Accolate.pdf

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INFORMATI ON FOR THE CONSUMER

ACCOLATE ®

(zafirlukast tablets)

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR

MEDICINE. For further information or advice, ask your doctor or pharmacist.

ACCOLATE TABLETS SHOULD BE USED ONLY TWICE A DAY

ACCOLATE is used to control asthma symptoms, and prevent your asthma from getting

worse. The effect of ACCOLATE lasts for up to 12 hours. That's why it is important to take

ACCOLATE twice a day, in the morning and evening. Regular ACCOLATE use will help to

control your symptoms; all day and all night.

ACCOLATE SHOULD NOT BE TAKEN WITH MEALS

You should take your ACCOLATE tablets on an empty stomach (at least 1 hour before or 2

hours after meals). This will ensure you absorb as much medicine as possible each time.

ACCOLATE SHOULD NOT BE USED AS RELIEF MEDICATION

ACCOLATE does not act quickly enough to be used as a relief medication. If you get a

sudden attack of wheezing and breathlessness between doses of ACCOLATE, you should take

one or two puffs from a fast-acting relief medication (e.g., formoterol, terbutaline, salbutamol)

that your doctor has given you.

Remember, if you have an attack that does not get better when you take the relief medication

you should see your doctor right away. You may need emergency treatment.

You should tell your doctor as soon as possible if you:

• are getting more attacks of wheezing, breathlessness or chest tightness,

• are using an increasing amount of fast-acting relief medication,

• start to wake up at night with chest tightness, wheezing or shortness of breath.

HOW YOUR MEDICINE WORKS

ACCOLATE is a leukotriene receptor antagonist that blocks substances called leukotrienes.

Leukotrienes cause narrowing and swelling of airways in your lungs. Blocking leukotrienes

improves asthma symptoms and helps prevent asthma attacks.

IMPORTANT POINTS TO NOTE BEFORE TAKING YOUR MEDICINE

Have you ever had to stop taking another medication for your breathing problems because it

caused problems or you were allergic to it? Have you ever been told that you have problems

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with your liver? If the answer is YES to either of these questions, make sure your doctor or

pharmacist knows as soon as possible.

Make sure your doctor knows about all other medicines you are taking ( including non-

prescription or over the counter products ), especially blood thinners (e.g. COUMADIN ® ),

allergy medications (e.g., SELDANE ® , HISMANAL ® ), acetylsalicylic acid (e.g., Aspirin ® ),

antibiotics, and theophylline.

You should tell your doctor if you have ever had a bad, unusual or allergic reaction to

zafirlukast or any of the other ingredients in ACCOLATE tablets.

USE OF THIS MEDICATION DURING PREGNANCY OR BREAST FEEDING

Do not take ACCOLATE during pregnancy or while breast-feeding without discussing this

with your doctor first. Similarly, let your doctor know about future pregnancies you are

planning.

TAKING YOUR MEDICINE

Follow your doctor's instructions about when and how to take your tablets. Please READ

THE LABEL on the package. Ask your doctor or pharmacist if you are not sure. For patients

12 years of age and older: the usual treatment with ACCOLATE is 20 mg twice daily.

• Swallow each tablet whole with a full glass of water.

• Do not take your tablet(s) with a meal (at least 1 hour before or 2 hours after

meals).

• Try to take your medicine at the same times each day.

Using ACCOLATE twice a day, regularly, is very important. Your tablets come in blister

cards of 10. All tablets in each card are the same. To help you remember your schedule,

blisters are labelled with 2 spots per day, (a.m. and p.m.). You can start ACCOLATE at any

time. When starting a card, note the day and time you took the tablet. Take your next tablet

approximately 12 hours later, punching out the tablet that corresponds with the time (a.m. or

p.m.). When you finish a card, begin another approximately 12 hours later. As you get to the

end of your last card, call your pharmacist for a refill, preferably before using the last four

tablets.

REMEMBER: Do not stop taking your tablets even if you are feeling well, unless your

doctor tells you.

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UNDESIRABLE EFFECTS THAT MAY BE EXPERIENCED WITH ACCOLATE

Like any medication, ACCOLATE may cause side effects in some people. Tell your doctor or

pharmacist if any of the following side effects bothers you or continues:

Very common (frequency of more than 1 in 10 patients) side effects that may occur:

• Infection, usually mild and predominantly affecting the respiratory tract.

