Montelukast Zentiva: detailed information

Package Leaflet: Information for the Patient

MONTELUKAST ZENTIVA

4 mg/5 mg Chewable Tablets
Generic Medicine
Please read this leaflet carefully before you or your child 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 or your child only. Do not give it to others, even if their symptoms are the same as yours or your child's, as it may be harmful.
If you or your child experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Montelukast Zentiva is and what it is used for
What you need to know before your child takes Montelukast Zentiva
How to take Montelukast Zentiva
Possible side effects
How to store Montelukast Zentiva
Contents of the pack and other information

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

The active substance in Montelukast Zentiva is montelukast, a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Zentiva improves asthma symptoms and helps to control asthma.

Your doctor has prescribed Montelukast Zentiva for the treatment of asthma for you or your child, to prevent asthma symptoms during both day and night.

Montelukast Zentiva is used for the treatment of patients aged [2–5] [6–14] years who are not adequately controlled with their current medications and require additional therapy.
Montelukast Zentiva may also be used as an alternative to inhaled corticosteroids in patients aged [2–5] [6–14] years who have not recently taken oral corticosteroids for asthma and who have shown inability to use inhaled corticosteroids.
Montelukast Zentiva also helps prevent exercise-induced narrowing of the airways in patients 2 years of age and older.

Your doctor will determine how to use Montelukast Zentiva depending on your or your child's symptoms and severity of asthma.

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

Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers;
Sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or physical exercise;
Swelling (inflammation) of the airway lining.

Asthma symptoms include coughing, wheezing, and chest tightness.

2. What you should know before you or your child take Montelukast Zentiva

Inform your doctor about any medical problems or allergies your child has or has had in the past.
Do not take or give Montelukast Zentiva to your child if:

He or she is allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before you or your child take Montelukast Zentiva.
If your or your child's asthma or breathing worsens, contact your doctor immediately.
Montelukast Zentiva must 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 or your child's emergency inhaled asthma medication available for asthma attacks.
It is important that you or your child take all asthma medications prescribed by the doctor. Montelukast Zentiva must not be used instead of other asthma medications prescribed by your doctor for you or your child.
Any patient taking anti-asthma medications should be aware that a combination of symptoms such as flu-like symptoms, tingling sensations, or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness may occur and should consult the doctor.
You or your child must not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen your or your child's 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 Zentiva, consult your child's doctor.

Children and adolescents
For children aged 2 to 5 years, Montelukast Zentiva 4 mg chewable tablets are available. Do not give Montelukast Zentiva 4 mg chewable tablets to children under 2 years of age.
For children aged 6 to 14 years, Montelukast Zentiva 5 mg chewable tablets are available. Do not give Montelukast Zentiva 5 mg chewable tablets to children under 6 years of age.

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

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 Zentiva with food and drink
Montelukast Zentiva chewable tablets must not be taken immediately with food. They should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding
This subsection does not apply to Montelukast Zentiva chewable tablets, as they are intended for use in children. However, the following information refers to the active substance, montelukast.
Women who are pregnant, think they may be pregnant, or are planning to have a baby should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will assess whether you can take montelukast during this period.
Breastfeeding
It is not known whether montelukast passes into breast milk. Women who are breastfeeding or intend to breastfeed should consult their doctor or pharmacist before taking this medicine.

Driving and using machines
This subsection does not apply to Montelukast Zentiva chewable tablets, as they are intended for use in children. However, the following information refers to the active substance, montelukast.
No effects on the ability to drive or use machines are expected with Montelukast Zentiva. However, individual responses to medicines may vary. Some adverse effects (such as dizziness and drowsiness) reported with Montelukast Zentiva may affect the ability of some patients to drive or use machines.

Montelukast Zentiva chewable tablets contain aspartame and sodium
This medicine contains 4.8 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine. It may be harmful to you or your child if you have phenylketonuria (PKU), a rare genetic disorder that causes phenylalanine to accumulate because the body cannot properly eliminate it.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Montelukast Zentiva

Montelukast Zentiva 4 mg chewable tablets: this medicine should be given to children under the supervision of an adult.
You or your child must take only one chewable tablet of Montelukast Zentiva per day as prescribed by your doctor.
It should be taken even when you or your child are not experiencing symptoms or are having an acute asthma attack.
Take or give your child this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor, paediatrician, or pharmacist.

