MONTELUKAST 4 mg Chewable Tablets

Зміст інструкції

1. MONTELUKAST ZENTIVA
   1. What is Montelukast Zentiva and what it is used for
   2. What you need to know before your child or you take Montelukast Zentiva
   3. How to take Montelukast Zentiva
   4. Possible side effects
   5. How to store Montelukast Zentiva
   6. Package Contents and Other Information
2. MONTELUKAST ZENTIVA
   1. What is Montelukast Zentiva and what it is used for
   2. What you need to know before you take Montelukast Zentiva
   3. How to take Montelukast Zentiva
   4. Possible side effects
   5. How to store Montelukast Zentiva
   6. Package Contents and Other Information

MONTELUKAST ZENTIVA

4 mg/5mg chewable tablets
Generic medicine

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 only for you or your child. Do not pass it on to others, even if their symptoms are the same as yours or your child’s, as it could be harmful.
• If you or your child gets any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active ingredient 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. By blocking leukotrienes, Montelukast Zentiva improves asthma symptoms and helps to control it.
Your doctor has prescribed Montelukast Zentiva for the treatment of asthma for you or your child,
to prevent asthma symptoms during the 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 medications and need additional treatment.
• Montelukast Zentiva can also be used as an alternative treatment to inhaled corticosteroids for patients aged [2 - 5] [6-14] years who have not recently taken oral corticosteroids for asthma and who have shown they are unable to use inhaled corticosteroids.
• Montelukast Zentiva also helps to prevent the narrowing of the airways triggered by exercise for 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 the severity of asthma. What is asthma?Asthma is a long-term illness that includes:
• Difficulty breathing due to narrowing of the airways. The narrowing of the airways gets worse and improves in response to various conditions;
• Sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or exercise;
• Swelling (inflammation) of the lining of the airways.

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

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

Inform your doctor about any medical problems or allergies that your child has or has had
in the past.

Do not give or allow your child to take Montelukast Zentiva

• If you/they are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsTalk to your doctor or pharmacist before you or your child take Montelukast Zentiva.
• If your asthma or breathing gets worse, contact your doctor immediately.
• Montelukast Zentiva should not be used to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given for your child. Always keep your or your child’s emergency inhaled medication for asthma attacks handy.
• It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast Zentiva should not be used instead of other asthma medications that your doctor has prescribed for you or your child.
• Any patient taking asthma medications should know that if they develop a combination of symptoms such as flu-like symptoms, tingling or numbness in the arms or legs, worsening lung symptoms and/or skin redness, they should consult a doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen your asthma or your child’s asthma.
• Patients should be aware that various neuropsychiatric events (e.g., changes in behavior and mood) have been reported in adults, adolescents and children treated with montelukast (see section 4). If you or your child develop these symptoms during treatment with Montelukast Zentiva, you should consult your child’s doctor. Children and adolescentsMontelukast Zentiva 4 mg chewable tablets are available for children from 2 to 5 years of age. Do not give Montelukast Zentiva 4 mg chewable tablets to children under 2 years of age. Montelukast Zentiva 5 mg chewable tablets are available for children from 6 to 14 years of age. Do not give Montelukast Zentiva 5 mg chewable tablets to children under 6 years of age. Other medicines and Montelukast ZentivaTell your doctor if you or your child is taking, has recently taken or might take any other medicines. Some medicines can interfere with the action of Montelukast Zentiva, or Montelukast Zentiva can interfere with the action of other medicines for your child. Tell your doctor or pharmacist if you or your child is taking the following medicines before starting to take 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 should not be taken immediately with meals,
it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding
This sub-paragraph does not apply to Montelukast Zentiva chewable tablets as it is
intended for use in children, however, the following information refers to the active ingredient
montelukast.
Women who are pregnant, who think they might become pregnant or who are planning to
become pregnant, should ask their doctor or pharmacist for advice before taking this
medicine.
Pregnancy
The 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 ask their doctor or
pharmacist for advice before taking this medicine.

Driving and operating machinery
This sub-paragraph is not applicable to Montelukast Zentiva chewable tablets as they are
intended for use in children. The information that follows, however, refers to the active
ingredient, montelukast.
No effects on the ability to drive and operate machinery are expected with the use of
Montelukast Zentiva. Individual responses to medicines can however vary. Some undesirable effects (such as dizziness and drowsiness) that have been reported with Montelukast Zentiva
can affect the ability of some patients to drive and operate machinery.

Montelukast Zentiva chewable tablets contains aspartame and sodium
This medicine contains 4.8 mg of aspartame in each 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 build up because the
body cannot dispose of it properly.
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 must be given to children under the supervision of an adult.
• You or your child should take only one chewable tablet of Montelukast Zentiva a day as prescribed by the doctor.
• It must be taken even when you or your child has no symptoms or is having an acute asthma attack.
• Always take or have your child take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, check with your doctor or pediatrician or pharmacist.

