Pulmicort Turbuhaler 400 micrograms/inhalation powder for inhalation: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

PULMICORT TURBUHALER 400 MICROGRAMS/INHALATION

INHALATION POWDER

(Budesonide)

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Package leaflet contents

What Pulmicort Turbuhaler 400 micrograms inhalation powder is and what it is used for
What you need to know before using Pulmicort Turbuhaler 400 micrograms inhalation powder
How to use Pulmicort Turbuhaler 400 micrograms inhalation powder
Possible side effects
Storage of Pulmicort Turbuhaler 400 micrograms inhalation powder
Contents of the pack and other information

1. What PULMICORT TURBUHALER 400 micrograms inhalation powder is and what it is used for

Pulmicort Turbuhaler is presented as an inhalation powder. The powder contains only budesonide. When you inhale through the inhaler's mouthpiece, the medicine reaches your lungs.

Budesonide belongs to a group of medicines called glucocorticoids, which are used to reduce inflammation. Pulmicort Turbuhaler reduces and prevents inflammation in the airways that causes your condition (asthma or chronic obstructive pulmonary disease, COPD).

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

2. What you need to know before starting to use PULMICORT TURBUHALER 400 micrograms inhalation powder

Do not use Pulmicort Turbuhaler 400 micrograms inhalation powder:

if you are allergic (hypersensitive) to budesonide.

Warnings and precautions

If you have previously experienced any unusual reaction to other medicines, inform your doctor.
In certain cases, Pulmicort Turbuhaler should be administered with special caution. You should always inform your doctor about any other conditions you may have, especially if you have or have had pulmonary tuberculosis, other recent infections, or liver problems.
This medicine has been prescribed for you to treat your condition (asthma or COPD). Do not use it for any other 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 periodically monitor their growth, as this medicine may cause a delay in growth.

Use of Pulmicort Turbuhaler 400 micrograms inhalation powder with other medicines

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

Medicines to treat fungal infections (such as itraconazole and ketoconazole).
Medicines for HIV (such as ritonavir or cobicistat).
Cimetidine (a medicine for stomach acidity).

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Pregnancy and breastfeeding

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

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

Use in children

Pulmicort should always be administered under the supervision of an adult to ensure correct administration of the medicine.

Driving and using machines

Pulmicort does not affect your ability to drive or operate tools or machinery.

3. How to use PULMICORT TURBUHALER 400 micrograms powder for inhalation

Follow exactly the dosing instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Method of use and route of administration

This medicine is administered by inhalation.

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

Before using Pulmicort Turbuhaler for the first time, it is important 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 be able to use the dosing system properly. Therefore, it is important to ensure that the child can correctly follow the instructions for use.

It is recommended that the dose of Pulmicort Turbuhaler be gradually reduced when you stop using this medicine; do not stop using it abruptly.

Remember to rinse your mouth with water after each inhalation, to remove any medicine remaining in the mouth that has not been absorbed into the lungs, which could cause adverse effects.

Dosage, frequency of administration, and duration of treatment

The dose of Pulmicort Turbuhaler should be individualized. Your doctor will advise you on the duration of your treatment with Pulmicort Turbuhaler. Do not take more doses than your doctor has indicated.

Each dose of Pulmicort Turbuhaler 400 micrograms powder for inhalation contains 400 micrograms of budesonide. You may require another dose strength 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 doses.

If your doctor has prescribed low doses (100–400 micrograms per day), the total daily dose may be taken as a single dose (in the morning or at night).

For children aged 6 years and older: 100–800 micrograms per day, divided into 1–4 doses.

If your doctor has prescribed low doses (100–400 micrograms per day), the total daily dose may be taken as a single dose (in the morning or at night).

In severe asthma and during worsening of the disease, some patients may benefit from dividing the daily dose into 3–4 doses per day.

You may start to feel better as early as the first day of using Pulmicort Turbuhaler, although it may take 1 or 2 weeks to achieve full effect. Therefore, it is important that you continue using Pulmicort Turbuhaler even when you are feeling well.

If your doctor has prescribed Pulmicort Turbuhaler and you are still undergoing treatment with cortisone-type tablets for asthma, your doctor may gradually reduce your tablet dose (over a period of weeks or months), until eventually discontinuing the previous treatment.

If you have switched from cortisone-type tablet treatment to Pulmicort Turbuhaler, symptoms of your disease may temporarily reappear, such as weakness and muscle or joint pain. If any of these symptoms concern you, or if you experience other symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor.

COPD

The recommended dose is 400 micrograms twice daily. 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 undergoing oral corticosteroid treatment, your doctor may gradually reduce your tablet dose (over a period of weeks or months), and may eventually discontinue the previous treatment.

If you have switched from oral corticosteroid treatment to Pulmicort Turbuhaler, some symptoms you previously experienced may temporarily reappear, such as weakness or muscle and joint pain. If any of these symptoms concern you, or if you experience other symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor.

Instructions for use/handling

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

Pulmicort Turbuhaler is a multi-dose inhaler

that delivers small doses of powder. (Figure 1)

When you inhale through the Turbuhaler, the powder will be released into your lungs. Therefore, it is important that you inhale strongly and deeply through the mouthpiece.