For children aged 2 to 5 years
The recommended dose is one 4 mg chewable tablet of Montelukast Zentiva once daily in the evening. Montelukast Zentiva should not be taken immediately after a meal; it should be taken at least 1 hour before or 2 hours after food. The tablets must be chewed before swallowing.
For children aged 6 to 14 years
The recommended dose is one 5 mg chewable tablet of Montelukast Zentiva once daily in the evening. Montelukast Zentiva should not be taken immediately after a meal; it should be taken at least 1 hour before or 2 hours after food. The tablets must be chewed before swallowing.

If you or your child is taking Montelukast Zentiva, make sure that you or your child do not take other medicines containing the same active substance, montelukast.
This medicine is for oral use.

If you or your child has taken more Montelukast Zentiva than you should
If you or your child has accidentally taken too much Montelukast Zentiva, or if someone else has taken the medicine by mistake, contact your doctor immediately.
In most reported cases of overdose, no adverse effects were observed. The most frequently reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take or give Montelukast Zentiva to your child
Try to give Montelukast Zentiva as prescribed. However, if you or your child misses a dose, continue taking the medicine as usual with the normal dose of one chewable tablet per day.
Do not take a double dose to make up for the missed tablet.

If you or your child stops taking Montelukast Zentiva
Your or your child's treatment with Montelukast Zentiva will be effective against asthma only if you or your child continue taking it.
It is important to continue taking Montelukast Zentiva for as long as your doctor has prescribed it. This will help you or your child keep asthma under control.

If you have any further 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.
In clinical studies with chewable tablets containing 4 mg of montelukast, the most commonly reported side effects (may affect up to 1 in 10 people) were:

Stomach ache.
Thirst.

Additionally, the following side effect has been reported in clinical studies with chewable tablets containing 5 mg of montelukast:

Headache.

These were mild in intensity and occurred more frequently in patients treated with Montelukast Zentiva than in those treated with placebo (a pill containing no active medicine).
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 (may affect up to 1 in 100 people):

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

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

Increased tendency to bleed.
Tremor.
Palpitations.

Very rare (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 rash (Churg-Strauss syndrome) (see section 2).
Low platelet count in the blood.
Changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and ideation.
Swelling (inflammation) of the lungs.
Severe skin reactions (erythema multiforme) which may occur without warning.
Inflammation of the liver (hepatitis). Other side effects during commercial use of the medicine

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

Upper respiratory tract infection.

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

Diarrhoea, feeling sick (nausea), being sick (vomiting).
Increased levels of liver enzymes.
Rash, fever.

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

Changes in behaviour and mood: abnormal dreams including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness.
Dizziness, drowsiness, tingling/numbness sensation.
Nosebleed.
Dry mouth, indigestion.
Bruising, itching, hives.
Joint or muscle pain, muscle spasms.
Involuntary loss of urine during sleep in children.
Weakness/tiredness, general feeling of being unwell, swelling (oedema).

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

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

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

Painful red swellings under the skin, most commonly on the front of the legs (erythema nodosum).
Changes in behaviour and mood: obsessive-compulsive symptoms, stuttering.

Reporting of side effects
If you or your child experience 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:
https://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 Zentiva

