Saslong

PACKAGE LEAFLET: INFORMATION FOR THE USER

SASLONG 4 mg chewable tablets

For children from 2 to 5 years
Equivalent medicine
Please read this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform 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 SASLONG 4MG IS 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. By blocking leukotrienes, SASLONG improves asthma symptoms and helps control asthma.
Your doctor has prescribed SASLONG for the treatment of your child's asthma, preventing asthma symptoms during both day and night.

• SASLONG is used for the treatment of children aged 2 to 5 years whose asthma is not adequately controlled with current therapy and who require additional treatment.
• SASLONG may also be used as an alternative to inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and who have shown inability to use inhaled corticosteroids.
• SASLONG also helps prevent exercise-induced narrowing of the airways in children aged 2 years 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 disease.
Asthma includes:

• difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers;
• sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or exercise;
• swelling (inflammation) inside the airways. Asthma symptoms include: coughing, shortness of breath, and chest tightness.

2. BEFORE TAKING SASLONG

Inform your doctor of any medical conditions or allergies your child has or has had.
Do not give SASLONG to your child if he/she
Is allergic (hypersensitive) to montelukast or to any of the excipients of SASLONG (see section
6, Other information).
Take special care with SASLONG

• If your child's asthma or breathing worsens, inform 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 for your child. Always carry the emergency inhaled medicine for asthma attacks.
• It is important that your child takes all asthma medications prescribed by the doctor. SASLONG must not replace other asthma treatments prescribed by your doctor for your child.
• If your child is taking anti-asthma medications, keep in mind that if he/she develops a combination of symptoms such as influenza-like feverish illness, tingling or numbness in arms or legs, worsening of lung symptoms, and/or rash, you should consult the 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 may affect the action of SASLONG, or SASLONG may affect the action of other
medicines your child is taking.
Inform your doctor or pharmacist if your child is taking or has recently taken any other
medicines, including those without a prescription.
Inform 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 certain other infections).

Taking SASLONG with food and drinks
SASLONG should not be taken immediately after eating; it should be taken at least one hour before or two
hours after food intake.
Pregnancy and breastfeeding
This subsection does not apply to SASLONG 4 mg chewable tablets, as it is intended for use in
children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.
Use during 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 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
This subsection does not apply to SASLONG 4 mg chewable tablets, as it is intended for use in
children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.
SASLONG is considered not to affect the ability to drive or operate machinery.
However, individual responses to treatment may vary. Some adverse 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 machinery.
Important information on some excipients in SASLONG
SASLONG chewable tablets contain aspartame, a source of phenylalanine. This may be
harmful for individuals with phenylketonuria.
If your child has phenylketonuria (a rare inherited metabolic disorder), you should be aware that each 4 mg chewable tablet contains phenylalanine equivalent to 0.898 mg of phenylalanine per dose.

3. HOW TO TAKE SASLONG

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

For children aged 2 to 5 years:
One 4 mg chewable tablet once daily, taken in the evening. SASLONG 4 mg chewable tablets should not be taken immediately after eating; they should be taken at least one hour before or two hours after food.
If your child is taking SASLONG, make sure he/she does not take other medicines containing the same active substance, montelukast.
SASLONG 4 mg chewable tablets are available for children aged 2 to 5 years.
SASLONG 5 mg chewable tablets are available for children aged 6 to 14 years.
The SASLONG 4 mg chewable tablet formulation 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 adverse effects have been reported in most overdose cases. 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 daily.
Do not take a double dose to make up for the missed dose.

If your child stops taking SASLONG
SASLONG can control your child's asthma only if taken continuously.
It is important that your child takes SASLONG regularly for the entire duration prescribed by the doctor.
It will help control your child's asthma.

If you have any questions about the use of this medicine, consult your child's doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, SASLONG may cause adverse reactions, although not everyone experiences them.
In clinical studies with SASLONG 4 mg chewable tablets, the most commonly reported adverse reactions
(occurring in at least 1 in 100 patients and fewer than 1 in 10 pediatric patients treated), considered to be
attributable to SASLONG, were:

• abdominal pain;
• thirst.

Additionally, the following adverse reaction was reported in clinical studies with SASLONG 10 mg film-coated tablets and 5 mg chewable tablets:

• headache.

These were usually mild and occurred more frequently in patients treated with SASLONG than in those receiving placebo (a pill containing no active medicinal ingredient).

