ALEAST 4 mg Chewable Tablet

Зміст інструкції

1. ALEAST 4 mg chewable tablets
   1. What is ALEAST and what is it used for
   2. What you need to know before your child takes ALEAST
   3. How to take ALEAST
   4. Possible side effects
   5. How to store ALEAST
   6. Package Contents and Other Information
2. ALEAST 5 mg chewable tablets
   1. What is ALEAST and what is it used for
   2. What you need to know before taking ALEAST
   3. How to take ALEAST
   4. Possible side effects
   5. How to store ALEAST
   6. Contents of the pack and other information

ALEAST 4 mg chewable tablets

Montelukast
Generic medicine
For children from 2 to 5 years

Read this leaflet carefully before your child takes this medicine as 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 your child. Do not give it to other people, even if their symptoms are the same as those of your child, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• 1. What ALEAST is and what it is used for
• 2. What you need to know before you take ALEAST
• 3. How to take ALEAST
• 4. Possible side effects
• 5. How to store ALEAST 6 Contents of the pack and other information

1. What is ALEAST and what is it used for

ALEAST 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, ALEAST improves asthma symptoms and helps to control asthma.
Your doctor has prescribed ALEAST to treat asthma, prevent asthma symptoms both during the day
and during the night.

• ALEAST is used for the treatment of patients from 2 to 5 years of age whose disease is not adequately controlled with their medications and who need additional therapy.
• ALEAST can also be used as an alternative treatment to inhaled corticosteroids in patients from 2 to 5 years of age who have not recently taken oral corticosteroids for asthma and who have shown they are unable to use inhaled corticosteroids.
• ALEAST also helps to prevent the narrowing of the airways caused by exercise.

The doctor will determine how ALEAST should be used in relation to the symptoms and the severity of your child’s asthma.

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

• Difficulty breathing due to the narrowing of the airways. This narrowing of the airways gets worse and better in response to various conditions.
• Airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air or exercise
• Swelling (inflammation) of the lining of the airways. Asthma symptoms include: coughing, wheezing and a feeling of tightness in the chest.

Page 1of 12

2. What you need to know before your child takes ALEAST

Tell the doctor about any illness or allergy your child has now or has had in the past.

Do not give ALEAST to your child if

• they are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If your child's asthma or breathing gets worse, contact your doctor immediately.
• ALEAST oral should not be used to treat acute asthma attacks. If an attack occurs, follow the instructions given to you by the doctor for your child. Always keep your child’s emergency inhaler medicine with you for asthma attacks.
• It is important that your child takes all asthma medicines prescribed by the doctor. ALEAST should not be used instead of other asthma medicines that the doctor has prescribed for your child.
• Every patient being treated with asthma medicines should be aware that if an association of symptoms such as flu-like syndrome, tingling or numbness of arms or legs, worsening of pulmonary symptoms and/or skin rash occurs, they should consult a doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also called non-steroidal anti-inflammatory drugs or NSAIDs) if their asthma gets worse.

Certain neuropsychiatric events (such as changes in behaviour and mood,
depression and suicidal thoughts) have been reported in patients of all ages treated with
montelukast (see section 4). If these symptoms develop while taking
montelukast, you should contact your doctor.
Children and adolescents
Chewable ALEAST 4 mg tablets are available for children from 2 to 5 years of age.
Chewable ALEAST 5 mg tablets are available for children from 6 to 14 years of age.
The efficacy and safety of ALEAST 4 mg chewable tablets have not been established in children under
2 years of age.

Other medicines and ALEAST
Some medicines can interfere with the way ALEAST works, or ALEAST can interfere with the way other
medicines work.
Tell your doctor or pharmacist if your child is taking, has recently taken or might
take any other medicines.
Tell your doctor if your child is taking the following medicines before starting to take
ALEAST:

• 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).

Taking ALEAST with food and drink
ALEAST 4 mg chewable tablets should not be taken with food; it should be taken
at least 1 hour before or 2 hours after food.
Page 2of 12
Pregnancy and breastfeeding
This section is not applicable to ALEAST 4 mg chewable tablets because it is intended for use in
children from 2 to 5 years of age; the information below, however, refers to the active ingredient,
montelukast.

Use in pregnancy
Limited data available in pregnancy databases do not suggest a causal relationship between montelukast and
malformations (e.g. limb defects) that have been rarely reported
in worldwide post-marketing experience.
Pregnant women, who suspect or are planning a pregnancy, or who are breastfeeding,
should consult their doctor before taking this medicine. The doctor will assess whether you can take
ALEAST under these circumstances.

