Prospect: information for the user

PULMICORT TURBUHALER 100 MICROGRAMS/INHALATION

INHALATION POWDER

(Budesonida)

1.Pulmicort Turbuhaler 100 micrograms inhalation powder and its use

2.What you need to know before starting to use Pulmicort Turbuhaler 100 micrograms inhalation powder

3.How to use Pulmicort Turbuhaler 100 micrograms inhalation powder

4.Adverse effects

5.Storage of Pulmicort Turbuhaler 100 micrograms inhalation powder

6. Contents of the package 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 asthma.

Pulmicort Turbuhaler 100 micrograms is indicated for the maintenance treatment of asthma.However, it does not relieve an acute asthma attack once it has started.It should be used regularly as prescribed by your doctor.

Do not use Pulmicort Turbuhaler 100 microgram 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). 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 100 microgram 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 purchased 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 100 microgram 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 "How to use Pulmicort Turbuhaler 100 micrograms powder for inhalation" section 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 that the dose of Pulmicort Turbuhaler be reduced gradually when stopping this medication, 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 of Pulmicort Turbuhaler must be individualized. Your doctor will indicate the duration of your treatment with Pulmicort Turbuhaler. Do not administer more doses than those indicated by your doctor.

Each dose of Pulmicort Turbuhaler 100 micrograms powder for inhalation contains 100 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:

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 daily total dose can be administered in a single occasion (in the morning or evening).

• For children 6 years 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 daily total dose can be administered in a single occasion (in the morning or evening).

You may start to feel 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 cortisone 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 changing treatment with cortisone 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 present any other such as headache, fatigue, nausea, or vomiting, contact your doctor.

Usage and handling instructions

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

NOTE:

Never exhale through the mouthpiece.

Always place 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 for the first time in the window of the dose indicator, there are approximately 20 doses left (Figure 4). When the red mark reaches the lower edge 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 drying 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 100 micrograms powder for inhalation than you should

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

It is essential that you use the dose indicated in 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 100 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 then continue with the usual treatment. Do not use a double dose to compensate for the missed doses.

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

Like all medicines,this medicine may 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 disappear:

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

Infrequent 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.
• Behavioral changes (especially in children).
• Restlessness.
• Nervousness.
• Like with other inhaled treatments, rarely a bronchospasm (i.e., a contraction of the airways, which causes " wheezing") may 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 may 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 effects not mentioned in this prospectus, 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 prospectus. You can also report them directly through the Spanish System for the 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.

Medicinesshould not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pulmicort Turbuhaler 100 micrograms powder for inhalation

The active ingredient is budesonide, each inhaled dose contains 100 micrograms of budesonide. It does not contain propellants or any other type of components (excipients).

Appearance of the product and contents of the packaging

Each package contains a dosing inhaler that can provide 200 doses.

Other presentations

- PULMICORT TURBUHALER 200 MICROGRAMS/INHALATION POWDER FOR INHALATION

- PULMICORT TURBUHALER 400 MICROGRAMS/INHALATION POWDER FOR INHALATION

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

AstraZeneca Farmacéutica Spain S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

Manufacturer responsible:

AstraZeneca AB

S-151 36 Södertälje

Sweden

Last review date of this leaflet: November 2017

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/