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ZAFIRLUKAST 20MG FILM-COATED TABLETS

Active substance(s): ZAFIRLUKAST / ZAFIRLUKAST / ZAFIRLUKAST

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Package leaflet: Information for the user

Accolate® 20mg film-coated tablets
(zafirlukast)

Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
Keep this leaflet. You may need
to read it again.
If you have any further
questions, ask your doctor or
pharmacist.
This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of
illness are the same as yours.
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
See section 4.
The name of your medicine is Accolate®
20mg film-coated tablets but will be
referred to as Accolate throughout this
leaflet.
What is in this leaflet:
1. What Accolate is and what it is
used for
2. What you need to know before
you take Accolate
3. How to take Accolate
4. Possible side effects
5. How to store Accolate
6. Contents of the pack and other
information

1. What Accolate is and what
it is used for
Accolate contains a medicine called
zafirlukast. This belongs to a group
of medicines called ‘leukotriene
antagonists’. This means that it
reduces the effects of ‘leukotrienes’.
These are natural substances in the
lung that cause asthma.
Accolate is used to control the
symptoms of your asthma.
It is also used to prevent your
asthma from getting worse.
Do not take Accolate to treat sudden
(acute) asthma attacks. Your doctor
will provide you with other medicines
to treat sudden attacks.

2. What you need to know
before you take Accolate
Do not take Accolate if:
If you are allergic to zafirlukast or
any of the other ingredients of
this medicine (listed in Section
6).
If you have ever had problems
with your liver.
If you have had problems with
your liver that were caused by
taking Accolate.
Do not take Accolate if any of the
above applies to you. If you are not
sure, talk to your doctor or
pharmacist before taking this
medicine.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Accolate:
If you are a smoker. This could
affect the amount of Accolate
that you need to take.
If you have kidney problems.
If you are not sure if the above apply
to you, talk to your doctor or
pharmacist before taking Accolate.
If you go into hospital let the medical
staff know that you are taking
Accolate.
Children
Accolate should not be given to
children under the age of 12 years.
Other medicines and Accolate
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines. This
includes medicines that you buy
without a prescription and herbal
medicines. This is because Accolate
can affect the way some medicines
work and some medicines can have
an effect on Accolate.
In particular, tell your doctor or
pharmacist if you are taking any of
the following medicines:
Theophylline (used to treat
asthma).
Erythromycin (an antibiotic).
Terfenadine (used to treat
hayfever).
Warfarin (used to thin the blood).
Aspirin (if you are taking it
frequently as a painkiller).
Fluconazole (used to treat fungal
infections).

Pregnancy and breast-feeding
If you are pregnant, think you
may be pregnant or are planning
to have a baby, ask your doctor
for advice before taking this
medicine. Your doctor will decide
whether you can take Accolate
during this time.
Do not take Accolate if you are
breast-feeding.
Driving and using machines
Accolate is not likely to affect you
being able to drive or use any tools
or machines.
Accolate contains lactose
Accolate contains lactose, which is a
type of sugar. If you have been told
by your doctor that you cannot
tolerate or digest some sugars (have
an intolerance to some sugars), talk
to your doctor before taking this
medicine.

3. How to take Accolate
Always take this medicine exactly as
your doctor has told you. Read the
label on the container to remind you
what the doctor said. Check with
your doctor or pharmacist if you are
not sure.
If you have been taking other
medicines for asthma, do not stop
taking them unless your doctor tells
you that you can.
Taking this medicine
Take Accolate every day as
prescribed by your doctor.
The recommended dose is one
20mg tablet taken twice a day.
This is usually one tablet at the
start of the morning and one
tablet last thing at night.
Try to take your medicine at the
same times each day.
Swallow each tablet whole with a
drink of water.
Do not take your tablets with a
meal.
Continue to take Accolate even
when your asthma is not causing
you any problems.
Do not stop taking your tablets
when you are feeling well, unless
your doctor tells you to.
If your asthma gets worse while you
are taking Accolate, follow the advice
that your doctor has given you for
treating sudden (acute) asthma
attacks and see your doctor as soon
as possible.
If you take more Accolate than
you should
If you take more Accolate than
prescribed by your doctor, ask your
doctor or pharmacist for advice.
If you forget to take Accolate
If you forget to take a dose, take
it as soon as you remember.
However, if it is nearly time for
the next dose, skip the missed
dose.
Do not take a double dose (two
doses at the same time) to make
up for a forgotten dose.

