SINGULAIR PAEDIATRIC 5 MG CHEWABLE TABLETS

Active substance: MONTELUKAST

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FRONT PAGE
SINGULAIR® PAEDIATRIC 5 mg chewable tablets

T03785

(montelukast sodium)

Patient Information Leaflet
This medicine is available as above name but
will be referred to as Singulair Paediatric
throughout the following:
Read all of this leaflet carefully before you or
your child start taking this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, please ask
your doctor or pharmacist.
• This medicine has been prescribed for you or
your child. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as your or your child’s.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Singulair Paediatric is and what it is
used for
2. Before you take Singulair Paediatric
3. How to take Singulair Paediatric
4. Possible side effects
5. How to store Singulair Paediatric
6. Further information

1. What Singulair Paediatric is and what it
is used for
Singulair Paediatric is a leukotriene receptor
antagonist that blocks substances called
leukotrienes. Leukotrienes cause narrowing
and swelling of airways in the lungs. By blocking
leukotrienes, Singulair Paediatric improves
asthma symptoms and helps control asthma.
Your doctor has prescribed Singulair Paediatric
to treat asthma, preventing your asthma
symptoms during the day and night.
• Singulair Paediatric is used for the
treatment of patients who are not adequately
controlled on their medication and need
additional therapy.
• Singulair Paediatric may also be used as an
alternative
treatment
to
inhaled
corticosteroids for 6 to 14 year old patients
who have not recently taken oral
corticosteroids for their asthma and have
shown that they are unable to use inhaled
corticosteroids.
• Singulair Paediatric also helps prevent the
narrowing of airways triggered by exercise.
Your doctor will determine how Singulair
Paediatric should be used depending on the
symptoms and severity of you or your child's
asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
• difficulty breathing because of narrowed
airways. This narrowing of airways worsens
and improves in response to various
conditions.
• sensitive airways that react to many things,
such as cigarette smoke, pollen, cold air, or
exercise.
• swelling (inflammation) in the lining of the
airways.
Symptoms of asthma include:
wheezing, and chest tightness.

Coughing,

2. Before you take Singulair Paediatric
Tell your doctor about any medical problems or
allergies you or your child has now or has had.
Do not take Singulair Paediatric if you or
your child
• is allergic (hypersensitive) to montelukast or
any of the other ingredients of Singulair
Paediatric (see 6. Further information).
Take special care with Singulair Paediatric
• If you or your child’s asthma or breathing gets
worse, tell your doctor immediately.
• Oral Singulair Paediatric is not meant to treat
acute asthma attacks. If an attack occurs,
follow the instructions your doctor has given
you or your child. Always have your inhaled
rescue medicine for asthma attacks with you.
• It is important that you or your child take all
asthma medications prescribed by your
doctor. Singulair Paediatric should not be
used instead of other asthma medications
your doctor has prescribed for you or your
child.

• Any patient on anti-asthma medicines should
be aware that if you develop a combination of
symptoms such as flu-like illness, pins and
needles or numbness of arms or legs,
worsening of pulmonary symptoms, and/or
rash, you should consult your doctor.
• You or your child should not take
acetyl-salicylic
acid
(aspirin)
or
anti-inflammatory medicines (also known as
non-steroidal anti-inflammatory drugs or
NSAIDs) if they make your asthma worse.
Use in children
For children 2 to 5 years old, Singulair
Paediatric 4 mg chewable tablets and Singulair
Paediatric 4 mg granules are available.
For children 6 to 14 years old, Singulair
Paediatric 5 mg chewable tablets are available.
Taking other medicines
Some medicines may affect how Singulair
Paediatric works, or Singulair Paediatric may
affect how other medicines work.
Please tell your doctor or pharmacist if you or
your child is taking or has recently taken other
medicines, including those obtained without a
prescription.
Tell your doctor if you or your child is taking the
following medicines before starting Singulair
Paediatric:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and
some other infections)
Taking Singulair Paediatric with food and
drink
Singulair Paediatric 5 mg chewable tablets
should not be taken immediately with food; it
should be taken at least 1 hour before or 2
hours after food.
Pregnancy and breast-feeding
Use in pregnancy
Women who are pregnant or intend to become
pregnant should consult their doctor before
taking Singulair. Your doctor will assess
whether you can take Singulair during this time.
Use in breast-feeding
It is not known if Singulair appears in breast
milk. You should consult your doctor before
taking Singulair if you are breast-feeding or
intend to breast-feed.
Driving and using machines
Singulair is not expected to affect your ability to
drive a car or operate machinery. However,
individual responses to medication may vary.
Certain side effects (such as dizziness and
drowsiness) that have been reported very rarely
with Singulair may affect some patients’ ability
to drive or operate machinery.
Important information about some of the
ingredients of Singulair Paediatric
Singulair Paediatric chewable tablets contain
aspartame, a source of phenylalanine. If your
child has phenylketonuria (a rare, hereditary
disorder of the metabolism) you should take into
account that each Singulair Paediatric 5 mg
chewable tablet contains phenylalanine
(equivalent to 0.842 mg phenylalanine per 5 mg
chewable tablet).

