Montelukast Teva Italia

Patient Information Leaflet: Information for the User

Montelukast Teva Italia 5 mg Chewable Tablets

For children aged 6 to 14 years
montelukast
Equivalent medicine
Please 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 or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to other people, even if their symptoms are the same as your child’s.
• If your child experiences any side effect, consult your doctor or pharmacist. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet
1 What Montelukast Teva Italia chewable tablets are and what they are used for
2 What you need to know before taking Montelukast Teva Italia chewable tablets
3 How to take Montelukast Teva Italia chewable tablets
4 Possible side effects
5 How to store Montelukast Teva Italia chewable tablets
6 Contents of the pack and other information

1. What Montelukast Teva Italia chewable tablets is and what it is used for

Montelukast Teva Italia is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause the narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Teva Italia improves asthma symptoms and helps control asthma.

Your doctor has prescribed Montelukast Teva Italia for the treatment of your child's asthma, to prevent asthma symptoms both during the day and at night.

Montelukast Teva Italia is used for the treatment of patients aged 6 to 14 years who are not adequately controlled with their current medications and require additional therapy.

Montelukast Teva Italia may also be used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and who have been shown to be unable to use inhaled corticosteroids.

Montelukast Teva Italia also prevents exercise-induced asthma symptoms in patients aged 6 years and older.

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

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

Asthma includes:

• Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
• Airway sensitivity to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
• Swelling (inflammation) of the airways.

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

2. What you should know before taking Montelukast Teva Italia chewable tablets

Inform your doctor of any current or past health problems or allergies your child may have.

Do not give Montelukast Teva Italia chewable tablets

• if your child is allergic to montelukast sodium or to any of the ingredients of this medicine (listed in section 6)

Warnings and precautions
Talk to your doctor or pharmacist before giving Montelukast Teva Italia chewable tablets to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast Teva Italia chewable tablets must not be used to treat acute asthma attacks. It will not help your child in such situations and must not be used for this purpose. If an asthma attack occurs, follow your doctor’s instructions. It is very important that the medication needed for such attacks is always readily available. Always keep your child’s emergency inhaled medication with you for asthma attacks.
• If your child needs inhaled beta-agonists more frequently than usual, contact your child’s doctor as soon as possible.
• It is important that your child takes all asthma medications prescribed by the doctor. Montelukast Teva Italia must not be used instead of other corticosteroid medications (either oral or inhaled) that your child is already taking.
• If your child has phenylketonuria, please note that Montelukast Teva Italia contains aspartame, a source of phenylalanine. The phenylalanine present in the tablets may be harmful to people with phenylketonuria.
• If your child is taking anti-asthma medications, you should know that if they develop a combination of flu-like symptoms, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness, you must consult your doctor.

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 (see section 4). If your child develops these symptoms while taking Montelukast Teva Italia, you must consult your child’s doctor.

Use in newborns and younger children: Montelukast Teva Italia chewable tablets are not recommended for children under 2 years of age.

Other medicines and Montelukast Teva Italia chewable tablets
Montelukast Teva Italia can be used together with other medicines your child may be taking for asthma. However, some medicines may interfere with how Montelukast Teva Italia works, or Montelukast Teva Italia may interfere with how your child’s other medicines work.

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those without a prescription. This is particularly important if the other medicines are:

• Phenobarbital (used to treat epilepsy)
• Phenytoin (used to treat epilepsy)
• Rifampicin (used to treat tuberculosis and some other infections)

Montelukast Teva Italia chewable tablets with food and drink
If Montelukast Teva Italia chewable tablets are taken in relation to meals, they should be taken in the evening, 1 hour before or 2 hours after a meal.

Pregnancy, breastfeeding and fertility
This section does not apply to Montelukast Teva Italia chewable tablets, as they are intended for use in children aged 6 to 14 years. However, the following information refers to the active substance, montelukast.

