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ZAFIRLUKAST 20MG TABLETS

Active substance(s): ZAFIRLUKAST

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ACCOLATE 20mg TABLETS / ZAFIRLUKAST 20mg TABLETS
(zafirlukast)
This product is available as any of the above names but will be referred to as Accolate
throughout the remainder of this leaflet.
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.
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 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.
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, 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
• Do not store above 30°C.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry
date refers to the last day of that month.
• If the tablets become discoloured or show signs of any deterioration, you should seek the
advice of your pharmacist who will advise you what to do.
• 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
What Accolate contains
Each tablet contains 20mg of the active ingredient zafirlukast.
The tablets are white round marked Accolate 20 on one side and plain on the reverse.
Accolate also contain the following ingredients:
Lactose, microcrystalline cellulose, povidone, magnesium stearate, croscarmellose sodium,
titanium dioxide (E171) and hypromellose.
Accolate is available as calendar blister packs of 56 tablets.
POM
PL: 15814/0159
This product is manufactured by AstraZeneca UK Limited, Macclesfield, Cheshire SK10
2NA and is procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 18.05.2016.
Accolate is a registered Trade Mark of AstraZeneca UK Limited, UK.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER
ACCOLATE 20mg TABLETS / ZAFIRLUKAST 20mg TABLETS
(zafirlukast)
This product is available as any of the above names but will be referred to as Accolate
throughout the remainder of this leaflet.
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.
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 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.
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, 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
• Do not store above 30°C.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry
date refers to the last day of that month.
• If the tablets become discoloured or show signs of any deterioration, you should seek the
advice of your pharmacist who will advise you what to do.
• 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
What Accolate contains
Each tablet contains 20mg of the active ingredient zafirlukast.
The tablets are white round marked Accolate 20 on one side and plain on the reverse.
Accolate also contain the following ingredients:
Lactose, microcrystalline cellulose, povidone, magnesium stearate, croscarmellose sodium,
titanium dioxide (E171) and hypromellose.
Accolate is available as calendar blister packs of 56 tablets.
POM
PL: 15814/0159
This product is manufactured by AstraZeneca Limited, Macclesfield, Cheshire SK10 2NA
and is procured from within the EU and repackaged by the Product Licence holder: O.P.D.
Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 18.05.2016.
Accolate is a registered Trade Mark of AstraZeneca UK Limited, UK.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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