Pulmicort Inhaler

Patient Information Leaflet

What you should know about Pulmicort® Inhaler

budesonide

What is in your Pulmicort Inhaler?

Pulmicort is a pressurised inhalation, suspension. Each puff from your Pulmicort Inhaler contains 200 micrograms of the active ingredient, budesonide. Other ingredients are sorbitan trioleate and CFCs (chlorofluorocarbons 11, 12 & 114). Each inhaler delivers 100 or 200 metered doses.

Budesonide belongs to a group of medicines called steroids, which are used to reduce inflammation.

Who makes your medicine?

The Marketing Authorisation for Pulmicort Inhaler is held by

Pulmicort Inhaler is manufactured by

What is your inhaler for?

Pulmicort Inhaler is used to treat bronchial asthma.

Before using your Pulmicort Inhaler

Make sure you have told your doctor about any other medicines that you are taking, including those you have bought without a prescription.

Please read the following questions carefully. They are being asked to help check that the medicine is suitable for you to take. If the answer to any of these questions is yes, you should talk to your doctor before using your Pulmicort Inhaler.

• Are you already taking another steroid medicine?
• Do you have tuberculosis (TB)?
• Do you suffer from reduced liver function?
• Are you pregnant, thinking of becoming pregnant or breast-feeding? If you become pregnant whilst using Pulmicort Inhaler, you should talk to your doctor as soon as possible.
• Have you got a cold or chest infection?
• Have you been taking a medicine for fungal infections (ketoconazole and itraconazole) for a long time?

Important: You should not use Pulmicort Inhaler if you have had problems in the past when taking medicines containing budesonide, or any of the other ingredients in this medicine listed earlier.

Taking your medicine

It is important to take your medicine as your doctor has told you. The instructions on the label should remind you of what the doctor said. Instructions for using your inhaler are given after the dosage section.

If you have been taking steroid tablets for your asthma, your doctor may reduce the number of tablets that you take, once you start to use Pulmicort Inhaler. If you have been taking oral steroids for a long time, your doctor may want you to have blood tests. You might experience some symptoms as a result of reducing your steroid tablets, in particular; stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea or vomiting occur, please contact your doctor immediately.

If a child has been using an inhaled steroid at high doses for a long time, then the doctor may monitor their height. Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation), if you have been taking a high dose of inhaled steroid for a long time. Your doctor may ask you to carry a steroid warning card to explain to others about your medication.

How to use Pulmicort Inhaler - Always shake the inhaler before use

• 1. Remove the dust cap from the plastic adapter and check that the mouthpiece is not blocked. Then shake the inhaler vigorously, so that the contents of the aerosol canister are properly mixed before each actuation.
• 2. Holding the inhaler with the mouthpiece near your lips, breathe out gently.
• 3. Put the mouthpiece between your lips. Start to breathe in slowly and deeply through your mouth. Keep breathing in and press the canister firmly to release a dose of Pulmicort. Keep breathing in for a short while after pressing the canister.
• 4. Hold your breath for 10 seconds, or as long as it is comfortable, before breathing out slowly. If you are to take a second puff, you should wait at least one minute before shaking the inhaler vigorously and repeating steps 2, 3 and 4.
• 5. After use, replace the dust cap on the plastic adapter.

Cleaning: The inhaler should be cleaned regularly (approximately once a week). Remove the aerosol canister and clean the plastic adapter in warm water, dry thoroughly and then replace the aerosol canister.

After taking your medicine

Like all medicines, as well as the effects that are needed, Pulmicort may sometimes cause side effects such as:

• Sore mouth (oral thrush). This is less likely to occur if you rinse your mouth out with water after you have taken a dose.
• Mild sore throat, coughing or a hoarse voice.

The following side effects may occur rarely, particularly if a high dose is taken for a long time, or if oral steroids are also taken (or used to be taken):

• An effect on the adrenal gland (a small gland next to the kidney). Your doctor may ask for a blood sample from time to time.
• Slowing the growth of children and adolescents.
• Changes in bone mineral density (thinning of the bones).
• Cataract (clouding of the lens in the eye).
• Glaucoma (increased pressure in the eye).

These effects are much less likely to occur than with oral steroids.

Other rare side effects are:

• Nervousness, restlessness, depression or odd behaviour.
• Allergic reactions, including skin rash, contact dermatitis (a skin disease), itchy rash, swelling (particularly around the mouth) or bronchospasm (tightening of the muscles in the airways, resulting in wheezing). If swelling occurs around the mouth, seek medical advice immediately.
• Skin bruising.

Very occasionally, inhaled drugs may cause acute wheezing. If this occurs, stop using Pulmicort immediately and seek medical advice.

If you experience any of these effects, or if you notice anything else unusual, tell your doctor or pharmacist.

Storing your medicine

• Keep your inhaler in a safe place, out of the reach and sight of children.
• Do not store this medicine above 30°C.
• Do not use your inhaler after the expiry date given on the box.

Warning: The aerosol canister is filled under pressure. The valve must not be damaged and the canister should not be exposed to high temperatures (above 40°C) or direct sunlight. Do not puncture or burn, even when empty.