Document: leaflet MAH BRAND_PLPI 20636-2664 change

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• leaflet MAH BRAND_PLPI 20636-2664

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Pulmicort® Respules® 1 mg nebuliser suspension

(budesonide)

PATIENT INFORMATION LEAFLET

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 side effects not listed in this leaflet. See section 4.

This medicine is available using the above name but will be referred to as Pulmicort Respules throughout this leaflet. Also available in 0.5 mg strength.

What is in this leaflet

1. What Pulmicort Respules are and what they are used for

2. What you need to know before you use Pulmicort Respules

3. How to use Pulmicort Respules

4. Possible side effects

5. How to store Pulmicort Respules

6. Contents of the pack and other information

1.    WHAT PULMICORT RESPULES ARE AND WHAT THEY ARE USED FOR

Pulmicort Respules contain 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.

-    Pulmicort Respules are used to treat asthma. They are also used to treat croup in infants and children.

-    A Respule is a small plastic container that contains a liquid. The liquid is put into a machine called a nebuliser. This machine turns the medicine into a fine mist which you breathe in through a face mask or mouthpiece.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE PULMICORT RESPULES

Do not use Pulmicort Respules:

-    If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Pulmicort Respules, tell your doctor or pharmacist if:

-    You have a lung infection.

-    You have a cold or chest infection.

-    You have liver problems.

Other medicines and Pulmicort Respules

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 Pulmicort Respules can affect the way some medicines work and some medicines can have an effect on Pulmicort Respules.

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 Pulmicort Respules unless your doctor tells you to.

-    If you get pregnant while using Pulmicort Respules, do not stop using Pulmicort Respules but talk to your doctor immediately.

Driving and using machines

Pulmicort Respules are not likely to affect you being able to drive or use

any tools or machines.

3. HOW TO USE PULMICORT RESPULES

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

-    The solution in a Respule must be put into a nebuliser and made into a fine mist before it can be breathed in. It is then inhaled through a face mask or mouthpiece. Instructions for using your nebuliser are given after the section 'How much to take'.

Note: Do not use an ultrasonic nebuliser with Pulmicort Respules.

-    Your asthma may improve within 2 days. However, it can take up to 4 weeks for the medicine to have its full effect. It is important to use Pulmicort Respules every day, even if you have no asthma symptoms at the time.

How much to take Asthma

Your doctor will tell you how much to take. This will depend on how severe your asthma is. Your doctor may lower your dose as your asthma improves.

-    The recommended starting dose in adults and children over 12 years is 1 mg to 2 mg (milligrams), twice a day.

-    Children under 12 years are usually prescribed a lower doses of 0.5 mg to 1 mg, twice a day.

Croup

The recommended dose for infants and children is 2 mg a day. This may be given all in one go, or 1 mg may be given followed by another 1 mg 30 minutes later.

Instructions for using Pulmicort Respules

1.    Break off a Respule from the strip. Leave the rest in the foil envelope.

2.    Shake the Respule gently.

3.    Hold upright. Twist off the top of the Respule to open.

4.    Place the open end of the Respule firmly inside the nebuliser cup. Squeeze slowly to put the liquid in the cup.

5.    Throw the empty Respule away. Put the top back on the nebuliser cup.

6.    Connect one end of the cup to the face mask or mouthpiece.

7.    Connect the other end of the cup to the air pump.

8.    Gently shake the cup.

9.    Turn on the nebuliser and breathe in the mist calmly and deeply using the face mask or mouthpiece. If you are using a mask, make sure the face mask fits tightly.

10.    You will know when your treatment is complete because the fine mist will stop coming out of your mask or mouthpiece.

11.    How long it takes to nebulise all the medicine depends on the type of equipment you use. It will also depend on the amount of medicine to be used.

12.    Rinse your mouth with water. Spit out the water. Do not swallow it. If you have used a face mask, wash your face as well.

13.    After each use, you must wash the nebuliser cup and mouthpiece (or face mask) in warm soapy water and rinse well. After washing, dry these parts by connecting to the air outlet or the compressor and blow air through them.

Important information about your asthma symptoms

If you feel you are getting breathless or wheezy while using Pulmicort Respules, you should continue to use Pulmicort Respules 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.

If you use more Pulmicort Respules 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 Pulmicort Respules than you should, contact your doctor or pharmacist for advice.

If you forget to use Pulmicort Respules

If you forget to take a dose, skip the missed dose and take the next dose as usual.

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 Pulmicort

Respules 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. This happens very rarely, affecting less than 1 in 10,000 people.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Pulmicort Respules are manufactured by AstraZeneca AB, S-15185, Sodertalje, Sweden and is procured from within in the EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref) 23.03.15[2]

Pulmicort and Respules are trademarks of AstraZeneca AB.

Budesonide Respules® 1 mg nebuliser suspension

PATIENT INFORMATION LEAFLET

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 side effects not listed in this leaflet. See section 4.

This medicine is available using the above name but will be referred to as Budesonide Respules throughout this leaflet. Also available in 0.5 mg strength.

