with rounded edges, and have "117" engraved on one side.
Montegen 10 mg film-coated tablets are available in blister packs containing: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140, 200 tablets, and in single-dose blister packs of 49x1, 50x1 and 56x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.r.l.
Via San Giuseppe Cottolengo, 15 – 20143 Milan, Italy
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48 – Quinto de' Stampi, 20089 Rozzano (Milan), Italy

Package leaflet: information for the user

Montegen 5 mg chewable tablets

montelukast
Please read this leaflet carefully before taking this medicine because it contains
important information for you or your child.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Montegen is and what it is used for

What Montegen is
Montegen contains the active substance montelukast, a leukotriene receptor antagonist.
How Montegen works
Leukotrienes are substances that cause narrowing and swelling of the airways in the lungs. Montegen works by blocking the interaction of leukotrienes with their receptors, thereby relieving asthma symptoms and helping to control the condition.
When Montegen should be used
Your doctor has prescribed Montegen 5 mg chewable tablets for you or your child for the treatment of asthma, to prevent asthma symptoms both during the day and at night.
Montegen 5 mg chewable tablets are used to treat pediatric patients aged 6 to 14 years whose asthma is not adequately controlled with their usual medication and who require additional therapy.
Montegen 5 mg chewable tablets 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 been shown unable to use inhaled corticosteroids.
Montegen 5 mg chewable tablets also prevent exercise-induced narrowing of the airways.
Your doctor will determine how Montegen 5 mg chewable tablets should be taken by you or your child, based on symptoms and the severity of asthma.
What asthma is
Asthma is a long-term condition.
The features of asthma are:

difficulty breathing due to narrowing of the airways, which worsens and improves in response to various triggers;
airways that react to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise;
swelling (inflammation) of the airways.

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

2. What you need to know before taking Montegen

Do not use Montegen

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 you or your child take Montegen 5 mg chewable tablets.
Be especially careful with Montegen:

if asthma or breathing worsens; in this case, contact your doctor immediately;
do not use Montegen to treat acute asthma attacks. If you or your child experience an acute asthma attack, follow the instructions provided by your doctor. Make sure you always have your prescribed inhaled emergency medication available for asthma attacks;
it is important that you or your child take all asthma medications as prescribed by your doctor. Montegen does not replace other asthma medicines prescribed for you or your child;
contact your doctor if you or your child are taking asthma medications and experience a combination of symptoms such as flu-like illness, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness;
you and your child must not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these cause worsening of 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, based on age group.
Other medicines and Montegen
Inform your doctor if you or your child are taking, have recently taken, or might take any other medicines.
Some medicines may affect how Montegen works, or Montegen may affect how other medicines work.
Inform your doctor if you or your child are taking the following medicines before starting Montegen 5 mg chewable tablets:

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

Montegen with food and drink
Montegen 5 mg chewable tablets should not be taken immediately before or after meals. The tablets must be taken at least 1 hour before or 2 hours after meals.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are a woman who is pregnant or planning a pregnancy, talk to your doctor before taking Montegen. Your doctor will decide whether or not you should take Montegen in this case.
Breastfeeding
It is not known whether Montegen passes into breast milk. If you are breastfeeding or planning to breastfeed your child, talk to your doctor before taking Montegen.
Driving and using machines
No effects of Montegen 5 mg chewable tablets on the ability to drive vehicles or operate machinery are expected. However, individual responses to the medicine may vary.
Some side effects (such as dizziness and drowsiness) reported after taking Montegen may affect the ability to drive vehicles and operate machinery; therefore, exercise appropriate caution under such circumstances.
Montegen 5 mg chewable tablets contain aspartame, a source of phenylalanine.
It may be harmful to your child if he or she has phenylketonuria.

