Montelukast Doc Generici: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST DOC 4 mg chewable tablets

Generic Medicine
For children from 2 to 5 years of age
Please read this leaflet carefully before your child starts taking this medicine
because it contains important information for him/her.
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 only. Do not give it to others,
even if their symptoms are the same as your child's, as it could be harmful.
If your child experiences any side effect, including those not listed in
this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:

What MONTELUKAST DOC is and what it is used for
What you need to know before taking MONTELUKAST DOC
How to take MONTELUKAST DOC
Possible side effects
How to store MONTELUKAST DOC
Contents of the pack and other information

1. What MONTELUKAST DOC is and what it is used for

MONTELUKAST DOC is a leukotriene receptor antagonist that blocks substances known as leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, MONTELUKAST DOC improves asthma symptoms and helps control the condition.
Your doctor has prescribed MONTELUKAST DOC for the treatment of your child's asthma to prevent asthma symptoms both during the day and at night.

MONTELUKAST DOC is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medications and require additional therapy.
MONTELUKAST DOC 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 shown inability to use inhaled corticosteroids.
MONTELUKAST DOC also prevents exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use MONTELUKAST DOC 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. Airway narrowing worsens and improves in response to various triggers.
Airway sensitivity to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
Swelling (inflammation) of the airways. Asthma symptoms include coughing, shortness of breath, and chest tightness.

2. What you should know before taking MONTELUKAST DOC

Inform your doctor about any illness or allergy your child currently has or has had in the past.
Do not give MONTELUKAST DOC 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.
MONTELUKAST DOC for oral use must not be used to treat acute asthma attacks.
If an asthma attack occurs, follow your doctor's instructions. Always keep your child's rescue
inhaled medications readily available for asthma attacks.
It is important that your child takes all asthma medications prescribed by the doctor.
MONTELUKAST DOC must not be used instead of other asthma medications prescribed by your
doctor for your child.
Every patient being treated with asthma medications should know that if they experience a
combination of symptoms such as flu-like symptoms, tingling or numbness in the arms or legs,
worsening of pulmonary symptoms and/or skin redness, they should consult their doctor.
Patients should be aware that various neuropsychiatric events (for example, changes in behaviour
and mood) have been reported in adults, adolescents and children treated with MONTELUKAST DOC
(see section 4). If you or your child develops these symptoms during treatment with MONTELUKAST DOC,
you should consult your child's doctor.
Your child should 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.

Children
For children between 2 and 5 years of age, MONTELUKAST DOC 4 mg chewable tablets are available.
For children between 6 and 14 years of age, MONTELUKAST DOC 5 mg chewable tablets are available.
The safety and efficacy of MONTELUKAST DOC 4 mg chewable tablets in children under 2 years of age
have not been established.

Other medicines and MONTELUKAST DOC
Some medicines may interfere with the action of MONTELUKAST DOC, or MONTELUKAST DOC may
interfere with the action of other medicines.
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other
medicines.
Before starting to take MONTELUKAST DOC, inform your doctor if your child is taking any of the
following medicines:
phenobarbital (used to treat epilepsy)
phenytoin (used to treat epilepsy)
rifampicin (used to treat tuberculosis and certain other infections)

MONTELUKAST DOC with food and drink
MONTELUKAST DOC 4 mg chewable tablets should not be taken immediately with meals; they should
be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding
This section is not relevant because MONTELUKAST DOC 4 mg chewable tablets are intended for use
in children aged 2 to 5 years. However, the information below refers to the active substance, montelukast.
Use during pregnancy
Limited data available from pregnancy do not suggest a causal relationship between montelukast and
the rare limb malformations (birth defects) reported in worldwide post-marketing experience.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine.
Use during breastfeeding
It is not known whether montelukast passes into breast milk. If you are breastfeeding or intend to breastfeed,
you should consult your doctor before taking montelukast.

Driving and using machines
This section is not relevant because MONTELUKAST DOC 4 mg chewable tablets are intended for use
in children aged 2 to 5 years. However, the information below refers to the active substance, montelukast.
No effects on the ability to drive vehicles or use machines are expected. Individual responses to medicines
may, however, vary. Some side effects (such as dizziness and somnolence), which have been reported very
rarely with montelukast, may affect the ability of some patients to drive vehicles and use machinery.