Pregnancy:
Women who are pregnant, planning to become pregnant, or who may become pregnant should consult their doctor before taking Montelukast Teva Italia.

Breastfeeding:
It is not known whether Montelukast Teva Italia chewable tablets pass into human milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast Teva Italia chewable tablets.

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
This section does not apply to Montelukast Teva Italia chewable tablets, as they are intended for use in children aged 6 to 14 years. However, the following information refers to the active substance, montelukast.

In adults, no effects of Montelukast Teva Italia on the ability to drive or use machines are expected. Individual responses to medicines may, however, vary. Some side effects (such as dizziness and drowsiness), which have been reported very rarely with montelukast, may affect the ability of some patients to drive or use machines.

Montelukast Teva Italia chewable tablets contain aspartame
This medicine contains 0.5 mg of aspartame per chewable tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot eliminate it properly.

Montelukast Teva Italia chewable tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, i.e. essentially “sodium-free”.

3. How to take Montelukast Teva Italia chewable tablets

Make sure your child always takes Montelukast Teva Italia exactly as directed by the doctor, even when your child has no symptoms or during an asthma attack.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose for children aged 6 to 14 years is one 5 mg Montelukast Teva Italia chewable tablet taken orally once daily in the evening.
If Montelukast Teva Italia is taken with food, it should be taken 1 hour before or 2 hours after a meal.
The safety and efficacy of Montelukast Teva Italia chewable tablets have not been established in children under 2 years of age.
For children aged 2 to 5 years, Montelukast Teva Italia 4 mg chewable tablets are available.
For children aged 2 to 5 years who have difficulty taking the chewable tablet, a 4 mg granule formulation is available.
For patients aged 15 years and older and adults, Montelukast Teva 10 mg film-coated tablets are available.
Montelukast Teva Italia chewable tablets must not be taken with other products containing the same active substance, montelukast.

If your child takes more Montelukast Teva Italia chewable tablets than they should
If your child (or someone else) takes more tablets at the same time, contact immediately the nearest hospital emergency department or your doctor. Overdose may cause abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity (involuntary movements).
Take this patient information leaflet, any remaining tablets, and the packaging with you to the hospital or doctor, so they can determine how many tablets have been taken.

If you forget to give Montelukast Teva Italia chewable tablets to your child
If your child forgets to take a dose, continue giving the medicine as usual. Do not give your child a double dose to make up for the missed tablet.

If your child stops treatment with Montelukast Teva Italia
It is important for your child to continue taking Montelukast Teva Italia for the entire duration prescribed by their doctor, whether or not symptoms are present, as this will help control your child's asthma. Treatment with Montelukast Teva Italia can only be effective against asthma if it is taken continuously.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If the child experiences any of the following side effects, you must contact the doctor or go to hospital
immediately:

In clinical studies with montelukast, the most commonly reported side effects (which may affect up to 1 in 10 patients) considered to be related to montelukast were:

• headache
• abdominal pain
• thirst

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

Additionally, since the medicine has been marketed, the following side effects have been reported:
Other side effects observed in some patients taking Montelukast include:

Very common: may affect more than 1 in 10 people

• upper respiratory tract infection

Common: may affect up to 1 in 10 people

• diarrhoea, nausea, vomiting
• fever
• rash
• increased liver enzymes

Uncommon: may affect up to 1 in 100 people

• allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing
• changes in behaviour and mood, abnormal dreams including nightmares, sleep disorders, sleep-walking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression
• dizziness, drowsiness, tingling/numbness, seizures
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• weakness/tiredness, malaise, swelling

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

• increased tendency to bleed
• tremor
• palpitations
• swelling under the skin

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

• hallucinations, disorientation, suicidal thoughts and actions, stuttering
• hepatitis (inflammation of the liver)
• painful red nodules under the skin, most commonly on the shins (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning
• hepatic eosinophilic infiltration

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as influenza-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or rash (Churg-Strauss syndrome) have been reported.
You must inform your doctor immediately if you experience one or more of these symptoms.
Ask your doctor or pharmacist if you would like more information about side effects.

Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. 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 Teva Italia chewable tablets

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 on the packaging.
The expiry date refers to the last day of the month.
Do not store above 25°C. Keep the blister in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater.
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 Teva Italia chewable tablets contain:

• The active substance is montelukast sodium, equivalent to 5 mg of montelukast.
• The excipients are: mannitol (E421), sodium lauryl sulfate, hydroxypropylcellulose, red iron oxide (E172), cherry flavour PHS-143671: (maltodextrins (maize) and modified starch E1450 (waxy maize)), aspartame (E951), sodium carboxymethyl starch type A, magnesium stearate.

Description of the appearance of Montelukast Teva Italia and pack sizes
Montelukast Teva Italia 5 mg chewable tablets are mottled pink in colour, square-shaped with rounded edges, marked with "93" on one side and "7425" on the other side of the tablet.
Montelukast Teva Italia 5 mg chewable tablets are available in packs of: 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets, and calendar packs of 7, 14, 28, 56 and 98 tablets.
Aluminium/aluminium blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 – Milan
Italy

Manufacturer
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen (Hungary)
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31546 Kraków (Poland)
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG (United Kingdom)
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem (Netherlands)
Merckle GmbH
Ludwig-Merckle-Str. 3, 89143 Blaubeuren (Germany)

This medicinal product is authorized in the European Economic Area Member States under the following names:
Belgium: Montelukast Teva 5 mg kauwtabletten
Bulgaria: Ephyra 5 mg Chewable Tablets
Germany: Montelukast ratiopharm junior 5 mg Kautabletten
France: Montelukast Teva 5 mg, comprimé à croquer
Italy: Montelukast Teva Italia 5 mg compresse masticabili
Luxembourg: Montelukast-ratiopharm junior 5 mg Kautabletten
Netherlands: Montelukast 5 mg Teva, kauwtabletten
United Kingdom: Montelukast 5 mg Chewable Tablets

This Patient Information Leaflet was last approved on

Package leaflet: information for the user

Montelukast Teva Italia 4 mg Chewable Tablets

For children from 2 to 5 years of age
montelukast
Equivalent medicine
Please read this leaflet carefully before your child takes this medicine, as it contains
important information.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if their symptoms appear the same as your child's.
• If your child experiences any side effect, contact your doctor or pharmacist. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet
7 What Montelukast Teva Italia Chewable Tablets are and what they are used for
8 What you need to know before taking Montelukast Teva Italia Chewable Tablets
9 How to take Montelukast Teva Italia Chewable Tablets
10 Possible side effects
11 How to store Montelukast Teva Italia Chewable Tablets
12 Contents of the pack and other information

1. What Montelukast Teva Italia chewable tablets are and what they are used for

Montelukast Teva Italia is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause the narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Teva Italia improves asthma symptoms and helps control asthma.

Your doctor has prescribed Montelukast Teva Italia for the treatment of your child's asthma, to prevent asthma symptoms both during the day and at night.

Montelukast Teva Italia is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medications and require additional therapy.

Montelukast Teva Italia 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 shown inability to use inhaled corticosteroids.

Montelukast Teva Italia also prevents exercise-induced asthma symptoms in patients aged 2 years and older.

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

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

Asthma includes:

• Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
• Airway hyperresponsiveness to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
• Swelling (inflammation) of the airways. Asthma symptoms include coughing, shortness of breath, and chest tightness.