3. How to take Montegen

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
For children aged 6 to 14 years
The recommended dose for children between 6 and 14 years of age is one 5 mg chewable tablet daily, to be taken in the evening. Montegen 5 mg chewable tablets should not be taken immediately before or after meals. The tablets should be taken at least 1 hour before or 2 hours after meals.
The tablets must be chewed before swallowing.
You or your child must take one tablet of Montegen daily by mouth, even when you have no symptoms or experience an acute asthma attack, as prescribed by the doctor.
If you or your child are already taking Montegen, make sure not to take other medicines at the same time that contain the same active substance (montelukast).
If you or your child take more Montegen than you should
Contact your doctor immediately.
In most reported cases of overdose, no adverse effects were observed. The most frequently reported symptoms following overdose in adults and children include: abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
If you or your child forget to take Montegen
Take/give Montegen 5 mg chewable tablets according to your doctor's instructions. However, if you or your child forget to take a tablet, continue treatment with Montegen according to the usual schedule (one tablet daily). Do not take/give a double dose to make up for the forgotten tablet.
If you or your child stop taking Montegen
Treatment with Montegen is effective against asthma only if taken continuously. It is important that you or your child continue taking Montegen 5 mg chewable tablets for the entire duration of treatment as prescribed by the doctor, which will help control your asthma or your child's asthma.
If you have any questions about using 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.

The adverse reaction considered related to the use of Montegen 5 mg chewable tablets, most commonly reported during clinical studies (may affect up to 1 in 10 people), was:

headache.

With the use of Montegen 10 mg film-coated tablets, the following has been reported:

abdominal pain.

If you notice any of the following serious adverse reactions, stop using Montegen and contact a doctor immediately:

Uncommon (may affect up to 1 in 100 people)

allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing;
changes in behaviour and mood: agitation including aggressive behaviour or hostility, depression;
seizures.

Rare (may affect up to 1 in 1,000 people)

increased tendency to bleeding;
tremor;
awareness of heartbeat (palpitations).

Very rare (may affect up to 1 in 10,000 people)

a group of symptoms such as flu-like syndrome, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2);
low platelet count in the blood;
changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions;
swelling (inflammation) of the lungs;
severe skin reactions (erythema multiforme) which may occur without warning;
inflammation of the liver (hepatitis).

Additionally, following marketing of the product, the following adverse reactions have been reported:

Very common (may affect more than 1 in 10 people)

upper respiratory tract infection.

Common (may affect up to 1 in 10 people)

diarrhoea, nausea, vomiting;
fever;
rash;
increased transaminase levels in the blood.

Uncommon (may affect up to 1 in 100 people)

changes in behaviour and mood: dream abnormalities including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness;
dizziness, somnolence, tingling;
nosebleeds;
dry mouth, digestive problems;
bruising, pruritus, urticaria;
joint or muscle pain, muscle cramps;
involuntary loss of urine during sleep in children;
weakness/tiredness, malaise, swelling.

Rare (may affect up to 1 in 1,000 people)

changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements.

Very rare (may affect up to 1 in 10,000 people)

red, painful nodules under the skin, most commonly located on the front of the legs (erythema nodosum).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 Montagen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word "EXP". The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
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 Montegen contains

The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.
The other components are: mannitol (E421), microcrystalline cellulose, hypromellose (E463), red iron oxide (E172), sodium croscarmellose, cherry flavor, aspartame (E951), and magnesium stearate.

Description of the appearance of Montegen and package contents
The 5 mg chewable tablets of Montegen are pink, round, biconvex tablets, with the number 275 imprinted on one side.
Montegen 5 mg chewable tablets are available in blister packs of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets, and in single-dose blister packs (unit dose) of: 49x1, 50x1 and 56x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.r.l.
Via San Giuseppe Cottolengo, 15 – 20143 Milan
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48 – Quinto de' Stampi, 20089 Rozzano (Milan)

Package leaflet: information for the user

Montegen 4 mg chewable tablets

montelukast
Please read this leaflet carefully before giving this medicine to your child
as it contains important information.