MONTELUKAST DOC 4 mg chewable tablets contain aspartame (E 951).
This medicine contains 0.24 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine.
It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine
due to the body's inability to metabolize it properly.

MONTELUKAST DOC 4 mg chewable tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, i.e. essentially ‘sodium-free’.

3. How to take MONTELUKAST DOC

This medicine should be administered to the child under the supervision of an adult. For children who have difficulty taking a chewable tablet, a granular formulation is available.
Your child must take only one tablet of MONTELUKAST DOC daily, as prescribed by your doctor.
The tablet should be taken even if the child has no symptoms or is experiencing an acute asthma attack.
Always give MONTELUKAST DOC to your child exactly as directed by the doctor. If you have any doubts, consult your doctor or pharmacist.
To be taken by mouth.
For children aged 2 to 5 years:
One 4 mg chewable tablet of MONTELUKAST DOC to be taken daily in the evening.
MONTELUKAST DOC 4 mg chewable tablets should not be taken immediately before or after meals. It should be taken at least 1 hour before or 2 hours after meals.
If your child is taking MONTELUKAST DOC, make sure they do not take other medicines containing the same active substance, montelukast.
If your child takes more MONTELUKAST DOC than they should
Contact your doctor immediately.
In most reports of overdose, no adverse effects have been observed. The most commonly reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
If you forget to give MONTELUKAST DOC to your child
Try to give MONTELUKAST DOC to your child as prescribed. However, if your child misses a dose, resume the usual schedule of one tablet daily.
Do not give your child a double dose to make up for the missed tablet.
If your child stops treatment with MONTELUKAST DOC
Treatment with MONTELUKAST DOC can be effective against asthma only if your child continues taking it. It is important that your child continues to take MONTELUKAST DOC for as long as your doctor has prescribed. This will help control your child's asthma. If you have any questions about using MONTELUKAST DOC, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with 4 mg montelukast chewable tablets, the side effects considered related to the use of the medicine most commonly reported (occurring in at least 1 in 100 patients and in fewer than 1 in 10 patients treated) were:
Abdominal pain
Thirst

Furthermore, the following side effect was 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 montelukast than in those treated with placebo (a tablet containing no active medicine).

The frequency of the possible side effects listed below is defined using the following convention:
Very common (affects at least 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects fewer than 1 in 10,000 people)

Additionally, the following side effects have been reported during the post-marketing use of the medicine:

Upper respiratory tract infection (very common)
Increased tendency to bleeding (rare)
Allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing (uncommon)
Behavioural and mood-related changes (altered dream content, including nightmares, restless sleep, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression (uncommon), tremor (rare), hallucinations, disorientation, suicidal thoughts and actions, stuttering (very rare)
Dizziness, drowsiness, tingling/numbness, seizures (uncommon)
Palpitations (rare)
Nosebleeds (uncommon)
Dry mouth, digestive disturbances (uncommon), diarrhoea, nausea, vomiting (common)
Hepatitis (inflammation of the liver) (very rare)
Rash (common), bruising, itching and urticaria (uncommon), painful red swellings under the skin, most commonly on the front of the legs (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning (very rare)
Joint or muscle pain, muscle cramps (uncommon)
Weakness/tiredness, malaise (uncommon), swelling, fever (common)

During treatment of asthmatic patients with montelukast, a combination of symptoms including flu-like illness, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) has been reported in very rare cases. You must inform your doctor immediately if your child experiences 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 www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MONTELUKAST DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Store the medicine in its original packaging to protect it from light and moisture.
Do not dispose of medicines 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 contents and other information

What MONTELUKAST DOC contains
The active substance is montelukast.
Each tablet of MONTELUKAST DOC 4 mg chewable tablets contains montelukast
sodium corresponding to 4 mg of montelukast.
The other components are:
Mannitol, microcrystalline cellulose, hypromellose (E 463), red iron oxide (E172),
sodium croscarmellose, cherry flavour (composed of: maltodextrin, gum arabic,
anisaldehyde, benzaldehyde, cinnamaldehyde, vanillin, heliotropine, ionones), aspartame (E 951), and
magnesium stearate.

