MONTELUKAST 4 mg Chewable Tablet

Зміст інструкції

1. Montelukast TecniGen 4 mg chewable tablets
   1. What is Montelukast TecniGen and what is it used for
   2. What you need to know before giving Montelukast TecniGen
   3. How to take Montelukast TecniGen
   4. Possible side effects
   5. How to store Montelukast TecniGen
   6. Contents of the pack and other information
2. Montelukast TecniGen 5 mg chewable tablets
   1. What is Montelukast TecniGen and what is it used for
   2. What you need to know before taking Montelukast TecniGen
   3. How to take Montelukast TecniGen
   4. Possible side effects
   5. How to store Montelukast TecniGen
   6. Contents of the pack and other information
3. Montelukast TecniGen 10 mg film-coated tablets
   1. What is Montelukast TecniGen and what is it used for
   2. What you need to know before taking Montelukast TecniGen
   3. How to take Montelukast TecniGen
   4. Possible side effects
   5. How to store Montelukast TecniGen
   6. Contents of the pack and other information

Montelukast TecniGen 4 mg chewable tablets

Generic medicine

Read this leaflet carefully before your child takes this medicine because
it contains important information.

• 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 only for your child. Do not give it to other people, even if their symptoms are the same as those of your child, as it could be dangerous.
• If your child experiences any side effects, including those not listed in this leaflet, ask your doctor, pharmacist or nurse.

Contents of this leaflet:

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

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

Montelukast TecniGen 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 TecniGen improves asthma symptoms and helps to
control it.
Your doctor has prescribed Montelukast TecniGen for the treatment of your child's asthma,
preventing symptoms during the day and night.

• Montelukast TecniGen 4 mg is used for the treatment of patients from 2 to 5 years of age whose disease is not adequately controlled by their medications and who need additional therapy.
• Montelukast TecniGen 4 mg 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 TecniGen 4 mg also helps to prevent airway narrowing induced by exercise in patients aged 2 years or older.

The doctor will determine how to use Montelukast TecniGen based 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. The narrowing of the airways worsens and improves in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air or exercise.
• swelling (inflammation) of the lining of the airways.

Asthma symptoms include: cough, wheezing and a feeling of tightness in the chest.

2. What you need to know before giving Montelukast TecniGen

Tell the doctor about any medical problems or allergies your child has now or has had in the past.

Do not give Montelukast TecniGen to your child if:

• they are allergic to montelukast or 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 gets worse, contact your doctor immediately.
• Montelukast TecniGen by mouth should not be used to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep your child's emergency inhaler medicine with you for asthma attacks.
• It is important that your child takes all the asthma medicines prescribed by the doctor. Montelukast TecniGen should not be used instead of other asthma medicines that the doctor has prescribed for your child.
• be aware of the need to consult the doctor if your child is taking asthma medicines, if they develop a combination of symptoms such as flu-like symptoms, tingling or numbness of arms or legs, worsening of lung symptoms and/or rash.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen 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 should consult your doctor.

Other medicines and Montelukast TecniGen
Some medicines can interfere with the action of Montelukast TecniGen or Montelukast TecniGen can interfere with the action of other medicines your child is taking.
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Tell your doctor if your child is taking the following medicines before starting to take 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 4 mg chewable tablets should not be taken immediately before or after meals but at least 1 hour before or 2 hours after meals.

Pregnancy, breastfeeding and fertility
This section is not applicable because Montelukast TecniGen 4 mg chewable tablets are intended for use in children from 2 to 5 years of age. The following information however refers to the active ingredient, montelukast.

Pregnancy
Women who are pregnant or planning a pregnancy should consult their doctor before taking montelukast. The doctor will decide whether you can take Montelukast TecniGen in 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 is not applicable because Montelukast TecniGen 4 mg chewable tablets are intended for use in children from 2 to 5 years of age. The following information however refers to the active ingredient, montelukast.
No effects of Montelukast TecniGen on the ability to drive and use machines are expected. Individual responses to the medicine may however vary. Some side effects (such as dizziness and drowsiness) reported very rarely with montelukast may affect the ability of some patients to drive and use machines.

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

3. How to take Montelukast TecniGen

• This medicine must be administered to the child under the supervision of an adult.
• Your child should take only one Montelukast TecniGen tablet a day as prescribed by the doctor.
• Your child should take the tablet even when they have no symptoms or are experiencing an acute asthma attack.
• Have your child take this medicine always following the doctor's instructions exactly. If you have any doubts, consult your pediatrician or pharmacist.
• The tablet must be taken orally.

