Montelukast Tecnigen: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast TecniGen 4 mg chewable tablets

Equivalent medicine
Please read this leaflet carefully before your child takes this medicine, as it contains important information.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
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, pharmacist, or nurse.

Contents of this leaflet:

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

1. What Montelukast TecniGen is and what it is used for

Your doctor has prescribed Montelukast TecniGen for the treatment of your child's asthma, preventing its symptoms during both day and night.

Montelukast TecniGen 4 mg is used for the treatment of patients aged 2 to 5 years whose disease is not adequately controlled with their current medications and who require additional therapy.
Montelukast TecniGen 4 mg 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 been shown unable to use inhaled corticosteroids.
Montelukast TecniGen 4 mg also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

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

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

Breathing difficulties caused by narrowing of the airways. Airway narrowing 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 lining of the airways.

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

2. What you should know before giving Montelukast TecniGen to your child

Inform your doctor of any medical conditions or allergies your child currently has or has had in the past.
Do not give Montelukast TecniGen to your child if:

he or she 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, pharmacist, or nurse before giving Montelukast TecniGen to your child.

If your child’s asthma or breathing worsens, contact your doctor immediately.
Oral Montelukast TecniGen must not be used to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has provided 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 TecniGen must not be used instead of other asthma medications prescribed for your child.
Be aware of the need to consult your doctor if your child, while taking anti-asthma medications, develops a combination of symptoms such as flu-like symptoms, tingling or numbness in arms or legs, worsening of lung symptoms and/or skin rash.
Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause worsening of 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 TecniGen (see section 4). If your child develops these symptoms during treatment with Montelukast TecniGen, you should consult your doctor.

Other medicines and Montelukast TecniGen
Some medicines may interfere with the action of Montelukast TecniGen, or Montelukast TecniGen may interfere with the action of other medicines your child is taking.
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Inform your doctor if your child is taking the following medicines before starting Montelukast TecniGen:

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

Montelukast TecniGen with food and drink
Montelukast TecniGen 4 mg chewable tablets should not be taken immediately before or after meals, but at least 1 hour before or 2 hours after eating.

Pregnancy, breastfeeding and fertility
This section does not apply because Montelukast TecniGen 4 mg chewable tablets are intended for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.
Pregnancy
Women who are pregnant or planning to become pregnant should consult their doctor before taking montelukast. The doctor will decide whether Montelukast TecniGen can be taken under these circumstances.
Breastfeeding
It is not known whether montelukast passes into breast milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast TecniGen.

Driving and using machines
This section does not apply because Montelukast TecniGen 4 mg chewable tablets are intended for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.
No effects of Montelukast TecniGen on the ability to drive or operate machinery are expected. However, individual responses to the medicine may vary. Some side effects (such as dizziness and drowsiness), which have been reported very rarely with montelukast, may affect the ability of some patients to drive or operate machinery.

Montelukast TecniGen contains aspartame
Montelukast TecniGen chewable tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare inherited metabolic disorder), you should be aware that each 4 mg chewable tablet contains phenylalanine (equivalent to 1.347 mg of phenylalanine per 4 mg chewable tablet).

3. How to take Montelukast TecniGen

This medicine should be administered to the child under the supervision of an adult.
Your child must take only one tablet of Montelukast TecniGen per day as prescribed by the doctor.
Your child must take the tablet even when they have no symptoms or during an acute asthma attack.
Always give this medicine to your child exactly as instructed by the doctor. If you have any doubts, consult your pediatrician or pharmacist.
The tablet must be taken by mouth.

Children from 2 to 5 years of age
One chewable tablet of Montelukast TecniGen 4 mg to be taken every evening.
Montelukast TecniGen 4 mg chewable tablets must not be taken immediately before or after meals, but at least 1 hour before or 2 hours after meals.
If your child is taking Montelukast TecniGen, make sure they do not take other products containing the same active substance, montelukast.
Montelukast TecniGen 4 mg chewable tablets are available for children aged 2 to 5 years.
Montelukast TecniGen 5 mg chewable tablets are available for children aged 6 to 14 years.
The use of Montelukast TecniGen 4 mg chewable tablets is not recommended in children under 2 years of age.

If your child takes more Montelukast TecniGen than they should
Contact your child's doctor immediately for advice.
In most overdose cases, no adverse effects have been reported. The most commonly reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to give Montelukast TecniGen to your child
Try to give Montelukast TecniGen to your child as prescribed. However, if you forget to give a dose, simply resume the usual schedule of one tablet once daily.
Do not give your child a double dose to make up for the missed dose.

If your child stops treatment with Montelukast TecniGen
Montelukast TecniGen can only control your child's asthma if they continue taking it.
It is important that your child continues to take Montelukast TecniGen for the entire duration prescribed by the doctor. This will help control your child's asthma.
If you have any questions about the use of this medicine, consult your pediatrician, pharmacist, or nurse.

