Leaflet: information for the user

PULMICORT TURBUHALER 400 MICROGRAMS/INHALATION

INHALATION POWDER

(Budesonida)

1.What Pulmicort Turbuhaler 400 micrograms inhalation powder is and what it is used for

2.What you need to know before you start using Pulmicort Turbuhaler 400 micrograms inhalation powder

3.How to use Pulmicort Turbuhaler 400 micrograms inhalation powder

4.Possible side effects

5.Storage of Pulmicort Turbuhaler 400 micrograms inhalation powder

6. Contents of the pack and additional information.

Pulmicort Turbuhaler is presentedin the form of inhalation powder.The powder contains only budesonide.Wheninspiredthrough the mouthpiece of the inhaler, the medication reaches the lungs.

Budesonide belongs to a group of medicines called glucocorticoids, which are used to reduce inflammation. Pulmicort Turbuhaler reduces and prevents airway inflammation causing your disease (asthma or chronic obstructive pulmonary disease, COPD).

Pulmicort Turbuhaler 400 micrograms is indicated for the maintenance treatment of diseases that are characterized by airway inflammation (asthma or COPD).However, it does not relieve an acute asthma attack when it has already started.It should be used regularly, as prescribed by your doctor.

Do not use Pulmicort Turbuhaler 400 micrograms powder for inhalation:

• if you are allergic (hypersensitive) to budesonide.

Warnings and precautions

• If you have experienced any unusual reaction to other medications in the past, inform your doctor.
• In certain cases, Pulmicort Turbuhaler should be administered with special caution. You should always inform your doctor of any other conditions you may have, especially if you have or have had pulmonary tuberculosis, other recent infections, or liver problems.
• This medication has been prescribed for the treatment of the condition you have (asthma or COPD). Do not use it for another condition unless your doctor tells you to. Do not give it to anyone else.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

• If administered to children, your doctor will regularly check their growth as this medication may cause growth retardation.

Use ofPulmicort Turbuhaler 400 micrograms powder for inhalationwith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications obtained without a prescription and herbal remedies. Some medications may increase the effects of Pulmicort, so your doctor will perform thorough checks if you are taking these medications. In particular, inform your doctor or pharmacist if you are using any of the following medications:

•Antifungal medications (such as itraconazole and ketoconazole).

•Medications for HIV (such as ritonavir or cobicistat).

•Cimetidine (medication for stomach acid).

Use in athletes

It is reported to athletes that this medication contains a component that may produce a positive result in doping control tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is no evidence that Pulmicort Turbuhaler 400 micrograms powder for inhalation can harm the mother or baby when used during pregnancy or breastfeeding. However, you should contact your doctor as soon as possible if you become pregnant during treatment with Pulmicort Turbuhaler. Pulmicort passes into breast milk, but in minimal amounts, which have no effect on the infant.

Use in children

Pulmicort should always be administered under the supervision of an adult, in order to ensure the correct administration of the medication.

Driving and operating machinery

Pulmicort does not affect your ability to drive or use tools or machines.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Administration form and route

This medication is administered by inhalation.

Your doctor will indicate the duration of your treatment with Pulmicort Turbuhaler. Do not exceed the recommended treatment duration.

Before starting the use of Pulmicort Turbuhaler for the first time, it is essential that you read the information included in the section “How to use Pulmicort Turbuhaler 400 micrograms powder for inhalation” and follow the instructions carefully.

Children may not use the dosing system properly. Therefore, it is essential to ensure that the child can follow the usage instructions correctly.

It is recommended to gradually reduce the dose of Pulmicort Turbuhaler when stopping its use, do not stop it abruptly.

Remember to rinse your mouth with water after each inhalation, to eliminate the part of the medication that remains in the mouth without being absorbed by the lungs, and which could cause adverse effects.

Dosage, frequency of administration, and treatment duration

The dose ofPulmicort Turbuhalermust be individualized. Your doctor will indicate the duration of your treatment withPulmicort Turbuhaler.Do not administer more doses than those indicated by your doctor.

Each dose of Pulmicort Turbuhaler 400 micrograms powder for inhalation contains 400 micrograms of budesonide.You may require another dose of Pulmicort Turbuhaler,(see section 6. “Other presentations”).

The recommended doses of Pulmicort Turbuhaler are as follows:

Asthma

Normal dose

• For adults and elderly:100-1,600 micrograms per day, divided into 1-4 administrations.

If your doctor has prescribed low doses (100-400 micrograms per day), the total daily dose can be administered in a single occasion (in the morning or evening).

• For children aged 6 or older:100-800 micrograms per day, divided into 1-4 administrations.

If your doctor has prescribed low doses (100-400 micrograms per day), the total daily dose can be administered in a single occasion (in the morning or evening).

In cases of severe asthma and during exacerbations of the disease, some patients may experience an improvement by dividing the daily dose into 3-4 administrations per day.

You may start feeling better already from the first day of using Pulmicort Turbuhaler, although it may take 1 or 2 weeks to achieve a complete effect. Therefore, it is essential not to stop using Pulmicort Turbuhaler even when you feel well.

If your doctor has prescribed Pulmicort Turbuhaler and you are still under treatment with corticosteroid tablets for asthma, you can gradually reduce the dose of tablets (over a period of weeks or months), until you finally stop the previous treatment.