Description of the appearance of MONTELUKAST DOC and pack contents
The MONTELUKAST DOC 4 mg chewable tablets are pink, oval-shaped, biconvex tablets.
Blister packs in pack sizes of: 7, 28, 30, 56 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici Srl
Via Turati 40
20121 Milan
Italy

Manufacturer:
Pharmathen S.A, 6 Dervenakion str., Pallini Attiki, 15351 Greece
Mylan bvba/sprl, Terhulpsesteenweg 6A, B-1560 Hoeilaart, Belgium

This instruction leaflet was last approved on
PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST DOC 5 mg chewable tablets

Generic Medicine
For children aged 6 to 14 years
Please read this leaflet carefully before your child starts taking this medicine, as it
contains important information for him/her.
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 only. Do not give it to other people, even if
their symptoms are the same as your child's, as it could be harmful.
If your child experiences any side effects, including those not listed in this leaflet, consult
your doctor or pharmacist. See section 4.
Contents of this leaflet:

What MONTELUKAST DOC is and what it is used for
What you need to know before taking MONTELUKAST DOC
How to take MONTELUKAST DOC
Possible side effects
How to store MONTELUKAST DOC
Contents of the pack and other information

1. What is MONTELUKAST DOC and what is it used for

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

MONTELUKAST DOC is used to treat patients aged 6 to 14 years whose asthma is not adequately controlled with their current medications and who require additional therapy.
MONTELUKAST DOC 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.
MONTELUKAST DOC also prevents exercise-induced narrowing of the airways in patients from 2 years of age onwards.

Your doctor will determine how to use MONTELUKAST DOC based on your child's symptoms and the severity of their asthma.
What is asthma?
Asthma is a long-term condition.
Asthma includes:

Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
Airway hyperreactivity to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
Swelling (inflammation) of the airways. Asthma symptoms include coughing, shortness of breath, and chest tightness.

2. What you need to know before taking MONTELUKAST DOC

Inform your doctor about any illness or allergy you or your child currently have or have had in the past.
Do not use MONTELUKAST DOC 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 or your child's asthma or breathing worsens, contact your doctor immediately.
MONTELUKAST DOC for oral use must not be used to treat acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always keep your child's rescue inhaled medications for asthma attacks with you.
It is important that you or your child take all asthma medications prescribed by the doctor.
MONTELUKAST DOC must not be used instead of other asthma medications prescribed by your doctor for you or your child.
Every patient being treated with asthma medications should know that if they experience a combination of symptoms such as flu-like illness, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin redness, they must consult their doctor.
Patients should be aware that various neuropsychiatric events (e.g., changes in behavior and mood) have been reported in adults, adolescents, and children treated with MONTELUKAST DOC (see section 4). If you or your child develops these symptoms during treatment with MONTELUKAST DOC, you must consult your child's doctor.
You or 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 your asthma.

Children and adolescents
MONTELUKAST DOC 4 mg chewable tablets are available for children aged 2 to 5 years.
MONTELUKAST DOC 5 mg chewable tablets are available for children aged 6 to 14 years.
The safety and efficacy of MONTELUKAST DOC chewable tablets in children under 2 years of age have not been established.

Other medicines and MONTELUKAST DOC
Some medicines may interfere with the action of MONTELUKAST DOC, or MONTELUKAST DOC 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.
Before starting to take MONTELUKAST DOC, inform your doctor if you or your child are taking any of the following medicines:
phenobarbital (used to treat epilepsy)
phenytoin (used to treat epilepsy)
rifampicin (used to treat tuberculosis and certain other infections)

MONTELUKAST DOC with food and drinks
MONTELUKAST DOC 5 mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding
Use during pregnancy
Limited data available from pregnancy do not suggest a causal relationship between montelukast and the rare limb malformations (birth defects) occasionally reported in worldwide post-marketing experience. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Use during breastfeeding
It is not known whether montelukast is excreted in breast milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking MONTELUKAST DOC.

Driving and using machines
MONTELUKAST DOC should not affect the ability to drive or operate machinery. However, individual responses to medicines may vary. Some side effects (such as dizziness and drowsiness), although reported very rarely with montelukast, may affect the ability to drive and operate machinery.

MONTELUKAST DOC 5 mg chewable tablets contain aspartame (E 951).
This medicine contains 0.30 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.

MONTELUKAST DOC 5 mg chewable tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, i.e. essentially 'sodium-free'.