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the blister and outer packaging (EXP.). The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration (such as change in colour, etc.).
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 Zentiva contains
The active substance is montelukast (as montelukast sodium).
Montelukast Zentiva 4 mg chewable tablets:
Each chewable tablet contains montelukast sodium equivalent to 4 mg of montelukast.
Montelukast Zentiva 5 mg chewable tablets:
Each chewable tablet contains montelukast sodium equivalent to 5 mg of montelukast.
The other components are:
Microcrystalline cellulose, mannitol, crospovidone type B, red iron oxide (E172),
hydroxypropylcellulose, disodium edetate, cherry flavour, aspartame (E 951), talc, magnesium
stearate.
Description of the appearance of Montelukast Zentiva and the contents of the pack
Montelukast Zentiva 4 mg chewable tablets are pink, oval, biconvex, 11.0 x 8.0 mm, with "M4" engraved on one side.
Montelukast Zentiva 5 mg chewable tablets are pink, round, biconvex, 9.6 mm in diameter, with "M5" engraved on one side.
Montelukast Zentiva is available in the following pack sizes:
Montelukast Zentiva 4 mg chewable tablets:
Nylon/Alu/PVC – Aluminium blisters: 20, 28, 50, 100 + 10 (sample) tablets.
HDPE bottle: 20, 28, 50, 100 + 10 (sample) tablets.
Montelukast Zentiva 5 mg chewable tablets:
Nylon/Alu/PVC – Aluminium blisters: 20, 28, 30, 50, 90, 100 + 10 (sample) tablets.
HDPE bottle: 20, 28, 30, 50, 90, 100 + 10 (sample) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Viale Bodio 37/b
20158 Milano, Italy
Manufacturer
Takeda Pharma Sp. z.o.o.
ul. Ksiestwa Lowickiego 12 - 99-420 Lyszkowice
Poland
Winthrop Arzneimittel GmbH
Bruningstrasse 50
65926 Frankfurt am Main
Germany
Saneca Pharmaceutical a.s.
Nitrianska 100
920 27 Hlohovec
Slovak Republic
HBM Pharma s.r.o.
Sklabinskà 30
036 80 Martin
Slovak Republic
This medicinal product is authorised in the European Economic Area countries under the
following names:
Montelukast Zentiva 4 mg chewable tablets:
Montelukast Zentiva 4 mg in Germany, Montelukast Zentiva in Italy
Montelukast Zentiva 5 mg chewable tablets:
Montelukast Zentiva 5 mg in Germany, Montelukast Zentiva in Italy

Patient Information Leaflet

MONTELUKAST ZENTIVA

10 mg film-coated tablets
Generic 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 others, even if they have the same symptoms as you, because it could 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 Zentiva is and what it is used for
What you need to know before taking Montelukast Zentiva
How to take Montelukast Zentiva
Possible side effects
How to store Montelukast Zentiva
Contents of the pack and other information

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

The active substance of Montelukast Zentiva is montelukast, a leukotriene receptor antagonist
that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and allergy symptoms. Montelukast Zentiva improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast Zentiva for the treatment of asthma, and to prevent asthma symptoms during the day and night.

Montelukast Zentiva is used for the treatment of adults and adolescents aged 15 years and older who are not adequately controlled with their current therapies and who require additional treatment;
Montelukast Zentiva also helps prevent narrowing of the airways caused by physical exercise;
In patients for whom Montelukast Zentiva is indicated for the treatment of asthma, Montelukast Zentiva may also relieve symptoms of seasonal allergic rhinitis.

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

Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers;
Sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or physical exercise;
Swelling (inflammation) of the lining of the airways.

Asthma symptoms include: coughing, wheezing, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grass, and weeds. Typical symptoms of seasonal allergies may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.

2. What you should know before taking Montelukast Zentiva

Inform your doctor about any illness or allergies you currently have or have had in the past.
Do not take Montelukast Zentiva

If you are allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Montelukast Zentiva
If your asthma or breathing worsens, contact your doctor immediately.
Montelukast Zentiva must not be used to treat acute asthma attacks. If you experience an asthma attack, follow the instructions given by your doctor. Always keep your emergency inhaled asthma medication with you.
It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast Zentiva must not be used instead of other asthma medications prescribed by your doctor.
Any patient being treated with asthma medications should be aware that if they develop a combination of symptoms such as flu-like symptoms, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness, they must consult their doctor.
You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen your asthma.
Patients should be aware that various neuropsychiatric events (for example, changes in behaviour and mood) have been reported in adults, adolescents and children treated with montelukast (see section 4). If you develop these symptoms while taking Montelukast Zentiva, you must consult your doctor. Children and adolescents Do not give this medicine to children under 15 years of age. Different formulations of this medicine are available for pediatric patients under 18 years of age, depending on age group.

Other medicines and Montelukast Zentiva
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Some medicines may interfere with the action of Montelukast Zentiva, or Montelukast Zentiva may interfere with the action of other medicines.
Inform your doctor if you are taking the following medicines before starting Montelukast Zentiva:

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).