Common (frequency of 1 to 10 per 100 patients) side effects that may occur:

• Mild gastrointestinal disturbance (indigestion or stomach upsets), increases in certain

liver enzymes, muscle pain, rash, mild headaches.

Uncommon (frequency of 1 to 10 per 1,000 patients) side effects that may occur:

• High level of bilirubin in your blood, swelling, feeling of discomfort, pain in the joints,

allergic reactions including skin rash and itching, sleeping difficulties.

Rare (frequency of 1 to 10 per 10,000 patients) side effects that may occur:

• Inflammation of the liver (hepatitis), swelling around your lips, face, tongue and

throat, blisters, bleeding disorders and bruising.

Very rare (frequency of less than 1 in 10,000) side effects that may occur:

• Marked decrease in the number of circulating white blood cells, severe liver injury,

including liver failure (which may result in liver transplantation or death).

ACCOLATE may cause some changes to occur in your liver, which may be of a serious

nature. If you think you have any of the following, stop taking ACCOLATE and tell your

doctor immediately :

• feel sick,

• feel tired or lacking energy,

• feel like you have flu,

• feel like you have lost your appetite,

• feel itchy,

• have pain on the right side of your stomach, just below your ribs,

• have a yellow colouring of your skin and eyes (jaundice)

• have dark urine

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• have discoloured and/or pale stools.

A condition known as Churg-Strauss syndrome, which includes a combination of certain

persistent or worsening symptoms, has been reported rarely in patients given ACCOLATE.

These symptoms may include: a flu-like illness, rash, pins and needles or numbness of arms or

legs, and severe sinusitis. These have occurred usually, but not always, in patients whose oral

corticosteroid medicine for asthma is being reduced or withdrawn. The possibility that

leukotriene receptor antagonists, including ACCOLATE, may be associated with the

emergence of Churg-Strauss syndrome has not been established. You must tell your physician

immediately if you experience a combination of these symptoms.

IF YOU TAKE TOO MUCH

Call your doctor, pharmacist or regional poison control centre right away in case of an

overdose.

IF YOU MISS A DOSE

If you forget to take a dose, do not worry. Take another tablet just as soon as you remember.

BUT if it is near the time for the next dose, wait until this dose is due. Then go on as before.

Do not take a double dose.

STORING YOUR MEDICINE

Keep your medicine where children cannot reach it. Your medicine can harm them.

You should store your tablets between 15 and 30°C (room temperature). Keep your tablets in

the original package.

If your doctor decides to stop your treatment, return your tablets to the pharmacist for

disposal.

Do not take your tablets after the expiry date on the package. Return the tablets to your

pharmacist for disposal.

WHAT'S IN YOUR ACCOLATE TABLET

Each ACCOLATE tablet contains 20 mg of zafirlukast. Each tablet is film coated and also

contains the inactive ingredients: croscarmellose sodium, lactose monohydrate,

microcrystalline cellulose, povidone, magnesium stearate, hypromellose and titanium dioxide.

REMEMBER: This medicine was prescribed only for YOU . Only a doctor knows who can

use it safely. Never give it to someone else. It may harm them, even if their symptoms are the

same as yours.

FURTHER INFORMATION

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

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If you have any questions or are not sure about anything to do with your medicine, then ask

your doctor or pharmacist. You may need to read this leaflet again. PLEASE DO NOT

THROW IT AWAY until you have finished your medicine.

This leaflet alerts you to some of the times you should call your doctor. Other situations

which cannot be predicted may arise. Nothing about this leaflet should stop you from calling

your doctor or pharmacist with any questions or concerns you have about using ACCOLATE.

NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current

information at the time of printing. Please refer to www.astrazeneca.ca to see if more up-to-date

information has been posted.

Customer Inquiries:

1 800 668 6000

ACCOLATE ® and the AstraZeneca logo are trade-marks of the AstraZeneca group of companies.

AstraZeneca Canada Inc.

Mississauga, ON

L4Y 1M4

Last revised: January 15, 2010

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