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ACCOLATE 20MG FILM-COATED TABLETS

Active substance(s): ZAFIRLUKAST

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P039321

Package leaflet: Information for the user

Accolate™ 20 mg film-coated tablets
zafirlukast

Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
• K
 eep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• T
 his 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.

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).

3.
4.
5.
6.

Driving and using machines
Accolate is not likely to affect you
being able to drive or use any tools or
machines.

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.
What is in this leaflet:
Your doctor will decide whether you
1. What Accolate is and what it is
can take Accolate during this time.
used for
• Do not take Accolate if you are
 hat you need to know before you
2. W
breast-feeding.
take Accolate
H
 ow to take Accolate
P
 ossible side effects
How to store Accolate
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.
 ccolate is used to control the
• A
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. Before you take Accolate
Do not take Accolate:
• 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.

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
20 mg 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.
If any of these happen, stop taking
Accolate and tell your doctor
straight away.
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.
If any of these happen, tell your doctor.
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).
If any of these happen, tell your doctor.
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 or pharmacist. This includes
any possible side effects not listed
in this leaflet. You can also report
side effects directly via Yellow Card
Scheme, Website: 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
• K
 eep this medicine out of the sight
and reach of children.
• D
 o not store above 30°C.
 eep your tablets in the container
• K
they came in.
• D
 o not use this medicine after the
expiry date which is stated on the
container. The expiry date refers to
the last day of that month.
• Do not throw away any medicines
via wastewater or household
waste. Ask your pharmacist how to
throw away medicines that you no
longer use. These measures will
help protect the environment.
6. Contents of the pack and other
information
What Accolate contains
The active substance is zafirlukast.
Each tablet contains 20mg of
zafirlukast.
The other ingredients are
croscarmellose sodium, hypromellose,
lactose, magnesium stearate,
microcrystalline cellulose, povidone,
titanium dioxide. Accolate contains
Lactose, see section 2.
What Accolate looks like and
contents of the pack
20 mg white, round biconvex filmcoated tablets intagliated with
'Accolate 20' on one side and plain on
the reverse.
Accolate 20 mg tablets are available
in aluminium laminate/foil blisters in
pack sizes of 56 and 100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation for
Accolate is held by
AstraZeneca UK Ltd, 600 Capability
Green, Luton, LU1 3LU, UK.
Accolate is manufactured by
AstraZeneca UK Ltd, Silk Road
Business Park, Macclesfield, Cheshire,
SK10 2NA, UK.

To listen to or request
a copy of this leaflet
in Braille, large print or
audio please call,
free of charge:
0800 198 5000 (UK only)
Please be ready to give
the following information:
Product name
Accolate 20mg
Film-coated Tablets
Reference number
17901/0001
This is a service provided
by the Royal National
Institute for Blind People.
This leaflet was last revised in:
January 2015
© AstraZeneca 2015
Accolate is a trade mark of the
AstraZeneca group of companies.
RSP 14 0063a

P039321

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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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