SASLONG 4 mg Chewable Tablets

Зміст інструкції

1. SASLONG 4 mg chewable tablets
   1. WHAT IS SASLONG 4MG AND WHAT IS IT USED FOR
   2. BEFORE TAKING SASLONG
   3. HOW TO TAKE SASLONG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE SASLONG
   6. FURTHER INFORMATION
2. SASLONG 5 mg chewable tablets
   1. WHAT IS SASLONG 4MG AND WHAT IS IT USED FOR
   2. BEFORE TAKING SASLONG
   3. HOW TO TAKE SASLONG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE SASLONG
   6. FURTHER INFORMATION
3. SASLONG 10 mg film-coated tablets
   1. WHAT IS SASLONG AND WHAT IT IS USED FOR
   2. BEFORE TAKING SASLONG
   3. HOW TO TAKE SASLONG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE SASLONG
   6. FURTHER INFORMATION

SASLONG 4 mg chewable tablets

For children from 2 to 5 years
Generic medicine

Read this leaflet carefully before taking this medicine.

• 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. Never give it to other people even if their symptoms are the same as your child’s, as it could be dangerous.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What SASLONG is and what it is used for
• 2. Before you take SASLONG
• 3. How to take SASLONG
• 4. Possible side effects
• 5. How to store SASLONG
• 6. Further information

1. WHAT IS SASLONG 4MG AND WHAT IS IT USED FOR

SASLONG is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes,
SASLONG improves asthma symptoms and helps control asthma.
Your doctor has prescribed SASLONG to treat your child's asthma, preventing asthma symptoms
during the day and at night.

• SASLONG is used for the treatment of children between the ages of 2 and 5 years who are not adequately controlled with their current care and require additional therapy.
• SASLONG can also be used as an alternative treatment to inhaled corticosteroidsfor children between the ages of 2 and 5 years who have recently not taken oral corticosteroids for asthma and have shown they are unable to take inhaled corticosteroids.
• SASLONG also helps to prevent airway narrowingtriggered by exercise in children 2 years of age and older. Your doctor will determine how to take SASLONG based on your child's symptoms and the severity of their asthma.

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

• difficulty breathing due to narrowing of the airways. This narrowing gets worse and better in response to various conditions;
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air or exercise;
• swelling (inflammation) inside the airways. Asthma symptoms include: coughing, shortness of breath and a tight chest.

2. BEFORE TAKING SASLONG

Tell your doctor about any medical problems or allergies your child has or has had.

Do not give SASLONG to your child if he/she
is allergic (hypersensitive) to montelukast or any of the other ingredients of SASLONG (see section
6, Further information)

Take special care with SASLONG

• If your child's asthma or breathing gets worse, tell your doctor immediately.
• SASLONG oral is not intended for the treatment of acute asthma attacks.If an attack occurs, follow the instructions your doctor has given for your child. Always carry your child's emergency inhaler for asthma attacks with you.
• It is important that your child takes all the asthma medicines prescribed by the doctor. SASLONG should not be used as a substitute for other asthma treatmentsthat the doctor has prescribed for your child.
• If your child is taking asthma medicines, be aware that if he/she develops a combination of symptoms, such as flu-like syndromes, tingling or numbness in the arms or legs, worsening of lung symptoms, and/or rash, he/she should consult a doctor.
• Your child should not take acetylsalicylic acid (aspirin) or other anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your child's asthma.

Taking SASLONG with other medicines
Some medicines can affect the action of SASLONG, or SASLONG can affect the action of other
medicines your child is taking.
Tell your doctor or pharmacist if your child is taking or has recently taken any other
medicines, including those available without a prescription.
Tell your doctor if your child is taking the following medicines before starting SASLONG:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections).

Taking SASLONG with food and drink
SASLONG should not be taken immediately after eating; it should be taken at least one hour before or two
hours after eating.

Pregnancy and breastfeeding
This subsection does not apply to SASLONG 4 mg chewable tablets as it is intended for use in
children from 2 to 5 years of age, however, the following information relates to the active ingredient, montelukast.

Use in pregnancy
Women who are pregnant or planning to become pregnant should consult their doctor before
taking SASLONG. Your doctor will assess whether you can take SASLONG during this period.

Use while breastfeeding
It is not known whether SASLONG passes into breast milk. You should consult your doctor before
taking SASLONG if you are breastfeeding or intend to breastfeed.