Children from 2 to 5 years of age
One chewable Montelukast TecniGen 4 mg tablet to be taken every day in the evening.
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 meals.
If your child is taking Montelukast TecniGen, make sure they do not take other products
containing the same active ingredient, montelukast.
Chewable Montelukast TecniGen 4 mg tablets are available for children from 2 to 5
years of age.
Chewable Montelukast TecniGen 5 mg tablets are available for children from 6 to 14
years of age.
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 cases of overdose, no adverse effects have been reported. 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 TecniGen to your child
Try to give Montelukast TecniGen to your child as it was prescribed. However if
you forget to have them take a dose, simply restart the usual schedule of one
tablet once a day.
Do not give your child a double dose to make up for a missed dose.

If your child stops treatment with Montelukast TecniGen
Montelukast TecniGen can only cure your child's asthma if your child continues to
take it.
It is important that your child continues to take Montelukast TecniGen for as long as
the doctor has prescribed it. This will help control your child's asthma.
If you have any doubts 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 everybody gets them.
In clinical studies with montelukast 4 mg chewable tablets, the side effects considered
related to the use of montelukast reported more commonly (occur in at least 1 patient out of
100 and in less than 1 pediatric patient out of 10) were:

• abdominal pain
• thirst

In addition, the following side effect has been 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 compared to those treated with placebo (a tablet that does not
contain any medicine).
The frequency of possible side effects listed below is defined using the following
convention:
Very common (affects at least 1 patient in 10)
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 patient in 10,000)
In addition, with the commercial use of the medicine, the following side effects have been reported:

• 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 [altered dream activity including nightmares, sleep disturbances, sleepwalking, irritability, feeling of anxiety, restlessness, agitation including aggressive behaviour or hostility, depression ( Uncommon), tremor ( Rare), hallucinations, disorientation, suicidal thoughts and behaviours ( Very rare)]
• 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), painful red nodules under the skin most commonly located 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)
• Stuttering ( Very rare)

In asthmatic patients treated with montelukast, very rare cases of a
combination of symptoms such as flu-like symptoms, pins and needles or numbness of arms and
legs, worsening of lung symptoms and/or rash (Churg-Strauss syndrome) have been reported.
You should immediately inform your doctor if your child develops one or more of these
symptoms.
Ask your doctor, pharmacist or nurse if you want more information about
side effects.
If your child gets any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in
this leaflet.

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 which is stated on the package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Montelukast TecniGen contains

• The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other ingredients 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 contents of the pack
Montelukast TecniGen 4 mg chewable tablets are film-coated tablets, pink in colour,
round and convex.
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

Distributor:
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

Montelukast TecniGen 5 mg chewable tablets

Generic medicine

Read this 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you or your child. Do not give it to other people, even if their symptoms are the same as yours or your child's, as it could be dangerous.
• If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse.

Contents of this leaflet:

• 6. What Montelukast TecniGen is and what it is used for.
• 7. What you need to know before you take Montelukast TecniGen.
• 8. How to take Montelukast TecniGen.
• 9. Possible side effects.
• 10. How to store Montelukast TecniGen.
• 6. Contents of the pack and other information.

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

Montelukast TecniGen 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 TecniGen improves asthma symptoms and helps to
control it.
Your doctor has prescribed Montelukast TecniGen for the treatment of asthma, preventing its
symptoms during the day and night.

• Montelukast TecniGen 5 mg is used for the treatment of patients from 6 to 14 years of age whose disease is not adequately controlled by their medications and who need additional therapy.
• Montelukast TecniGen 5 mg can also be used as an alternative treatment to inhaled corticosteroids for patients from 6 to 14 years of age who have not recently taken oral corticosteroids for asthma and who have shown they are unable to use inhaled corticosteroids.
• Montelukast TecniGen 5 mg also helps to prevent the narrowing of the airways induced by exercise in patients aged 6 years and over.

Your doctor will decide how to use Montelukast TecniGen based 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. The narrowing of the airways gets worse and better in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air or exercise.
• swelling (inflammation) of the lining of the airways.

The symptoms of asthma include: cough, wheezing and a feeling of tightness in the chest.

