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PACKAGE LEAFLET: INFORMATION FOR THE USER

Your medicine is available using the name Budesonide 100 micrograms Turbohaler, but will be referred to as Budesonide Turbohaler throughout this leaflet. Other strengths (200mcg & 400mcg) are also available.

Read all of this leaflet carefully before you start using 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 Budesonide Turbohaler is and what it is used for

2.    What you need to know before you use Budesonide Turbohaler

3.    How to use Budesonide Turbohaler

4.    Possible side effects

5.    How to store Budesonide Turbohaler

6.    Contents of the pack and other information

1.    WHAT BUDESONIDE TURBOHALER IS AND WHAT IT IS USED FOR

Budesonide Turbohaler is an inhaler. It contains a medicine called budesonide. This belongs to a group of medicines called 'corticosteroids'. It works by reducing and preventing swelling and inflammation in your lungs.

Your doctor has prescribed this medicine to treat asthma. Your doctor will prescribe two asthma inhalers: Budesonide Turbohaler and a separate 'reliever inhaler'.

•    Use Budesonide Turbohaler every day, as your doctor has told you to. This helps to prevent asthma symptoms from happening.

•    Use your 'reliever inhaler' when you get asthma symptoms, to make it easier to breathe again.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE BUDESONIDE TURBOHALER

Do not use Budesonide Turbohaler:

If you are allergic to budesonide.

Warnings and precautions

Talk to your doctor or pharmacist before using Budesonide Turbohaler if:

•    You have a lung infection.

•    You have a cold or chest infection or any problems with your breathing.

•    You have or have ever had tuberculosis (TB).

•    You have liver problems.

Other medicines and Budesonide Turbohaler

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 Budesonide Turbohaler can affect the way some medicines work and some medicines can have an effect on Budesonide Turbohaler.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    Steroid medicines.

•    Medicines to treat fungal infections (such as itraconazole and ketoconazole).

•    HIV protease inhibitors (such as ritonavir and nelfinavir).

Pregnancy, breast-feeding and fertility

•    If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use Budesonide Turbohaler unless your doctor tells you to.

•    If you get pregnant while using Budesonide Turbohaler, do not stop using Budesonide Turbohaler but talk to your doctor immediately.

Driving and using machines

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

Information you may have to carry while you are using Budesonide Turbohaler

If you are using a high dose of Budesonide Turbohaler your doctor may ask you to carry a steroid warning card. This explains to others about your medication.

3. HOW TO USE BUDESONIDE TURBOHALER

•    Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    If Budesonide Turbohaler is to be used by your child, make sure they use it correctly as your doctor has told you.

•    It is important to use Budesonide Turbohaler every day, even if you have no asthma symptoms at the time.

•    Your breathing may improve within 2 days. However it can take up to 4 weeks for the medicine to have its full effect.

Important information about your asthma symptoms

If you feel you are getting breathless or wheezy while using Budesonide Turbohaler, you should continue to use Budesonide Turbohaler but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

• Your breathing is getting worse or you often wake up at night with asthma.

• Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual. These signs could mean that your condition is not being properly controlled and you may need different or additional treatment immediately.

Unscrew the white cover and lift it off.

Hold your Budesonide Turbohaler upright with brown base at the bottom. Do not hold the mouthpiece when you turn the grip. Turn the brown base as far as it will go in one direction. Then turn it back as far as it will go in the other direction. It does not matter which way you turn first. You should hear a click sound. Perform the procedure twice.

The Budesonide Turbohaler is now ready for use, and you should not repeat the above procedure again. To take a dose, please follow the instructions below.

How to take an inhalation

Every time you need to take an inhalation, follow the instructions below.

1.    Unscrew the white cover and lift it off.

2.    Hold your Budesonide Turbohaler upright with the brown base at the bottom.

3.    Do not hold the mouthpiece when you load your Budesonide Turbohaler. To load your Budesonide Turbohaler with a dose, turn the brown base as far as it will go in one direction. Then turn it as far as it will go in the other direction. It does not matter which way you turn it first. You should hear a click sound. Your Budesonide Turbohaler is now loaded and ready to use. Only load your Budesonide Turbohaler when you need to use it.

4.    Hold your Budesonide Turbohaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your Budesonide Turbohaler.

5.    Place the mouthpiece gently between your teeth. Close your lips. Breathe in as deeply and as hard as you can through your mouth. Do not chew or bite on the mouthpiece.

6.    Remove your Budesonide Turbohaler from your mouth. Then breathe out gently.

The amount of medicine that is inhaled is very small. This means you may not be able to taste it after inhalation. If you have followed the instructions, you can still be confident that you have inhaled the dose and the medicine is now in your lungs.

