Montelukast Mylan: detailed information

Package leaflet: Information for the patient

Montelukast Mylan 4 mg chewable tablets

Montelukast
Equivalent medicine
For children from 2 to 5 years
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, pharmacist, or nurse.
This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you or your child experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Montelukast Mylan 4 mg chewable tablets are and what they are used for
What you need to know before giving Montelukast Mylan 4 mg chewable tablets
How to give Montelukast Mylan 4 mg chewable tablets
Possible side effects
How to store Montelukast Mylan 4 mg chewable tablets
Contents of the pack and other information

1. What is Montelukast Mylan 4 mg chewable tablets and what is it used for?

Montelukast Mylan 4 mg chewable tablets contain montelukast, which 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 Mylan 4 mg chewable tablets improve asthma symptoms and help control asthma.
Your doctor has prescribed Montelukast Mylan 4 mg chewable tablets for the treatment of your child's asthma to prevent asthma symptoms both during the day and at night.

Montelukast Mylan 4 mg chewable tablets are used to treat patients aged 2 to 5 years who are not adequately controlled with their current medications and require additional therapy.
Montelukast Mylan 4 mg chewable tablets 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 Mylan 4 mg chewable tablets also prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use Montelukast Mylan 4 mg chewable tablets based on your child's symptoms and the severity of their asthma.

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

Breathing difficulties due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
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.

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

2. What you should know before giving Montelukast Mylan 4 mg chewable tablets to your child

Inform your doctor about any current or past medical conditions and any allergies your child may have.
Do not give Montelukast Mylan 4 mg chewable tablets 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

If your child's asthma or breathing worsens, contact your doctor immediately.
Montelukast Mylan 4 mg chewable tablets must not be used to treat acute asthma attacks. If an asthma attack occurs, follow the instructions given by your doctor for your child. Always keep your child's rescue inhaled medication available for asthma attacks. Speak with your doctor if you or your child need more rescue inhaled medication than usual for acute asthma attacks.
It is important that your child takes all asthma medications prescribed by the doctor. Montelukast Mylan 4 mg chewable tablets must not be used instead of other asthma medicines prescribed for your child.
If your child is taking anti-asthma medications, be aware that if a combination of symptoms develops—such as flu-like symptoms, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin redness—you should consult your doctor.
Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen his or her asthma.

Children and adolescents
Do not administer this medicine to children under 2 years of age.
For children aged 2 to 5 years, the formulation Montelukast Mylan 4 mg chewable tablets may be available.
For children aged 6 to 14 years, the formulation Montelukast Mylan 5 mg chewable tablets may be available.

Other medicines and Montelukast Mylan 4 mg chewable tablets
Some medicines may interfere with the action of Montelukast Mylan 4 mg chewable tablets, or Montelukast Mylan 4 mg chewable tablets 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, including those not requiring a prescription.
Inform your doctor if your child is taking any of the following medicines before starting Montelukast Mylan 4 mg chewable 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).

Pregnancy and breastfeeding
This section does not apply to Montelukast Mylan 4 mg chewable tablets, as they are intended for use in children aged 2 to 5 years. However, the following information refers to the active substance montelukast.
Use during pregnancy
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can or cannot take montelukast under these circumstances.
Use during breastfeeding
It is not known whether montelukast passes into breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Montelukast Mylan 4 mg chewable tablets.

Driving and using machines
This section does not apply to Montelukast Mylan 4 mg chewable tablets, as they are intended for use in children aged 2 to 5 years. However, the following information refers to the active substance montelukast.
Montelukast is not considered to affect the ability to drive or use machinery. However, individual responses to medicines may vary. Some side effects (such as dizziness and drowsiness), although reported very rarely with montelukast, could affect the ability to drive vehicles and operate machinery.

Montelukast Mylan 4 mg chewable tablets contain aspartame
Montelukast Mylan 4 mg chewable tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare inherited metabolic disorder), please note that each tablet contains phenylalanine (equivalent to an amount of phenylalanine equal to 1.12 mg per chewable tablet).

3. How to take Montelukast Mylan 4 mg chewable tablets

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

This medicine must be administered to children under the supervision of an adult.
Your child must take only one Montelukast Mylan 4 mg chewable tablet per day as prescribed by the doctor.
The tablet must be taken even if your child has no symptoms or an acute asthma attack.
The tablet must be taken by mouth.