In the case of switching from corticosteroid tablets to Pulmicort Turbuhaler, some symptoms of your disease may temporarily reappear, such as weakness and pain in the muscles and joints. If any of these symptoms concern you, or if you experience any other symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor.

Chronic Obstructive Pulmonary Disease (COPD)

The recommended dose is 400 micrograms twice a day. Follow your doctor's instructions carefully, which may differ from the information contained in this leaflet.

If your doctor has prescribed Pulmicort Turbuhaler and you are still under treatment with oral corticosteroids, they may reduce the dose of tablets gradually (over a period of weeks or months), and may even stop the previous treatment.

In the case of switching from oral corticosteroids to Pulmicort Turbuhaler, some symptoms you previously experienced may temporarily reappear, such as weakness, or pain in the muscles and joints. If any of these symptoms concern you, or if you experience any other symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor.

Usage instructions/handling

Please read the instructions carefully before starting to use your medication.

NOTE:

Never exhale through the mouthpiece.

Always replace the cap properly after use.

As the amount of powder dispensed is very small, you may not notice any taste after inhalation. However, you can be sure that you have inhaled the dose if you have followed the instructions.

Cleaning

The mouthpiece must be cleaned regularly (once a week) with a dry cloth.Do not use water to clean the mouthpiece.

Dose indicator

When you see the red mark on the dose indicator window for the first time, there are approximately 20 doses left (Figure 4). When the red mark reaches the bottom of the window, the inhaler will not release the correct amount of medication and it should be discarded (Figure 5). The sound you hear when shaking the inhaler is due to a desiccant agent and not the medication.

Disposal

Always ensure that you dispose of your used Turbuhaler responsibly, as some of the medication will remain inside.

If you use more Pulmicort Turbuhaler 400 micrograms powder for inhalation than you should

If you have used more Pulmicort Turbuhaler than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the leaflet to the healthcare professional.

It is essential to use the dose indicated on the packaging (reserved space for the pharmacist) or the dose prescribed by your doctor, as using more inhalations will increase the risk of adverse effects without improving efficacy. Do not increase or decrease your dose without consulting your doctor.

If you forgot to use Pulmicort Turbuhaler 400 micrograms powder for inhalation

If you forget to use one of the doses of Pulmicort Turbuhaler, administer the recommended inhalations as soon as you remember and continue with your usual treatment. Do not use a double dose to compensate for the missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicinecan cause side effects, although not everyone will experience them.

Usually, no side effects occur during the use of Pulmicort Turbuhaler. However, inform your doctor about the following side effects that bother you or do not go away:

Frequent side effects: May affect up to 1 in 10 people

• Mild throat irritation.
• Cough.
• Snoring.
• Mouth and throat fungal infections.
• Pneumonia (lung infection) in patients with COPD.

Inform your doctor if you have any of the following symptoms while inhaling budesonide, they may be symptoms of a lung infection:

• Fever or chills

• Increased mucus production, change in mucus color

• Increased cough or difficulty breathing

Less frequent side effects:May affect up to 1 in 100 people

• Cataracts (loss of transparency of the lens in the eye).
• Anxiety.
• Depression.
• Tremors.
• Muscle cramps.
• Blurred vision.

Rare side effects:May affect up to 1 in 1000 people

• Allergic reactions, including skin rash, contact dermatitis, urticaria, and angioedema (inflammation of the face, lips, and/or tongue with difficulty swallowing and breathing).
• Bruises on the skin.
• Alterations in behavior (especially in children).
• Restlessness.
• Nervousness.
• Like with other inhaled treatments, rarely a bronchospasm (i.e., a contraction of the airways, which causes " wheezing") can occur.

• Effects on the adrenal glands (small glands located near the kidneys).

• Delayed growth.

Side effects of unknown frequency that may include

• Sleep disorders,hyperactivity or aggression.
• Glaucoma (increased eye pressure).

Inhaled corticosteroids can affect the normal production of steroid hormones in the body, especially if high doses are used for a long time. These effects include:

• Changes in bone mineral density (bone loss).

These effects are much less likely with inhaled corticosteroids than with oral corticosteroids.

In rare cases, other general effects of inhaled corticosteroid treatment may occur, which may be suspected if you feel tired, or experience headaches, nausea, or vomiting.

In some children and adolescents treated with Pulmicort, a small decrease in growth (of approximately 1 cm) has been observed, which only occurs during the first year of treatment, and the corresponding adult height is eventually recovered.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Always replace the cap after using Pulmicort Turbuhaler. Do not store at a temperature above 30 °C.

Do not use this medication after the expiration date that appears on the packaging and on the inhaler label after CAD/EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Pulmicort Turbuhaler 400 micrograms powder for inhalation

The active ingredient is budesonide, each inhaled dose contains 400 micrograms. It does not contain propellants or any other type of component (excipients).

Appearance of the product and contents of the packaging

Each package contains a dosing inhaler that can provide 100 doses.

Other presentations

- PULMICORT TURBUHALER 100 MICROGRAMS/INHALATION POWDER FOR INHALATION

- PULMICORT TURBUHALER 200 MICROGRAMS/INHALATION POWDER FOR INHALATION

Holder of the marketing authorization and responsible for manufacturing

Holder:

AstraZeneca Farmacéutica Spain S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

Responsible for manufacturing:

AstraZeneca AB

S-151 36 Södertälje

Sweden

Last review date of this leaflet: November 2017

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/