Accolate 20mg

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.

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).

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.

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.

Allergic reactions (uncommon, affecting less than 1 in 100 people)

The signs include:

• Skin rash and itching.
• Swelling caused by a build up of fluid. This is also known as ‘oedema’.

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

Blood problems (rare, affecting less than 1 in 1,000 people)

The signs include:

• Bruising more easily.
• Bleeding disorders, including heavy menstrual periods.
• A high temperature (fever) that does not go away.
• Sore throats which happen often.

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

Liver problems (rare, affecting less than 1 in 1,000 people)

Rarely, people taking Accolate get liver problems. These problems range from non-serious changes to your liver (shown in blood tests) to serious conditions such as liver failure. 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, 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.

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)

• Feeling of discomfort or generally feeling unwell.
• Stomach and gut problems, such as feeling or being sick, diarrhoea or stomach pain. These effects are usually mild.
• Headache. This is usually mild.
• Chest infections.
• Difficulty sleeping.

Rare (affects less than 1 in 1,000 people)

• Bruising.
• Pain in the joints or muscles.