7.    If you are to take a second inhalation, repeat steps 2 to 6.

8.    Replace the cover by screwing it back on tightly after use.

9.    Rinse your mouth out with water after inhaling your prescribed dose.

Do not try to remove or twist the mouthpiece. It is fixed to your Budesonide Turbohaler and must not be taken off.

Do not use your Budesonide Turbohaler if it has been damaged or if the mouthpiece has come apart from your Budesonide Turbohaler.

Cleaning your Budesonide Turbohaler

Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.

When to start using a new Budesonide Turbohaler

When you first see a red mark in the indicator window, there are about 20 doses left. You will then need to see your doctor for another prescription. When the red mark has reached the bottom of the indicator window, you must start using your new Budesonide Turbohaler.

Note:

•    The brown base will still twist and 'click' even when your Budesonide Turbohaler is empty.

•    The sound that you hear as you shake your Budesonide Turbohaler is produced by a drying agent and not the medicine. Therefore the sound does not tell you how much medicine is left in your Budesonide Turbohaler.

•    If you load your Budesonide Turbohaler more than once by mistake before taking your dose, you will still only receive one dose.

If you use more Budesonide Turbohaler than you should

It is important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should not increase or decrease your dose without seeking medical advice.

If you use more Budesonide Turbohaler than you should, contact your doctor or pharmacist for advice.

If you forget to use Budesonide Turbohaler

If you forget to take a dose, skip the missed dose and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop using Budesonide Turbohaler

Do not stop using this medicine even when your asthma gets better, unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If either of the following happen to you, stop using Budesonide Turbohaler and talk to your doctor immediately:

•    Swelling of your face, particularly around your mouth (with possible swelling of the lips, tongue, eyes and ears), rash, itching, contact dermatitis (a skin problem), hives and bronchospasm (tightening of the muscles in the airways which causes wheezing). This may mean that you are having an allergic reaction. This happens rarely, affecting less than 1 in 1,000 people.

•    Sudden wheezing after inhaling your medicine. If this happens, also use your 'reliever' inhaler straight away. This happens very rarely, affecting less than 1 in 10,000 people.

Other possible side effects:

Common (may affect up to 1 in 10 people)

•    Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your Budesonide Turbohaler.

•    Mild sore throat, coughing and a hoarse voice.

Rare (may affect up to 1 in 1,000 people)

•    Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable. These effects are more likely to occur in children.

•    Bruising of the skin.

•    Loss of voice.

•    Hoarse voice (in children).

Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time, for example 400 micrograms or more daily for several years. The effects include:

•    changes in bone mineral density (thinning of the bones).

•    cataract (clouding of the lens in the eye).

•    glaucoma (increased pressure in the eye).

•    a slowing of the rate of growth of children and adolescents (rare). If high doses are given over several years, final adult height may be reduced by about 1 cm.

•    an effect on the adrenal gland (a small gland next to the kidney) (rare).

These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 BUDESONIDE TURBOHALER

•    Keep out of the sight and reach of children.

•    Do not use your Budesonide Turbohaler after the expiry date printed on the carton or label. The expiry date refers to the last day of that month.

•    Do not store above 30°C.

•    If your doctor tells you to stop using Budesonide Turbohaler, please take it back to the pharmacist for safe disposal. Only keep the product if your doctor tells you to.

•    If your medicine appears to be discoloured or show any other signs of deterioration, please return it to your pharmacist who will advise you further.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Budesonide Turbohaler contains

The active substance is budesonide. There are no other ingredients.

What Budesonide Turbohaler looks like and contents of the pack

Budesonide Turbohaler is one breath-actuated metered dose powder inhaler with a white plastic body and cover and a light brown turning grip. On the base of the turning grip 'Budesonide 100' is embossed and a Braille code. The inhaler comprises of a mouthpiece, a dosing mechanism, an indicator window and a substance store containing white powder for inhalation.

Budesonide Turbohaler contains 200 actuations.

Each metered dose contains 100 micrograms of budesonide.

Manufacturer

Budesonide Turbohaler is manufactured by AstraZeneca AB., S-151 85 Sodertalje, Sweden.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

PL No: 08929/0551

Leaflet revision and issue date: 02.06.16

Turbohaler® is a registered trademarks of the AstraZeneca group of companies.

To request a copy of this leaflet in Braille, large print or audio, please call 01302 365000 and ask for the Regulatory Department.

Please be ready to give the following information:

Product name:    Budesonide Turbohaler 100

Reference number:    08929/0551

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