Use during breastfeeding
It is not known whether ALEAST is excreted in breast milk. If you are breastfeeding or intend to breastfeed,
you should consult your doctor before taking ALEAST.

Driving and using machines
This section is not applicable to ALEAST 4 mg chewable tablets because it is intended for use in
children from 2 to 5 years of age; the information below, however, refers to the active ingredient,
montelukast.
Effects on the ability to drive or operate machinery are not expected. Individual responses to medicines
can, however, vary. Some side effects (such as dizziness and drowsiness) that have been reported
very rarely with ALEAST may affect some patients’ ability to drive vehicles or
use machines.

ALEAST chewable tablets contains aspartame.
Contains a source of phenylalanine. May be harmful to patients with phenylketonuria. If your
child suffers from the genetic defect phenylketonuria, you should be aware that each chewable tablet of ALEAST 4 mg contains phenylalanine (equivalent to 0.24 mg of phenylalanine per
4 mg chewable tablet).

3. How to take ALEAST

• This medicine should be administered to the child under the supervision of an adult. For children who have difficulty taking a chewable tablet, a formulation in the form of an oral granules is available.
• Your child should take only one ALEAST tablet once a day as prescribed by the doctor.
• The tablet should be taken even if your child has no symptoms or is having an acute asthma attack.
• Always give ALEAST to your child exactly as instructed by the doctor. If you have any doubts, consult your doctor or pharmacist.
• Give the tablet by mouth.

For children from 2 to 5 years of age:
One chewable ALEAST 4 mg tablet per day, to be taken in the evening. ALEAST 4 mg chewable tablets
should not be taken with food, it should be taken at least 1 hour before or 2 hours after
food.
If your child is taking ALEAST, make sure your child does not take other products that
contain the same active ingredient, montelukast.

If your child takes more ALEAST than they should
Page 3of 12
Consult your doctor immediately.
In the majority of overdosage reports, there have been no side effects. The symptoms
most frequently reported in case of overdosage in adults and children include abdominal
pain, drowsiness, thirst, headache, vomiting and hyperactivity.

If you forget to give ALEAST to your child
Try to give ALEAST as prescribed. However, if your child forgets to take a
tablet, continue with the usual schedule of one tablet per day.
Do not give a double dose to make up for the missed one.

If your child stops taking ALEAST
ALEAST can treat your child's asthma only if your child continues to take it.
It is important to continue taking ALEAST for as long as prescribed by the doctor. This will help to
control your child's asthma.
If you have any doubts about the use of this product, 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 ALEAST 4 mg chewable tablets, the most commonly reported side effects (in more than 1 patient per 100 but in less than 1 in 10 patients treated) thought to be
related to the medicine are:

• 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 ALEAST compared to those treated with placebo (a tablet that does not contain
medicine).
In addition, the following side effects have been reported with 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, nausea, vomiting
• skin rash
• fever.

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 and swallowing
• changes related to behaviour or mood (abnormal dreams, including nightmares, sleep disturbances, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive or hostile behaviour, depression)
• dizziness, drowsiness, pins and needles/numbness, convulsions
• nosebleed
• bruising, itching, hives

Pag. 4di 12

• dry mouth, indigestion
• muscle or joint pain, muscle cramps
• weakness/fatigue, malaise, swelling.

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)

• hepatitis (inflammation of the liver)
• red lumps under the skin most commonly on the legs (erythema nodosum), severe skin reactions (erythema multiforme) which can occur without warning
• hallucinations, disorientation, thoughts and actions of suicide
• stuttering.

In asthmatic patients treated with montelukast, a complex of
symptoms such as flu-like illness, pins and needles or numbness in the arms or legs, worsening
of lung symptoms and/or rash (Churg-Strauss syndrome) has been reported in very rare cases. You should report to your doctor immediately if
you or your child develop one or more of these symptoms.

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
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 ALEAST

• Keep out of sight and reach of children .
• Do not use the medicine after the expiry date indicated on the label. The expiry date refers to the last day of that month.
• Store in the original packaging to protect it from light and moisture.
• 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 ALEAST contains

• The active ingredient is: montelukast ALEAST chewable tablets 4 mg contain montelukast sodium equivalent to 4 mg of montelukast.
• The other excipients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose (E463), red iron oxide (E172), sodium croscarmellose, cherry flavour (consisting of: maltodextrin, gum arabic, anisaldehyde, benzaldehyde, cinnamaldehyde, vanillin, heliotropine, ionones), aspartame (E951), and magnesium stearate.

