Budesonide Easihaler

1. What is Budesonide Easyhaler and what is it used for

The active substance of Budesonide Easyhaler is budesonide. Budesonide is in the form of a powder in an inhaler called Easyhaler. The powder is inhaled through the mouthpiece of the inhaler into the lungs. Budesonide works by reducing and preventing swelling and inflammation in the lungs.
Budesonide Easyhaler belongs to a group of medicines used for preventivepurposes. It is used to prevent asthma symptoms. It belongs to a group of medicines called corticosteroids.
Budesonide will NOT stop an asthma attack that has already started. For this reason, you should always carry a fast-acting rescuemedicine for widening the airways (a beta-agonist) with you.
The noticeable effect of budesonide may only occur after several days of treatment, while the maximum effect occurs after several weeks. Budesonide Easyhaler should be used regularly to prevent inflammation associated with asthma. You should take this medicine systematically, as recommended, even if you do not feel any symptoms.

2. Important information before using Budesonide Easyhaler

When not to use Budesonide Easyhaler

If you are allergic to:

• budesonide,
• any other ingredient of this medicine (listed in section 6), which is lactose (containing small amounts of milk protein).

In this case, you should contact your doctor, who will change the medicine to another one.

Warnings and precautions

You should inform your doctor beforeusing Budesonide Easyhaler if you have:

• pulmonary tuberculosis,
• any untreated bacterial, viral, or fungal infection of the mouth, respiratory tract, including the lungs,
• severe liver disease.

If you experience blurred vision or other vision disturbances, you should contact your doctor.
After inhalation, you should rinse your mouth to prevent fungal infection of the mouth.
Budesonide Easyhaler is not recommended for use in children under 6 years of age.

Budesonide Easyhaler and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Some medicines may enhance the effect of Budesonide Easyhaler, and your doctor may want to monitor your condition closely when taking such medicines (including some HIV medicines: ritonavir, cobicistat).
You should tell your doctor if you are using:

• nasal sprays containing corticosteroids,
• corticosteroid tablets,
• antifungal medicines containing itraconazole or ketoconazole.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor for advice before using this medicine. Both for the fetus and the mother, it is important to ensure adequate treatment of asthma during pregnancy. As with other medicines used during pregnancy, the benefits of using budesonide for the mother should be weighed against the potential risk to the fetus. You should use the smallest effective dose of budesonide to ensure adequate control of asthma.

Driving and using machines

Budesonide Easyhaler has not been shown to affect the ability to drive or use machines.
The Budesonide Easyhaler inhalation powder contains a small amount of lactose, which is unlikely to cause problems even if you have lactose intolerance. If you have intolerance to some sugars, you should contact your doctor before using this medicine.
Lactose contains small amounts of milk protein, which may cause an allergic reaction.

3. How to use Budesonide Easyhaler

This medicine should always be used as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
Your doctor has prescribed the correct strength and dose of the medicine for you. You should follow your doctor's instructions carefully.
Replacing corticosteroid tablets with Budesonide Easyhaler:
You should inform your doctor if you have been using corticosteroid tablets (e.g., cortisone tablets) to treat asthma. Your doctor may recommend gradually reducing the number of tablets and eventually stopping treatment over several weeks. If during this period of gradual withdrawal you feel unwell, you should contact your doctor, but do not stop using Budesonide Easyhaler.

Use in adults (including the elderly) and adolescents (12-17 years):

• 1-2 doses inhaled in the morning and evening or once a day in the evening.

Use in children (6-11 years):

• 1-2 doses inhaled in the morning and evening or once a day in the evening.

During treatment, your doctor may modify the dose of the medicine from time to time to determine the smallestdose necessary to keep your asthma under control (maintenance dose).
If Budesonide Easyhaler is to be used by a child, you should ensure that they can use the medicine correctly.
In addition to the preventive medicine - Budesonide Easyhaler, you will also need a rescue medicine for widening the airways:
Budesonide will NOT stop an asthma attack that has already started. For this reason, you should always carry a fast-acting rescuemedicine for widening the airways (a beta-agonist) in case you experience acute asthma symptoms.
If you are regularly using a rescue inhaler (beta-agonist), you should use it before administering Budesonide Easyhaler (preventive medicine).
Worsening of asthma symptoms during treatment:
You should contact your doctor as soon as possible if:

• your wheezing or chest tightness worsens during treatment
• you need to use your rescue medicine more often than before
• your rescue medicine does not help as effectively as before. In this case, your asthma may be worsening, and you may need additional treatment.