Driving and using machines
This subsection does not apply to SASLONG 4 mg chewable tablets as it is intended for use in
children from 2 to 5 years of age, however, the following information relates to the active ingredient, montelukast.
SASLONG is not thought to affect the ability to drive or operate machinery.
However, individual responses to treatment may vary. Some undesirable effects (such as dizziness and
drowsiness) that have been reported very rarely with SASLONG may influence the ability of some
patients to drive or use machines.

Important information about some of the ingredients of SASLONG
SASLONG chewable tablets contains aspartame, a source of phenylalanine. It may be
dangerous for people with phenylketonuria.
If your child has phenylketonuria (a rare inherited metabolic disorder), you should be aware that each 4 mg chewable tablet contains phenylalanine in an amount equal to 0.898 mg of phenylalanine per
dose.

3. HOW TO TAKE SASLONG

• This medicine must be given to a child under the supervision of an adult.
• Your child should take only one SASLONG tablet a day as prescribed by the doctor.
• Always have your child take SASLONG exactly as your doctor has instructed. If you have any doubts, consult your child's doctor or pharmacist.
• Take by mouth.

For children from 2 to 5 years:
One chewable tablet of 4 mg per day to be taken in the evening. SASLONG 4 mg chewable tablets

must notbe taken immediately after eating; it must be taken at least one hour before or two hours after
food intake.
If your child is taking SASLONG, make sure he/she does not take other medicines that contain the
same active ingredient, montelukast.
For children from 2 to 5 years, SASLONG 4 mg chewable tablets are available.
For children from 6 to 14 years, SASLONG 5 mg chewable tablets are available.
The formulation of SASLONG 4 mg chewable tablet is not recommended for children under 2 years
of age.

If your child takes more SASLONG than he/she should
Contact your child's doctor immediately for advice.
No side effects have been reported in most overdose reports. The most
common symptoms associated with overdose in adults and children include abdominal pain, insomnia, thirst,
headache, vomiting and hyperactivity.

If you forget to give SASLONG to your child
Try to give SASLONG as prescribed. However, if your child misses a dose, resume the usual schedule of
one tablet once a day.
Do not use a double dose to make up for a missed dose.

If your child stops SASLONG treatment
SASLONG can cure your child's asthma only if he/she takes it continuously.
It is important that your child takes SASLONG continuously for the entire period that the doctor prescribes.
This will help to control your child's asthma.
If you have any doubts about the use of this medicine, consult your child's doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, SASLONG can cause side effects, although not everybody gets them.
In clinical studies with SASLONG 4 mg chewable tablets, the most commonly reported side effects
(occur in at least 1 in 100 patients and in less than 1 in 10 pediatric patients treated) that are thought to be
attributable to SASLONG were:

• abdominal pain;
• thirst. Furthermore, the following side effect has been reported in clinical studies with SASLONG 10 mg film-coated tablets and 5 mg chewable tablets:
• headache. Usually, these were mild and occurred more frequently in patients treated with SASLONG rather than with placebo (a pill that does not contain any medicine).

The frequency of possible side effects listed below is defined using the following
convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1000 people
Very rare: may affect up to 1 in 10,000 people
In addition, during the time the medicine has been on the market, the following have been reported:

• upper respiratory tract infections (very common);
• increased tendency to bleed (rare);
• allergic reactions, including rash, swelling of the face, lips, tongue and/or throat, which can cause difficulty in breathing and swallowing (uncommon);
• changes in behaviour and mood [strange dreams, such as nightmares, sleep disturbances, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive or hostile behaviour, depression (uncommon), tremor (rare), hallucinations, disorientation, thoughts and actions of suicide (very rare)];
• dizziness, drowsiness, tingling/numbness, convulsions (uncommon);
• palpitations (rare);
• diarrhoea, nausea, vomiting (common), dry mouth, indigestion (uncommon);
• elevated levels in the blood of transaminases (ALT, AST) (common), hepatitis (inflammation of the liver) (very rare)
• rash (common), bruising, itching, hives (uncommon), painful and red nodules under the skin usually on the shins (erythema nodosum), severe skin reactions (erythema multiforme) (very rare)
• joint or muscle pain, muscle cramps (uncommon);
• fever (common), feeling unwell/fatigue, malaise, swelling (uncommon);

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like symptoms, tingling or numbness of the arms and legs,
worsening of lung symptoms and/or rash (Churg-Strauss syndrome) have been reported.
Tell your doctor immediately if your child develops 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 at:
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide
more information on the safety of this medicine

5. HOW TO STORE SASLONG

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date indicated by the 6 digits after SCAD on the blister. The first two
numbers indicate the month, the last four numbers indicate the year. The expiry date refers to the last
day of the month.
Store in the original package to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

6. FURTHER INFORMATION

What SASLONG contains
The active ingredient is montelukast.
Each tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
The excipients are: mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose (E 463),
red iron oxide (E 172), sodium croscarmellose, cherry flavour (E1518- glyceryl triacetate; E1450- sodium
octenylsuccinate), aspartame (E 951) and magnesium stearate.