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them. The following
side effects can happen with this
medicine.
Allergic reactions (uncommon, may
affect up to 1 in 100 people)
The signs include:
Skin rash and itching.
Swelling around your lips, face,
tongue and throat.
If any of these happen, stop taking
Accolate and tell your doctor
straight away.
Liver problems
Accolate may affect your liver. These
liver effects range from non-serious
increases in liver enzymes
(common, may affect up to 1 in 10
people) detected by blood tests to
serious conditions such as liver
failure (very rare, may affect up to
1 in 10,000 people). A very small
number of people have died from
liver failure.
Your doctor may ask you to have
blood tests before and during
treatment with Accolate to check
whether there are any problems with
your liver.
The signs of liver problems include:
Yellowing of your skin or the
whites of your eyes (jaundice).

Pain on the right side of your
stomach and just below your
ribs.
Loss of appetite.
Feeling itchy.
Feeling tired, having no energy
or feeling like you have flu.
Feeling as though you are going
to be sick or actually being sick.

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.

6. Contents of the pack and
other Information

If any of these happen, stop taking
Accolate and tell your doctor
straight away.

What Accolate contains:
The active ingredient in Accolate is
zafirlukast.

Infection (very common, may affect
more than 1 in 10 people.)
The signs include:
A high temperature (fever) that
does not go away.
Frequent sore throats.

Each film-coated tablet contains
20mg zafirlukast.

If any of these happen, tell your
doctor.

The other ingredients are
croscarmellose sodium, lactose
monohydrate, microcrystalline
cellulose, povidone, magnesium
stearate, hypromellose and titanium
dioxide (E171).

Bleeding problems (rare, may
affect up to 1 in 1,000 people)
The signs include:
Bleeding disorders, including
heavy menstrual periods.
Low platelet count (symptoms
include bleeding or bruising
more easily than normal).

What Accolate looks like and
contents of the pack
Accolate is white, round, biconvex,
film-coated tablets intagliated with
'Accolate 20' on one side and plain on
the reverse.
Accolate is available as calendar
blister packs of 56 tablets.

If any of these happen, tell your
doctor.

Manufactured by: AstraZeneca UK
Limited, Silk Road Business Park,
Macclesfield, UK.

Unusual conditions
Unusual conditions called
‘Churg-Strauss syndrome’ and
‘eosinophilic pneumonia’ have been
seen in a very small number of
people taking Accolate for asthma.
The signs include a combination of
the following:
Sinusitis. This can cause a
feeling of fullness in the nose,
cheeks and behind your eyes.
Feeling like you have flu.
Feeling more and more
breathless.
Pain in the area of your stomach
or gut.
Skin rash.
A feeling of ‘pins and needles’ or
numbness of your arms or legs.
If you notice more than one of these
signs, tell your doctor straight
away.
Other possible side effects:
Common (may affect up to 1 in 10
people)
Stomach and gut problems, such
as feeling or being sick,
diarrhoea or stomach pain.
These effects are usually mild.
Headache. This is usually mild.
Pain in the muscles.
Uncommon (may affect up to 1 in
100 people)
Swelling.
Difficulty sleeping.
Pain in the joints.
Feeling of discomfort or
generally feeling unwell.
Rare (may affect up to 1 in 1,000
people)
Blisters
Very rare (may affect up to 1 in
10,000 people)
Marked decrease in the number
of circulating white blood cells.
Not known (frequency cannot be
estimated)
Reduced feeling in the
skin/tingling feeling such as ‘pins
and needles’.
Feeling dizzy.
Nightmares
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 Accolate
Keep out of the sight and reach of
children.
Do not store above 30°C.
Store in the original package.
Do not take the tablets after the
expiry date which is stated on the
carton and blister label after ‘Exp’.
The expiry date refers to the last
day of the month.
If the tablets become discoloured
or show any signs of
deterioration, seek the advice of
your pharmacist.

