Montelukast Aurobindo Pharma Italia: detailed information

Package leaflet: Information for the user

Montelukast Aurobindo Pharma Italia 5 mg chewable tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of this leaflet:

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

1. What Montelukast Aurobindo Pharma Italia is and what it is used for

What Montelukast Aurobindo Pharma Italia is
Montelukast Aurobindo Pharma Italia is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Montelukast Aurobindo Pharma Italia works
Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Aurobindo Pharma Italia improves asthma symptoms and helps control asthma.

When Montelukast Aurobindo Pharma Italia should be used
Your doctor has prescribed Montelukast Aurobindo Pharma Italia for the treatment of your child's asthma, preventing asthma symptoms during both day and night.

Montelukast Aurobindo Pharma Italia is used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled on their current therapy and require additional treatment.
Montelukast Aurobindo Pharma Italia may also be used as an alternative treatment to inhaled corticosteroids in children aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and who have shown inability to use inhaled corticosteroids.
Montelukast Aurobindo Pharma Italia also helps prevent exercise-induced narrowing of the airways. Your doctor will determine how Montelukast Aurobindo Pharma Italia should be taken based on your child's symptoms and severity of asthma.

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

Difficulty breathing 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 exercise.
Swelling (inflammation) inside the airways.

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

2. What you need to know before taking Montelukast Aurobindo Pharma Italia

Tell your doctor about any medical conditions or allergies your child has or has had.
Do not take Montelukast Aurobindo Pharma Italia

If you or your child are allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Montelukast Aurobindo Pharma Italia.
If your child’s asthma or breathing worsens, inform your doctor immediately.
Montelukast Aurobindo Pharma Italia oral is not intended for the treatment of acute asthma attacks.
If an attack occurs, follow the instructions your doctor has given you for your child. Always keep your
child’s emergency inhaled medicine for asthma attacks with you.
It is important that your child takes all asthma medicines prescribed by the doctor.
Montelukast Aurobindo Pharma Italia must not be substituted for any other asthma treatments prescribed
by the doctor for your child.
If your child is being treated with asthma medicines, keep in mind that if he/she develops a combination
of symptoms such as influenza-like feverish conditions, tingling or numbness in the arms or legs, worsening
of pulmonary symptoms, and/or skin rashes, you should consult the doctor.
Your child should not take acetylsalicylic acid (aspirin) or other anti-inflammatory medicines (also known
as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen his/her 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 (see section 4). If you or your child
develops these symptoms during treatment with montelukast, you must consult your doctor.
Use in children
Do not give this medicine to children under 6 years of age.
Different formulations of this medicine are available for paediatric patients under 18 years of age, based on age group.
Other medicines and Montelukast Aurobindo Pharma Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may affect the action of Montelukast Aurobindo Pharma Italia, or Montelukast Aurobindo Pharma Italia may affect the action of other medicines your child is taking.
Inform your doctor if your child is taking the following medicines before starting Montelukast Aurobindo
Pharma Italia:

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

Taking Montelukast Aurobindo Pharma Italia with food and drink and alcohol
Montelukast Aurobindo Pharma Italia 5 mg chewable tablets should not be taken immediately after eating; it should be taken at least one hour before or two hours after food intake.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking Montelukast Aurobindo Pharma Italia.
Use during pregnancy
Your doctor will decide whether you can take Montelukast Aurobindo Pharma Italia under these circumstances.
Breastfeeding
It is not known whether Montelukast Aurobindo Pharma Italia is present in breast milk. You should consult your doctor before taking Montelukast Aurobindo Pharma Italia if you are breastfeeding or intend to breastfeed.
Driving and using machines
Montelukast Aurobindo Pharma Italia is considered not to affect the ability to drive or use machinery. However, individual responses to treatment may vary. Some adverse effects (such as dizziness and somnolence) that have been reported with Montelukast Aurobindo Pharma Italia may affect the ability of some patients to drive or use machinery.
Montelukast Aurobindo Pharma Italia contains 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 0.842 mg of phenylalanine per 5 mg chewable tablet).
Montelukast Aurobindo Pharma Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Montelukast Aurobindo Pharma Italia

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

You or your child must take only one tablet of Montelukast Aurobindo Pharma Italia daily, as prescribed by the doctor.
This medicine must be taken even if you or your child do not have symptoms or if you experience an acute asthma attack.

For children aged 6 to 14 years:
The recommended dose is one 5 mg chewable tablet taken once daily in the evening.
If you or your child are taking Montelukast Aurobindo Pharma Italia, make sure that you or your child do not
take other medicines containing the same active substance, montelukast.
This medicine is for oral use.
The tablets must be chewed before swallowing.
Montelukast Aurobindo Pharma Italia 5 mg chewable tablets must not be taken immediately
before or after meals; they should be taken at least 1 hour before or 2 hours after meals.