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 considered related to montelukast use (occurring in at least 1 patient in 100 and in fewer than 1 pediatric patient in 10) were:

abdominal pain
thirst

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

headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active medicine).

The frequency of the possible side effects listed below is defined using 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)

In addition, the following side 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 swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing ( Uncommon )
changes in behaviour and mood [dream abnormalities including nightmares, sleep disorders, sleep-walking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression ( Uncommon ), tremor ( Rare ), hallucinations, disorientation, suicidal thoughts and behaviour ( Very rare )]
dizziness, somnolence, paraesthesia/numbness, seizures ( Uncommon )
palpitations ( Rare )
nosebleeds ( Uncommon )
diarrhoea, nausea, vomiting ( Common ), dry mouth, dyspepsia ( Uncommon )
hepatitis (inflammation of the liver) ( Very rare )
rash ( Common ), bruising, pruritus, urticaria ( Uncommon ), painful red lumps under the skin, usually 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, malaise, swelling ( Uncommon )
Stuttering ( Very rare )

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported.

You must contact your doctor immediately if your child experiences one or more of these symptoms.

Talk to your doctor, pharmacist, or nurse if you want more information about side effects.

If your child experiences any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.

5. How to store Montelukast TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". 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 medicines 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 TecniGen contains

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

Description of the appearance of Montelukast TecniGen and pack sizes
Montelukast TecniGen 4 mg chewable tablets are pink, film-coated, round and convex tablets.
Montelukast TecniGen 4 mg chewable tablets are supplied in blisters of 28 tablets.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder:
TECNIMEDE – Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra, Portugal

Sales Licence Holder:
TECNIGEN S.r.l.
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI)

Manufacturers responsible for batch release:
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2 Abrunheira, 2710-089 Sintra, Portugal

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast TecniGen 5 mg Chewable Tablets

Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you or your child.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms appear to be the same as yours or your child's, as it may be harmful.
If you or your child experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse.

Contents of this leaflet:

What Montelukast TecniGen is and what it is used for.
What you need to know before taking Montelukast TecniGen.
How to take Montelukast TecniGen.
Possible side effects.
How to store Montelukast TecniGen.
Package contents and other information.

1. What Montelukast TecniGen is and what it is used for

Montelukast TecniGen is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause the narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast TecniGen improves asthma symptoms and helps control the disease.
Your doctor has prescribed Montelukast TecniGen for the treatment of asthma, preventing its symptoms during both day and night.

Montelukast TecniGen 5 mg is used for the treatment of patients aged 6 to 14 years whose asthma is not adequately controlled with their current medications and who require additional therapy.
Montelukast TecniGen 5 mg 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 shown inability to use inhaled corticosteroids.
Montelukast TecniGen 5 mg also helps prevent exercise-induced narrowing of the airways in patients aged 6 years and older.

Your doctor will determine how to use Montelukast TecniGen based on the symptoms and severity of asthma in you or your child.
What is asthma?
Asthma is a long-term disease.
Asthma involves:

breathing difficulties due to narrowing of the airways. This narrowing 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 lining of the airways.

Symptoms of asthma include: coughing, wheezing, and chest tightness.

2. What you should know before taking Montelukast TecniGen

Inform your doctor of any medical conditions or allergies you or your child currently have or have had in the past.
Do not take Montelukast TecniGen 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, pharmacist, or nurse before you or your child take Montelukast TecniGen:

If your or your child's asthma or breathing worsens, contact your doctor immediately.
Montelukast TecniGen for oral use must not be used to treat acute asthma attacks. If an attack occurs, follow the instructions provided by your doctor for you or your child. Always keep emergency inhaled medications for asthma attacks with you.
It is important that you or your child take all asthma medications prescribed by the doctor. Montelukast TecniGen must not be used instead of other asthma medications prescribed by your doctor for you or your child.
Every patient taking anti-asthma medications should be aware of the need to consult a doctor if a combination of symptoms develops, such as flu-like symptoms, tingling or numbness in arms or legs, worsening of lung symptoms and/or skin rash.
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 cause worsening of 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 TecniGen (see section 4). If your child develops these symptoms during treatment with Montelukast TecniGen, you must consult the doctor.