What ALEAST looks like and contents of the pack
ALEAST 4 mg chewable tablets are pink, oval, biconvex.
Page 5of 12
Packs of 28, 56 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Lanova Farmaceutici S.r.l., Via Conca D’oro, 212 – 00141 Roma

Manufacturer:
Pharmathen S.A.
Dervenakion 6
Pallini 15351, Attiki
Greece
Tel.: +30 210 6664300
Fax: +30 210 6666749
E-mail: [email protected]

Alternative manufacturer for secondary packaging (including batch release without controls):

La.Fa.Re. S.r.l.
Via Sacerdote Benedetto Cozzolino 77
80056 Ercolano (NA) – Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: ALEAST
Page 6of 12

ALEAST 5 mg chewable tablets

Montelukast
Generic medicine
For children from 6 to 14 years

Read this leaflet carefully before your child takes this medicine as it contains
important information for them.

• 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 your child. Do not give it to other people, even if their symptoms are the same as those of your child, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.
• 1. What ALEAST is and what it is used for
• 2. What you need to know before your child takes ALEAST
• 3. How to take ALEAST
• 4. Possible side effects
• 5. How to store ALEAST 6 Contents of the pack and other information

1. What is ALEAST and what is it used for

ALEAST is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, ALEAST improves asthma symptoms and helps to control asthma.
Your doctor has prescribed ALEAST to treat asthma, to prevent asthma symptoms both during the day
and during the night.

• ALEAST is used for the treatment of patients from 6 to 14 years of age whose disease is not adequately controlled with their medications and who need additional therapy.
• ALEAST can also be used as an alternative treatment to inhaled corticosteroids in patients from 6 to 14 years of age who have not recently taken oral corticosteroids for asthma and who have shown they are unable to use inhaled corticosteroids.
• ALEAST also helps to prevent the narrowing of the airways caused by exercise.

The doctor will determine how ALEAST should be used in relation to the symptoms and the severity of your child’s asthma.

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

• Difficulty breathing due to narrowing of the airways. This narrowing of the airways gets worse and better in response to various conditions.
• Airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air or exercise
• Swelling (inflammation) of the lining of the airways. Asthma symptoms include: coughing, wheezing and a feeling of tightness in the chest.

Page 7of 12

2. What you need to know before taking ALEAST

Inform your doctor about any illness or allergy your child has at present or has had in the past.

Do not take and do not give to your child ALEAST if you or your child

• is allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If your asthma or breathing, or that of your child, gets worse, contact your doctor immediately.
• ALEAST oral should not be used to treat acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor for your child. Always keep your rescue inhaler medicine with you for asthma attacks.
• It is important that you or your child take all asthma medicines prescribed by your doctor. ALEAST should not be used instead of other asthma medicines that your doctor has prescribed for you or your child.
• Every patient being treated with asthma medicines should be aware that if an association of symptoms such as flu-like syndrome, tingling or numbness of arms or legs, worsening of lung symptoms and/or skin rash occurs, 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 your asthma gets worse.

Certain neuropsychiatric events (e.g. behavioural and mood changes, depression and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking montelukast, you should contact your doctor.
Children and adolescents
Chewable ALEAST 4 mg tablets are available for children from 2 to 5 years of age.
Chewable ALEAST 5 mg tablets are available for children from 6 to 14 years of age.
The efficacy and safety of ALEAST chewable tablets have not been established in children under 2 years of age.

Other medicines and ALEAST
Some medicines can interfere with the way ALEAST works, or ALEAST can interfere with the way other medicines work.
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines, including those available without a prescription.
Tell your doctor if you or your child are taking the following medicines before starting to take ALEAST:

• 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)

Taking ALEAST with food and drink
ALEAST 5 mg chewable tablets should not be taken with food, it should be taken at least 1 hour before or 2 hours after food.

Pregnancy and breastfeeding

Use in pregnancy
Page. 8of 12
Limited data available from pregnancy registries do not suggest a causal association between montelukast and malformations (e.g. limb defects) that have been rarely reported in worldwide post-marketing experience.
Pregnant women, who suspect they are pregnant or who are planning a pregnancy, or who are breastfeeding, should consult their doctor before taking this medicine. The doctor will assess whether you can take ALEAST under these circumstances.

Use during breastfeeding
It is not known whether ALEAST is excreted in human milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking ALEAST.

Driving and using machines
No effects on the ability to drive or operate machinery are expected. However, individual responses to medicines may vary. Some side effects (such as dizziness and drowsiness) that have been reported very rarely with ALEAST may affect some patients’ ability to drive vehicles or use machinery.