If you or your child take more Montelukast Aurobindo Pharma Italia than you should
Contact your doctor immediately for advice.
No adverse effects have been reported in most overdose cases. The most common
symptoms associated with overdose in adults and children include abdominal pain, drowsiness,
thirst, headache, vomiting, and hyperactivity.

If you or your child forget to take Montelukast Aurobindo Pharma Italia or forget to give it to your child
Try to take Montelukast Aurobindo Pharma Italia as prescribed. However, if you or your child miss a dose,
resume the usual schedule of one tablet per day.
Do not take a double dose to make up for the missed dose.

If you or your child stop taking Montelukast Aurobindo Pharma Italia
Montelukast Aurobindo Pharma Italia will only control your or your child's asthma if taken regularly.
It is important to continue taking Montelukast Aurobindo Pharma Italia for the entire duration prescribed by the doctor.
It will help control your or your child's asthma.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with montelukast 5 mg chewable tablets, the most commonly reported side effects (which may affect up to 1 in 10 people) considered to be due to montelukast were:

headache.

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

abdominal pain.

These side effects were usually mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (a pill containing no active drug).
Serious side effects
Contact your doctor immediately if you experience any of the following side effects, which may be serious and for which you may need urgent medical treatment.
Uncommon: the following may affect up to 1 in 100 people

Allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing.
Changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression.
Seizure (fit).

Rare: the following may affect up to 1 in 1,000 people

Increased tendency to bleed.
Tremor.
Palpitations.

Very rare: the following may affect up to 1 in 10,000 people

A combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2).
Low platelet count in the blood.
Changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions.
Swelling (inflammation) of the lungs.
Severe skin reactions (erythema multiforme) which may occur without warning.
Inflammation of the liver (hepatitis).

Other side effects during post-marketing use of the medicine
Very common: the following may affect more than 1 in 10 people

Upper respiratory tract infection.

Common: the following may affect up to 1 in 10 people

Diarrhoea, nausea, vomiting.
Rash.
Fever.
Elevated liver enzymes.

Uncommon: the following may affect up to 1 in 100 people

Changes in behaviour and mood: dream abnormalities, including nightmares, insomnia, sleepwalking, irritability, anxiety, restlessness.
Dizziness, drowsiness, tingling/numbness.
Nosebleed.
Dry mouth, digestive disturbances.
Bruising, itching, hives.
Joint or muscle pain, muscle cramps.
Involuntary loss of urine during sleep in children.
Weakness/tiredness, malaise, swelling.

Rare: the following may affect up to 1 in 1,000 people

Changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements.
Very rare: the following may affect up to 1 in 10,000 people
Painful red swellings under the skin, usually on the front of the legs (erythema nodosum).
Changes in behaviour and mood: obsessive-compulsive symptoms, stuttering.

Reporting of side effects
If you get any side effects, including any 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.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Aurobindo Pharma Italia

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 blister and carton after EXP. The
expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
[HDPE bottle containing 500 tablets]
Use within 12 months after first opening the HDPE bottle.
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 Aurobindo Pharma Italia contains

The active substance is montelukast. Each chewable tablet contains montelukast sodium equivalent to 5 mg of montelukast.
The excipients are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose 2% (6-10 mPaS), sodium croscarmellose, red iron oxide (E 172), aspartame (E 951), artificial cherry flavour (containing flavouring ingredients and modified food starch), and magnesium stearate.

Description of the appearance of Montelukast Aurobindo Pharma Italia and pack contents
Chewable tablets.
Pinkish, mottled, round, biconvex, uncoated tablets, with 'X' engraved on one side and '53' on the other side.
Montelukast Aurobindo Pharma Italia chewable tablets are available in PVC/Polymide/Aluminium foil/PVC blister packs and in HDPE bottles with polypropylene closure containing silica gel as desiccant.
Pack sizes:
Blister packs: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140 and 200 chewable tablets.
HDPE bottle: 30, 90 and 500 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road
South Ruislip HA4 6QD
United Kingdom

This medicinal product is authorised in the European Economic Area countries under the following names:
France Montelukast Arrow Lab 5 mg, chewable tablet
Germany Montelukast Aurobindo 5 mg chewable tablets
Ireland Montelukast Paediatric 5 mg Chewable Tablets
Italy Montelukast Aurobindo Pharma Italia
Malta Montelukast Aurobindo 5 mg Chewable Tablets
Netherlands Montelukast Aurobindo 5 mg, chewable tablets
Poland Montelukast Aurovitas
Portugal Montelucaste Aurobindo 5 mg chewable tablets
Romania Montelukast Aurobindo 5 mg Chewable Tablets
Spain Montelukast Aurovitas 5 mg chewable tablets EFG
United Kingdom Montelukast 5 mg chewable tablets

