Pulmicort Turbuhaler

• Medicine for oral inhalation (inhaler)
• Reduces respiratory distress due to asthma/COPD
• Used daily
• Suitable for use during pregnancy/breastfeeding

About Pulmicort

Pulmicort is an inhalation medicine. It contains the active ingredient budesonide, which is a type of medicine known as a corticosteroid (adrenal cortex hormone).

This medicine works by reducing and preventing inflammation in your lungs. Pulmicort also protects the lungs from triggers that worsen inflammation, such as smoke, fog, dust mite or pets.

Pulmicort is prescribed in patients with asthma or chronic obstructive pulmonary disease (COPD) with coughing and respiratory distress.

How to use Pulmicort

It is important to use Pulmicort every day, even if you have no asthma symptoms at the time. In order for this medicine to work it must be taken every day for a prolonged period.

Pulmicort comes with an inhaler: the Turbuhaler. The package leaflet contains step-by-step instructions for preparing the inhaler for use and using it correctly. Follow these instructions closely.

The general guidelines for use are listed below.

• Prepare the Turbuhaler for use according to the instructions in the package leaflet.
• Hold your Turbuhaler away from your mouth. Breathe out gently as far as comfortable. Do not breathe out through your Turbuhaler.
• Place the mouthpiece gently between your teeth (do not bite the mouthpiece). Close your lips. Breathe in as deeply and as hard as you can through your mouth.
• Remove the Turbuhaler from your mouth. Then breathe out gently.
• If you need to take a second in inhalation, follow the above steps.
• Replace the cover by screwing it back on tightly after use.
• Rinse your mouth out with water after inhaling your prescribed dose and spit it out.

Dosage

Pulmicort is available in various strengths (100, 200 or 400 micrograms budesonide per inhaled dose of powder). Strength and inhalation frequency must be determined by a doctor. The general guidelines for use are listed below.

Adults:

The recommended dose at the start of treatment is a maximum of 1600 micrograms a day:

• one inhalation of Pulmicort 200 Turbuhaler or Pulmicort 400 Turbuhaler, twice to four times a day.

Or:

• two inhalations of Pulmicort 100 Turbuhaler, twice to four times a day.

Children aged six and above:

The recommended dose at the start of treatment is a maximum of 400 micrograms a day:

• one inhalation of Pulmicort 100 Turbuhaler, twice to four times a day.

Or:

• one inhalation of Pulmicort 200 Turbuhaler, twice a day.

The doctor may lower the dose to, for instance, one in halation once daily, if the desired effect is achieved.

Note: Do not use Pulmicort to treat asthma symptoms as they happen. Use your separate 'reliever inhaler' for this purpose. If you feel you are getting breathless or wheezy while using Pulmicort, stop using Pulmicort and contact your doctor immediately.

Alcohol/driving

Pulmicort is unlikely to affect your ability to drive or operate machinery. This medicine does not interact with alcohol.

Used too much/forgot to take/stop taking Pulmicort

If you use more Pulmicort than prescribed by your doctor, consult your doctor or pharmacist.

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

Do not stop using Pulmicort without consulting a doctor first.

When not to use Pulmicort

Do not use Pulmicort if you are hypersensitive to any of the ingredients in this medicine (see section 'What Pulmicort contains').

When should this medicine be used with caution?

Consult a doctor before using the Pulmicort Turbuhaler if:

• You have a bacterial respiratory infection (e.g., tuberculosis) or a viral infection or fungal infection of the airways. Your doctor may need to adjust your dose.
• You experience symptoms such as pain in muscles and joints, tiredness, headache, nausea and vomiting. These symptoms may occur when switching from anti-inflammatory tablets (e.g., prednisolone) to the Pulmicort Turbuhaler. Your doctor may need to adjust your dose.
• You have allergic reactions after switching from anti-inflammatory tablets to the Pulmicort Turbuhaler. This is because anti-inflammatory medicines suppress allergic responses.
• You have liver problems. Talk to your doctor or pharmacist before taking this medicine.
• You have recently taken corticosteroids (e.g., prednisolone) in tablet form. You may have decreased adrenal function. Your medicine may need to be adjusted.

Pregnancy and breastfeeding

Consult a doctor on the use of Pulmicort if you are pregnant or think you may be pregnant.

Pulmicort can be used while breastfeeding. There is no research that suggests that this medicine is not safe for you or your baby.

Other medicines and Pulmicort

Medicines to treat fungal infections (e.g., ketoconazole and itraconazole) and HIV medicines (protease inhibitors) can intensify the effects of Pulmicort. Consult a doctor if you need to take these medicines for more than one to two weeks.

Please tell your doctor or pharmacist if you are taking or have recently taken any of these or other medicines, including herbal remedies and medicines obtained without a prescription.

Side effects

Medicines can cause side effects, although some people may not experience any. Side effects that are known to be associated with Pulmicort include:

Common (may affect up to 1 in 10 people):

• Fungal infections in the mouth or throat.
• Irritation of the throat.
• Hoarseness.
• Coughing.

Uncommon (may affect up to 1 in 100 people):

• Disturbed sleep.
• Anxiety.
• Feeling over-excited.
• Aggression.

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

• Acute or delayed hypersensitivity, with skin rash, allergic skin reactions, skin rash with severe itching and lumps (hives or urticaria), inflammation of the skin with sudden moisture accumulation underneath the skin and in mucous membranes (e.g., throat, tongue), breathing difficulties and/or itching and skin rash (angioedema). If this happens to you, contact a doctor immediately.
• Severe, life-threatening allergic reaction to certain substances (anaphylactic reaction).
• Decreased adrenal function.
• Growth retardation in children.
• Restlessness.
• Nervousness.
• Feeling of serious dejection and despair (depression).
• Behaviour disorders (mainly in children).
• Acute asthma attack.
• Loss of voice or hoarse voice.
• Bruises.

Frequency not known:

• Raised pressure in the eye (glaucoma).
• Clouding in the lens of the eye (cataract).

Consult a doctor if the side effects are severe or if you experience side effects that are not listed in the package leaflet.

What Pulmicort contains

The active substance is budesonide. Pulmicort Turbuhaler does not contain any other ingredients.

The manufacturers of Pulmicort are:

AstraZeneca AB Forskargatan 18
S-151 85 Södertälje
Sweden

AstraZeneca Dunkerque Production 224, Avenue de la Dordogne BP 41
F-59944 Dunkerque Cedex 2
France

Package leaflet

Read the package leaflet before use. The official package leaflet of Pulmicort is available for download here.