The frequency of the possible adverse reactions 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

Additionally, the following adverse reactions have been reported since the medicine has been marketed:

• upper respiratory tract infections (very common);
• increased tendency to bleed (rare);
• allergic reactions, including rashes, swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing (uncommon);
• changes in behavior and mood [such as strange dreams, including nightmares, sleep disturbances, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behavior or hostility, depression (uncommon), tremor (rare), hallucinations, disorientation, suicidal thoughts and actions (very rare)];
• dizziness, drowsiness, tingling/numbness, seizures (uncommon);
• palpitations (rare);
• diarrhea, nausea, vomiting (common), dry mouth, indigestion (uncommon);
• elevated blood levels of transaminases (ALT, AST) (common), hepatitis (inflammation of the liver) (very rare);
• skin rash (common), bruising, pruritus, urticaria (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), malaise/fatigue, feeling unwell, swelling (uncommon).

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as influenza-like fever, tingling or numbness in the arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported.
Inform your doctor immediately if your child experiences one or more of these symptoms.

Reporting of adverse reactions
If you experience any adverse reaction, contact your doctor or pharmacist. This includes any possible adverse reaction not listed in this leaflet. You can also report adverse reactions directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, 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 stated as the 6 digits following SCAD on the blister. The first two
digits indicate the month, the last four digits indicate the year. The expiry date refers to the last day of the month.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. OTHER INFORMATION

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

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

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

Manufacturer responsible for batch release
MC Pharma AD
Zemliane Str. 35
1618 Sofia
Bulgaria

This medicinal product is authorized in EEA Member States under the following names
DE: Montelukast Hormosan 4 mg Kautabletten
IT: SASLONG 4 mg chewable tablets

This Patient Information Leaflet was last approved on

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

SASLONG 5 mg chewable tablets

For children aged 6 to 14 years
Equivalent medicine
Please read this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 it could be dangerous.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform 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 SASLONG 4MG IS 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. By blocking leukotrienes,
SASLONG improves asthma symptoms and helps control asthma.
Your doctor has prescribed SASLONG for the treatment of asthma, to prevent asthma symptoms during the day and night.

• SASLONG is used for the treatment of patients whose asthma is not adequately controlled with current therapy and who require additional treatment.
• SASLONG may also be used as an alternative to inhaled corticosteroids in children aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and who have shown inability to use inhaled corticosteroids.
• SASLONG also helps prevent exercise-induced narrowing of the airways. Your doctor will determine how to take SASLONG based on the symptoms and severity of asthma in you or your child.

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

• difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers;
• sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or exercise;
• swelling (inflammation) inside the airways. Asthma symptoms include: coughing, shortness of breath, and tightness in the chest.

2. BEFORE TAKING SASLONG

Tell your doctor about any medical conditions or allergies you or your child have ever had.
Do not take SASLONG if you or your child
Are allergic (hypersensitive) to montelukast or to any of the excipients in SASLONG (see section 6,
Other information).

Take special care with SASLONG

• If your asthma or your child's breathing worsens, inform your doctor immediately.
• SASLONG oral is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions your doctor has given you for yourself or for your child. Always carry your emergency inhaled medication for asthma attacks.
• All patients taking anti-asthma medications should be aware that if they develop a combination of symptoms such as influenza-like feverish illness, tingling or numbness in the arms or legs, worsening of lung symptoms, and/or rash, they should consult their 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 aged 2 to 5 years.
SASLONG 5 mg chewable tablets are available for children aged 6 to 14 years.

Taking SASLONG with other medicines
Some medicines may affect the action of SASLONG, or SASLONG may affect the action of other medicines your child is taking.
Inform your doctor or pharmacist if your child is taking or has recently taken any other medicines, including those not requiring a prescription.
Inform your doctor if you or your child is taking any of the following medicines before starting SASLONG:

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

Taking SASLONG with food and drinks
SASLONG 5 mg chewable tablets should not be taken immediately after eating; it should be taken at least one hour before or two hours after food intake.

Pregnancy and breastfeeding
Use during pregnancy
Women who are pregnant or planning to become pregnant should consult their doctor before taking SASLONG. Your doctor will decide whether you may take SASLONG during this time.
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 operating machinery
SASLONG is considered not to affect the ability to drive or operate machinery.
However, individual responses to treatment may vary. Some adverse effects (such as dizziness and drowsiness), which have been reported very rarely with SASLONG, may affect the ability of some patients to drive or operate machinery.

Important information about some excipients in SASLONG
SASLONG chewable tablets contain aspartame, a source of phenylalanine. This may be
harmful for patients with phenylketonuria. If your child has phenylketonuria (a rare inherited metabolic disorder), you should be aware that each 5 mg chewable tablet contains phenylalanine in an amount equivalent to 1.123 mg of phenylalanine per dose.