Package leaflet: Information for the user

Montelukast Aurobindo Pharma Italia 4 mg chewable tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of this leaflet:

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

2. What Montelukast Aurobindo Pharma Italia is and what it is used for

What Montelukast Aurobindo Pharma Italia is
Montelukast Aurobindo Pharma Italia is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Aurobindo Pharma Italia works
Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Aurobindo Pharma Italia improves asthma symptoms and helps control asthma.
When Montelukast Aurobindo Pharma Italia should be used
Your doctor has prescribed Montelukast Aurobindo Pharma Italia for the treatment of your child’s asthma, preventing asthma symptoms during both day and night.

Montelukast Aurobindo Pharma Italia is used for the treatment of children aged between 2 and 5 years whose asthma is not adequately controlled with their current therapy and who require additional treatment.
Montelukast Aurobindo Pharma Italia may also be used as an alternative to inhaled corticosteroids in children aged between 2 and 5 years who have not recently taken oral corticosteroids for asthma and who have shown inability to use inhaled corticosteroids.
Montelukast Aurobindo Pharma Italia also helps prevent exercise-induced narrowing of the airways in children from the age of 2 years.

Your doctor will determine how Montelukast Aurobindo Pharma Italia should be taken based on your child’s symptoms and the severity of their asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:

Difficulty breathing 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 exercise.
Swelling (inflammation) inside the airways.

Asthma symptoms include: coughing, breathlessness, and tightness in the chest.

4. What you should know before taking Montelukast Aurobindo Pharma Italia

Tell your doctor about any medical conditions or allergies your child has or has had.
Do not give Montelukast Aurobindo Pharma Italia to your child if he/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 or pharmacist before giving montelukast to your child.

If your child's asthma or breathing worsens, inform your doctor immediately.
Montelukast Aurobindo Pharma Italia oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep your child’s rescue inhaler medication with you for asthma attacks.
It is important that your child takes all asthma medications prescribed by the doctor. Montelukast Aurobindo Pharma Italia must not replace other asthma treatments prescribed for your child.
If your child is being treated with asthma medications, keep in mind that if he/she develops a combination of symptoms such as influenza-like fever, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin rashes, you should consult the doctor.
Your child should not take acetylsalicylic acid (aspirin) or other anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen his/her 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 (see section 4). If you or your child develop these symptoms during treatment with montelukast, you must consult your doctor.
Children and adolescents
Do not give this medicine to children under 2 years of age.
Different formulations of this medicine are available for paediatric patients under 18 years of age, depending on age group.
Other medicines and Montelukast Aurobindo Pharma Italia
Inform your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including those obtained without a prescription.
Some medicines may affect the action of Montelukast Aurobindo Pharma Italia, or Montelukast Aurobindo Pharma Italia may affect the action of other medicines your child is taking.
Inform your doctor if your child is taking the following medicines before starting Montelukast Aurobindo Pharma Italia:

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

Taking Montelukast Aurobindo Pharma Italia with food and drinks and alcohol
Montelukast Aurobindo Pharma Italia 4 mg chewable tablets should not be taken immediately after eating; it should be taken at least one hour before or two hours after food.
Pregnancy and breastfeeding and fertility
This subsection does not apply to Montelukast Aurobindo Pharma Italia chewable tablets, as it is intended for use in children aged 2 to 5 years.
Driving and using machines
This subsection does not apply to Montelukast Aurobindo Pharma Italia 4 mg chewable tablets, as it is intended for use in children aged 2 to 5 years; however, the following information refers to the active substance, montelukast.
Montelukast Aurobindo Pharma Italia is considered not to affect the ability to drive or operate machinery. However, individual responses to treatment may vary. Some side effects (such as dizziness and somnolence), which have been reported very rarely with Montelukast Aurobindo Pharma Italia, may affect the ability of some patients to drive or use machinery.
Montelukast Aurobindo Pharma Italia contains 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 0.674 mg of phenylalanine per 4 mg chewable tablet).
Montelukast Aurobindo Pharma Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

5. How to take Montelukast Aurobindo Pharma Italia

Give this medicine to your child exactly as directed by the doctor or pharmacist. If you have any doubts, consult your child's doctor or pharmacist.

This medicine must be given to a child under the supervision of an adult.
Your child must take only one tablet of Montelukast Aurobindo Pharma Italia per day as prescribed by the doctor.
This medicine should be taken even if your child has no symptoms or during an acute asthma attack.