For children aged 2 to 5 years
The recommended dose is one 4 mg chewable tablet once daily in the evening. Montelukast Mylan 4 mg chewable tablets should not be taken immediately before or after meals; it should be taken at least 1 hour before or 2 hours after meals.
If your child is taking Montelukast Mylan 4 mg, make sure your child is not taking other medicines containing the same active substance, montelukast.

If your child takes more Montelukast Mylan 4 mg chewable tablets than they should
Contact your doctor immediately.
No adverse effects have been reported in most cases of overdose. The most commonly reported symptoms with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, malaise (vomiting), and hyperactivity.

If you forget to give Montelukast Mylan 4 mg chewable tablets to your child
Try to administer Montelukast Mylan 4 mg chewable tablets as prescribed. However, if your child misses a dose, continue giving the medicine as usual with the next dose—do not give a double dose to make up for the missed one.

If your child stops treatment with Montelukast Mylan 4 mg chewable tablets
Montelukast Mylan 4 mg chewable tablets can be effective against your child's asthma only if treatment is continued.
It is important that your child continues taking Montelukast Mylan 4 mg chewable tablets for as long as the doctor has prescribed. This will help keep your child's asthma under control.

If you have any questions 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 will get them.
If your child experiences any of the following side effects, you must stop giving this medicine and seek immediate medical advice from a doctor or go to the nearest hospital emergency department.

Uncommon (may affect up to 1 in 100 people)

Severe allergic reaction (called anaphylaxis) which may include difficulty breathing, dizziness and collapse.
Seizures (epileptic fits).

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

Swelling of the face, lips, mouth, tongue and/or throat which may cause difficulty in swallowing or breathing (angioedema).

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

Yellowing of the skin or eyes which may be due to hepatitis (liver inflammation), liver problems (hepatic eosinophilic infiltration).
Suicidal thoughts and actions.
Chest pain with dry cough, fever, shortness of breath and breathlessness due to lung inflammation caused by an increase in a type of white blood cells (pulmonary eosinophilia).

During treatment of asthmatic patients with montelukast, a very rare occurrence of a combination of symptoms has been reported, including flu-like symptoms, tingling or numbness in the arms or legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome). Inform your doctor immediately if one or more of these symptoms occur.

In clinical studies with montelukast 4 mg chewable tablets, the side effects considered related to the use of montelukast chewable tablets most commonly reported (occurring in up to 1 in 10 children) 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 film-coated tablets:

Headache

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

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

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

Upper respiratory tract infections.

Common: (may affect up to 1 in 10 people)

Diarrhoea
Feeling unwell (nausea)
Malaise (vomiting)
Rash
Increased liver enzymes detectable in blood tests
Fever

Uncommon: (may affect up to 1 in 100 people)

Changes in behaviour and mood, e.g. changes in dream activity including nightmares, sleep disorders, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression, tremor
Dizziness, drowsiness
Tingling, numbness
Nosebleeds
Dry mouth
Indigestion
Bruising, itching, urticaria
Joint or muscle pain, muscle cramps
Fatigue, feeling unwell
Swelling.

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

Increased tendency to bleed
Attention disorders
Memory impairment
Irregular or rapid heartbeat (palpitations)

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

Hallucinations (seeing, sensing or hearing things that do not exist), disorientation
Red, swollen nodules under the skin, most commonly on the front of the legs (erythema nodosum)
Skin rash which may include blister formation and resemble a small "target" (a dark central spot surrounded by a lighter area, with a dark ring around the edge), known as erythema multiforme.

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 Montelukast Mylan 4 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack, bottle, or blister after the wording “EXP”. The expiry date refers to the last day of that month.
Bottle: once opened, use within 100 days.
Store the product in the original packaging to protect it 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 Montelukast Mylan 4 mg chewable tablets contain

The active substance is montelukast. One chewable tablet contains montelukast sodium, equivalent to 4 mg of montelukast.
The other components are: Mannitol, granules Microcrystalline cellulose Croscarmellose sodium Magnesium stearate Sodium lauryl sulfate Anhydrous colloidal silica Aspartame (see section 2 “Montelukast Mylan 4 mg chewable tablets contain aspartame”) (E 951) Cherry flavour (maize maltodextrins, benzyl alcohol (E 1519), triethyl citrate (E 1505)).