Description of the appearance of SASLONG and contents of the pack
SASLONG 4 mg chewable tablets are pink, oval and biconvex tablets with MOK4 imprinted on one side
and PHD471 on the other.
Packaged in oPA/Al/PVC blisters contained in cardboard boxes.
Pack sizes of 14, 20, 28, 30, 50, 98 and 100 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040, Pomezia (Roma)
Italy.

Manufacturer responsible for batch release
MC Pharma AD
ZemlianeStr 35
1618 Sofia
Bulgaria

This medicinal product is authorised in the Member States of the EEA with the following names
DE:MontelukastHormosan4mgKautabletten

IT:SASLONG 4mg chewable tablets

SASLONG 5 mg chewable tablets

For children from 6 to 14 years old
Generic medicine

Read this leaflet carefully before taking this medicine.

• 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. Never give it to other people even if their symptoms are the same as yours, because it could be dangerous.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What SASLONG is and what it is used for
• 2. Before taking SASLONG
• 3. How to take SASLONG
• 4. Possible side effects
• 5. How to store SASLONG
• 6. Further information

1. WHAT IS SASLONG 4MG AND WHAT IS IT USED FOR

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

• SASLONG is used for the treatment of patients who are not adequately controlled in their care and need further therapy.
• SASLONG can also be used as an alternative treatment to inhaled corticosteroidsfor children between the ages of 6 and 14 who have not recently taken oral corticosteroids for asthma and have shown they are unable to take inhaled corticosteroids.
• SASLONG also helps to prevent narrowing of the airwaysstimulated by exercise. Your doctor will determine how to take SASLONG based on your or your child's symptoms and the severity of asthma.

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

• difficulty breathing due to narrowing of the airways. This narrowing gets worse and better in response to various conditions;
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air or exercise;
• swelling (inflammation) inside the airways. Asthma symptoms include: coughing, shortness of breath and a tight chest.

2. BEFORE TAKING SASLONG

Inform your doctor about any medical problems or allergies that you or your child has or has had.

Do not take SASLONG if you or your child
is allergic (hypersensitive) to montelukast or any of the other ingredients of SASLONG (see section 6,
Further information)

Take special care with SASLONG

• If your or your child's asthma or breathing gets worse, tell your doctor immediately.
• SASLONG oral is not indicated for the treatment of acute asthma attacks.If an attack occurs, follow the instructions your doctor has given you or your child. Always carry your emergency inhaler for asthma attacks with you.
• All patients on asthma medications should be aware that if they develop a combination of symptoms, such as flu-like syndromes with fever, tingling or numbness in the arms or legs, worsening of lung symptoms, and/or rash, they should consult a 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 or your child's asthma.

Use in children
SASLONG 4 mg chewable tablets are available for children from 2 to 5 years of age.
SASLONG 5 mg chewable tablets are available for children from 6 to 14 years of age.

Taking SASLONG with other medicines
Some medicines can affect the action of SASLONG, or SASLONG can affect the action of other
medicines of your child.
Tell your doctor or pharmacist if your child is taking or has recently taken any other
medicines, including those available without a prescription.
Tell your doctor if you or your child are taking the following medicines before starting SASLONG:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections).

Taking SASLONG with food and drink
SASLONG 5 mg chewable tablets should not be taken immediately after eating; they should be taken
at least one hour before or two hours after a meal.

Pregnancy and breastfeeding

Use in pregnancy
Pregnant women or those planning to become pregnant should consult their doctor before
taking SASLONG. Your doctor will assess whether you can take SASLONG during this period.

Use while breastfeeding
It is not known whether SASLONG passes into breast milk. You should consult your doctor before taking
SASLONG if you are breastfeeding or intend to breastfeed.

Driving and using machines
SASLONG is not thought to affect the ability to drive or operate machinery.
However, individual responses to treatment may vary. Some undesirable effects (such as dizziness and
drowsiness) that have been reported very rarely with SASLONG may affect the ability of some
patients to drive or use machines.