Montelukast Zentiva with food and drink
Montelukast Zentiva film-coated tablets can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will decide whether you can take Montelukast Zentiva during pregnancy.
Breastfeeding
It is not known whether montelukast passes into breast milk. If you are breastfeeding or intend to breastfeed, you must consult your doctor before taking Montelukast Zentiva.
Driving and using machines
No effects on the ability to drive or operate machinery are expected with Montelukast Zentiva. However, individual responses to medicines may vary. Some side effects (such as dizziness and drowsiness) reported with montelukast may affect the ability of some patients to drive or operate machinery.
Montelukast Zentiva film-coated tablets contain lactose monohydrate and sodium.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Montelukast Zentiva

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

You should take one tablet of Montelukast Zentiva once daily as prescribed by your doctor.
You should continue taking it even when you have no symptoms or are not experiencing an acute asthma attack.

For adults and adolescents aged 15 years and older
The recommended dose is one 10 mg tablet taken once daily in the evening.
If you are taking Montelukast Zentiva, make sure you are not also taking other medicines
containing the same active substance, montelukast.
This medicine is for oral use.
Montelukast Zentiva 10 mg may be taken with or without food.

If you take more Montelukast Zentiva than you should
Contact your doctor immediately.
In most reported cases of overdose, no adverse effects occurred. 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 Zentiva
Try to take Montelukast Zentiva as prescribed. However, if you forget to take a tablet, continue
taking the medicine as your usual dose of one tablet per day. Do not take a double dose to make
up for the forgotten tablet.

If you stop taking Montelukast Zentiva
Montelukast Zentiva will only control your asthma if you continue taking it.
It is important that you continue taking Montelukast Zentiva for the entire duration prescribed by
your doctor. This will help you control your asthma.

If you have any further 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.
In clinical studies with film-coated tablets containing 10 mg of montelukast, the most commonly reported side effects (may affect up to 1 in 10 people) were:

Stomach ache.
Headache.

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

Allergic reactions including rash, 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 (convulsion).

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

Increased tendency to bleed.
Tremor.
Palpitations. Very rare (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 rash (Churg-Strauss syndrome) (see section 2).
Low platelet count in the blood.
Changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and ideation.
Swelling (inflammation) of the lungs.
Severe skin reactions (erythema multiforme) which may occur without warning.
Inflammation of the liver (hepatitis). Other side effects during commercial use of the medicine

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

Upper respiratory tract infection. Common (may affect up to 1 in 10 people)
Diarrhoea, feeling unwell (nausea), being sick (vomiting).
Increased levels of liver enzymes.
Rash, fever.

Uncommon (may affect up to 1 in 100 people)

Changes in behaviour and mood: abnormal dreams including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness.
Dizziness, drowsiness, sensation of tingling/numbness.
Nosebleed.
Dry mouth, indigestion.
Bruising, itching, urticaria.
Joint or muscle pain, muscle spasms.
Involuntary loss of urine during sleep in children.
Weakness/sensation of tiredness, general feeling of being unwell, swelling (oedema). Rare (may affect up to 1 in 1,000 people)
Changes in behaviour and mood: attention disorder, memory impairment, uncontrolled muscle movements.

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

Painful red swellings under the skin, most commonly 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 http://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 Zentiva

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and outer packaging (EXP.). The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration (colour change, etc.).
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 Zentiva contains
The active substance is montelukast (as montelukast sodium).
Each film-coated tablet contains montelukast sodium equivalent to 10 mg of montelukast.
The other components are:
Tablet core:
Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, disodium edetate, magnesium stearate.
Tablet coating:
Hypromellose, hydroxypropylcellulose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Montelukast Zentiva and package contents
The 10 mg film-coated tablets of Montelukast Zentiva are beige-colored, round, biconvex, film-coated tablets with a diameter of 8.1 mm.
Montelukast Zentiva is available in the following pack sizes:
Nylon/Alu/PVC – Aluminium blisters: 20, 28, 30, 50, 90, 100 + 10 (sample) tablets.
HDPE bottles: 20, 28, 30, 50, 90, 100 + 10 (sample) tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale Bodio 37/b
20158 Milano, Italy

Manufacturer
Takeda Pharma Sp. z.o.o.
ul. Ksiestwa Lowickiego 12 - 99-420 Lyszkowice
Poland
Winthrop Arzneimittel GmbH
Bruningstrasse 50
65926 Frankfurt am Main
Germany
Saneca Pharmaceutical a.s.
Nitrianska 100
920 27 Hlohovec
Slovak Republic
HBM Pharma s.r.o.
Sklabinskà 30
036 80 Martin
Slovak Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Montelukast Zentiva 10 mg in Germany, Montelukast Zentiva in Italy