Description of the appearance of Montelukast Mylan 4 mg chewable tablets and contents of the
pack
Montelukast Mylan 4 mg chewable tablets are available as tablets of white to cream colour, oval-shaped, with edges curving outwards, imprinted with an "M" on one side and "MS1" on the other.
The tablets are available in the following pack sizes:
Blister packs containing 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 112 or 200 tablets or unit-dose blisters of 28x1 tablets.
White plastic bottles with non-transparent plastic caps containing cotton wool and a container with desiccant (do not ingest the desiccant), in packs containing 28, 56, 100, 112, 200 & 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mylan S.p.A. Via Vittor Pisani 20 – 20124 Milano - Italy
Manufacturer
McDermott Laboratories Limited trading as Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Generics [UK] Limited
Station Close
Potters Bar,
Hertfordshire, EN6 1TL
United Kingdom
Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary
This medicinal product is authorised in the European Economic Area countries under the following
names:
Austria: Montelukast Arcana 4 mg - Kautabletten für Kleinkinder
Belgium: Montemyl 4mg Kauwtabletten
Cyprus: Montelukast/Generics 4mg
Germany: Montelukast Mylan 4 mg Kautabletten
Greece: Montelukast/Mylan μασώμενο δισκίο 4 mg
Ireland: Montelukast Mylan 4mg Chewable Tablets
Italy: Montelukast Mylan
Luxembourg: Montemyl 4mg comprimés à croquer
Malta: Montelukast Mylan 4mg
Netherlands: Montelukast Kauwtablet Mylan 4mg, Kauwtablet
Poland: Telugen 4mg
Portugal: Montelucaste Mylan 4mg
United Kingdom: Montelukast 4mg Chewable Tablets
Czech Republic: Montelukast Mylan 4mg
Romania: Montelukast Mylan 4 mg comprimate masticabile
Slovakia: Montelukast Mylan 4mg
Slovenia: Montelukast Mylan 4 mg žvečljive tablete
Spain: Montelukast Mylan 4 mg comprimidos masticables EFG
Hungary: Montelukast Mylan 4mg

Patient information leaflet: information for the patient

Montelukast Mylan 5 mg Chewable Tablets

Montelukast
Generic medicine
For children aged 6 to 14 years
Please read this leaflet carefully before administering/taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful. If you or your child experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Montelukast Mylan 5 mg chewable tablets are and what they are used for
What you need to know before taking/administering Montelukast Mylan 5 mg chewable tablets
How to take Montelukast Mylan 5 mg chewable tablets
Possible side effects
How to store Montelukast Mylan 5 mg chewable tablets
Contents of the pack and other information

1. What Montelukast Mylan 5 mg chewable tablets are and what they are used for

Montelukast Mylan 5 mg chewable tablets contain montelukast, which 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 Mylan 5 mg chewable tablets improve asthma symptoms and help control asthma.
Your doctor has prescribed Montelukast Mylan 5 mg chewable tablets for the treatment of asthma, to prevent asthma symptoms in you or your child both during the day and at night.

Montelukast Mylan 5 mg chewable tablets are used to treat patients whose asthma is not adequately controlled with their current medications and who require additional therapy.
Montelukast Mylan 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 shown inability to use inhaled corticosteroids.
Montelukast Mylan 5 mg chewable tablets also prevent exercise-induced narrowing of the airways.

Your doctor will determine how to use Montelukast Mylan 5 mg chewable tablets depending 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. Airway narrowing worsens and improves in response to various triggers.
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.
Asthma symptoms include: Cough, wheezing, and chest tightness.

2. What you need to know before taking/giving Montelukast Mylan 5 mg chewable tablets

Inform your doctor about any current or past medical conditions and any allergies your child may have.
Do not take or give Montelukast Mylan 5 mg chewable tablets 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