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 only for your child. Do not give it to others, even if their symptoms are the same as your child's, as it could be harmful.
If your child experiences any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Montegen is and what it is used for
What you need to know before your child takes Montegen
How to take Montegen
Possible side effects
How to store Montegen
Contents of the pack and other information

1. What Montegen is and what it is used for

What Montegen is
Montegen contains the active substance montelukast, a leukotriene receptor antagonist.
How Montegen works
Leukotrienes are substances that cause narrowing and swelling of the airways in the lungs. Blocking leukotrienes improves asthma symptoms and helps control the condition.
Montegen works by blocking the interaction of leukotrienes with their receptors, thereby relieving asthma symptoms and helping to control the disease.
When Montegen should be used
Montegen 4 mg chewable tablets are indicated for the treatment of asthma in children, to prevent daytime and nighttime asthma symptoms.
Montegen 4 mg chewable tablets are used in children aged 2 to 5 years who are not adequately controlled with their usual medication and require additional therapy.
Montegen 4 mg chewable tablets may also be used as an alternative to inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and who have shown inability to use inhaled corticosteroids.
Montegen 4 mg chewable tablets also prevent exercise-induced narrowing of the airways in children over 2 years of age.
Your doctor will determine how to use Montegen 4 mg tablets based on your child's symptoms and the severity of their asthma.
What is asthma?
Asthma is a long-term condition.
The characteristics of asthma are:

difficulty breathing due to narrowing of the airways, which worsens and improves in response to various triggers;
airways that react to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise;
swelling (inflammation) of the airways.

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

2. What you should know before your child takes Montegen

Inform your doctor about any current or past medical conditions and any allergies your child may have.
Do not give Montegen to your child

if they 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 giving Montegen 4 mg chewable tablets to your child.
Exercise particular caution with Montegen:

if your child's asthma or breathing worsens; in this case, contact your doctor immediately;
do not give Montegen to your child for the treatment of acute asthma attacks. If your child experiences an acute asthma attack, follow the instructions provided by your doctor;
ensure you always have the emergency inhaled medication prescribed by your doctor for your child's asthma attacks;
it is important that your child takes all asthma medications prescribed by the doctor. Montegen does not replace other asthma medications prescribed for your child;
consult your doctor if your child is taking asthma medications and develops a combination of symptoms such as flu-like illness, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness; do not give acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also called non-steroidal anti-inflammatory drugs or NSAIDs) to your child if these cause worsening of 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 age group.
Other medicines and Montegen
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Some medicines may affect how Montegen works, or Montegen may affect how other medicines work.
Inform your doctor if your child is taking the following medicines before starting treatment with Montegen 4 mg chewable tablets:

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

Montegen with food and drinks
Montegen 4 mg chewable tablets should not be taken immediately before or after meals.
Give Montegen to your child at least 1 hour before or 2 hours after meals.
Pregnancy and breastfeeding
This section does not apply because Montegen 4 mg chewable tablets are intended for use in children aged 2 to 5 years. However, the information below refers to the active substance, montelukast.
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Montegen in this case.
Breastfeeding
It is not known whether Montegen is excreted in breast milk. If you are breastfeeding or planning to breastfeed your child, consult your doctor before taking Montegen.
Driving and using machines
This section does not apply to Montegen 4 mg chewable tablets, as they are intended for use in children aged 2 to 5 years. However, the information below refers to the active substance, montelukast.
No effects of Montegen on the ability to drive or operate machinery are expected. However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and drowsiness) reported after taking Montegen may affect the ability to drive and use machinery; therefore, appropriate caution should be exercised in such circumstances.
Montegen 4 mg chewable tablets contain aspartame, a source of phenylalanine.
It may be harmful to your child if they have phenylketonuria.

3. How to use Montegen

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 must be given to your child under the supervision of an adult. For children who have difficulty taking a chewable tablet, a granule formulation of Montegen is available.
For children aged 2 to 5 years:
The recommended dose is one 4 mg chewable tablet once daily, taken in the evening.
Montegen 4 mg chewable tablets should not be taken immediately before or after meals.
Give Montegen to your child at least 1 hour before or 2 hours after meals.
The tablets must be chewed before swallowing.
Give only one tablet of Montegen per day to your child by mouth, even when no symptoms are present or during an acute asthma attack, as prescribed by the doctor.
If your child is already taking Montegen, make sure they do not simultaneously take other medicines containing the same active substance (montelukast).
If your child takes more Montegen than they should
Contact your doctor immediately.
In most reports of overdose, no adverse effects have been observed. The symptoms most frequently reported following overdose in adults and children include: abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
If you forget to give Montegen to your child
Give Montegen 4 mg chewable tablets to your child as directed by your doctor. However, if you forget to give a dose, continue treatment with Montegen as usual (one tablet daily). Do not give a double dose to make up for the missed tablet.
If your child stops treatment with Montegen
Treatment with Montegen is effective against asthma only if taken continuously. It is important that your child continues taking Montegen 4 mg chewable tablets for the entire duration of treatment as prescribed by the doctor, which will help control their asthma.
If you have any doubts about using 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.

