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ACCOLATE TABLETS 20MG

Active substance(s): ZAFIRLUKAST / ZAFIRLUKAST

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371 LEAFLET Accolate 20160819

PACKAGE LEAFLET: INFORMATION FOR THE USER

ACCOLATE® TABLETS 20mg
ZAFIRLUKAST TABLETS 20mg
(zafirlukast)
Your medicine is known as Accolate Tablets 20mg but will be
referred to as Accolate throughout the following patient information
leaflet.

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.

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.

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



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.

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.

Driving and using machines

Accolate contains lactose

What is in this leaflet:
1. What Accolate is and what it is used for

3. HOW TO TAKE ACCOLATE

2. What you need to know before you 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.

3. How to take Accolate
4. Possible side effects
5. How to store Accolate

If you have been taking other medicines for asthma, do not stop
taking them unless your doctor tells you that you can.

6. Contents of the pack and other information

Taking this medicine


Take Accolate every day as prescribed by your doctor.

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’.

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.

These are natural substances in the lung that cause asthma.



Swallow each tablet whole with a drink of water.



Accolate is used to control the symptoms of your asthma.



Do not take your tablets with a meal.



It is also used to prevent your asthma from getting worse.



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.

Do not take Accolate to treat sudden (acute) asthma attacks. Your
doctor will provide you with other medicines to treat sudden attacks.

Do not take Accolate:

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 are allergic to zafirlukast or any of the other ingredients of
this medicine (listed in Section 6).

If you take more Accolate than you should



If you have ever had problems with your liver.



If you have had problems with your liver that were caused by
taking Accolate.

2. BEFORE YOU TAKE 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.

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.

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.

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

Reporting of side effects

Accolate 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.

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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

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.

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.



The tablets should be stored at a temperature not above 30°C
in the original packaging.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
before taking them.



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 any of these happen, tell your doctor.
Bleeding problems (rare, may affect up to 1 in 1,000 people)

6. CONTENTS OF THE PACK AND OTHER INFORMATION

The signs include:

What Accolate contain



Bleeding disorders, including heavy menstrual periods.



Low platelet count (symptoms include bleeding or bruising more
easily than normal).

Each film-coated tablet contains 20mg of the active ingredient
zafirlukast.

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:

Accolate also contains the following inactive ingredients:
croscarmellose sodium, lactose, microcrystalline cellulose,
povidone, magnesium stearate, hypromellose and titanium dioxide
(E171).
What Accolate looks like and contents of the pack
Accolate is white, round tablet marked ACCOLATE 20 on one side.



Sinusitis. This can cause a feeling of fullness in the nose,
cheeks and behind your eyes.

Accolate is available as calendar blister packs of 56.



Feeling like you have flu.

Product Licence holder



Feeling more and more breathless.



Pain in the area of your stomach or gut.



Skin rash.

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.



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.

Manufacturer
This product is manufactured by AstraZeneca UK Ltd, Macclesfield,
Cheshire, UK.

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.

POM

PL 08747/0371

Leaflet revision date: 19 August 2016
Accolate® is a registered trademark of AstraZeneca UK Limited.

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.

371 LEAFLET Accolate 20160819

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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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