If your or your child's asthma or breathing worsens, contact your doctor immediately.
Montelukast Mylan 5 mg chewable tablets must not be used to treat acute asthma attacks. If an asthma attack occurs, follow the instructions provided by your doctor for you or your child. Always keep your child's emergency inhaled medication available for asthma attacks. Speak with your doctor if you or your child need to use more emergency inhaled medication than usual for acute asthma attacks.
It is important that you or your child take all asthma medications prescribed by the doctor. Montelukast Mylan 5 mg chewable tablets must not be used instead of other asthma medications prescribed by your doctor for you or your child.
Every patient being treated with anti-asthma medications should be aware that if a combination of symptoms such as flu-like symptoms, tingling or numbness in arms or legs, worsening of pulmonary symptoms and/or skin redness develops, medical advice must be sought.
You or your child must not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Children and adolescents
Do not administer this medicine to children under 6 years of age.
For children aged 2 to 5 years, a 4 mg chewable tablet formulation of montelukast may be available.
For children aged 6 months to 5 years, a 4 mg granule formulation of montelukast may be available.
Other medicines and Montelukast Mylan 5 mg chewable tablets
Some medicines may interfere with the action of Montelukast Mylan 5 mg chewable tablets, or Montelukast Mylan 5 mg chewable tablets 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, including those not requiring a prescription.
Inform your doctor if you or your child are taking any of the following medicines before starting Montelukast Mylan 5 mg chewable 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 the blood).

Pregnancy and breastfeeding
Use during pregnancy
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether or not you can take montelukast under these circumstances.
Use during breastfeeding
It is not known whether montelukast passes into breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Montelukast Mylan 5 mg chewable tablets.
Driving and using machines
Montelukast is not considered to interfere with the ability to drive or operate machinery. However, individual responses to medicines may vary. Some very rare side effects (such as dizziness and drowsiness) reported with montelukast may affect the ability to drive vehicles and operate machinery.
Montelukast Mylan 5 mg chewable tablets contain aspartame
Montelukast Mylan 5 mg chewable tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare inherited metabolic disorder), note that each tablet of Montelukast Mylan 5 mg chewable tablets contains phenylalanine (equivalent to an amount of phenylalanine equal to 1.12 mg per chewable tablet).

3. How to take Montelukast Mylan 5 mg chewable tablets

Always make sure that you or your child take this medicine exactly as your doctor has instructed. If you have any doubts, contact your doctor or pharmacist.

You or your child must take only one Montelukast Mylan 5 mg chewable tablet per day, as prescribed by your doctor.
The tablet must be taken even if you or your child do not have symptoms or an acute asthma attack.
Take the tablet by mouth.

For children aged 6 to 14 years
The recommended dose is one 5 mg chewable tablet once daily in the evening. Montelukast Mylan 5 mg chewable tablets should not be taken immediately before or after food; they should be taken at least 1 hour before or 2 hours after meals.
If you or your child are taking Montelukast Mylan 5 mg chewable tablets, ensure that you or your child are not taking any other medicines containing the same active substance, montelukast.

If you or your child take more Montelukast Mylan 5 mg chewable tablets than you should
Contact your doctor immediately.
Undesirable effects have not been reported in most cases of overdose. The most frequently reported symptoms with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, malaise (vomiting), and hyperactivity.

If you forget to take Montelukast Mylan 5 mg chewable tablets or forget to give them to your child
Try to take Montelukast Mylan 5 mg chewable tablets as prescribed. However, if you or your child miss a dose, continue taking the medicine as usual with the normal dose of one tablet once daily.
Do not take a double dose to make up for the forgotten tablet.

If you or your child stop taking Montelukast Mylan 5 mg chewable tablets
Montelukast Mylan 5 mg chewable tablets can only be effective in controlling your asthma or your child’s asthma if treatment is continued.
It is important to continue taking Montelukast Mylan 5 mg chewable tablets for as long as your doctor has prescribed. This will help keep your asthma or your child’s asthma under control.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you or your child experience any of the following symptoms, you or your child must stop taking this medicine and seek immediate medical attention or go to the nearest hospital emergency department.

Uncommon (may affect up to 1 in 100 people)

Severe allergic reaction (called anaphylaxis) which may include difficulty breathing, dizziness and collapse.
Seizures (epileptic fits).

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

Swelling of the face, lips, mouth, tongue and/or throat which may cause difficulty in swallowing or breathing (angioedema).

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

Yellowing of the skin or eyes which may be due to hepatitis (inflammation of the liver), liver problems (hepatic eosinophilic infiltration).
Suicidal thoughts and actions.
Chest pain with dry cough, fever, shortness of breath and breathlessness due to lung inflammation caused by an increase in a type of white blood cells (pulmonary eosinophilia).