ALEAST chewable tablets contains aspartame.
Contains a source of phenylalanine. May be harmful to patients with phenylketonuria. If you or your child have phenylketonuria you should be aware that each 5 mg chewable tablet contains phenylalanine (equivalent to 0.30 mg of phenylalanine per 5 mg chewable tablet).

3. How to take ALEAST

• This medicine should be administered to the child under the supervision of an adult. For children who have difficulty taking a chewable tablet, a formulation in the form of an oral granules is available.
• Your child should take only one ALEAST tablet once a day as prescribed by the doctor.
• The tablet should be taken even if your child has no symptoms or is having an acute asthma attack.
• Always have your child take ALEAST exactly as instructed by the doctor. If you have any doubts, consult your doctor or pharmacist.

For children from 6 to 14 years of age:
One chewable ALEAST 5 mg tablet per day, to be taken in the evening. ALEAST 5 mg chewable tablets
should not be taken with food, it should be taken at least 1 hour before or 2 hours after
food.
If you or your child are taking ALEAST, make sure that you or your child do not take other
products that contain the same active ingredient, montelukast.

If you or your child take more ALEAST than you should
Consult your doctor immediately.
In the majority of overdosage reports, there have been no side effects. The symptoms
most frequently reported in case of overdosage in adults and children include abdominal
pain, drowsiness, thirst, headache, vomiting and hyperactivity.

If you forget to take ALEAST or to give ALEAST to your child
Try to take ALEAST as prescribed. However, if you or your child forget to take
a tablet, continue with the usual schedule of one tablet a day.
Do not take a double dose to make up for a missed one.

If you or your child stop taking ALEAST
Page 9of 12
ALEAST can treat your asthma or your child's asthma only if you or your child continue to
take it.
It is important to continue taking ALEAST for the entire time prescribed by the doctor. This will help you
control your asthma and your child's asthma.
If you have any doubts about the use of this product, 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 ALEAST 5 mg chewable tablets, the most commonly reported side effects (in more than 1 in 100 but less than 1 in 10 patients) thought to be related to the
medicine are:

• headache

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

• abdominal pain

These side effects were usually mild and occurred more frequently in
patients treated with ALEAST compared to those treated with placebo (a tablet that does not contain
medicine).
In addition, the following side effects have been reported with 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, nausea, vomiting
• skin rash
• fever.

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 and swallowing
• changes related to behaviour or mood (abnormal dreams, including nightmares, sleep disturbances, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive or hostile behaviour, depression)
• dizziness, drowsiness, pins and needles/numbness, convulsions
• nosebleed
• bruising, itching, hives
• dry mouth, indigestion
• muscle or joint pain, muscle cramps
• weakness/fatigue, feeling unwell, swelling.

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)

• hepatitis (liver inflammation) Page. 10of 12
• red lumps under the skin most commonly on the legs (erythema nodosum), severe skin reactions (erythema multiforme) which can occur without warning
• hallucinations, disorientation, suicidal thoughts and actions
• stammering.

In asthmatic patients treated with montelukast, a complex of
symptoms such as flu-like illness, pins and needles or numbness in the arms or legs, worsening of lung
symptoms and/or rash (Churg-Strauss syndrome) has been reported in very rare cases. You should tell your doctor immediately if you or your child develop one or more of these symptoms.

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
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 ALEAST

• Keep out of sight and reach of children .
• Do not use the medicine after the expiry date indicated on the label. The expiry date refers to the last day of that month.
• Store in the original packaging to protect it from light and moisture.
• 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. Contents of the pack and other information

What ALEAST contains

• The active ingredient is: montelukast. ALEAST 5 mg chewable tablet contains montelukast sodium equivalent to 5 mg of montelukast.
• The other excipients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose (E463), red iron oxide (E172), sodium croscarmellose, cherry flavour (consisting of: maltodextrin, gum arabic, anisaldehyde, benzaldehyde, cinnamaldehyde, vanillin, heliotropin, ionones), aspartame (E951), magnesium stearate.

What ALEAST looks like and contents of the pack
ALEAST 5 mg chewable tablets are pink, round, biconvex.
Packs of 28, 56 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer:

Marketing Authorisation Holder
Lanova Farmaceutici S.r.l., Via Conca D’oro, 212 – 00141 Roma

Manufacturer:.
Pharmathen S.A.
Dervenakion 6
Pallini 15351, Attiki
Page 11of 12
Greece
Tel.: +30 210 6664300
Fax: +30 210 6666749
E-mail: [email protected]

Alternative manufacturer for secondary packaging (including batch release without controls):

La.Fa.Re. S.r.l.
Via Sacerdote Benedetto Cozzolino 77
80056 Ercolano (NA) – Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: ALEAST
Page 12of 12