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

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

Montelukast TecniGen with food and drink
Montelukast TecniGen 5 mg chewable tablets must not be taken immediately before or after meals, but at least 1 hour before or 2 hours after meals.
Pregnancy, breastfeeding, and fertility
Pregnancy
Women who are pregnant or planning a pregnancy should consult their doctor before taking montelukast. Your doctor will decide whether you can take Montelukast TecniGen under these circumstances.
Breastfeeding
It is not known whether montelukast passes into breast milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast TecniGen.
Driving and using machines
No effects of Montelukast TecniGen on the ability to drive or operate machinery are expected. However, individual responses to the medicine may vary. Some side effects (such as dizziness and drowsiness), which have been reported very rarely with montelukast, may affect the ability of some patients to drive or operate machinery.
Montelukast TecniGen contains aspartame
Montelukast TecniGen chewable tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare inherited metabolic disorder), you should be aware that each 5 mg chewable tablet contains phenylalanine (equivalent to an amount of phenylalanine equal to 1.684 mg per 5 mg chewable tablet).

3. How to take Montelukast TecniGen

You or your child must take only one tablet of Montelukast TecniGen per day as prescribed by your doctor.
You or your child must take the tablet even when you do not have symptoms or during an acute asthma attack.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The tablet must be taken orally.

Children aged 6 to 14 years
One chewable tablet of Montelukast TecniGen 5 mg to be taken once daily in the evening.
Montelukast TecniGen 5 mg chewable tablets should not be taken immediately before or after meals, but at least 1 hour before or 2 hours after meals.
If you or your child are taking Montelukast TecniGen, make sure that you or your child do not take other products containing the same active substance, montelukast.

If you or your child take more Montelukast TecniGen than you should
Contact your doctor immediately for advice.
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 or give your child Montelukast TecniGen
Try to take Montelukast TecniGen as prescribed. However, if you forget to take or give your child a dose, simply resume your regular schedule of one tablet once daily.
Do not take or give your child a double dose to make up for the missed dose.

If you or your child stop taking Montelukast TecniGen
Montelukast TecniGen can only control your or your child's asthma if you or your child continue taking it.
It is important to continue taking Montelukast TecniGen for the entire duration prescribed by your doctor. This will help control your or your child's asthma.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

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 adverse reactions considered related to montelukast use reported most commonly (occurring in at least 1 patient in 100 and in less than 1 pediatric patient in 10) were:

abdominal pain
thirst

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

headache

These adverse reactions were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active medicine).

The frequency of the possible side effects listed below is defined using 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 less than 1 in 10,000 people)

Additionally, the following side effects have been reported since the medicine has been marketed:

upper respiratory tract infections ( Very common )
increased tendency to bleeding ( Rare )
allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing ( Uncommon )
changes in behaviour and mood [changes in dream activity including nightmares, sleep disorders, sleep-walking, irritability, anxious feelings, restlessness, agitation including aggressive behaviour or hostility, depression ( Uncommon ), tremor ( Rare ), hallucinations, disorientation, suicidal thoughts and behaviour ( Very rare )]
dizziness, somnolence, tingling/numbness, seizures ( Uncommon )
palpitations ( Rare )
nosebleeds ( Uncommon )
diarrhoea, nausea, vomiting ( Common ), dry mouth, dyspepsia ( Uncommon )
hepatitis (inflammation of the liver) ( Very rare )
rash ( Common ), bruising, pruritus, urticaria ( Uncommon ), painful red lumps under the skin, usually 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, malaise, swelling ( Uncommon )
stuttering ( Very rare )

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) have been reported.

You must inform your doctor immediately if you or your child experience one or more of these symptoms.

Talk to your doctor, pharmacist or nurse if you want more information about side effects.

If you or your child experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.

5. How to store Montelukast TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". 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 medicines 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 Montelukast TecniGen contains

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

Description of the appearance of Montelukast TecniGen and pack contents
Montelukast TecniGen 5 mg chewable tablets are pink film-coated, round, convex tablets with a raised "+" on one side.
Montelukast TecniGen 5 mg chewable tablets are supplied in blisters containing 28 tablets.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder:
TECNIMEDE – Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra, Portugal
Concessionaire for sale:
TECNIGEN S.r.l.
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI), Italy
Manufacturers responsible for batch release:
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2 Abrunheira, 2710-089 Sintra, Portugal

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

Montelukast TecniGen 10 mg film-coated 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse.

Contents of this leaflet:

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

1. What Montelukast TecniGen is and what it is used for

Montelukast TecniGen is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause the narrowing and swelling of the airways in the lungs and cause allergic symptoms. By blocking leukotrienes, Montelukast TecniGen improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast TecniGen for the treatment of asthma, preventing its symptoms during both day and night.

Montelukast TecniGen 10 mg is used for the treatment of patients aged 15 years and older whose disease is not adequately controlled by their current medications and who require additional therapy.
Montelukast TecniGen 10 mg is also used to prevent exercise-induced narrowing of the airways in patients aged 15 years and older.
In asthmatic patients for whom it is indicated for the treatment of asthma, Montelukast TecniGen 10 mg may also provide relief from symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Montelukast TecniGen based on your symptoms and the severity of your asthma.
What is asthma?
Asthma is a long-term condition.
Asthma includes:

breathing difficulties due to narrowing of the airways. Airway narrowing worsens and improves in response to various conditions.
sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or physical exercise.
swelling (inflammation) of the lining of the airways.

