Aleast

Package leaflet: Information for the user

ALEAST 4 mg chewable tablets

Montelukast
Generic medicine
For children from 2 to 5 years of age
Please read this leaflet carefully before your child takes 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 your child only. Do not give it to others, even if their symptoms are the same as your child's, because it may be dangerous.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this package leaflet:

1. What ALEAST is and what it is 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

1. What ALEAST is and what it is 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 control asthma.
Your doctor has prescribed ALEAST to treat asthma and to prevent asthma symptoms both during the day
and during the night.

• ALEAST is used for the treatment of patients aged 2 to 5 years whose disease is not adequately controlled with their current medications and who require additional therapy.
• ALEAST may also be used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and who have been shown unable to use inhaled corticosteroids.
• ALEAST also helps prevent airway narrowing caused by physical exercise.

Your doctor will determine how ALEAST should be used based on your child's symptoms and the severity of their asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:

• Difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
• Sensitive airways that react to many things, 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.

2. What you should know before taking ALEAST

Inform your doctor about any illness or allergies your child currently has or has had in the past.
Do not give ALEAST 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

• If your child's asthma or breathing worsens, contact your doctor immediately.
• ALEAST oral is not to be used for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep the emergency inhaled medication for asthma attacks with you.
• It is important that your child takes all asthma medications prescribed by the doctor. ALEAST must not be used instead of other asthma medications prescribed by your doctor for your child.
• Every patient being treated with anti-asthma medications should be aware that if a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms and/or skin rash occurs, medical advice must be sought.
• 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 his or her asthma.

Various neuropsychiatric events (e.g. behavioural and mood-related changes,
depression and suicidal thoughts) have been reported in patients of all ages treated with
montelukast (see section 4). If such symptoms occur while taking
montelukast, you must contact the doctor.
Children and adolescents
For children aged 2 to 5 years, ALEAST 4 mg chewable tablets are available.
For children aged 6 to 14 years, ALEAST 5 mg chewable tablets are available.
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 may interfere with the way ALEAST works, or ALEAST may interfere with the way other medicines work.
Inform your doctor or pharmacist if your child is taking or has recently taken or might take any other medicines.
Inform your doctor if your child is taking any of the following medicines before starting ALEAST:

• 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 plasma).

Taking ALEAST with food and drink
ALEAST 4 mg chewable tablets must not be taken with food; they should be taken at least 1 hour before or 2 hours after food.
Pregnancy and breastfeeding
This section does not apply to ALEAST 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.
Use during pregnancy
Limited data available from pregnancy registries do not suggest a causal relationship between montelukast and malformations (e.g. limb defects), which have been rarely reported in worldwide post-marketing experience.
Women who are pregnant, suspect they may be pregnant, are planning a pregnancy, or are breastfeeding should consult their doctor before taking this medicine. The doctor will decide whether ALEAST can be taken 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 does not apply to ALEAST 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.
No effects on the ability to drive or use machines are expected. However, individual responses to medicines may vary. Some side effects (such as dizziness and somnolence), which have been reported very rarely with ALEAST, may affect the ability of some patients to drive vehicles or operate machinery.
ALEAST chewable tablets contain aspartame.
It contains a source of phenylalanine. It may be harmful for patients with phenylketonuria. If your child has the genetic disorder phenylketonuria, you should be aware that each 4 mg chewable tablet 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, an oral granule formulation is available.
• Your child must take only one ALEAST tablet once daily as prescribed by the doctor.
• The tablet should be taken even if your child has no symptoms or is experiencing an acute asthma attack.
• Always give ALEAST to your child exactly as directed by the doctor. If you have any doubts, consult the doctor or pharmacist.
• Give the tablet by mouth.

For children aged 2 to 5 years:
One ALEAST 4 mg chewable tablet daily, to be taken in the evening. ALEAST 4 mg chewable tablets must not be taken with food; they 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 containing the same active substance, montelukast.

If your child takes more ALEAST than they should
Contact your doctor immediately.
In most overdose reports, no adverse effects were observed. The most frequently reported symptoms in cases of overdose 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 misses a dose, continue with the usual schedule of one tablet daily.
Do not give a double dose to make up for the missed dose.

If your child stops treatment with ALEAST
ALEAST can only control your child's asthma if taken regularly.
It is important to continue taking ALEAST for the entire duration prescribed by the doctor. This will help control your child's asthma.
If you have any questions 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 everyone gets them.

In clinical studies with ALEAST 4 mg chewable tablets, the most commonly reported side effects (in more than 1 out of 100 patients but less than 1 out of 10 treated patients) considered to be related to the medicine were:

• abdominal pain
• thirst.

Additionally, 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 generally mild and occurred more frequently in patients treated with ALEAST than in those treated with placebo (a tablet containing no active ingredient).

Furthermore, the following side effects have been reported during the 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, nausea, vomiting
• 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 or swallowing
• changes in behaviour or mood (abnormal dreams, including nightmares, sleep disorders, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression)
• dizziness, drowsiness, tingling/numbness, seizures
• nosebleeds
• bruising, itching, hives
• dry mouth, indigestion
• muscle or joint pain, muscle cramps
• weakness/tiredness, malaise, swelling.

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)

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

In asthmatic patients treated with montelukast, a combination of symptoms including a flu-like illness, tingling or numbness in the arms or legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) has been reported very rarely. You must inform your doctor immediately if you or your child experience one or more of these symptoms.