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

For children from 6 to 14 years
The recommended dose is 1 chewable tablet of Montelukast Zentiva 5 mg once a day to be taken in the evening. Montelukast Zentiva should not be given immediately after a meal; it should be taken at least 1 hour before or 2 hours after a meal. The tablets must be
chewed before swallowing.
If you or your child are taking Montelukast Zentiva, make sure that you or your child do not
take other medicines containing the same active ingredient, montelukast.
The medicine is for oral use.

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

If you forget to take or give Montelukast Zentiva to your child
Try to give Montelukast Zentiva as it has been prescribed. However, if you or your child miss
a dose, continue to have the medicine taken according to the usual dosage of one chewable
tablet a day.
Do not give a double dose to make up for a forgotten tablet.

If you or your child stops taking Montelukast Zentiva
Treatment with Montelukast Zentiva for you or your child may be effective against asthma
only if you or your child continues to take it.
It is important to continue taking Montelukast Zentiva for as long as your doctor has
prescribed it. This will help to control your asthma or your child's 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 everyone will experience 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 pain.
• Thirst.

In addition, 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 compared to those treated with placebo (a pill that does not contain
medicine).

Serious side effects
Tell 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 skin rash, swelling of the face, lips, tongue and/or throat which can cause difficulty breathing or swallowing.
• Changes in behaviour and mood: agitation including aggressive behaviour or hostility, depression.
• Convulsions.

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

• Increased tendency to bleed.
• Tremor.
• Palpitations.

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

• A complex of symptoms such as flu-like illness, tingling or numbness in the arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss Syndrome) (see paragraph 2).
• Low platelet count in the blood.
• Changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and ideation.
• Inflammation of the lungs.
• Severe skin reactions (erythema multiforme) that can occur without warning.
• Inflammation of the liver (hepatitis). Other side effects during post-marketing 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.
• Skin 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.
• Nosebleeds.
• Dry mouth, indigestion.
• Bruising, itching, hives.
• Joint or muscle pain, muscle spasms.
• Involuntary passing of urine during sleep by children.
• Weakness/feeling tired, general feeling of being unwell, swelling (edema). Rare(may affect up to 1 in 1,000)
• Changes in behaviour and mood: attention disorder, memory impairment, uncontrolled muscle movements.

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

• Swelling of the subcutaneous tissue of reddish colour, painful, located most commonly on the anterior surface 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 effects, including those not listed in
this leaflet, please tell your doctor or pharmacist. You can also report side effects
directly through 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 indicated on the blister and the 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 (change of color
etc.).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Montelukast Zentiva contains
The active ingredient 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 ingredients are:
Microcrystalline cellulose, mannitol, crospovidone type B, red iron oxide (E172),
hydroxypropylcellulose, disodium edetate, cherry flavour, aspartame (E 951), talc, magnesium
stearate.

Description of Montelukast Zentiva and package contents
Montelukast Zentiva 4 mg chewable tablets are pink, oval, biconvex, measuring
11.0 x 8.0 mm, with “M4” imprinted on one side.
The chewable tablets of MONTELUKAST ZENTIVA 5 mg are pink, round,
biconvex with a diameter of 9.6 mm, with “M5” imprinted on one side.
Montelukast Zentiva is available in packs of:
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 Milan, 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 Member States of the European Economic Area under
the following denominations:
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

MONTELUKAST ZENTIVA

10 mg film-coated tablets
Equivalent medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Montelukast Zentiva is and what it is used for
• 2. What you need to know before you take Montelukast Zentiva
• 3. How to take Montelukast Zentiva
• 4. Possible side effects
• 5. How to store Montelukast Zentiva
• 6. Contents of the pack and other information

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

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

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

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

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

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

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

What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) represent
an allergic reaction often caused by pollen carried in the air by plants, grass and seeds. Typical symptoms of seasonal allergies may include: stuffy, runny, itchy nose;
sneezing; watery, swollen, red, itchy eyes.

2. What you need to know before you take Montelukast Zentiva

Inform your doctor about any illness or allergy you have now or have had in the past.

Do not take Montelukast Zentiva

• If you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsTalk to your doctor or pharmacist before taking Montelukast Zentiva
• If your asthma or breathing gets worse, contact your doctor immediately.
• Montelukast Zentiva should not be used to treat acute asthma attacks. If attacks occur, follow the instructions given to you by your doctor. Always keep your emergency inhaler medicine for asthma attacks with you.
• It is important that you or your child take all asthma medicines prescribed by the doctor. Montelukast Zentiva should not be used instead of other asthma medicines that the doctor has prescribed.
• Any patient being treated with asthma medicines should know that if they develop a combination of symptoms such as flu-like symptoms, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin rash, they should consult a doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen your asthma.
• Patients should be aware that various neuropsychiatric events (e.g., changes in behavior and mood) have been reported in adults, adolescents and children treated with montelukast (see section 4). If you develop these symptoms while taking Montelukast Zentiva, you should consult your doctor. Childrenand adolescentsDo not give this medicine to children under 15 years of age. There are different forms of this medicine available for pediatric patients under 18 years of age based on the age group .