The side effects considered related to the use of Montegen 4 mg chewable tablets, reported most commonly during clinical studies (may affect up to 1 in 10 people), were:

abdominal pain;
thirst.

With the use of Montegen 10 mg film-coated tablets and Montegen 5 mg chewable tablets, the following has been reported during clinical studies:

headache.

If you notice any of the following serious side effects, stop using Montegen and contact a doctor immediately:

Uncommon (may affect up to 1 in 100 people)

allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing;
changes in behaviour and mood: agitation including aggressive behaviour or hostility, depression;
seizures.

Rare (may affect up to 1 in 1,000 people)

increased tendency to bleeding;
tremor;
awareness of heartbeat (palpitations).

Very rare (may affect up to 1 in 10,000 people)

a group of symptoms such as flu-like syndrome, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2);
low platelet count in the blood;
changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions;
swelling (inflammation) of the lungs;
severe skin reactions (erythema multiforme) which may occur without warning;
inflammation of the liver (hepatitis).

Additionally, following marketing of the product, the following side effects have been reported:

Very common (may affect more than 1 in 10 people)

upper respiratory tract infection.

Common (may affect up to 1 in 10 people)

diarrhoea, nausea, vomiting;
fever;
rash;
increased levels of transaminases in the blood.

Uncommon (may affect up to 1 in 100 people)

changes in behaviour and mood: dream abnormalities including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness;
dizziness, drowsiness, tingling;
nosebleeds;
dry mouth, digestive problems;
bruising, itching, urticaria;
joint or muscle pain, muscle cramps;
involuntary loss of urine during sleep in children;
weakness/tiredness, malaise, swelling.

Rare (may affect up to 1 in 1,000 people)

changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements.

Very rare (may affect up to 1 in 10,000 people)

red, painful nodules under the skin, most commonly located on the front of the legs (erythema nodosum).

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 may 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 Montagen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word "EXP". The first two digits indicate the month, the last four digits indicate the year. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
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 Montegen contains

The active substance is montelukast. Each tablet contains sodium montelukast, equivalent to 4 mg of montelukast.
The other components are: mannitol (E421), microcrystalline cellulose, hypromellose (E463), red iron oxide (E172), croscarmellose sodium, cherry flavour, aspartame (E951) and magnesium stearate.

Description of the appearance of Montegen and contents of the pack
The 4 mg chewable tablets of Montegen are pink, oval-shaped, biconvex, with the number 711 engraved on one side.
Montegen 4 mg chewable tablets are available in blister packs containing: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets, and in unit-dose blister packs (single dose) of 49x1, 50x1 and 56x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Neopharmed Gentili S.r.l.
Via San Giuseppe Cottolengo, 15 – 20143 Milan
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48 – Quinto de' Stampi, 20089 Rozzano (Milan)
Package leaflet: information for the user

Montegen 4 mg granules

montelukast
Please read this leaflet carefully before giving this medicine to your child, 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 your child only. Do not give it to others, even if their symptoms are the same as your child's, as it could be harmful.
If your child experiences any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Montegen is and what it is used for
What you need to know before your child takes Montegen
How to use Montegen
Possible side effects
How to store Montegen
Contents of the pack and other information