2. What you should know before taking Montelukast Teva Italia chewable tablets

Inform your doctor about any health problems or allergies your child currently has or has had in the past.
Do not give Montelukast Teva Italia chewable tablets

• if your child is allergic to montelukast sodium or to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before giving Montelukast Teva Italia chewable tablets to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast Teva Italia chewable tablets must not be used to treat acute asthma attacks. It will not help your child in such situations and must not be used for this purpose. If an asthma attack occurs, follow your doctor's instructions exactly. It is very important that the medicine needed for such attacks is always readily available. Always keep your child's emergency inhaled asthma medication with you.
• If your child needs inhaled beta-agonists more often than usual, contact your child's doctor as soon as possible.
• It is important that your child takes all asthma medicines prescribed by the doctor. Montelukast Teva Italia chewable tablets must not be used instead of other corticosteroid medicines (either oral or inhaled) that your child is already taking.
• If your child has phenylketonuria, please note that Montelukast Teva Italia chewable tablets contain aspartame, a source of phenylalanine. The phenylalanine present in the tablets could be harmful to people with phenylketonuria.
• If your child is taking anti-asthma medicines, you should know that if he or she develops a combination of flu-like symptoms, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness, you must consult the doctor.

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 your child develops such symptoms during treatment with Montelukast Teva Italia, you should consult your child's doctor.
Use in newborns and younger children: Montelukast Teva Italia chewable tablets are not recommended for children under 2 years of age.
Other medicines and Montelukast Teva Italia chewable tablets
Montelukast Teva Italia chewable tablets can be used together with other medicines your child may be taking for asthma. However, some medicines may interfere with the way Montelukast Teva Italia works, or Montelukast Teva Italia may interfere with the way your child's other medicines work.
Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those without a prescription. This is particularly important if the other medicines are:

• Phenobarbital (used to treat epilepsy)
• Phenytoin (used to treat epilepsy)
• Rifampicin (used to treat tuberculosis and some other infections)

Montelukast Teva Italia chewable tablets with food and drink
If Montelukast Teva Italia chewable tablets are taken with regard to meals, they should be taken in the evening, 1 hour before or 2 hours after meals.
Pregnancy, breastfeeding and fertility
This section does not apply to Montelukast Teva Italia 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.
Pregnancy
Women who are pregnant, planning a pregnancy, or who may become pregnant should consult their doctor before taking Montelukast Teva Italia chewable tablets.
Breastfeeding
It is not known whether Montelukast Teva Italia chewable tablets pass into human milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast Teva Italia chewable tablets.
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 this medicine.
Driving and using machines
This section does not apply to Montelukast Teva 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.
In adults, Montelukast Teva Italia is not expected to affect the ability to drive or operate machinery. However, individual responses to medicines may vary. Some side effects (such as dizziness and somnolence), which have been reported very rarely with montelukast, may affect the ability of some patients to drive or operate machinery.
Montelukast Teva Italia chewable tablets contain aspartame
This medicine contains 0.5 mg of aspartame.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.
Montelukast Teva Italia chewable tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, i.e. essentially "sodium-free".

3. How to take Montelukast Teva Italia chewable tablets

Make sure your child always takes Montelukast Teva Italia chewable tablets exactly as directed by the doctor, even when your child has no symptoms or during an asthma attack.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose for children aged 2 to 5 years is one 4 mg Montelukast Teva Italia chewable tablet taken orally once daily in the evening.
If Montelukast Teva Italia is taken with food, it should be taken 1 hour before or 2 hours after a meal.
The safety and efficacy of Montelukast Teva Italia has not been established in children under 2 years of age.
For children aged 2 to 5 years who have difficulty taking the chewable tablet, a 4 mg granule formulation is available.
For children aged 6 to 14 years, Montelukast Teva Italia 5 mg chewable tablets are available.
For patients aged 15 years and older and adults, Montelukast Teva 10 mg film-coated tablets are available.
Montelukast Teva Italia must not be taken together with other products containing the same active substance, montelukast.

If your child takes more Montelukast Teva Italia chewable tablets than they should
If your child (or someone else) takes too many tablets at once, contact immediately the nearest hospital emergency department or your doctor. Overdose may cause abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity (involuntary movements).
Take this patient information leaflet, any remaining tablets, and the packaging with you to the hospital or doctor, so they can determine how many tablets have been taken.