2. What you need to know before taking Montelukast TecniGen

Tell your doctor about any medical problems or allergies that you or your child have at the present time 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
Consult your doctor, pharmacist or nurse before you or your child take Montelukast TecniGen:

• If your asthma or breathing worsens, contact your doctor immediately.
• Montelukast TecniGen by mouth should not be used to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has provided for you or your child. Always keep your emergency inhaler medicine with you for asthma attacks.
• It is important that you or your child take all the asthma medicines prescribed by your doctor. Montelukast TecniGen should not be used in place of other asthma medicines that your doctor has prescribed for you or your child.
• Every patient taking asthma medicines should be aware of the need to consult a doctor if a combination of symptoms such as flu-like syndrome, tingling or numbness of arms or legs, worsening of lung symptoms and/or skin rash develops.
• 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 cause your asthma to worsen.
• 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 should consult your doctor

Children
Chewable tablets of Montelukast TecniGen 4 mg are available for children from 2 to 5 years of age.
Chewable tablets of Montelukast TecniGen 5 mg are available for children from 6 to 14 years of age.

Other medicines and Montelukast TecniGen
Some medicines can interfere with the action of Montelukast TecniGen or Montelukast TecniGen can interfere with the action of other medicines.
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Tell your doctor if you or your child are taking the following medicines before starting to take 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 should 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 currently pregnant or who are planning a pregnancy should consult their doctor before taking montelukast. The doctor will determine 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 vehicles and use machines are expected. Individual responses to the medicine may however vary. Some side effects (such as dizziness and drowsiness) reported very rarely with montelukast may affect the ability of some patients to drive vehicles and use machines.

Montelukast TecniGen contains aspartame
Montelukast TecniGen chewable tablets contains aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare inherited metabolic disorder), they 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 Montelukast TecniGen tablet a day as prescribed by your doctor.
• You or your child must take the tablet even when you do not have symptoms or are having an acute asthma attack.
• Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor or pharmacist.
• The tablet must be taken by mouth.

Children from 6 to 14 years of age
One chewable Montelukast TecniGen 5 mg tablet to be taken every 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 ingredient, 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 symptoms
reported most frequently with 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 it has been prescribed to you. However, if you forget to
take or give your child a dose, simply restart the usual schedule of
one tablet once a day.
Do not take or give your child a double dose to make up for the forgotten
dose.

If you or your child stop taking Montelukast TecniGen
Montelukast TecniGen can cure your or your child's asthma only if you or your child
continue to take it.
It is important to continue taking Montelukast TecniGen for the entire time that your doctor
has prescribed it. This will help control your or your child's asthma.
If you have any doubts about the use of 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 side effects considered
related to the use of montelukast reported more commonly (occur in at least 1 patient out of
100 and in less than 1 pediatric patient out of 10) were:

• abdominal pain
• thirst

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

• upper respiratory tract infections ( Very common)
• increased tendency to bleeding ( Rare)
• allergic reactions including swelling of the face, lips, tongue and/or throat which can cause difficulty in breathing or swallowing ( Uncommon)
• changes in behaviour and mood [altered dream activity including nightmares, sleep disturbances, sleepwalking, irritability, feeling of anxiety, restlessness, agitation including aggressive behaviour or hostility, depression ( Uncommon), tremor ( Rare), hallucinations, disorientation, suicidal thoughts and behaviours ( Very rare)]
• 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), painful red nodules under the skin most commonly 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)
• Stuttering ( Very rare)

In asthmatic patients treated with montelukast, very rare cases of a
combination of symptoms such as flu-like symptoms, pins and needles or numbness of arms and
legs, worsening of lung symptoms and/or rash (Churg-Strauss syndrome) have been reported.
You should immediately inform your doctor if you or your child develop one or more of these
symptoms.
Talk to your doctor, pharmacist or nurse if you would like more information about
side effects.
If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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 which is stated on the package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Montelukast TecniGen contains

• The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.
• The other ingredients 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 contents of the pack
Montelukast TecniGen 5 mg chewable tablets are film-coated tablets, pink in colour,
round, convex, with a “+” in relief on one side.
Montelukast TecniGen 5 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

Distributor:
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

Montelukast TecniGen 10 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.

Contents of this leaflet:

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

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

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

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

The doctor will determine how to use Montelukast TecniGen based on the symptoms and severity
of asthma.

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

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

The symptoms of asthma include: cough, wheezing and a feeling of tightness in the chest.

What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are a
allergic reaction often caused by airborne pollen from trees, grasses and weeds.
Typical symptoms of seasonal allergy include: stuffy, runny and itchy nose; sneezing, eyes
that water, swell, redden and itch.