3. How to take Singulair Paediatric
• You or your child should take only one tablet
of Singulair Paediatric once a day as
prescribed by your doctor.
• It should be taken even when you or your
child has no symptoms or has an acute
asthma attack.
• Always take Singulair Paediatric as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
• To be taken by mouth
For children 6 to 14 years of age:
One Singulair Paediatric 5 mg chewable tablet
daily to be taken in the evening. Singulair
Paediatric 5 mg chewable tablets should not be
taken immediately with food; it should be taken
at least 1 hour before or 2 hours after food.
If you or your child is taking Singulair Paediatric,
be sure that you or your child does not take any
other products that contain the same active
ingredient, montelukast.

BACK PAGE
If you or your child takes more Singulair
Paediatric than you should
Contact your doctor immediately for advice.
There were no side effects reported in the
majority of overdose reports. The most
frequently occurring symptoms reported with
overdose in adults and children included
abdominal pain, sleepiness, thirst, headache,
vomiting, and hyperactivity.
If you forget to take Singulair Paediatric or
give Singulair Paediatric to your child
Try to take Singulair Paediatric as prescribed.
However, if you or your child misses a dose, just
resume the usual schedule of one tablet once
daily.
Do not take a double dose to make up for a
forgotten dose.
If you or your child stops taking Singulair
Paediatric
Singulair Paediatric can treat you or your child’s
asthma only if you or your child continues to
take it.
It is important to continue taking Singulair
Paediatric for as long as your doctor prescribes.
It will help control you or your child’s asthma.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Singulair Paediatric can
cause side effects, although not everybody gets
them.
In clinical studies with Singulair Paediatric
5 mg chewable tablets, the most commonly
reported side effects (occurring in at least 1 of
100 patients and less than 1 of 10 paediatric
patients treated) thought to be related to
Singulair Paediatric were:
• headache
Additionally, the following side effect was
reported in clinical studies with Singulair
10 mg film- coated tablets:
• abdominal pain
These were usually mild and occurred at a
greater frequency in patients treated with
Singulair than placebo (a pill containing no
medication).
The frequency of possible side effects listed
below is defined using the following convention:
Very common (affects at least 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Additionally, while the medicine has been on the
market, the following have been reported:
• upper respiratory infection (Very common)
• increased bleeding tendency (Rare)
• allergic reactions including swelling of the
face, lips, tongue, and/or throat which may
cause difficulty in breathing or swallowing
(Uncommon)
• behaviour and mood related changes [dream
abnormalities, including nightmares, trouble
sleeping, sleep walking, irritability, feeling
anxious, restlessness, agitation including
aggressive behaviour or hostility, depression
(Uncommon); tremor (Rare); hallucinations,
disorientation, suicidal thoughts and actions
(Very rare)]
• dizziness,
drowsiness,
pins
and
needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry
mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• rash (Common); bruising, itching, hives
(Uncommon); tender red lumps under the
skin most commonly on your shins
(erythema nodosum), severe skin reactions
(erythema multiforme) that may occur
without warning (Very rare)
• joint or muscle pain, muscle cramps
(Uncommon)
• fever (Common); tiredness, feeling unwell,
swelling (Uncommon)

Ask your doctor or pharmacist for more
information about side effects. If any of the side
effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.

5. How to store Singulair Paediatric
Keep out of the sight and reach of children.
Do not use this medicine after the date shown
by the six numbers following EXP on the blister.
The first two numbers indicate the month; the
last four numbers indicate the year.
This medicine expires at the end of the month
shown.
Store in the original package to protect from
light and moisture.
Do not store above 30°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
If the medicine becomes discoloured or shows
any other signs of deterioration, you should
seek the advice of your doctor or pharmacist
who will tell you what to do.