Symptoms of asthma include: coughing, wheezing, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne tree, grass, and weed pollens.
Typical symptoms of seasonal allergies include: stuffy, runny, and itchy nose; sneezing; and watery, swollen, red, and itchy eyes.

2. What you need to know before taking Montelukast TecniGen

Inform your doctor of any medical conditions or allergies you currently have or have had in the past.
Do not take Montelukast TecniGen 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, pharmacist, or nurse before taking Montelukast TecniGen.

If your asthma or breathing worsens, contact your doctor immediately.
Oral Montelukast TecniGen must not be used to treat acute asthma attacks. If an attack occurs, follow the instructions provided by your doctor. Always keep your emergency inhaled asthma medication with you.
It is important that you and your child take all asthma medications prescribed by your doctor.
Montelukast TecniGen must not be used instead of other asthma medications prescribed by your doctor.
Every patient taking anti-asthma medications should be aware of the need to consult a doctor if a combination of symptoms develops, such as flu-like symptoms, tingling or numbness in arms or legs, worsening of pulmonary symptoms and/or skin rash.
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 (e.g., changes in behavior and mood) have been reported in adults, adolescents, and children treated with Montelukast TecniGen (see section 4). If you or your child develops these symptoms during treatment with Montelukast TecniGen, consult your doctor.

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

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

Montelukast TecniGen with food and drink
Montelukast TecniGen 10 mg may be taken with or without food.
Pregnancy, breastfeeding, and fertility
Pregnancy
Women who are pregnant or planning a pregnancy should consult their doctor before taking Montelukast TecniGen. Your doctor will decide whether you can take Montelukast TecniGen under these circumstances.
Breastfeeding
It is not known whether montelukast passes into breast milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast TecniGen.
Driving and using machines
No effects of Montelukast TecniGen on the ability to drive or operate machinery are expected. However, individual responses to the medicine may vary. Some side effects (such as dizziness and somnolence), which have been reported very rarely with montelukast, may affect the ability of some patients to drive or operate machinery.
Montelukast TecniGen contains lactose
Montelukast TecniGen 10 mg film-coated tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Montelukast TecniGen

You should take only one tablet of Montelukast TecniGen daily, as prescribed by your doctor.
You should take the tablet even when you have no symptoms or during an acute asthma attack.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The tablet must be taken by mouth.

Adults aged 15 years and older
One 10 mg tablet to be taken once daily in the evening. Montelukast TecniGen 10 mg may be taken with or without food.
If you are taking Montelukast TecniGen, make sure you do not take other products containing the same active substance, montelukast.

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

If you forget to take Montelukast TecniGen
Try to take Montelukast TecniGen as prescribed. However, if you forget to take a dose, simply resume your usual once-daily dosing schedule.
Do not take a double dose to make up for the missed dose.

If you stop taking Montelukast TecniGen
Montelukast TecniGen will only control asthma if you continue taking it.
It is important to continue taking Montelukast TecniGen for the entire duration prescribed by your doctor. This will help you control your asthma.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

abdominal pain
headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active medicine).
The frequency of the possible side effects listed below is defined using 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 less than 1 in 10,000 people)

In addition, the following side 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 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, sleep disorders, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression ( Uncommon ), tremor ( Rare ), hallucinations, disorientation, suicidal thoughts and behaviours ( Very rare )]
dizziness, drowsiness, tingling/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 ), painful red lumps under the skin, usually 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, malaise, swelling ( Uncommon )
Stuttering ( Very rare )

Very rare cases of a combination of symptoms including flu-like illness, tingling or numbness of arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported in asthmatic patients treated with montelukast.
You must contact your doctor immediately if your child experiences one or more of these symptoms.
Talk to your doctor, pharmacist or nurse if you want more information about side effects.
If any side effect occurs, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.

5. How to store Montelukast TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 TecniGen contains

The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
The other components are: Tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, hydroxypropylcellulose and magnesium stearate. Film coating: hypromellose, hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of Montelukast TecniGen and pack sizes
Montelukast TecniGen 10 mg film-coated tablets are pink, round, convex tablets.
Montelukast TecniGen 10 mg film-coated tablets are supplied in blisters of 28 tablets.
Marketing Authorization Holder and manufacturer
Marketing Authorization Holder:
TECNIMEDE – Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra, Portugal
Concessionaire for sale:
TECNIGEN S.r.l.
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI)
Manufacturers responsible for batch release:
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2 Abrunheira, 2710-089 Sintra, Portugal