2. What you need to know before taking Montelukast TecniGen

Tell your doctor about any medical problems or allergies you have now or have had in the past.

Do not take Montelukast TecniGen if:

• you are allergic to montelukast or 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 gets worse, contact your doctor immediately.
• Montelukast TecniGen by mouth should not be used to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you. Always keep your emergency inhaler medicine with you for asthma attacks.
• It is important that you and your child take all asthma medicines prescribed by your doctor.
• Montelukast TecniGen should not be used in place of other medicines that your doctor has prescribed for asthma.
• Every patient taking asthma medicines should be aware of the need to consult a doctor if a combination of symptoms such as flu-like symptoms, tingling or numbness of arms or legs, worsening of lung symptoms and/or skin rash develops.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.
• 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 while taking Montelukast Tecnigen, you should consult your doctor.

Children
Chewable tablets of Montelukast TecniGen 4 mg are available for children aged between 2 and 5 years.
Chewable tablets of Montelukast TecniGen 5 mg are available for children aged between 6 and 14 years.

Other medicines and Montelukast TecniGen
Some medicines can interfere with the action of Montelukast TecniGen or Montelukast TecniGen can interfere with the action of other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking the following medicines before starting to take 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 the blood)

Montelukast TecniGen with food and drink
Montelukast TecniGen 10 mg can 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. The doctor will decide if you can take Montelukast TecniGen under these circumstances.

Breastfeeding
It is not known whether montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Montelukast TecniGen.

Driving and using machines
No effects of Montelukast TecniGen on the ability to drive and use machines are expected. Individual responses to the medicine may however vary. Some side effects (such as dizziness and drowsiness) very rarely reported with montelukast may affect the ability of some patients to drive and use machines.

Montelukast TecniGen contains lactose
Montelukast TecniGen 10 mg film-coated tablets contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Montelukast TecniGen

• You must take only one Montelukast TecniGen tablet a day as prescribed by your doctor.
• You must take the tablet even when you do not have symptoms or are having an acute asthma attack.
• Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
• The tablet must be taken by mouth.

Adults aged 15 years and over
One 10 mg tablet to be taken every evening. Montelukast TecniGen 10 mg can
be taken with or without food.
If you are taking Montelukast TecniGen, make sure you are not taking other products containing the
same active ingredient, 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 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 TecniGen
Try to take Montelukast TecniGen as it has been prescribed to you. However, if you forget to
take a dose, simply restart your usual schedule of one tablet once a day.
Do not take a double dose to make up for a missed dose.

If you stop taking Montelukast TecniGen
Montelukast TecniGen can only cure asthma if you continue to take it.
It is important to continue taking Montelukast TecniGen for as long as your doctor
has prescribed it. This will help you control your asthma.
If you have any doubts about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

• abdominal pain
• headache

These side effects were generally mild and occurred more frequently in
patients treated with montelukast compared to those treated with placebo (a tablet that does not
contain any medicine).
The frequency of possible side effects listed below is defined using the following
convention:
Very common (affects at least 1 patient in 10)
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 patient in 10,000)
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 bleeding ( Rare)
• allergic reactions including swelling of the face, lips, tongue and/or throat which can cause difficulty in breathing or swallowing ( Uncommon)
• changes in behaviour and mood [dream activity disturbance including nightmares, sleep disturbances, sleepwalking, irritability, feeling of anxiety, restlessness, agitation including aggressive behaviour or hostility, depression ( Uncommon), tremor ( Rare), hallucinations, disorientation, suicidal thoughts and behaviours ( Very rare)]
• 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), painful red nodules under the skin most commonly located 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)
• Stuttering ( Very rare)

In asthmatic patients treated with montelukast, very rare cases of a
combination of symptoms such as flu-like symptoms, pins and needles or numbness of arms and
legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) have been reported.
You should immediately inform your doctor if your child develops one or more of these
symptoms.
Ask your doctor, pharmacist or nurse if you want more information regarding side
effects.
If any side effects occur, including those not listed in this leaflet, please
tell 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 which is stated on the package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Montelukast TecniGen contains

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

Description of the appearance of Montelukast TecniGen and contents of the pack
Montelukast TecniGen 10 mg film-coated tablets are pink, round
and convex tablets.
Montelukast TecniGen 10 mg film-coated 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

Distributor:
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