371 LEAFLET Accolate 20140401

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

•    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.

•    Do not take Accolate if you are breast-feeding.

Driving and using tools and machines

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

Important information about some of the ingredients of Accolate

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

2.    Before you take Accolate

3.    How to take Accolate

4.    Possible side effects

5.    How to store Accolate

6.    Further 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. BEFORE YOU TAKE ACCOLATE

Do not take Accolate if:

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

•    You have ever had problems with your liver.

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

Take special care with Accolate

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 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.

Taking other medicines

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.

3. HOW TO TAKE ACCOLATE

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.

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

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 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.

•    Swallow each tablet whole with a drink of water.

•    Do not take your tablets with a meal.

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.

Stopping Accolate

•    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.

4. POSSIBLE SIDE EFFECTS

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 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 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.

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

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 sick.

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 data))

•    Bruising more easily.

•    A high temperature (fever) that does not go away.

If any of these happen, tell your doctor straight away.

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 (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)

•    Swelling.

•    Difficulty sleeping.

•    Pain in the joints.

•    Feeling of discomfort or generally feeling unwell.

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

•    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.

6. FURTHER INFORMATION

What Accolate contain

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

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. Accolate is available as calendar blister packs of 56.

Product Licence holder

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

Manufacturer

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

POM    PL 08747/0371

Leaflet revision date: 1 April 2014

371 LEAFLET Accolate 20140401