3. HOW TO TAKE SASLONG

• You or your child must take only one tablet of SASLONG per day as prescribed by the doctor.
• It must be taken even when you or your child has no symptoms or is experiencing an acute asthma attack.
• Always take/give SASLONG exactly as directed by the doctor. If you have any doubts, consult your doctor, your child's doctor, or pharmacist.
• Take by mouth.

For children aged 6 to 14 years:
One 5 mg chewable tablet daily, taken in the evening. SASLONG 5 mg chewable tablets must not be taken immediately after eating; it should be taken at least one hour before or two hours after food.
If you or your child is taking SASLONG, make sure that you or your child do not take other medicines containing the same active substance, montelukast.

If you or your child takes more SASLONG than you/they should
Contact your doctor immediately for advice.
No adverse effects have been reported in most overdose cases. 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 forget to give it to your child
Try to take/give SASLONG as prescribed. However, if you or your child misses a dose, resume 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 stops taking SASLONG
SASLONG can only control your or your child's asthma if taken continuously.
It is important that you or your child continue taking SASLONG for the entire duration prescribed by the doctor. This will help control your or your child's asthma.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, SASLONG may cause adverse reactions, although not everyone experiences them.
In clinical studies with SASLONG 4 mg chewable tablets, the most commonly reported adverse reactions
(occurring in at least 1 in 100 patients and less than 1 in 10 pediatric patients treated) considered to be
attributable to SASLONG were:

• abdominal pain;
• thirst.
  Additionally, the following adverse reaction 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 than in those receiving placebo (a pill containing no active medicinal ingredient).

The frequency of the possible adverse reactions 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

Additionally, since the medicine has been on the market, the following adverse reactions have been reported:

• upper respiratory tract infections (very common);
• increased tendency to bleeding (rare);
• allergic reactions, including rashes, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing and swallowing (uncommon);
• changes in behavior and mood [strange dreams, such as nightmares, sleep disturbances, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behavior or hostility, depression (uncommon), tremor (rare), hallucinations, disorientation, suicidal thoughts and actions (very rare)];
• dizziness, drowsiness, tingling/numbness, seizures (uncommon);
• palpitations (rare);
• diarrhea, nausea, vomiting (common), dry mouth, indigestion (uncommon);
• elevated blood levels of transaminases (ALT, AST) (common), hepatitis (liver inflammation) (very rare);
• skin rash (common), bruising, itching, urticaria (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), malaise/tiredness, feeling unwell, swelling (uncommon).

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as influenza-like fever, tingling or numbness in the arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported.
Inform your doctor immediately if your child experiences one or more of these symptoms.

Reporting of adverse reactions
If you experience any adverse reaction, consult your doctor or pharmacist. This includes any possible adverse reaction not listed in this leaflet. You can also report adverse reactions directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, 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 stated as six digits following "EXP" on the blister. The first two
digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last
day of the month.
Store in the original packaging to protect from light and moisture.
Medicines must 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. PACKAGE LEAFLET INFORMATION

What SASLONG contains
The active substance 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
octenyl succinate), aspartame (E 951) and magnesium stearate.

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

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

Responsible manufacturer for batch release
MC Pharma AD
Zemliane Str 35
1618 Sofia
Bulgaria

This medicinal product is authorized in EEA Member States under the following names
DE: MontelukastHormosan 5mg Kautabletten
IT: SASLONG 5mg compresse masticabili

This package leaflet was last reviewed on

PATIENT LEAFLET: INFORMATION FOR THE USER

SASLONG 10 mg film-coated tablets

For adolescents and adults from 15 years of age
Equivalent medicine
Please 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 others, even if their symptoms are the same as yours, as it could be dangerous.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform 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 SASLONG IS 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 responsible for
allergic symptoms. By blocking leukotrienes, SASLONG improves asthma symptoms, helps control asthma,
and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed SASLONG for the treatment of asthma, to prevent asthma symptoms
during both day and night.

• SASLONG is used for the treatment of adolescents and adults aged 15 years and older who are not adequately controlled with their current therapy and require additional treatment.
• SASLONG also helps prevent exercise-induced narrowing of the airways.
• In those asthmatic 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 you should take SASLONG based on the severity and nature of your asthma symptoms.

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

• difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers.
• sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) inside the airways. Asthma symptoms include: coughing, shortness of breath, and tightness in the chest.

What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal rhinitis) are allergic reactions often caused by airborne pollen from trees and grasses. Symptoms of seasonal allergies usually include a runny, itchy, and blocked nose, as well as swollen, red, watery, and itchy eyes.

