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SINGULAIR PAEDIATRIC 5 MG CHEWABLE TABLETS

Active substance: MONTELUKAST

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FRONT PAGE
T05509

Singulair® PAEDIATRIC 5 mg chewable tablets
(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 yours 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.

• 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.

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

Use in children

1. WHAT SINGULAIR PAEDIATRIC IS
AND WHAT IT IS USED FOR

Taking other medicines
Some medicines may affect how SINGULAIR
Paediatric works, or SINGULAIR Paediatric
may affect how other medicines work.

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.

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.

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.

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: Coughing,
wheezing, and chest tightness.

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.

2. BEFORE YOU
PAEDIATRIC

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).

TAKE

SINGULAIR

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.

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.

3. HOW
TO
PAEDIATRIC

TAKE

SINGULAIR

• 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

BACK PAGE
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. The tablets are to be chewed
before swallowing.
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.
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, sleepwalking,
irritability, feeling anxious, restlessness,
agitation including aggressive behaviour or
hostility, depression (Uncommon); tremor,
disturbance
in
attention,
memory
impairment
(Rare);
hallucinations,
disorientation, suicidal thoughts and
actions (Very rare)]
• dizziness,
drowsiness,
pins
and
needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed
(Uncommon),
swelling
(inflammation) of the lungs (Very rare)
• 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); weakness/tiredness,
feeling unwell, swelling (Uncommon)
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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

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 5mg 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: 14/01/2015
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).

T05509

FRONT PAGE
T05510

MONTELUKAST® PAEDIATRIC 5 mg chewable tablets
(montelukast sodium)

Patient Information Leaflet
This medicine is available as above name but
will be referred to as Montelukast Paediatric
throughout the following:

• 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.

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 yours 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: Coughing,
wheezing, and chest tightness.
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.

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
PAEDIATRIC

TAKE

MONTELUKAST

• 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.

BACK PAGE
• 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. The tablets are to be chewed
before swallowing.
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.
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.

• 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); weakness/tiredness,
feeling unwell, swelling (Uncommon)
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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
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 you have any further questions on the use of
this product, ask your doctor or pharmacist.

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.

4.

6. Further information

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, sleepwalking,
irritability, feeling anxious, restlessness,
agitation including aggressive behaviour or
hostility, depression (Uncommon); tremor,
disturbance
in
attention,
memory
impairment
(Rare);
hallucinations,
disorientation, suicidal thoughts and
actions (Very rare)]
• dizziness,
drowsiness,
pins
and
needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed
(Uncommon),
swelling
(inflammation) of the lungs (Very rare)
• diarrhoea, nausea, vomiting (Common); dry
mouth, indigestion (Uncommon)

What Montelukast Paediatric contains
• The active substance is: montelukast.
Each tablet contains montelukast sodium
which corresponds to 5mg 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
MONTELUKAST engraved on one side, and
MSD 275 on the other.
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: 14/01/2015
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).
T05510

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Source: Medicines and Healthcare Products Regulatory Agency

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