Other medicines and Montelukast Zentiva
Tell your doctor if you are taking, have recently taken or might take any
other medicine, including those available without a prescription.
Some medicines can interfere with the action of Montelukast Zentiva, or Montelukast Zentiva can
interfere with the action of other medicines.
Tell your doctor if you are taking the following medicines before starting to take 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 film-coated tablets can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The doctor will determine if you can take Montelukast Zentiva during this period.
Breastfeeding
It is not known whether montelukast passes into breast milk. If you are breastfeeding or intend to
breastfeed, you should consult your doctor before taking Montelukast Zentiva.

Driving and using machines
No effects on the ability to drive and use machines are expected with the use of
Montelukast Zentiva. Individual responses to medicines can however vary. Some side
effects (such as dizziness and drowsiness) that have been reported with montelukast may
affect the ability of some patients to drive and use machines.

Montelukast Zentiva film-coated tablets contains lactose monohydrate and sodium.
If your doctor has told you that you have an intolerance to some 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 following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.

• You must take one Montelukast Zentiva tablet once a day as prescribed by your doctor.
• You must take it even when you do not have symptoms or are not experiencing an acute asthma attack.

For adults and adolescents 15 years of age and over
The recommended dose is one 10 mg tablet to be taken once a day in the evening.
If you are taking Montelukast Zentiva, you must be sure that you are not taking other medicines
that contain the same active ingredient, montelukast.
This medicine is for oral use.
Montelukast Zentiva 10 mg can be taken with or without food.

If you take more Montelukast Zentiva than you should
Contact your doctor immediately.
In the majority of overdose reports, no adverse effects have been reported. The
symptoms most frequently reported with overdose in adults and children
include abdominal pain, drowsiness, thirst, headache, vomiting and hyperactivity.

If you forget to take Montelukast Zentiva
Try to take Montelukast Zentiva as it has been prescribed to you. However, if you forget to
take a tablet, continue to take the medicine according to the usual dosage of one
tablet a day. Do not take a double dose to make up for a missed tablet.

If you stop taking Montelukast Zentiva
Montelukast Zentiva can treat your asthma only if you continue to take it.
It is important that you continue to take Montelukast Zentiva for the entire time prescribed by
your doctor. This will help you control your asthma.
If you have any further questions on 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 pain.
• Headache.

These were usually mild and occurred more frequently in patients treated with montelukast compared to those treated with placebo (a tablet that does not contain active substance).

Serious side effects
Tell 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 skin 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.
• Convulsions.

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

• Increased tendency to bleed.
• Tremor.
• Palpitations. Very rare (may affect up to 1 in 10,000)
• A complex of symptoms such as flu-like illness, tingling or numbness in the 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, thoughts and suicidal ideation.
• Inflammation of the lungs.
• Severe skin reactions (erythema multiforme) which can occur without warning.
• Inflammation of the liver (hepatitis). Other side effects during post-marketing experience

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 sleeping, sleepwalking, irritability, feeling anxious, restlessness.
• Dizziness, drowsiness, sensation of tingling/numbness.
• Nosebleed.
• Dry mouth, indigestion.
• Bruising, itching, hives.
• Joint or muscle pain, muscle spasms.
• Involuntary passing of urine during sleep by children.
• Weakness/feeling tired, general feeling of being unwell, swelling (oedema). Rare (may affect up to 1 in 1,000)
• Changes in behaviour and mood: attention disorder, memory impairment, uncontrolled muscle movements.

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

• Painful, reddish lumps 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date indicated on the blister and the 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 (change of colour
etc.).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Montelukast Zentiva contains
The active ingredient is montelukast (as montelukast sodium).
Each film-coated tablet contains montelukast sodium equivalent to 10 mg of montelukast.
The other ingredients are:
Tablet core:
Microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, disodium edetate, magnesium
stearate.
Tablet coating:
Hypromellose, hydroxypropyl cellulose, titanium dioxide (E171) yellow iron oxide (E172), iron oxide
red (E172).

Description of the appearance of Montelukast Zentiva and package contents
Montelukast Zentiva 10 mg film-coated tablets are beige in colour, round,
biconvex, film-coated with a diameter of 8.1 mm.
Montelukast Zentiva is available in packs of:
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 Milan, 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 Member States of the European Economic Area under
the following denominations:
Montelukast Zentiva 10 mg in Germany, Montelukast Zentiva in Italy