2. BEFORE TAKING SASLONG

Inform your doctor of any medical conditions or allergies you have or have had.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicinal product.
Do not take SASLONG if
You are allergic (hypersensitive) to montelukast or to any of the excipients of SASLONG (see 6. Further
information).
Take special care with SASLONG

• If your asthma or breathing worsens, inform your doctor.
• Oral SASLONG 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 inhaled medicine for asthma attacks.
• It is important that you take all asthma medications prescribed by your doctor. SASLONG must not replace other asthma treatments prescribed by your doctor.
• All patients taking anti-asthma medications should be aware that if they develop a combination of symptoms such as influenza-like feverish conditions, tingling or numbness in arms or legs, worsening of pulmonary symptoms, and/or rash, they must consult their doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Use in children
For children aged 2 to 5 years, SASLONG 4 mg chewable tablets are available.
For children aged 6 to 14 years, SASLONG 5 mg chewable tablets are available.
Taking SASLONG with other medicines
Some medicines may affect the action of SASLONG, or SASLONG may affect the action of other
medicines.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those not requiring a prescription.
Inform 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 certain other infections).

Taking SASLONG with food and drink
SASLONG may be taken with or without food.
Pregnancy and breastfeeding
Use during 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 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 considered not to affect the ability to drive or use machines.
However, individual responses to treatment may vary. Some adverse 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 excipients of SASLONG
SASLONG contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her
before taking this medicinal product.

3. HOW TO TAKE SASLONG

• You should take only one tablet of SASLONG once daily as prescribed by your doctor.
• It should be taken even when you do not have symptoms or when you are experiencing an acute asthma attack.
• Always take SASLONG exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• Take orally.

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

If you take more Montelukast than you should
Contact your doctor immediately for advice.
No adverse effects have been reported in most overdose cases. The most frequently reported 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 miss a dose, resume your usual regimen of one film-coated tablet once daily.
Do not take a double dose to make up for the missed dose.

If you stop taking SASLONG
SASLONG can only control your asthma if taken continuously.
It is important that you continue taking SASLONG for the entire duration prescribed by your doctor. This will help control your asthma.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, SASLONG may cause adverse effects, although not everybody experiences them.

In clinical studies with SASLONG 4 mg chewable tablets, the most commonly reported adverse effects (occurring in at least 1 in 100 patients and less than 1 in 10 pediatric patients treated) considered to be attributable to SASLONG were:

• abdominal pain;
• thirst.

Additionally, the following adverse effect has been reported in clinical studies with SASLONG 10 mg film-coated tablets and 5 mg chewable tablets:

• headache.

These were usually mild and occurred more frequently in patients treated with SASLONG than in those treated with placebo (a pill containing no active drug).

The frequency of the possible adverse 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

Additionally, since the medicine has been on the market, the following adverse effects have been reported:

• upper respiratory tract infections (very common);
• increased tendency to bleed (rare);
• allergic reactions, including rashes, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing (uncommon);
• changes in behavior and mood [strange dreams, such as nightmares, sleep disturbances, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behavior or hostility, depression (uncommon), tremor (rare), hallucinations, disorientation, suicidal thoughts and actions (very rare)];
• dizziness, drowsiness, tingling/numbness, seizures (uncommon);
• palpitations (rare);
• diarrhea, nausea, vomiting (common), dry mouth, indigestion (uncommon);
• elevated blood levels of transaminases (ALT, AST) (common), hepatitis (liver inflammation) (very rare);
• skin rash (common), bruising, itching, urticaria (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), malaise/tiredness, feeling unwell, swelling (uncommon).

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as influenza-like fever, tingling or numbness in the arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported.

Inform your doctor immediately if your child experiences one or more of these symptoms.

Reporting of adverse effects
If you notice any adverse effect, talk to your doctor or pharmacist. This includes any possible adverse effect not listed in this leaflet. You can also report adverse effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili
By reporting adverse 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 following SCAD. on the blister. The first two digits indicate the month, the last four digits indicate the year. The expiry date refers to the last day of the month.
• Do not store above 30°C. Store in the original packaging to protect the medicine from light and moisture.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. FURTHER INFORMATION

What SASLONG contains
The active substance 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.
Coating film: black iron oxide (E172), hypromellose, red iron oxide (E172), polyethylene glycol, titanium dioxide (E171), yellow iron oxide (E172), Macrogol (6000).

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

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

Manufacturer responsible for batch release:
MC Pharma AD
Zemliane Str. 35
1618 Sofia
Bulgaria

This medicinal product is authorized in EEA Member States under the following names:
DE: Montelukast Hormosan 10 mg Film Tablets
IT: SASLONG 10 mg film-coated tablets

This leaflet was last approved on