Important information about some of the ingredients of SASLONG
SASLONG chewable tablets contains aspartame, a source of phenylalanine. It may be
dangerous for people with phenylketonuria.If your child has phenylketonuria (a rare
inherited metabolic disorder), you should consider that each 5 mg chewable tablet contains
phenylalanine in an amount equal to 1.123 mg of phenylalanine per dose.

3. HOW TO TAKE SASLONG

• You or your child must take only one SASLONG tablet 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/give SASLONG exactly as your doctor has instructed. If you have any doubts, ask your doctor or your child’s doctor or pharmacist.
• Take by mouth.

For children from 6 to 14 years:
One chewable 5 mg tablet per day to be taken in the evening. SASLONG 5 mg chewable tablets

must notbe taken immediately after eating; it must be taken at least one hour before or two hours after
eating.
If you or your child are taking SASLONG, make sure that you or your child do not take other medicines that
contain the same active ingredient, montelukast.

If you or your child takes more SASLONG than you should
Contact your doctor immediately for advice.
No adverse effects have been reported in most overdose reports. The most
common symptoms associated with overdose in adults and children include abdominal pain, insomnia, thirst,
headache, vomiting and hyperactivity.

If you forget to take SASLONG or to give SASLONG to your child
Try to take/give SASLONG as prescribed. However, if you or your child forgets a dose,
resume the usual pattern of one tablet once a day.
Do not use a double dose to make up for a missed dose.

If you or your child stops taking SASLONG
SASLONG can only control your or your child’s asthma if you or your child takes it continuously.
It is important that you or your child take SASLONG continuously for the entire period that the doctor
prescribes. This will help to control your or your child’s 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, SASLONG can cause side effects, although not everybody gets them.
In clinical studies with SASLONG 4 mg chewable tablets, the most commonly reported side effects
(occur in at least 1 in 100 patients and in less than 1 in 10 pediatric patients treated) that are thought to be
attributable to SASLONG were:

• abdominal pain;
• thirst. Furthermore, the following side effect was reported in clinical studies with SASLONG 10 mg film-coated tablets and 5 mg chewable tablets:
• headache. Usually, these were mild and occurred more frequently in patients treated with SASLONG rather than with placebo (a pill that does not contain any medicine).

The frequency of possible side effects listed below is defined using the following
convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
In addition, during the time the medicine has been on the market, the following have been reported:

• upper respiratory tract infections (very common);
• increased tendency to bleed (rare);
• allergic reactions, including rash, swelling of the face, lips, tongue and/or throat, which can cause difficulty in breathing and swallowing (uncommon);
• changes in behaviour and mood [strange dreams, such as nightmares, sleep disturbances, sleepwalking, irritability, feeling of anxiety, restlessness, agitation including aggressive or hostile behaviour, depression (uncommon), tremor (rare), hallucinations, disorientation, thoughts and actions of suicide (very rare)];
• dizziness, drowsiness, tingling/numbness, convulsions (uncommon);
• palpitations (rare);
• diarrhoea, nausea, vomiting (common), dry mouth, indigestion (uncommon);
• elevated blood levels of transaminases (ALT, AST) (common), hepatitis (inflammation of the liver) (very rare)
• rash (common), bruising, itching, hives (uncommon), painful, red nodules under the skin usually on the shins (erythema nodosum), severe skin reactions (erythema multiforme) (very rare)
• joint or muscle pain, muscle cramps (uncommon);
• fever (common), feeling unwell/fatigue, sensation of malaise, swelling (uncommon);

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like symptoms, tingling or numbness of the arms and legs,
worsening of lung symptoms and/or rash (Churg-Strauss syndrome) have been reported.
Tell your doctor immediately if your child develops 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 at:
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide
more information on the safety of this medicine.

5. HOW TO STORE SASLONG

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date indicated by the 6 digits after SCAD . on the blister. The first two
numbers indicate the month, the last four numbers indicate the year. The expiry date refers to the last
day of the month.
Store in the original package to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. FURTHER INFORMATION

What SASLONG contains
The active ingredient is montelukast.
Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.
The excipients are: mannitol, microcrystalline cellulose, low substituted hydroxypropyl cellulose (E 463),
red iron oxide (E 172), sodium croscarmellose, cherry flavour (E1518- glyceryl triacetate; E1450- sodium
octenylsuccinate), aspartame (E 951) and magnesium stearate.