1. What Montegen is and what it is used for

What Montegen is
Montegen contains the active substance montelukast, a leukotriene receptor antagonist.
How Montegen works
Leukotrienes are substances that cause narrowing and swelling of the airways in the lungs.
Montegen works by blocking the interaction of leukotrienes with their receptors, thereby relieving asthma symptoms and helping to control the disease.
When Montegen should be used
Montegen 4 mg granules is indicated for the treatment of asthma in children, to prevent asthmatic symptoms both during the day and at night.
Montegen 4 mg granules is used in children aged 6 months to 5 years who are not adequately controlled with their usual medication and require additional therapy.
Montegen 4 mg granules may also be used as an alternative to inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and who have been shown unable to use inhaled corticosteroids.
Montegen 4 mg granules also prevents exercise-induced narrowing of the airways in children over 2 years of age.
Your doctor will determine how Montegen 4 mg granules should be administered to your child, based on symptoms and severity of asthma.
What is asthma?
Asthma is a long-term disease.
The characteristics of asthma are:

difficulty in breathing due to narrowing of the airways, which worsens and improves in response to various triggers;
airways that react to many irritant stimuli, such as cigarette smoke, pollen, cold air, or physical exercise;
swelling (inflammation) of the airways.

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

2. What you need to know before using Montegen

Do not give Montegen to your child

if he/she is allergic to montelukast or to any of the other ingredients of this medicine (see section 6).

Warnings and precautions
Talk to your doctor or pharmacist before giving Montegen 4 mg granules to your child.
Be especially careful with Montegen:

if your child's asthma or breathing worsens, in which case contact your doctor immediately;
do not give Montegen to your child for the treatment of acute asthma attacks. If your child experiences an acute asthma attack, follow the instructions provided by your doctor. Make sure you always have the emergency inhaled medicines prescribed by your doctor for your child's asthma attacks;
it is important that your child takes all asthma medications prescribed by the doctor. Montegen does not replace other asthma medicines prescribed for your child;
consult your doctor if your child is taking asthma medicines and develops a combination of symptoms such as flu-like symptoms, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness;
do not give acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) to your child if these cause worsening of asthma.

Children and adolescents
Do not give this medicine to children under 6 months of age.
Different formulations of this medicine are available for pediatric patients under 18 years of age, depending on age group.
Other medicines and Montegen
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Some medicines may affect how Montegen works, or Montegen may affect how other medicines work.
Tell your doctor if your child is taking any of the following medicines before starting treatment with Montegen 4 mg granules:

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

Montegen with food and drinks
Montegen 4 mg granules can be taken regardless of meals.
Pregnancy and breastfeeding
This section does not apply to Montegen 4 mg granules, as it is intended for use in children aged 6 months to 5 years. However, the information below refers to the active substance, montelukast.
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether or not you can take Montegen in this case.
Breastfeeding
It is not known whether Montegen passes into breast milk. If you are breastfeeding or intend to breastfeed your child, consult your doctor before taking Montegen.
Driving and using machines
This section does not apply to Montegen 4 mg granules, as it is intended for use in children aged 6 months to 5 years. However, the information below refers to the active substance, montelukast.
No effects on the ability to drive or operate machinery are expected. However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and drowsiness) reported after taking Montegen may affect the ability to drive and use machinery; therefore, exercise appropriate caution under such circumstances.

3. How to use Montegen

Give this medicine to your child exactly as directed by the doctor or
pharmacist. If you have any doubts, consult the doctor or pharmacist.
This medicine must be administered to your child under the supervision of an adult.
The recommended dose for children aged 6 months to 5 years is one sachet of
4 mg granules once daily, to be taken in the evening.
If the package contains two sachets joined together, separate the sachets by tearing along the vertical
perforated line and use only one sachet.
Give only one sachet of Montegen per day to your child, by oral administration, even when symptoms are absent or during an acute asthma attack, as prescribed by the doctor.
If your child is already taking Montegen, make sure they do not simultaneously take other
medicines containing the same active substance (montelukast).
The 4 mg granule formulation of Montegen is not recommended for use in children under
6 months of age.
For children aged 2 to 5 years, Montegen is also available as 4 mg chewable tablets.
How to administer Montegen 4 mg granules to your child
This medicine is for oral use.