6. Further information
What Singulair Paediatric contains
• The active substance is: montelukast.
Each tablet contains montelukast sodium
which corresponds to 5 mg of montelukast.
• The other ingredients are:
microcrystalline cellulose, croscarmellose
sodium, magnesium stearate, red iron oxide
(E172), mannitol, hyprolose, cherry flavour
and aspartame (E951).
What Singulair Paediatric looks like and
contents of the pack
The tablets are pink, round, biconvex with
SINGULAIR engraved on one side, and MSD
275 on the other.
Singulair Paediatric comes in blister packs of
28 tablets.
Manufacturer and Product Licence Holder
Singulair Paediatric is manufactured by Merck
Sharp & Dohme BV, Waarderweg 39, Haarlem,
2031 BN, The Netherlands. It is procured from
within the EU by the Product Licence Holder:
Swinghope Limited, Brandon House, Marlowe
Way, Croydon CR0 4XS and repackaged by
Interport Limited, Brandon House, Marlowe
Way, Croydon CR0 4XS.
POM
PL No: 10380/1435
Leaflet revision date: 05/10/12
Singulair® is a registered trademark of Merck &
Co., Inc., USA.
Information is given by:
In UK:
Asthma UK, Providence House,
Providence
Place,
London
N1
ONT.
Alternatively phone the Asthma UK Adviceline
on 08457 010203, Monday to Friday 9 am to
5 pm, calls charged at local rate.
In Ireland: The Asthma Society of Ireland,
Eden House, 15-17 Eden Quay, Dublin 1.
Alternatively phone The Asthma Live Line on
01 8788122, Monday, Wednesday, Thursday
10am to 1pm, or 01 8788511 9am to 5pm, or
The Asthma Line on callsave 1850 44 5464.
(The Asthma UK and The Asthma Society of
Ireland are independent charities working to
conquer asthma and are not associated with
Merck Sharp & Dohme Limited or Swinghope
Limited.)

In asthmatic patients treated with montelukast,
very rare cases of a combination of symptoms
such as flu-like illness, pins and needles or
numbness of arms and legs, worsening of
pulmonary
symptoms
and/or
rash
(Churg-Strauss syndrome) have been reported.
You must tell your doctor right away if you get
one or more of these symptoms.

T03785

FRONT PAGE
MONTELUKAST PAEDIATRIC 5 mg chewable tablets

T03786

(montelukast sodium)

Patient Information Leaflet
This medicine is available as above name but
will be referred to as Montelukast Paediatric
throughout the following:
Read all of this leaflet carefully before you or
your child start taking this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, please ask
your doctor or pharmacist.
• This medicine has been prescribed for you or
your child. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as your or your child’s.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Montelukast Paediatric is and what it
is used for
2. Before you take Montelukast Paediatric
3. How to take Montelukast Paediatric
4. Possible side effects
5. How to store Montelukast Paediatric
6. Further information

1. What Montelukast Paediatric is and
what it is used for
Montelukast Paediatric is a leukotriene receptor
antagonist that blocks substances called
leukotrienes. Leukotrienes cause narrowing
and swelling of airways in the lungs. By blocking
leukotrienes, Montelukast Paediatric improves
asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast
Paediatric to treat asthma, preventing your
asthma symptoms during the day and night.
• Montelukast Paediatric is used for the
treatment of patients who are not adequately
controlled on their medication and need
additional therapy.
• Montelukast Paediatric may also be used as
an alternative treatment to inhaled
corticosteroids for 6 to 14 year old patients
who have not recently taken oral
corticosteroids for their asthma and have
shown that they are unable to use inhaled
corticosteroids.
• Montelukast Paediatric also helps prevent
the narrowing of airways triggered by
exercise.
Your doctor will determine how Montelukast
Paediatric should be used depending on the
symptoms and severity of you or your child's
asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
• difficulty breathing because of narrowed
airways. This narrowing of airways worsens
and improves in response to various
conditions.
• sensitive airways that react to many things,
such as cigarette smoke, pollen, cold air, or
exercise.
• swelling (inflammation) in the lining of the
airways.
Symptoms of asthma include:
wheezing, and chest tightness.