Description of SASLONG and package contents
SASLONG 5 mg chewable tablets are pink, round and biconvex tablets with MOK5 imprinted on one
side and PHD471 on the other.
Packaged in oPA/Al/PVC blisters contained in cardboard boxes.
Packs of 14, 20, 28, 30, 50, 98 and 100 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040, Pomezia (Roma)
Italy.

Manufacturer responsible for batch release
MC Pharma AD
ZemlianeStr 35
1618 Sofia
Bulgaria

This medicinal product is authorised in the Member States of the EEA with the following names
DE:MontelukastHormosan 5mg Kautabletten

IT:SASLONG 5mg chewable tablets

SASLONG 10 mg film-coated tablets

For adolescents and adults from 15 years of age
Generic medicine

Read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to other people even if their symptoms are the same as yours, as it could be dangerous.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What SASLONG is and what it is used for
• 2. Before taking SASLONG
• 3. How to take SASLONG
• 4. Possible side effects
• 5. How to store SASLONG
• 6. Further information

1. WHAT IS SASLONG AND WHAT IT IS USED FOR

SASLONG is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and are also a cause of
allergic symptoms. By blocking leukotrienes, SASLONG improves asthma symptoms, helps controlasthma
and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed SASLONG for the treatment of asthma, preventing asthma symptoms
during the day and night.

• SASLONG is used for the treatment of adolescents and adults starting from 15 years of age who are not adequately controlled in their care and require further therapy.
• SASLONG also helps to prevent narrowing of the airwaysstimulated by exercise.
• In those asthma patients for whom SASLONG is indicated for the treatment of asthma, SASLONG also provides symptomatic relief from seasonal allergic rhinitis.Your doctor will determine how to take SASLONG based on your symptoms and the severity of your asthma.

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

• difficulty breathing due to narrowing of the airways. This narrowing gets worse and better in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air or exercise.
• swelling (inflammation) inside the airways. Asthma symptoms include: coughing, shortness of breath and a tight chest.

What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal rhinitis) are an allergic reaction
often caused by pollen in the air from trees and lawns. Symptoms of seasonal allergies
usually include a stuffy, runny nose with itching, swollen and red eyes with tearing and itching.

2. BEFORE TAKING SASLONG

Inform your doctor about any medical condition or allergy you have or have had.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.

Do not take SASLONG if
You are allergic (hypersensitive) to montelukast or any of the excipients of SASLONG (see section 6. Further
information).

Take special care with SASLONG

• If your asthma or breathing gets worse, inform your doctor.
• SASLONG oral is not indicated for the treatment of acute asthma attacks.If you have an attack, follow the instructions given to you by your doctor. Always carry your emergency inhaler for asthma attacks with you.
• It is important that you take all asthma medicines prescribed by your doctor. SASLONG must notbe used as a substitute for other asthma treatmentsprescribed by your doctor.
• All patients taking asthma medicines should be aware that if they develop a combination of symptoms, such as flu-like syndromes with fever, tingling or numbness in the arms or legs, worsening of lung symptoms, and/or rash, they should consult a doctor.
• You 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.

Use in children
For children from 2 to 5 years, SASLONG 4 mg chewable tablets are available.
For children from 6 to 14 years, SASLONG 5 mg chewable tablets are available.

Taking SASLONG with other medicines
Some medicines can affect the action of SASLONG, or SASLONG can affect the action of other
medicines.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription.
Tell your doctor if you are taking the following medicines before starting SASLONG:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections).

Taking SASLONG with food and drink
SASLONG can be taken with or without food.

Pregnancy and breastfeeding

Use during pregnancy
Pregnant women or those planning to become pregnant should consult their doctor before
taking SASLONG. Your doctor will assess whether you can take SASLONG during this period.

Use during breastfeeding
It is not known whether SASLONG passes into breast milk. You should consult your doctor before taking
SASLONG if you are breastfeeding or intend to breastfeed.

Driving and using machines
SASLONG is not thought to affect the ability to drive or operate machinery.
However, individual responses to treatment may vary. Some undesirable effects (such as dizziness and
drowsiness) that have been reported very rarely with SASLONG may affect the ability of some
patients to drive or use machines.

Important information about some of the excipients of SASLONG
SASLONG contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact
them before taking this medicine.

3. HOW TO TAKE SASLONG

• You must take only one SASLONG tablet once a day as prescribed by your doctor.
• It must be taken even when you have no symptoms or have an acute asthma attack.
• Always take SASLONG following exactly your doctor’s instructions. If you have any doubts, ask your doctor or pharmacist.
• Take by mouth.

