Pulmicort Respules 0.5mg

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Pulmicort Respules are and what they are used for
2. Before you use Pulmicort Respules
3. How to use Pulmicort Respules
4. Possible side effects
5. How to store Pulmicort Respules
6. Further information

Do not use Pulmicort Respules if:

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

Take special care with Pulmicort Respules

Before you use Pulmicort Respules, tell your doctor or pharmacist if:

• You have a lung infection.
• You have a cold or chest infection.
• You have liver problems.

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 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 and breast-feeding

• If you are pregnant, or planning to get pregnant, talk to your doctor before using Pulmicort Respules - 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.
• If you are breast-feeding, talk to your doctor before using Pulmicort Respules.

Driving and using machines

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

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 usual 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 dose of 0.5 mg to 1 mg, twice a day.

Croup

The usual 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 face 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.

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, 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.

Other possible side effects:

Common (affects less than 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 Pulmicort.
• Mild sore throat, coughing and a hoarse voice.

Rare (affects less than 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.

What Pulmicort Respules 0.5 mg contain

The active substance is budesonide. Each Pulmicort Respule 0.5 mg contains 0.5 mg of the active ingredient, budesonide.

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

What Pulmicort Respules 0.5 mg look like and the contents of the pack

Each Respule contains 2 millilitres (ml) of sterile solution.

The solution must be nebulised (made into a fine mist) before it can be breathed in.

Pulmicort Respules 0.5 mg are packed in strips of 5 inside a foil envelope. Each carton contains 20 Respules.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Pulmicort Respules 0.5 mg is held by

Pulmicort Respules 0.5 mg are manufactured by

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Product name Pulmicort Respules 0.5 mg

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