Coughing,

2. Before you take Montelukast Paediatric
Tell your doctor about any medical problems or
allergies you or your child has now or has had.
Do not take Montelukast Paediatric if you or
your child
• is allergic (hypersensitive) to Montelukast or
any of the other ingredients of Montelukast
Paediatric (see 6. Further information).
Take special care with Montelukast
Paediatric
• If you or your child’s asthma or breathing gets
worse, tell your doctor immediately.
• Oral Montelukast Paediatric is not meant to
treat acute asthma attacks. If an attack
occurs, follow the instructions your doctor
has given you or your child. Always have
your inhaled rescue medicine for asthma
attacks with you.
• It is important that you or your child take all
asthma medications prescribed by your
doctor. Montelukast Paediatric should not be
used instead of other asthma medications
your doctor has prescribed for you or your
child.

• Any patient on anti-asthma medicines should
be aware that if you develop a combination of
symptoms such as flu-like illness, pins and
needles or numbness of arms or legs,
worsening of pulmonary symptoms, and/or
rash, you should consult your doctor.
• You or your child should not take
acetyl-salicylic
acid
(aspirin)
or
anti-inflammatory medicines (also known as
non-steroidal anti-inflammatory drugs or
NSAIDs) if they make your asthma worse.
Use in children
For children 2 to 5 years old, Montelukast
Paediatric 4 mg chewable tablets and
Montelukast Paediatric 4 mg granules are
available.
For children 6 to 14 years old, Montelukast
Paediatric 5 mg chewable tablets are available.
Taking other medicines
Some medicines may affect how Montelukast
Paediatric works, or Montelukast Paediatric
may affect how other medicines work.
Please tell your doctor or pharmacist if you or
your child is taking or has recently taken other
medicines, including those obtained without a
prescription.
Tell your doctor if you or your child is taking the
following medicines before starting Montelukast
Paediatric:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and
some other infections)
Taking Montelukast Paediatric with food and
drink
Montelukast Paediatric 5 mg chewable tablets
should not be taken immediately with food; it
should be taken at least 1 hour before or 2
hours after food.
Pregnancy and breast-feeding
Use in pregnancy
Women who are pregnant or intend to become
pregnant should consult their doctor before
taking Montelukast. Your doctor will assess
whether you can take Montelukast during this
time.
Use in breast-feeding
It is not known if Montelukast appears in breast
milk. You should consult your doctor before
taking Montelukast if you are breast-feeding or
intend to breast-feed.
Driving and using machines
Montelukast is not expected to affect your ability
to drive a car or operate machinery. However,
individual responses to medication may vary.
Certain side effects (such as dizziness and
drowsiness) that have been reported very rarely
with Montelukast may affect some patients’
ability to drive or operate machinery.
Important information about some of the
ingredients of Montelukast Paediatric
Montelukast Paediatric chewable tablets
contain aspartame, a source of phenylalanine.
If your child has phenylketonuria (a rare,
hereditary disorder of the metabolism) you
should take into account that each Montelukast
Paediatric 5 mg chewable tablet contains
phenylalanine
(equivalent
to
0.842 mg
phenylalanine per 5 mg chewable tablet).

3. How to take Montelukast Paediatric
• You or your child should take only one tablet
of Montelukast Paediatric once a day as
prescribed by your doctor.
• It should be taken even when you or your
child has no symptoms or has an acute
asthma attack.
• Always take Montelukast Paediatric as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
• To be taken by mouth
For children 6 to 14 years of age:
One Montelukast Paediatric 5 mg chewable
tablet daily to be taken in the evening.
Montelukast Paediatric 5 mg chewable tablets
should not be taken immediately with food; it
should be taken at least 1 hour before or 2
hours after food.
If you or your child is taking Montelukast
Paediatric, be sure that you or your child does
not take any other products that contain the
same active ingredient, montelukast.

