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Active substance(s): ZAFIRLUKAST

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371 LEAFLET Accolate 20140401


Your medicine is known as Accolate Tablets 20mg but will be
referred to as Accolate throughout the following patient information
Read all of this leaflet carefully before you start taking this

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

Talk to your doctor before taking Accolate if you are pregnant or
may become pregnant. Your doctor will decide whether you can
take Accolate during this time.

Keep this leaflet. You may need to read it again.

 Do not take Accolate if you are breast-feeding.
Driving and using tools and machines

If you have any further questions, ask your doctor or

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

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

Important information about some of the ingredients of

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or

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.

In this leaflet:


1. What Accolate is and what it is used for

Always take Accolate exactly as your doctor has told you. Read the
label on the container to remind you what the doctor said. You
should check with your doctor or pharmacist if you are not sure.

2. Before you take Accolate
3. How to take Accolate
4. Possible side effects

Accolate should not be given to children under the age of 12 years.

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. Further information

Taking this medicine

Take Accolate every day as prescribed by your doctor.


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 usual 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.

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.

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.

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

If you take more Accolate than you should
Do not take Accolate if:

If you take more Accolate than prescribed by your doctor, ask your
doctor or pharmacist for advice.
If you forget to take Accolate

You are allergic (hypersensitive) to zafirlukast or any of the
other ingredients of Accolate (listed in Section 6: Further

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

You have ever had problems with your liver.

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

Do not take a double dose (two doses at the same time) to
make up for a forgotten dose.

Stopping Accolate

Do not take Accolate if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Accolate.

Continue to take Accolate even when your asthma is not
causing you any problems.

Take special care with Accolate

Do not stop taking your tablets when you are feeling well,
unless your doctor tells you to.

Check with your doctor or pharmacist before taking Accolate if:

You are a smoker. This could affect the amount of Accolate that
you need to take.

You have kidney problems.


If you go into hospital let the medical staff know that you are taking

Like all medicines, Accolate can cause side effects, although not
everybody gets them. The following side effects can happen with
this medicine.
Allergic reactions (uncommon, affecting 1 to 10 users in 100

Taking other medicines

The signs include:

Please tell your doctor or pharmacist if you are taking, or have
recently taken, 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.

Skin rash and itching.

Swelling around your lips, face, tongue and throat.

If you are not sure if the above apply to you, talk to your doctor or
pharmacist before taking Accolate.

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, affecting less than 1
in 10 people) detected by blood tests to serious conditions such as
liver failure (not known, can not be estimated from available data).
A very small number of people have died from liver failure.

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:

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.

By reporting side effects, you can help provide more information on
the safety of this medicine.

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

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 you notice any of the following, and they do not go away, this
might also mean that you have liver problems:

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

If any of these happen, and they do not go away, talk to your
doctor or pharmacist.
Infection (very common, affecting more than 1 per 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 straight away.
Blood problems (rare, affecting 1 to 10 per 10,000 people)
The signs include:

Bleeding disorders, including heavy menstrual periods.

 Low platelet count.
Blood problems (not known (cannot be estimated from available

Bruising more easily.

What Accolate contain
Each film-coated tablet contains 20mg of the active ingredient
Accolate also contains the following inactive ingredients:
croscarmellose sodium, lactose, microcrystalline cellulose,
povidone, magnesium stearate, hypromellose and titanium dioxide
What Accolate looks like and contents of the pack
Accolate is white, round tablet marked ACCOLATE 20 on one side.

 A high temperature (fever) that does not go away.
If any of these happen, tell your doctor straight away.

Accolate is available as calendar blister packs of 56.

Unusual conditions

Product Licence holder

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:

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

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

If you notice more than one of these signs, tell your doctor
straight away.
Other possible side effects:
Common (affects less than 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 (affects less than 1 in 100 people)


Difficulty sleeping.

Pain in the joints.

Feeling of discomfort or generally feeling unwell.

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

PL 08747/0371

Leaflet revision date: 1 April 2014
371 LEAFLET Accolate 20140401

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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.