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Figure 1

Preparing the Turbuhaler for the first time:

Before using Pulmicort Turbuhaler for the first time, you must prepare the inhaler for use.

Unscrew and lift off the cover.

Hold the inhaler in an upright position with the base at the bottom (Figure 2). Do not hold the mouthpiece when turning the base. Turn the base fully in one direction and then turn it fully in the opposite direction. It does not matter in which direction you turn first. During this procedure, you will hear a click. You must perform this procedure twice.

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Figure 2

The inhaler is now ready for use and you should not repeat the previous procedure. To inhale a dose, please follow the instructions below.

HOW TO USE PULMICORT TURBUHALER To administer a dose, simply follow the instructions below.
Unscrew and lift the cover. Hold the inhaler in an upright position with the base at the bottom (Figure 2). Do not hold the mouthpiece when turning the base. To load a dose into the inhaler, turn the base fully in one direction, then turn it fully back in the opposite direction. It does not matter which direction you turn first. During this process, you will hear a click.
Hold the inhaler away from your mouth. Breathe out. Do not blow through the mouthpiece.
Gently place the mouthpiece between your teeth, close your lips and inhale steadily and deeply through the device (Figure 3). Do not bite or press on the mouthpiece.	Figure 3
Remove the inhaler from your mouth before breathing out.
If another inhalation is needed, repeat steps 2–5.
Replace the cover firmly after use.
Rinse your mouth with water after inhaling the prescribed dose.

NOTE:

Never expel air through the mouthpiece.

Always replace the cap properly after use.

Since the amount of powder dispensed is very small, you may not notice any taste after inhalation. However, rest assured that you have inhaled the dose correctly if you have followed the instructions.

Cleaning

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

Dose indicator

When you first see a red mark appearing in the dose indicator window, approximately 20 doses remain (Figure 4). When the red mark reaches the lower edge of the window, the inhaler will no longer deliver the correct amount of medication and must be discarded (Figure 5). The sound heard when shaking the inhaler is due to a dispersing agent and not the medication itself.

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Black text on white background displaying the words Figure 5 in serif typeface

Disposal

Always dispose of your used Turbuhaler responsibly, as some medication may remain inside.

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

If you have used more Pulmicort Turbuhaler than prescribed, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount used. It is advisable to bring the medicine package and leaflet to the healthcare professional.

It is important that you use the dose indicated on the packaging (space reserved for the pharmacist) or the one prescribed by your doctor, since using more inhalations will increase the risk of adverse effects without improving efficacy. You must not increase or decrease your dose without consulting your doctor.

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

If you forget to take a dose of Pulmicort Turbuhaler, take the recommended inhalations as soon as you remember, and then continue with your regular treatment schedule. Do not use a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects are usually not experienced during the use of Pulmicort Turbuhaler. However, inform your doctor of any adverse effects that are bothersome or do not go away:

Common adverse effects: May affect up to 1 in 10 people

Mild throat irritation.
Cough.
Hoarseness.
Fungal infection of the mouth and throat.
Pneumonia (lung infection) in patients with COPD.

Inform your doctor if you experience any of the following symptoms while inhaling budesonide, as they could be signs of a lung infection:

Fever or chills
Increased mucus production, change in mucus color
Increased cough or increased breathing difficulties

Uncommon adverse effects: May affect up to 1 in 100 people

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

Rare adverse effects: May affect up to 1 in 1,000 people

Allergic-type reactions, including skin rash, contact dermatitis, urticaria, and angioedema (swelling of the face, lips and/or tongue with difficulty swallowing and breathing).
Bruising of the skin.
Behavioral changes (especially in children).
Restlessness.
Nervousness.
As with other inhaled treatments, bronchospasm (i.e., contraction of the airways causing "wheezing") may rarely occur.
Effects on the adrenal glands (small glands located next to the kidneys).
Growth retardation.

Adverse effects with unknown frequency may include

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

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

changes in bone mineral density (decreased bone strength).

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

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

In some children and adolescents treated with Pulmicort, a slight reduction in growth (approximately 1 cm) has been observed, which normally occurs only during the first year of treatment, with eventual recovery of the expected adult height.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of PULMICORT TURBUHALER 400 micrograms inhalation powder

Keep this medicine out of sight and reach of children.

Always replace the cap after using Pulmicort Turbuhaler. Do not store above 30 ºC.

Do not use this medicine after the expiry date which is stated on the packaging and on the label of the inhaler after CAD/EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pulmicort Turbuhaler 400 micrograms inhalation powder

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

Appearance of the product and contents of the pack

Each pack contains one dosing inhaler capable of delivering 100 doses.

Other presentations

PULMICORT TURBUHALER 100 MICROGRAMS/INHALATION INHALATION POWDER
PULMICORT TURBUHALER 200 MICROGRAMS/INHALATION INHALATION POWDER

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

AstraZeneca Farmacéutica Spain S.A.
C/ Puerto de Somport 21-23
28050 Madrid
Spain

Manufacturer:

AstraZeneca AB
S-151 36 Södertälje
Sweden

Date of the most recent review of this package leaflet: November 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/