Reporting of side effects

If you 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
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 the sight and reach of children.
• Do not use the medicine after the expiry date stated 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What ALEAST contains

• The active substance is: montelukast. ALEAST 4 mg chewable tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other excipients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose (E463), red iron oxide (E172), croscarmellose sodium, 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-shaped, biconvex tablets.
Pack sizes: 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 Rome, Italy

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: ALEAST

Package leaflet: Information for the user

ALEAST 5 mg chewable tablets

Montelukast
Generic medicine
For children from 6 to 14 years of age
Please 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 for your child only. Do not give it to others, even if their symptoms are the same as your child's, because it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this package leaflet:

1. What ALEAST is and what it is 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

1. What ALEAST is and what it is 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 control asthma.
Your doctor has prescribed ALEAST for the treatment of asthma and to prevent asthma symptoms both during the day
and at night.

• ALEAST is used to treat patients aged 6 to 14 years whose disease is not adequately controlled with their current medications and who require additional therapy.
• ALEAST 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 unable to use inhaled corticosteroids.
• ALEAST also helps prevent exercise-induced narrowing of the airways.

Your doctor will determine how ALEAST should be used based on your child's symptoms and the severity of their asthma.
What is asthma?
Asthma is a long-term disease.
Asthma involves:

• Difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
• Sensitive airways that react to many things, 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.

2. What you should know before taking ALEAST

Inform your doctor of any illness or allergy your child currently has or has had in the past.
Do not take and do not give your child ALEAST if you or your child

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

Warnings and precautions

• If your asthma or breathing, or your child's, worsens, contact your doctor immediately.
• ALEAST oral is not to be used for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep your child’s emergency inhaled medication with you.
• It is important that you or your child take all asthma medications prescribed by the doctor. ALEAST must not be used instead of other asthma medications prescribed for you or your child.
• Every patient being treated with anti-asthma medications should be aware that if symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of pulmonary symptoms and/or skin rash occur, you should consult your doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Various neuropsychiatric events (e.g. behavioural and mood-related changes,
depression and suicidal thoughts) have been reported in patients of all ages treated with
montelukast (see section 4). If you develop such symptoms while taking
montelukast, you must contact your doctor.
Children and adolescents
For children aged 2 to 5 years, ALEAST 4 mg chewable tablets are available.
For children aged 6 to 14 years, ALEAST 5 mg chewable tablets are available.
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 may interfere with the action of ALEAST, or ALEAST may interfere with the action of other medicines.
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines, including those without a prescription.
Inform 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 certain other infections)
• gemfibrozil (used to treat high plasma lipid levels)

Taking ALEAST with food and drinks
ALEAST 5 mg chewable tablets must not be taken with food; they should be taken at least 1 hour before or 2 hours after food.
Pregnancy and breastfeeding
Use during pregnancy
Limited data available from pregnancy registries do not suggest a causal relationship between montelukast and malformations (e.g. limb defects), which have been rarely reported in worldwide post-marketing experience.
Women who are pregnant, suspect they may be pregnant, 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
Effects on the ability to drive or use machines are not expected. However, individual responses to medicines may vary. Some side effects (such as dizziness and somnolence), which have been reported very rarely with ALEAST, may affect the ability to drive vehicles or use machines in some patients.
ALEAST chewable tablets contain aspartame.
It contains a source of phenylalanine. It may be harmful for patients with phenylketonuria. If you or your child have phenylketonuria, please note 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, an oral granule formulation is available.
• Your child must take only one ALEAST tablet once daily as prescribed by the doctor.
• The tablet should be taken even if your child has no symptoms or is experiencing an acute asthma attack.
• Always give ALEAST to your child exactly as directed by the doctor. If you have any doubts, consult your doctor or pharmacist.

For children aged 6 to 14 years:
One 5 mg chewable tablet of ALEAST daily, taken in the evening. ALEAST 5 mg chewable tablets must not be taken with food; they 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 containing the same active substance, montelukast.

If you or your child take more ALEAST than you should
Contact your doctor immediately.
In most reports of overdose, no adverse effects were observed. The most frequently reported symptoms in cases of overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you or your child forget to take ALEAST
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 per day.
Do not take a double dose to make up for the missed dose.

If you or your child stop taking ALEAST
ALEAST can control your asthma or your child's asthma only if you or your child continue taking it.
It is important to continue taking ALEAST for the entire duration prescribed by the doctor. This will help control your asthma or your child's asthma.

If you have any questions 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 everyone gets them.

In clinical studies with ALEAST 5 mg chewable tablets, the most commonly reported side effects (in more than 1 patient out of 100 but less than 1 out of 10) 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 generally mild and occurred more frequently in patients treated with ALEAST than in those treated with placebo (a tablet containing no active drug).

Furthermore, the following side effects have been reported 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, nausea, vomiting
• 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 breathing or swallowing difficulties
• changes in behaviour or mood (abnormal dreams, including nightmares, sleep disorders, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression)
• dizziness, drowsiness, tingling/numbness, seizures
• nosebleeds
• bruising, itching, hives
• dry mouth, indigestion
• muscle or joint pain, muscle cramps
• weakness/tiredness, malaise, swelling

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)

• hepatitis (inflammation of the liver)
• red lumps under the skin, usually on the legs (nodular erythema), severe skin reactions (erythema multiforme) which may occur without warning
• hallucinations, disorientation, suicidal thoughts and actions
• stuttering

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported. You must contact your doctor immediately if you or your child experience one or more of these symptoms.

Reporting of side effects

If you experience any side effects, 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 ALEAST

• Keep out of the sight and reach of children.
• Do not use the medicine after the expiry date stated 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ALEAST contains

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

What ALEAST looks like and contents of the pack
ALEAST 5 mg chewable tablets are pink, round, biconvex tablets.
Pack sizes: 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 Rome, Italy
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 testing):
La.Fa.Re. S.r.l.
Via Sacerdote Benedetto Cozzolino 77
80056 Ercolano (NA) – Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: ALEAST