BACK PAGE
If you or your child takes more Montelukast
Paediatric than you should
Contact your doctor immediately for advice.
There were no side effects reported in the
majority of overdose reports. The most
frequently occurring symptoms reported with
overdose in adults and children included
abdominal pain, sleepiness, thirst, headache,
vomiting, and hyperactivity.
If you forget to take Montelukast Paediatric
or give Montelukast Paediatric to your child
Try to take Montelukast Paediatric as
prescribed. However, if you or your child misses
a dose, just resume the usual schedule of one
tablet once daily.
Do not take a double dose to make up for a
forgotten dose.
If you or your child stops taking Montelukast
Paediatric
Montelukast Paediatric can treat you or your
child’s asthma only if you or your child
continues to take it.
It is important to continue taking Montelukast
Paediatric for as long as your doctor prescribes.
It will help control you or your child’s asthma.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Montelukast Paediatric can
cause side effects, although not everybody gets
them.
In clinical studies with Montelukast Paediatric
5 mg chewable tablets, the most commonly
reported side effects (occurring in at least 1 of
100 patients and less than 1 of 10 paediatric
patients treated) thought to be related to
Montelukast Paediatric were:
• headache
Additionally, the following side effect was
reported in clinical studies with Montelukast
10 mg film- coated tablets:
• abdominal pain
These were usually mild and occurred at a
greater frequency in patients treated with
Montelukast than placebo (a pill containing no
medication).
The frequency of possible side effects listed
below is defined using the following convention:
Very common (affects at least 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Additionally, while the medicine has been on the
market, the following have been reported:
• upper respiratory infection (Very common)
• increased bleeding tendency (Rare)
• allergic reactions including swelling of the
face, lips, tongue, and/or throat which may
cause difficulty in breathing or swallowing
(Uncommon)
• behaviour and mood related changes [dream
abnormalities, including nightmares, trouble
sleeping, sleep walking, irritability, feeling
anxious, restlessness, agitation including
aggressive behaviour or hostility, depression
(Uncommon); tremor (Rare); hallucinations,
disorientation, suicidal thoughts and actions
(Very rare)]
• dizziness,
drowsiness,
pins
and
needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry
mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• rash (Common); bruising, itching, hives
(Uncommon); tender red lumps under the
skin most commonly on your shins
(erythema nodosum), severe skin reactions
(erythema multiforme) that may occur
without warning (Very rare)
• joint or muscle pain, muscle cramps
(Uncommon)
• fever (Common); tiredness, feeling unwell,
swelling (Uncommon)

Ask your doctor or pharmacist for more
information about side effects. If any of the side
effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.

5. How to store Montelukast Paediatric
Keep out of the sight and reach of children.
Do not use this medicine after the date shown
by the six numbers following EXP on the blister.
The first two numbers indicate the month; the
last four numbers indicate the year.
This medicine expires at the end of the month
shown.
Store in the original package to protect from
light and moisture.
Do not store above 30°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
If the medicine becomes discoloured or shows
any other signs of deterioration, you should
seek the advice of your doctor or pharmacist
who will tell you what to do.

6. Further information
What Montelukast Paediatric contains
• The active substance is: montelukast.
Each tablet contains montelukast sodium
which corresponds to 5 mg of montelukast.
• The other ingredients are:
microcrystalline cellulose, croscarmellose
sodium, magnesium stearate, red iron oxide
(E172), mannitol, hyprolose, cherry flavour
and aspartame (E951).
What Montelukast Paediatric looks like and
contents of the pack
The tablets are pink, round, biconvex with
SINGULAIR engraved on one side, and MSD
275 on the other.
Montelukast Paediatric comes in blister packs
of 28 tablets.
Manufacturer and Product Licence Holder
Montelukast Paediatric is manufactured by
Merck Sharp & Dohme BV, Waarderweg 39,
Haarlem, 2031 BN, The Netherlands. It is
procured from within the EU by the Product
Licence Holder: Swinghope Limited, Brandon
House, Marlowe Way, Croydon CR0 4XS and
repackaged by Interport Limited, Brandon
House, Marlowe Way, Croydon CR0 4XS.
POM
PL No: 10380/1435
Leaflet revision date: 05/10/12
Information is given by:
In UK:
Asthma UK, Providence House,
Providence
Place,
London
N1
ONT.
Alternatively phone the Asthma UK Adviceline
on 08457 010203, Monday to Friday 9 am to 5
pm, calls charged at local rate.
In Ireland: The Asthma Society of Ireland,
Eden House, 15-17 Eden Quay, Dublin 1.
Alternatively phone The Asthma Live Line on
01 8788122, Monday, Wednesday, Thursday
10am to 1pm, or 01 8788511 9am to 5pm, or
The Asthma Line on callsave 1850 44 5464.
(The Asthma UK and The Asthma Society of
Ireland are independent charities working to
conquer asthma and are not associated with
Merck Sharp & Dohme Limited or Swinghope
Limited.)

In asthmatic patients treated with Montelukast,
very rare cases of a combination of symptoms
such as flu-like illness, pins and needles or
numbness of arms and legs, worsening of
pulmonary
symptoms
and/or
rash
(Churg-Strauss syndrome) have been reported.
You must tell your doctor right away if you get
one or more of these symptoms.

T03786

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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