In clinical studies with montelukast 5 mg chewable tablets, the side effects considered related to the use of montelukast chewable tablets most commonly reported (occurring in up to 1 in 10 children) was:

Headache.

Additionally, the following side effect was reported in clinical studies with montelukast 10 mg film-coated tablets:

Abdominal pain.

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

Furthermore, the following side effects have been reported during post-marketing use of the medicine:

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

Upper respiratory tract infections.

Common: (may affect up to 1 in 10 people)

Diarrhoea,
Feeling unwell (nausea)
Malaise (vomiting)
Rash
Increased liver enzymes detectable in blood tests
Fever

Uncommon: (may affect up to 1 in 100 people)

Changes in behaviour and mood, e.g. changes in dream activity including nightmares, sleep disorders, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression, tremor
Dizziness, drowsiness
Tingling, numbness
Nosebleeds
Dry mouth
Indigestion
Bruising, itching, hives
Joint or muscle pain, muscle cramps
Fatigue, feeling unwell
Swelling.

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

Increased tendency to bleed
Attention disorders
Memory impairment
Irregular or rapid heartbeats (palpitations)

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

Hallucinations (seeing, perceiving or hearing things that do not exist), disorientation
Red, swollen lumps under the skin, most commonly on the front of the legs (erythema nodosum)
Skin rash which may blister and resemble a small "target" (a dark central spot surrounded by a lighter area, with a dark ring around the edge), known as erythema multiforme.

Reporting of side effects
If you or your child experience any side effects, 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 Montelukast Mylan 5 mg

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 pack, bottle, or blister after the term "EXP". The expiry date refers to the last day of that month.
Bottle: once opened, use within 100 days.
Store the product in the original packaging to protect it 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 Montelukast Mylan 5 mg chewable tablets contain

The active substance is montelukast. One chewable tablet contains montelukast sodium, equivalent to 5 mg of montelukast.
The other ingredients are: Mannitol, granules Microcrystalline cellulose Sodium croscarmellose Magnesium stearate Sodium lauryl sulfate Anhydrous colloidal silica Aspartame (see section 2 “Montelukast Mylan 5 mg chewable tablets contains aspartame”) (E 951) Cherry flavour (maize maltodextrins, benzyl alcohol (E 1519), triethyl citrate (E 1505)).

Description of the appearance of Montelukast Mylan 5 mg chewable tablets and pack sizes
Montelukast Mylan 5 mg chewable tablets are available as tablets with a colour ranging from white to cream, round in shape, with edges curving outwards, marked with an "M" on one side and "MS2" on the other.
The tablets are available in the following pack sizes:
Blister packs containing 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 112 or 200 tablets.
White plastic bottles with non-transparent plastic caps containing cotton wool and a desiccant container (do not ingest the desiccant), in packs containing 28, 56, 100, 112, 200 & 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A. Via Vittor Pisani 20 – 20124 Milano - Italy

Manufacturer
McDermott Laboratories Limited trading as Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Generics [UK] Limited
Station Close
Potters Bar,
Hertfordshire, EN6 1TL
United Kingdom
Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria: Montelukast Arcana 5 mg - Kautabletten für Kinder
Belgium: Montemyl 5 mg Kauwtabletten
Cyprus: Montelukast/Generics 5 mg
Finland: Montelukast Mylan 5 mg
France: Montelukast Mylan 5 mg, comprimé à croquer
Germany: Montelukast Mylan 5 mg Kautabletten
Greece: Montelukast/Mylan μασώμενο δισκίο 5 mg
Ireland: Montelukast Mylan 5 mg Chewable Tablets
Italy: Montelukast Mylan
Luxembourg: Montemyl 5 mg, comprimé à croquer
Malta: Montelukast Mylan 5 mg
Netherlands: Montelukast Mylan 5 mg, Kauwtablet
Portugal: Montelucaste Mylan 5 mg
United Kingdom: Montelukast Mylan 5 mg Chewable Tablets
Czech Republic: Montelukast Mylan 5 mg
Romania: Montelukast Mylan 5 mg comprimate masticabile
Slovakia: Montelukast Mylan 5 mg
Slovenia: Montelukast Mylan 5 mg žvečljive tablete
Spain: Montelukast Mylan 5 mg comprimidos masticables EFG
Sweden: Montelukast Mylan 5 mg
Hungary: Montelukast Mylan 5 mg