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Accolate® 20mg film-coated tablets;
PL 18799/2938
POM
Leaflet date: 02.08.2016

Package leaflet: Information for the user

Zafirlukast 20mg film-coated tablets
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
Keep this leaflet. You may need
to read it again.
If you have any further
questions, ask your doctor or
pharmacist.
This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of
illness are the same as yours.
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
See section 4.
The name of your medicine is
Zafirlukast 20mg film-coated tablets but
will be referred to as Zafirlukast
throughout this leaflet.
What is in this leaflet:
1. What Zafirlukast is and what it is
used for
2. What you need to know before
you take Zafirlukast
3. How to take Zafirlukast
4. Possible side effects
5. How to store Zafirlukast
6. Contents of the pack and other
information

1. What Zafirlukast is and
what it is used for
Zafirlukast tablet contains a medicine
called zafirlukast. This belongs to a
group of medicines called
‘leukotriene antagonists’. This means
that it reduces the effects of
‘leukotrienes’.
These are natural substances in the
lung that cause asthma.
Zafirlukast is used to control the
symptoms of your asthma.
It is also used to prevent your
asthma from getting worse.
Do not take Zafirlukast to treat
sudden (acute) asthma attacks. Your
doctor will provide you with other
medicines to treat sudden attacks.

2. What you need to know
before you take Zafirlukast
Do not take Zafirlukast if:
If you are allergic to zafirlukast or
any of the other ingredients of
this medicine (listed in Section
6).
If you have ever had problems
with your liver.
If you have had problems with
your liver that were caused by
taking Zafirlukast.
Do not take Zafirlukast if any of the
above applies to you. If you are not
sure, talk to your doctor or
pharmacist before taking this
medicine.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Zafirlukast:
If you are a smoker. This could
affect the amount of Zafirlukast
that you need to take.
If you have kidney problems.
If you are not sure if the above apply
to you, talk to your doctor or
pharmacist before taking Zafirlukast.
If you go into hospital let the medical
staff know that you are taking
Zafirlukast.
Children
Zafirlukast should not be given to
children under the age of 12 years.
Other medicines and Zafirlukast
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines. This
includes medicines that you buy
without a prescription and herbal
medicines. This is because
Zafirlukast can affect the way some
medicines work and some medicines
can have an effect on Zafirlukast.
In particular, tell your doctor or
pharmacist if you are taking any of
the following medicines:
Theophylline (used to treat
asthma).
Erythromycin (an antibiotic).
Terfenadine (used to treat
hayfever).
Warfarin (used to thin the blood).
Aspirin (if you are taking it
frequently as a painkiller).
Fluconazole (used to treat fungal
infections).

Pregnancy and breast-feeding
If you are pregnant, think you
may be pregnant or are planning
to have a baby, ask your doctor
for advice before taking this
medicine. Your doctor will decide
whether you can take Zafirlukast
during this time.
Do not take Zafirlukast if you are
breast-feeding.
Driving and using machines
Zafirlukast is not likely to affect you
being able to drive or use any tools
or machines.
Zafirlukast contains lactose
Zafirlukast contains lactose, which is
a type of sugar. If you have been told
by your doctor that you cannot
tolerate or digest some sugars (have
an intolerance to some sugars), talk
to your doctor before taking this
medicine.

3. How to take Zafirlukast
Always take this medicine exactly as
your doctor has told you. Read the
label on the container to remind you
what the doctor said. Check with
your doctor or pharmacist if you are
not sure.
If you have been taking other
medicines for asthma, do not stop
taking them unless your doctor tells
you that you can.
Taking this medicine
Take Zafirlukast every day as
prescribed by your doctor.
The recommended dose is one
20mg tablet taken twice a day.
This is usually one tablet at the
start of the morning and one
tablet last thing at night.
Try to take your medicine at the
same times each day.
Swallow each tablet whole with a
drink of water.
Do not take your tablets with a
meal.
Continue to take Zafirlukast even
when your asthma is not causing
you any problems.
Do not stop taking your tablets
when you are feeling well, unless
your doctor tells you to.
If your asthma gets worse while you
are taking Zafirlukast, follow the
advice that your doctor has given
you for treating sudden (acute)
asthma attacks and see your doctor
as soon as possible.
If you take more Zafirlukast than
you should
If you take more Zafirlukast than
prescribed by your doctor, ask your
doctor or pharmacist for advice.
If you forget to take Zafirlukast
If you forget to take a dose, take
it as soon as you remember.
However, if it is nearly time for
the next dose, skip the missed
dose.
Do not take a double dose (two
doses at the same time) to make
up for a forgotten dose.

