Pulmicort Turbuhaler 100 micrograms/inhalation powder for inhalation
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What PULMICORT TURBUHALER 100 micrograms inhalation powder is and what it is used for
- 2. What you need to know before using PULMICORT TURBUHALER 100 micrograms inhalation powder
- 3. How to use PULMICORT TURBUHALER 100 micrograms inhalation powder
- 4. Possible adverse effects
- 5. Storage of PULMICORT TURBUHALER 100 micrograms inhalation powder
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
PULMICORT TURBUHALER 100 MICROGRAMS/INHALATION
INHALATION POWDER
(Budesonide)
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
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Package leaflet
- What Pulmicort Turbuhaler 100 micrograms inhalation powder is and what it is used for
- What you need to know before using Pulmicort Turbuhaler 100 micrograms inhalation powder
- How to use Pulmicort Turbuhaler 100 micrograms inhalation powder
- Possible side effects
- How to store Pulmicort Turbuhaler 100 micrograms inhalation powder
- Contents of the pack and other information
1. What PULMICORT TURBUHALER 100 micrograms inhalation powder is and what it is used for
Pulmicort Turbuhaler is supplied as an inhalation powder. The powder contains only budesonide. When inhaled through the mouthpiece of the inhaler, the medicine reaches the 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 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 must be used regularly, as prescribed by your doctor.
2. What you need to know before using PULMICORT TURBUHALER 100 micrograms inhalation powder
Do not use Pulmicort Turbuhaler 100 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 of 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). 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 review their growth, as this medicine may cause a delay in growth.
Using Pulmicort Turbuhaler 100 micrograms inhalation powder with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription and herbal medicines. Some medicines may increase the effects of Pulmicort, so your doctor will monitor you closely if you are taking these medicines. In particular, inform your doctor or pharmacist if you are taking 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
There is no evidence that Pulmicort Turbuhaler 100 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 during treatment 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 operating machinery
Pulmicort does not affect your ability to drive or operate tools or machinery.
3. How to use PULMICORT TURBUHALER 100 micrograms inhalation powder
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, please 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 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 100 micrograms inhalation powder” and carefully follow the instructions.
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 those your doctor has indicated.
Each dose of Pulmicort Turbuhaler 100 micrograms inhalation powder contains 100 micrograms of budesonide. You may require another strength of Pulmicort Turbuhaler (see section 6, “Other presentations”).
The recommended doses of Pulmicort Turbuhaler are as follows:
Normal dose
- For adults and elderly patients: 100–1,600 micrograms per day, divided into 1–4 administrations.
If your doctor has prescribed a low dose (100–400 micrograms per day), the total daily dose may be taken as a single dose (in the morning or evening).
- For children aged 6 years and older: 100–800 micrograms per day, divided into 1–4 administrations.
If your doctor has prescribed a low dose (100–400 micrograms per day), the total daily dose may be taken as a single dose (in the morning or evening).
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 feel 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 you finally discontinue the previous treatment.
If you have switched from cortisone-type tablets to Pulmicort Turbuhaler, some symptoms of your condition may temporarily reappear, such as weakness and muscle or joint pain. If any of these symptoms concern you, or if you experience any 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 multidose 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 breathe in deeply and forcefully through the mouthpiece. |
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 the cap. 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, 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. |
Figure 2 |
The inhaler is now ready for use and you must not repeat the above procedure. To inhale a dose, please follow the instructions given below. |
HOW TO USE PULMICORT TURBUHALER To administer a dose, simply follow the instructions below. | |
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Figure 3 |
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NOTE:
Never blow air through the mouthpiece.
Always replace the cap properly after use.
Since the amount of powder dispensed is very small, you may not taste anything after inhalation. However, rest assured that you have inhaled the dose if you have followed the instructions correctly.
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 in the dose indicator window, approximately 20 doses remain (Figure 4). When the red mark reaches the bottom 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 drying agent and not the medication.
Disposal
Always dispose of your used Turbuhaler responsibly, as some medication may remain inside.
If you use more Pulmicort Turbuhaler 100 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, stating the name of the medication and the amount taken. It is advisable to bring the container and the package 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. Do not increase or decrease your dose without consulting your doctor.
If you forget to use Pulmicort Turbuhaler 100 micrograms powder for inhalation
If you forget to take one of your doses 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 not usually experienced during use of Pulmicort Turbuhaler. However, inform your doctor if you experience any of the following adverse effects that are troublesome 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
- Worsening cough or increased difficulty breathing
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 1000 people
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Allergic-type reactions, including skin rash, contact dermatitis, urticaria, and angioedema (swelling of the face, lips and/or tongue with difficulty swallowing and breathing).
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Bruising of the skin.
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Behavioural changes (especially in children).
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Restlessness.
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Nervousness.
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As with other inhaled treatments, bronchospasm (i.e. contraction of the airways causing "wheezing") may rarely occur.
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Effects on the adrenal glands (small glands located near the kidneys).
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Growth retardation.
Adverse effects with unknown frequency that 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 prolonged periods. These effects include:
- changes in bone mineral density (decreased bone).
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 usually occurs only during the first year of treatment, with eventual recovery of 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 it is an effect not listed in this leaflet. You may also report them directly via 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 100 micrograms inhalation powder
Keep this medicine out of the sight and reach of children.
Always replace the cap after using Pulmicort Turbuhaler. Do not store above 30 °C.
Do not use this medicine after the expiry date 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 collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Pulmicort Turbuhaler 100 micrograms inhalation powder
The active substance 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 pack
Each pack contains one dosimeter inhaler capable of delivering 200 doses.
Other presentations
- PULMICORT TURBUHALER 200 MICROGRAMS/INHALATION INHALATION POWDER
- PULMICORT TURBUHALER 400 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 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 Medical Devices (AEMPS) http://www.aemps.gob.es/