For patients 15 years and older
One 10 mg tablet to be taken once daily in the evening. SASLONG 10 mg can be taken with or
without food.
If you are taking SASLONG, make sure you are not taking any other product with the same active
ingredient, montelukast.

If you take more Montelukast than you should
Contact your doctor immediately for advice.
No adverse effects have been reported in the majority of overdose reports. The most
common symptoms associated with overdose in adults and children include abdominal pain, insomnia, thirst,
headache, vomiting and hyperactivity.

If you forget to take SASLONG
Try to take SASLONG as prescribed. However, if you forget a dose, resume your usual schedule of
one film-coated tablet once a day.
Do not take a double dose to make up for a missed dose.

If you stop taking SASLONG
SASLONG can only control your asthma if you continue to take it.
It is important that you continue to take SASLONG for the entire period your doctor prescribes it. This will help
to 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, SASLONG can cause side effects, although not everybody gets them.
In clinical studies with SASLONG 4 mg chewable tablets, the most commonly reported side effects
(occur in at least 1 in 100 patients and in less than 1 in 10 pediatric patients treated) that are thought to be
attributable to SASLONG were:

• abdominal pain;
• thirst. Furthermore, the following side effect was reported in clinical studies with SASLONG 10 mg film-coated tablets and 5 mg chewable tablets:
• headache. Usually, these were mild and occurred more frequently in patients treated with SASLONG rather than with placebo (a pill that does not contain any medicine).

The frequency of possible side effects listed below is defined using the following
convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1000 people
Very rare: may affect up to 1 in 10,000 people
In addition, during the period the medicine has been on the market, the following have been reported:

• upper respiratory tract infections (very common);
• increased tendency to bleeding (rare);
• allergic reactions, including rash, swelling of face, lips, tongue and/or throat, which can cause difficulty in breathing and swallowing (uncommon);
• changes in behaviour and mood [strange dreams, such as nightmares, sleep disturbances, sleepwalking, irritability, feeling of anxiety, restlessness, agitation including aggressive or hostile behaviour, depression (uncommon), tremor (rare), hallucinations, disorientation, thoughts and actions of suicide (very rare)];
• dizziness, drowsiness, tingling/numbness, convulsions (uncommon);
• palpitations (rare);
• diarrhoea, nausea, vomiting (common), dry mouth, indigestion (uncommon);
• elevated levels in the blood of transaminases (ALT, AST) (common), hepatitis (inflammation of the liver) (very rare)
• rash (common), bruising, itching, hives (uncommon), painful, red nodules under the skin usually on the shins (erythema nodosum), severe skin reactions (erythema multiforme) (very rare)
• joint or muscle pain, muscle cramps (uncommon);
• fever (common), feeling unwell/fatigue, malaise, swelling (uncommon);

In asthmatic patients treated with montelukast, very rare cases have been reported of a combination of
symptoms such as flu-like symptoms, tingling or numbness of the arms and legs,
worsening of lung symptoms and/or rash (Churg-Strauss syndrome).
Tell your doctor immediately if your child develops 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 at:
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more
information on the safety of this medicine

5. HOW TO STORE SASLONG

• Keep out of the reach and sight of children.
• Do not use this medicine after the expiry date indicated by the 6 digits after SCAD. on the blister. The first two numbers indicate the month, the last four numbers indicate the year. The expiry date refers to the last day of the month.
• Do not store at a temperature above 30°C. Store in the original packaging to protect the medicine from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. FURTHER INFORMATION

What SASLONG contains
The active ingredient is montelukast.
Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
The excipients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (E463),
magnesium stearate. Film coating: black iron oxide (E172), hypromellose, red iron oxide (E
172), polyethylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), Macrogol (6000).

Description of the appearance of SASLONG and contents of the pack
SASLONG 10 mg film-coated tablets are beige in colour, square and biconvex with MOK10 imprinted
on one side and PHD471 on the other.
Blisters in packs of 14, 20, 28, 30, 50, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
So.Se.Pharm S.r.l.
Via dei Castelli Romani, 22
00040, Pomezia (Roma)
Italy

Manufacturer responsible for batch release:
MC Pharma AD
ZemlianeStr 35
1618 Sofia
Bulgaria

This medicinal product is authorised in the Member States of the EEA with the following names
DE:MontelukastHormosan 10mg Filmtabletten

IT:SASLONG 10mg film-coated tablets