3. How to take MONTELUKAST DOC

This medicine should be administered to the child under the supervision of an adult. For children who have difficulty taking a chewable tablet, a granule formulation is available.
Your child must take only one tablet of MONTELUKAST DOC daily, as prescribed by the doctor.
The tablet must be taken even if the child has no symptoms or is experiencing an acute asthma attack.
Always give MONTELUKAST DOC to your child exactly as directed by the doctor. If you have any doubts, consult your doctor or pharmacist.
For oral use.
For children aged 6 to 14 years:
One 5 mg chewable tablet of MONTELUKAST DOC to be taken once daily in the evening.
MONTELUKAST DOC 5 mg chewable tablets must not be taken immediately before or after meals. It should be taken at least 1 hour before or 2 hours after meals.
If you or your child are taking MONTELUKAST DOC, make sure that you do not take other medicines containing the same active substance, montelukast.
If you or your child take more MONTELUKAST DOC than you should
Contact your doctor immediately.
In most reports of overdose, no adverse effects were observed. The most frequently reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take MONTELUKAST DOC or forget to give it to your child
Try to take or give MONTELUKAST DOC to your child as prescribed. However, if you or your child miss a dose, resume the usual schedule of one tablet per day.
Do not take or give a double dose to make up for the missed tablet.
If you or your child stop taking MONTELUKAST DOC
Treatment with MONTELUKAST DOC will only be effective against asthma if you or your child continue taking it. It is important that you or your child continue taking MONTELUKAST DOC for as long as your doctor has prescribed. This will help control your asthma. If you have any further questions about the use of MONTELUKAST DOC, consult 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 5 mg montelukast chewable tablets, the most commonly reported side effects considered related to the use of the medicine were:

Headache

Additionally, the following side effect was reported in clinical studies with 10 mg montelukast film-coated tablets:

Abdominal pain

These side effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active ingredient).

The frequency of the possible side effects listed below is defined according to the following convention:

Very common (affects at least 1 in 10 people)
Common (affects from 1 to 10 in 100 people)
Uncommon (affects from 1 to 10 in 1,000 people)
Rare (affects from 1 to 10 in 10,000 people)
Very rare (affects fewer than 1 in 10,000 people)

Additionally, the following side effects have been reported during post-marketing use of the medicine:

Upper respiratory tract infection (very common)
Increased tendency to bleeding (rare)
Allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing (uncommon)
Changes in behaviour and mood (changes in dream content, including nightmares, restless sleep, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression (uncommon), tremor (rare), hallucinations, disorientation, suicidal thoughts and actions, stuttering (very rare))
Dizziness, drowsiness, tingling/numbness, seizures (uncommon)
Palpitations (rare)
Nosebleed (uncommon)
Dry mouth, digestive disorders (uncommon), diarrhoea, nausea, vomiting (common)
Hepatitis (inflammation of the liver) (very rare)
Rash (common), bruising, itching and urticaria (uncommon), painful red swellings under the skin, most commonly on the front of the legs (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning (very rare)
Joint or muscle pain, muscle cramps (uncommon)
Weakness/tiredness (uncommon), malaise, swelling, fever (common)

During treatment of asthmatic patients with montelukast, in very rare cases, a combination of symptoms has been reported, including flu-like illness, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome). You must inform your doctor immediately if you or your child experiences 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 at www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MONTELUKAST DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Store the medicine 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What MONTELUKAST DOC contains
The active substance is montelukast.
Each tablet of MONTELUKAST DOC 5 mg chewable tablets contains sodium montelukast equivalent to 5 mg of montelukast.
The other components are:
Mannitol, microcrystalline cellulose, hypromellose (E 463), red iron oxide (E172), croscarmellose sodium,
cherry flavour (composed of: maltodextrin, gum arabic, anisaldehyde, benzaldehyde,
cinnamaldehyde, vanillin, piperonal, ionones), aspartame (E 951), and magnesium stearate.
Description of the appearance of MONTELUKAST DOC and package contents
The MONTELUKAST DOC 5 mg chewable tablets are pink-coloured, round, biconvex tablets.
Blister packs in pack sizes of: 7, 28, 30, 56 and 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici Srl
Via Turati 40
20121 Milano
Italy
Manufacturer:
Pharmathen S.A., 6 Dervenakion str., Pallini Attiki, 15351 Greece
Mylan bvba/sprl, Terhulpsesteenweg 6A, B-1560 Hoeilaart, Belgium
This patient information leaflet was last approved on