What is in this leaflet

1. What Budesonide Respules are and what they are used for

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

3. How to use Budesonide Respules

4. Possible side effects

5. How to store Budesonide Respules

6. Contents of the pack and other information

1.    WHAT BUDESONIDE RESPULES ARE AND WHAT THEY ARE USED FOR

Budesonide Respules contain 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.

-    Budesonide Respules are used to treat asthma. They are also used to treat croup in infants and children.

-    A Respule is a small plastic container that contains a liquid. The liquid is put into a machine called a nebuliser. This machine turns the medicine into a fine mist which you breathe in through a face mask or mouthpiece.

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

Do not use Budesonide Respules:

-    If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Budesonide Respules, tell your doctor or pharmacist if:

-    You have a lung infection.

-    You have a cold or chest infection.

-    You have liver problems.

Other medicines and Budesonide Respules

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

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 Respules unless your doctor tells you to.

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

Driving and using machines

Budesonide Respules are not likely to affect you being able to drive or use any tools or machines.

3. HOW TO USE BUDESONIDE RESPULES

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

-    The solution in a Respule must be put into a nebuliser and made into a fine mist before it can be breathed in. It is then inhaled through a face mask or mouthpiece. Instructions for using your nebuliser are given after the section 'How much to take'.

Note: Do not use an ultrasonic nebuliser with Budesonide Respules.

-    Your asthma may improve within 2 days. However, it can take up to 4 weeks for the medicine to have its full effect. It is important to use Budesonide Respules every day, even if you have no asthma symptoms at the time.

How much to take Asthma

Your doctor will tell you how much to take. This will depend on how severe your asthma is. Your doctor may lower your dose as your asthma improves.

-    The recommended starting dose in adults and children over 12 years is 1 mg to 2 mg (milligrams), twice a day.

-    Children under 12 years are usually prescribed a lower doses of 0.5 mg to 1 mg, twice a day.

Croup

The recommended dose for infants and children is 2 mg a day. This may be given all in one go, or 1 mg may be given followed by another 1 mg 30 minutes later.

Instructions for using Budesonide Respules

1.    Break off a Respule from the strip. Leave the rest in the foil envelope.

2.    Shake the Respule gently.

3.    Hold upright. Twist off the top of the Respule to open.

4.    Place the open end of the Respule firmly inside the nebuliser cup. Squeeze slowly to put the liquid in the cup.

5.    Throw the empty Respule away. Put the top back on the nebuliser cup.

6.    Connect one end of the cup to the face mask or mouthpiece.

7.    Connect the other end of the cup to the air pump.

8.    Gently shake the cup.

9.    Turn on the nebuliser and breathe in the mist calmly and deeply using the face mask or mouthpiece. If you are using a mask, make sure the face mask fits tightly.

10.    You will know when your treatment is complete because the fine mist will stop coming out of your mask or mouthpiece.

11.    How long it takes to nebulise all the medicine depends on the type of equipment you use. It will also depend on the amount of medicine to be used.

12.    Rinse your mouth with water. Spit out the water. Do not swallow it. If you have used a face mask, wash your face as well.

13.    After each use, you must wash the nebuliser cup and mouthpiece (or face mask) in warm soapy water and rinse well. After washing, dry these parts by connecting to the air outlet or the compressor and blow air through them.

Important information about your asthma symptoms

If you feel you are getting breathless or wheezy while using Budesonide Respules, you should continue to use Budesonide Respules 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.

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

If you forget to use Budesonide Respules

If you forget to take a dose, skip the missed dose and take the next dose as usual.

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

Respules 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. This happens very rarely, affecting less than 1 in 10,000 people.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Budesonide Respules are manufactured by AstraZeneca AB, S-15185, Sodertalje, Sweden and is procured from within in the EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref) 23.03.15[2] Respules is a trademark of AstraZeneca AB.

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 Budesonide.

-    Mild sore throat, coughing and a hoarse voice.

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

-    Rash on the face after using the face mask. You can stop this from happening by washing your face after using the face mask.

-    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. 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).

-    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 side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme.

Website: 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 RESPULES

Keep in a safe place, out of the sight and reach of children.

Once a foil envelope has been opened, the Respules inside should be used within 3 months.

Note: It is best to mark the opening date on the foil envelope to help you remember.

If only some of the suspension is used, the remaining suspension in the Respule should be thrown away immediately.

Do not store above 30^oC. Do not freeze. Store in an upright position. Respules should be kept in the original foil envelope to protect them from light

Do not use Budesonide Respules after the expiry date printed on the carton and foil envelope.

If your doctor tells you to stop taking this medicine, return any unused Respules to your pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

If your Respules become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Budesonide Respules contain

Budesonide Respules contain budesonide in the form of a nebuliser suspension.

Each 2 ml Respule contains 1 mg of the active ingredient, budesonide.

Each ml of nebuliser suspension contains 0.50 mg budesonide.

The other ingredients are disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate and water for injections.

What Budesonide Respules look like and the contents of the pack

Each Budesonide Respule contains 2 ml of a white to off-white nebuliser suspension (made into a fine mist for inhalation).

The Budesonide Respules are packed in strips of 5 inside a foil envelope; each carton contains 5 Respules or 20 Respules.