For children aged 2 to 5 years:
The recommended dose is one 4 mg chewable tablet once daily, taken in the evening.
If your child is taking Montelukast Aurobindo Pharma Italia, make sure he/she does not take other medicines containing the same active substance, montelukast.
This medicine is for oral use.
The tablets must be chewed before swallowing.
Montelukast Aurobindo Pharma Italia 4 mg chewable tablets must not be taken immediately before or after meals; it should be taken at least 1 hour before or 2 hours after eating.

If your child takes more Montelukast Aurobindo Pharma Italia than he/she should
Contact your child's doctor immediately for advice.
No adverse effects have been reported in most cases of overdose. The most common symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

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

If your child stops taking Montelukast Aurobindo Pharma Italia
Montelukast Aurobindo Pharma Italia will only control your child's asthma if treatment is continued.
It is important that your child continues taking Montelukast Aurobindo Pharma Italia for the entire duration prescribed by the doctor. It will help control your child's asthma.

If you have any questions about using this product, consult your child's doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical studies with montelukast 4 mg chewable tablets, the most commonly reported side effects (which may affect up to 1 in 10 people) thought to be due to montelukast were:

abdominal pain;
thirst.

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

headache.

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

Serious side effects
Speak to your doctor immediately if you notice any of the following side effects, which may be serious and for which you may need urgent medical treatment.

Uncommon: the following may affect up to 1 in 100 people

Allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing.
Changes in behaviour and mood: agitation including aggressive behaviour or hostility, depression.
Seizure (fit).

Rare: the following may affect up to 1 in 1,000 people

Increased tendency to bleeding.
Tremor.
Palpitations.

Very rare: the following may affect up to 1 in 10,000 people

A combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2).
Low platelet count in the blood.
Changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions.
Swelling (inflammation) of the lungs.
Severe skin reactions (erythema multiforme) which may occur without warning.
Inflammation of the liver (hepatitis).

Other side effects during the medicine’s commercial use
Very common: the following may affect more than 1 in 10 people

Upper respiratory tract infection.

Common: the following may affect up to 1 in 10 people

Diarrhoea, nausea, vomiting.
Rash.
Fever.
Elevated liver enzymes.

Uncommon: the following may affect up to 1 in 100 people

Changes in behaviour and mood: dream abnormalities, including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness.
Dizziness, drowsiness, tingling/numbness.
Nosebleed.
Dry mouth, digestive disturbances.
Bruising, itching, urticaria.
Joint or muscle pain, muscle cramps.
Involuntary loss of urine during sleep in children.
Weakness/tiredness, malaise, swelling.

Rare: the following may affect up to 1 in 1,000 people

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

Very rare: the following may affect up to 1 in 10,000 people

Painful, red, swollen lumps under the skin, usually found on the front of the legs (erythema nodosum).
Changes in behaviour and mood: obsessive-compulsive symptoms, stuttering.

Reporting of side effects
If you get any side effects, including ones 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.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Aurobindo Pharma Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Store in the original packaging to protect from light and moisture.
[HDPE bottle containing 500 tablets]
Use within 12 months after first opening the HDPE bottle.
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 Aurobindo Pharma Italia contains

The active substance is montelukast. Each chewable tablet contains montelukast sodium equivalent to 4 mg of montelukast.
The excipients are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose 2% (6-10 mPa·s), sodium croscarmellose, red iron oxide (E172), aspartame (E951), artificial cherry flavour (containing flavouring agents and modified food starch), and magnesium stearate.

Description of the appearance of Montelukast Aurobindo Pharma Italia and package contents
Chewable tablets.
Pink, mottled, oval, biconvex, uncoated tablets, marked with 'X' on one side and '52' on the other side.
Montelukast Aurobindo Pharma Italia chewable tablets are available in PVC/Polyamide/Aluminium foil/PVC blister packs and in HDPE bottles with polypropylene closure containing silica gel as desiccant.
Pack sizes:
Blister packs: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140 and 200 chewable tablets.
HDPE bottles: 30, 90 and 500 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
France: Montelukast Arrow Lab 4 mg, chewable tablet
Germany: Montelukast Aurobindo 4 mg Kautabletten
Italy: Montelukast Aurobindo Pharma Italia
Malta: Montelukast Aurobindo 4 mg Chewable Tablets
Netherlands: Montelukast Aurobindo 4 mg, kauwtabletten
Poland: Montelukast Aurovitas
Portugal: Montelucaste Aurobindo 4 mg comprimidos para mastigar
Romania: Montelukast Aurobindo 4 mg Comprimate masticabile
Spain: Montelukast Aurovitas 4 mg comprimidos masticables EFG
United Kingdom: Montelukast 4 mg chewable tablets