Pulmicort Turbohaler 400

• 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.

1. What Pulmicort Turbohaler is and what it is used for
2. What you need to know before you use Pulmicort Turbohaler
3. How to use Pulmicort Turbohaler
4. Possible side effects
5. How to store Pulmicort Turbohaler
6. Contents of the pack and other information

If you are allergic to budesonide.

Talk to your doctor or pharmacist before using Pulmicort 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.

Contact your doctor if you experience blurred vision or other visual disturbances.

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 Turbohaler can affect the way some medicines work and some medicines can have an effect on Pulmicort Turbohaler and your doctor may wish to monitor you carefully.

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 medicines (such as ritonavir or cobicistat-containing products).

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

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

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

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

Use your Pulmicort Turbohaler every day. This helps to prevent asthma symptoms from happening. Your doctor will advise you of the correct dose to treat your asthma. Your doctor will reduce your medication to the lowest dose needed to control your asthma.

Adults and children (13 years and above)

• The recommended dose is 1 or 2 inhalations, twice a day (in the morning and in the evening).
• Your doctor may increase this to a maximum of 1600 micrograms a day.
• If your asthma is getting worse and you are using your ‘reliever inhaler’ more often or you have more symptoms:
  • double your dose of Pulmicort Turbohaler immediately and talk to your doctor as soon as possible
  • double your dose by taking twice as many inhalations each time.

• The recommended dose is 1 or 2 inhalations, twice a day (in the morning and in the evening).
• The doctor may increase this to a maximum of 800 micrograms a day.

• Only use your Turbohaler once a day if your doctor has told you to.
• Use your Turbohaler at the same time each evening.
  Adults and children (13 years and above)
  • The recommended dose is 1 or 2 inhalations, in the evening.
  • If your asthma is getting worse and you are using your ‘reliever inhaler’ more often or you have more symptoms:
    • double your dose immediately and talk to your doctor as soon as possible
    • double your dose by taking the same number of inhalations your doctor has told you twice a day (once in the morning and once in the evening).
      
  Use in Children (5 - 12 years of age)
  • The recommended dose is 1 or 2 inhalations, in the evening.
  • The maximum dose is 400 micrograms a day.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.

Always keep your ‘reliever inhaler’ with you to use when you need it. Do not use Pulmicort Turbohaler to treat asthma symptoms - use your ‘reliever inhaler’.

Before using Pulmicort Turbohaler for the first time you need to prepare the Turbohaler for use.

Unscrew the white cover and lift it off.

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

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

1. Unscrew the white cover and lift it off.
2. Hold your Turbohaler upright with the brown base at the bottom.
3. Do not hold the mouthpiece when you load your Turbohaler. To load your 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 Turbohaler is now loaded and ready to use. Only load your Turbohaler when you need to use it.
4. Hold your Turbohaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your 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 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 Turbohaler and must not be taken off. Do not use your Turbohaler if it has been damaged or if the mouthpiece has come apart from your Turbohaler.

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

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 Turbohaler.

Note:

• The brown base will still twist and ‘click’ even when your Turbohaler is empty.
• The sound that you hear as you shake your 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 Turbohaler.
• If you load your Turbohaler more than once by mistake before taking your dose, you will still only receive one dose.

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 Turbohaler than you should, contact your doctor or pharmacist for advice.

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.

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

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 Turbohaler.
• Mild sore throat, coughing and a hoarse voice.
• Pneumonia (infection of the lung) in COPD patients.

Tell your doctor if you have any of the following while taking budesonide they could be symptoms of a lung infection:

• Fever or chills.
• Increased mucus production, change in mucus colour.
• Increased cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

• Feeling worried, restless and nervous.
• Depression.
• Trembling and shaking.
• Cataract (clouding of the lens in the eye).
• Muscle cramps.
• Blurred vision.

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

• Sleeping problems, feeling 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).
• 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.

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.

The active substance is budesonide. There are three different strengths.

Pulmicort Turbohaler 100 contains 200 doses (inhalations). Each metered dose contains 100 micrograms of budesonide.

Pulmicort Turbohaler 200 contains 100 doses (inhalations). Each metered dose contains 200 micrograms of budesonide.

Pulmicort Turbohaler 400 contains 50 doses (inhalations). Each metered dose contains 400 micrograms of budesonide.

There are no other ingredients.

Pulmicort Turbohaler is an inhaler containing your medicine. Each Turbohaler contains 50, 100 or 200 doses (inhalations) and has a white body with a brown base.

The Marketing Authorisations for Pulmicort Turbohaler are held by

Pulmicort Turbohaler is manufactured by

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Reference number

Pulmicort Turbohaler 100 17901/0162

Pulmicort Turbohaler 200 17901/0163

Pulmicort Turbohaler 400 17901/0164

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