Do not open the sachet until ready to use;
Montegen granules may be administered: o directly into the mouth; or OR mixed with a spoonful of soft food, cold or at room temperature (e.g. apple puree, ice cream, carrot and rice puree);
mix the entire contents of the Montegen granules with a spoonful of soft food, cold or at room temperature, and ensure that the dose is completely mixed with the food;
ensure that your child takes immediately (within 15 minutes) the entire contents of the spoon containing the mixture of granules and food. IMPORTANT: do not store the granule/food mixture for later use;
Montegen granules must not be dissolved in liquids. However, you may give liquids to your child after administration of Montegen granules;
Montegen granules may be taken regardless of meals.

If your child takes more Montegen than they should
Contact your doctor immediately.
In most overdose reports, no adverse effects have been observed. The most frequently reported
symptoms following overdose in adults and children include: abdominal pain, drowsiness, thirst,
headache, vomiting and hyperactivity.
If you forget to give Montegen to your child
Give Montegen 4 mg granules to your child as directed by the doctor. However, if
you forget to administer a sachet to your child, continue treatment with Montegen according to the
usual schedule (one sachet per day).
Do not give a double dose to make up for the forgotten dose.
If your child stops treatment with Montegen
Treatment with Montegen is effective against asthma only if taken continuously. It is
important that your child continues taking Montegen 4 mg granules for the entire duration of
treatment, as prescribed by the doctor, to help control their asthma.
If you have any questions 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.

The side effects considered related to the use of Montegen 4 mg granules, most commonly reported in clinical studies (may affect up to 1 in 10 people), were:

diarrhea;
hyperactivity;
asthma;
itching and scaly skin;
rash.

With the use of Montegen 10 mg film-coated tablets and Montegen 4 mg or 5 mg chewable tablets, the following were reported in clinical studies:

abdominal pain;
headache;
thirst.

If you notice any of the following serious side effects, stop using Montegen and contact a doctor immediately:

Uncommon (may affect up to 1 in 100 people)

allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing;
changes in behaviour and mood: agitation including aggressive behaviour or hostility, depression;
seizures.

Rare (may affect up to 1 in 1,000 people)

increased tendency to bleed;
tremor;
awareness of heartbeat (palpitations).

Very rare (may affect up to 1 in 10,000 people)

a group of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or rash (Churg-Strauss syndrome) (see section 2);
low platelet count in the blood;
changes in behaviour and mood: hallucinations, disorientation; suicidal thoughts and actions;
swelling (inflammation) of the lungs;
severe skin reactions (erythema multiforme) which may occur without warning;
inflammation of the liver (hepatitis).

Additionally, following marketing of the product, the following side effects have been reported:

Very common (may affect more than 1 in 10 people)

upper respiratory tract infection.

Common (may affect up to 1 in 10 people)

diarrhea, nausea, vomiting;
fever;
rash;
increased levels of transaminases in the blood.

Uncommon (may affect up to 1 in 100 people)

changes in behaviour and mood: dream abnormalities, including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness;
dizziness, drowsiness, tingling;
nosebleeds;
dry mouth, digestive problems;
bruising, itching, urticaria;
joint or muscle pain, muscle cramps;
involuntary loss of urine during sleep in children;
weakness/feeling tired, malaise, swelling.

Rare (may affect up to 1 in 1,000 people)

changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements.

Very rare (may affect up to 1 in 10,000 people)

red, painful nodules under the skin, usually located on the front of the legs (erythema nodosum).

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 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 Montagen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet after the word "EXP". The first two digits indicate the month, the last four digits indicate the year. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Montegen contains

The active substance is montelukast. Each sachet of granules contains sodium montelukast, equivalent to 4 mg of montelukast.
The other components are: mannitol (E421), hypromellose (E463) and magnesium stearate.

Description of the appearance of Montegen and contents of the pack
Montegen is a white granular powder.
It is available in packs containing: 7 sachets, 10x2 dual pouches, 14x2 dual pouches, 15x2 dual pouches. One single sachet corresponds to one dose.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.r.l.
Via San Giuseppe Cottolengo, 15 – 20143 Milan
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48 – Quinto de' Stampi, 20089 Rozzano (Milan)