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them. The following
side effects can happen with this
medicine.
Allergic reactions (uncommon, may
affect up to 1 in 100 people)
The signs include:
Skin rash and itching.
Swelling around your lips, face,
tongue and throat.
If any of these happen, stop taking
Zafirlukast and tell your doctor
straight away.
Liver problems
Zafirlukast may affect your liver.
These liver effects range from nonserious increases in liver enzymes
(common, may affect up to 1 in 10
people) detected by blood tests to
serious conditions such as liver
failure (very rare, may affect up to
1 in 10,000 people). A very small
number of people have died from
liver failure.
Your doctor may ask you to have
blood tests before and during
treatment with Zafirlukast to check
whether there are any problems with
your liver.
The signs of liver problems include:
Yellowing of your skin or the
whites of your eyes (jaundice).

Pain on the right side of your
stomach and just below your
ribs.
Loss of appetite.
Feeling itchy.
Feeling tired, having no energy
or feeling like you have flu.
Feeling as though you are going
to be sick or actually being sick.

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.

6. Contents of the pack and
other Information

If any of these happen, stop taking
Zafirlukast and tell your doctor
straight away.

What Zafirlukast contains:
The active ingredient in Zafirlukast is
zafirlukast.

Infection (very common, may affect
more than 1 in 10 people.)
The signs include:
A high temperature (fever) that
does not go away.
Frequent sore throats.

Each film-coated tablet contains
20mg zafirlukast.

If any of these happen, tell your
doctor.

The other ingredients are
croscarmellose sodium, lactose
monohydrate, microcrystalline
cellulose, povidone, magnesium
stearate, hypromellose and titanium
dioxide (E171).

Bleeding problems (rare, may
affect up to 1 in 1,000 people)
The signs include:
Bleeding disorders, including
heavy menstrual periods.
Low platelet count (symptoms
include bleeding or bruising
more easily than normal).

What Zafirlukast looks like and
contents of the pack
Zafirlukast is white, round, biconvex,
film-coated tablets intagliated with
'Accolate 20' on one side and plain on
the reverse.
Zafirlukast is available as calendar
blister packs of 56 tablets.

If any of these happen, tell your
doctor.

Manufactured by: AstraZeneca UK
Limited, Silk Road Business Park,
Macclesfield, UK.

Unusual conditions
Unusual conditions called
‘Churg-Strauss syndrome’ and
‘eosinophilic pneumonia’ have been
seen in a very small number of
people taking Zafirlukast for asthma.
The signs include a combination of
the following:
Sinusitis. This can cause a
feeling of fullness in the nose,
cheeks and behind your eyes.
Feeling like you have flu.
Feeling more and more
breathless.
Pain in the area of your stomach
or gut.
Skin rash.
A feeling of ‘pins and needles’ or
numbness of your arms or legs.
If you notice more than one of these
signs, tell your doctor straight
away.
Other possible side effects:
Common (may affect up to 1 in 10
people)
Stomach and gut problems, such
as feeling or being sick,
diarrhoea or stomach pain.
These effects are usually mild.
Headache. This is usually mild.
Pain in the muscles.
Uncommon (may affect up to 1 in
100 people)
Swelling.
Difficulty sleeping.
Pain in the joints.
Feeling of discomfort or
generally feeling unwell.
Rare (may affect up to 1 in 1,000
people)
Blisters
Very rare (may affect up to 1 in
10,000 people)
Marked decrease in the number
of circulating white blood cells.
Not known (frequency cannot be
estimated)
Reduced feeling in the
skin/tingling feeling such as ‘pins
and needles’.
Feeling dizzy.
Nightmares.
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 Zafirlukast
Keep out of the sight and reach of
children.
Do not store above 30°C.
Store in the original package.
Do not take the tablets after the
expiry date which is stated on the
carton and blister label after ‘Exp’.
The expiry date refers to the last
day of the month.
If the tablets become discoloured
or show any signs of
deterioration, seek the advice of
your pharmacist.

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Zafirlukast 20mg film-coated
tablets;
PL 18799/2938
POM
Leaflet date: 02.08.2016

Expand Transcript

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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