If you forget to give Montelukast Teva Italia chewable tablets to your child
If your child forgets to take a dose, continue giving the medicine as usual. Do not give your child a double dose to make up for the forgotten tablet.

If your child stops treatment with Montelukast Teva Italia chewable tablets
It is important for your child to continue taking Montelukast Teva Italia chewable tablets for as long as the child's doctor has prescribed, whether or not symptoms are present, as this will help control your child's asthma. Treatment with Montelukast Teva Italia chewable tablets can only be effective against asthma if taken consistently.
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 everyone experiences them.
If your child experiences any of the following side effects, you must contact the doctor or go to hospital immediately:

In clinical studies with montelukast, the most commonly reported side effects (may affect up to 1 in 10 patients), considered to be related to montelukast, were:

• abdominal pain
• thirst
• headache

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

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

Very common: may affect more than 1 in 10 people

• upper respiratory tract infection

Common: may affect up to 1 in 10 people

• diarrhoea, nausea, vomiting
• fever
• rash
• increased liver enzymes

Uncommon: may affect up to 1 in 100 people

• allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing
• changes in behaviour and mood, abnormal dreams including nightmares, sleep disorders, sleep-walking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression
• dizziness, drowsiness, tingling/numbness, seizures
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria (hives)
• joint or muscle pain, muscle cramps
• weakness/tiredness, malaise, swelling

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

• increased tendency to bleed
• tremor
• palpitations
• swelling under the skin

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

• hallucinations, disorientation, suicidal thoughts and actions, stuttering
• hepatitis (inflammation of the liver)
• painful red nodules under the skin, most commonly on the shins (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning
• hepatic eosinophilic infiltration

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms have been reported, including flu-like symptoms, tingling or numbness in arms and legs, worsening of lung symptoms and/or rash (Churg-Strauss syndrome).
You must inform your doctor immediately if you experience one or more of these symptoms.
Ask your doctor or pharmacist if you would like more information about side effects.

Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. 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 Teva Italia chewable tablets

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 outer packaging.
The expiry date refers to the last day of the month.
Do not store above 25°C. Keep the blister in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater. 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 Teva Italia chewable tablets contain

• The active substance is montelukast sodium, equivalent to 4 mg of montelukast.
• The excipients are: mannitol (E421), sodium lauryl sulfate, hydroxypropylcellulose, red iron oxide (E172), cherry flavour PHS-143671: (maltodextrins (maize) and modified starch E1450 (waxy maize)), aspartame (E951), sodium carboxymethylstarch type A, magnesium stearate.

Description of the appearance of Montelukast Teva Italia and contents of the pack
Montelukast Teva Italia 4 mg chewable tablets are mottled pink in colour, triangular in shape with rounded edges, marked with "93" on one side and "7424" on the other side of the tablet.
Montelukast Teva Italia 4 mg chewable tablets are available in packs of: 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets, and in calendar packs of 7, 14, 28, 56 and 98 tablets.
Aluminium/aluminium blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 – Milan, Italy

Manufacturer
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen (Hungary)
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31546 Kraków (Poland)
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG (United Kingdom)
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem (Netherlands)
Merckle GmbH
Ludwig-Merckle-Str. 3, 89143 Blaubeuren (Germany)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Belgium: Montelukast Teva 4 mg kauwtabletten
Bulgaria: Ephyra 4 mg Chewable Tablets
Germany: Montelukast-ratiopharm mini 4 mg Kautabletten
Italy: Montelukast Teva Italia 4 mg compresse masticabili
Luxembourg: Montelukast-ratiopharm mini 4 mg Kautabletten
Netherlands: Montelukast 4 mg Teva, kauwtabletten
United Kingdom: Montelukast 4 mg Chewable Tablets

This leaflet was last approved on