Using a higher dose of Budesonide Easyhaler than recommended

If you use a higher dose or more doses than recommended, you should contact your doctor as soon as possible. If your doctor does not recommend otherwise, you should continue using Budesonide Easyhaler.
It is important to take the dose of the medicine as instructed in the leaflet or as recommended by your doctor. Do not increase or decrease the dose of the medicine without consulting your doctor.

Missing a dose of Budesonide Easyhaler

If you miss a dose, you should use it as soon as possible or use the next dose according to the dosing schedule. It is best to use the medicine at the same time every day.
Do not use a double dose to make up for a missed dose.

Stopping use of Budesonide Easyhaler

You should not stop using Budesonide Easyhaler without consulting your doctor. If you suddenly stop using this medicine, your asthma symptoms may worsen.
If you have any further questions about using this medicine, you should ask your doctor, pharmacist, or nurse.

Instructions for using the Easyhaler inhaler are at the end of the leaflet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common( may affect up to 1 in 10 people)
Irritation of the throat, difficulty swallowing, coughing, and fungal infections (thrush) in the mouth or throat. If you experience any of these side effects, do not stop using Budesonide Easyhaler. You should consult your doctor.
You can reduce the risk of these side effects by rinsing your mouth and throat with water or brushing your teeth after each dose of the medicine. Do not swallow the water after rinsing; spit it out.
Uncommon( may affect up to 1 in 100 people)
Anxiety, depression, cataract, blurred vision, muscle cramps, and tremors.
Rare( may affect up to 1 in 1,000 people)
Too high or too low levels of cortisol in the blood. Weakened adrenal gland function (adrenal insufficiency). Skin rash, itching, bruising, hoarseness, and restlessness. Delayed growth in children.
Changes in behavior, particularly in children.
Rarely, severe allergic reactionsmay occur:
If you experience itching, rash, redness of the skin, swelling of the eyelids, lips, or throat, wheezing, low blood pressure, or fainting soon after using the medicine, you should:

• stop using Budesonide Easyhaler
• contact your doctor immediately.

Shortness of breath immediately after using the medicine:
Rarely, inhaled medicines may cause worsening of wheezing and shortness of breath (bronchospasm) immediately after using the medicine. In this case, you should:

• stop using Budesonide Easyhaler
• use a fast-acting medicine for widening the airways
• contact your doctor immediately.

Very rare( may affect up to 1 in 10,000 people)
Glaucoma. Decreased bone density (osteoporosis).
Unknown( frequency cannot be estimated from the available data)
Sleep problems, aggression, psychomotor hyperactivity (difficulty sitting still), and irritability. The occurrence of these side effects is much more likely in children.
If you think you have experienced any of these rare side effects or are concerned that they may occur, you should talk to your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Department of Medicinal Product Registration, Medical Devices, and Biocidal Products):
Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Budesonide Easyhaler

The medicine should be kept out of the sight and reach of children.
Before first use: store in a closed foil bag.
After opening the foil bag: store at a temperature below 30°C, protect from moisture. It is recommended to store the Easyhaler inhaler in its protective packaging.
The Budesonide Easyhaler inhaler can be used for a maximum of 6 months after opening the foil bag.
To remember the opening date, you should write it down. __________
If the Budesonide Easyhaler gets wet, it should be replaced with a new one.
Do not use this medicine after the expiry date stated on the label and carton after: "EXP".
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Budesonide Easyhaler contains

• The active substance is budesonide.
• The other ingredient is lactose monohydrate (which contains milk proteins).

What Budesonide Easyhaler looks like and contents of the pack

White or almost white powder.
Budesonide Easyhaler 100 micrograms/dose inhalation powder

• 200 doses + protective packaging for the inhaler
• 200 doses
• 2 x 200 doses
• 600 doses (3 x 200 doses)

Budesonide Easyhaler 200 micrograms/dose inhalation powder

• 120 doses
• 200 doses + protective packaging for the inhaler
• 200 doses
• 2 x 200 doses
• 600 doses (3 x 200 doses)

Budesonide Easyhaler 400 micrograms/dose inhalation powder

• 100 doses + protective packaging for the inhaler
• 100 doses
• 2 x 100 doses
• 3 x 100 doses

Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland, Hungary, Germany
Budesonid Easyhaler
Spain
Budesonida Easyhaler
Belgium, Poland
Budesonide Easyhaler
Slovenia
Budesonid Orion Easyhaler
Netherlands
Budesonide Orion Easyhaler
United Kingdom
Easyhaler Budesonide
Norway, Sweden, Denmark, Czech Republic, Slovakia, Austria, Estonia, Lithuania, Latvia, Malta
Giona Easyhaler
Date of last revision of the leaflet:14.10.2021
Detailed and up-to-date information about the use of this medicine is available by scanning the QR code (located on both the outer packaging and the inhaler label) using a smartphone.
The same information is available on the website: www.oeh.fi/bupl
QR code for the website www.oeh.fi/bupl

How to use the Easyhaler inhaler

Information about the Easyhaler inhaler

The Budesonide Easyhaler inhaler may differ from inhalers you have used before. Therefore, it is very important to use it correctly, as incorrect use may result in you not receiving the correct amount of medicine. This may lead to worsening of your condition or inadequate treatment of asthma.
Your doctor, nurse, or pharmacist will show you how to use the inhaler correctly.
You should make sure you understand how to use the inhaler correctly. If you are unsure, you should contact your doctor, nurse, or pharmacist. As with all inhalers, caregivers should ensure that children prescribed Budesonide Easyhaler use the correct inhalation technique, as described below. You can also use the video instructions at: www.oeh.fi/bupl

Using the Easyhaler inhaler for the first time

The Easyhaler inhaler is supplied in a foil bag. Do not open the bag until you are ready to start using the medicine, as it helps to keep the powder in the inhaler dry. If you are ready to start treatment, open the packaging and write down the opening date, e.g., in a calendar. The inhaler can be used for 6 months after removal from the foil bag.

HOW TO USE THE INHALER

Step 1: SHAKING Remove the mouthpiece cover. Holding the inhaler upright, shake the inhaler up and down 3-5 times.

SHAKE 3-5 TIMES

Important information to remember It is important to keep the inhaler upright. If you accidentally click the inhaler while shaking, you should remove the powder from the mouthpiece as instructed below.

Step 2: CLICKING Holding the inhaler upright, hold it with your index finger and thumb. Press the inhaler until you hear a click, and then release the pressure on the inhaler until you hear the click again. This will release a dose of the medicine. You can only click once.

CLICK ONCE

Important information to remember The inhaler will not click if the mouthpiece cover is not removed. You can only click once. If you click more than once, you should remove the powder from the mouthpiece, see below. To release a dose of the medicine, press before inhaling, but not at the same time. While pressing and inhaling the dose, keep the inhaler upright, which prevents the powder from falling out of the inhalation channel before inhaling.

Step 3: INHALATION Holding the inhaler upright. Breathe normally. Place the mouthpiece in your mouth between your teeth and close your lips tightly around the mouthpiece. Take a strong and deep breath. Remove the inhaler from your mouth, hold your breath for at least 5 seconds, then breathe normally.

INHALATION

Important information to remember Make sure the entire mouthpiece is in your mouth, which allows the medicine to be delivered correctly to the lungs. Make sure your lips are tightly closed around the mouthpiece. Do not exhale into the inhaler. This is important: it may block the inhaler. If you exhale into the inhaler, you should remove the powder from the mouthpiece, see below.

How to remove powder from the mouthpiece If you accidentally click the inhaler or click it multiple times, or exhale into the inhaler, you should remove the powder from the mouthpiece: Tap the mouthpiece on a table or your hand to remove the powder. Then start again from the "Shaking-Clicking-Inhalation" steps.

Cleaning the Easyhaler inhaler

You should keep the inhaler dry and clean. If necessary, the mouthpiece of the inhaler can be cleaned with a dry cloth or tissue. Do not use water. The powder in the Easyhaler inhaler is sensitive to moisture.

Using the Easyhaler inhaler in the protective packaging The inhaler can be used in the protective packaging, which helps to increase the product's durability. Before placing the inhaler in the protective packaging, make sure the mouthpiece cover is covering the mouthpiece, which prevents accidental activation of the inhaler. You can use the inhaler without removing it from the protective packaging. Use according to the above instructions, 1. Shaking, 2. Clicking, 3. Inhalation. Remember to: Keep the inhaler upright while clicking and inhaling. Replace the mouthpiece cover after taking a dose to prevent accidental activation of the inhaler.

Switching to a new Easyhaler inhaler The inhaler has a dose counter, which shows the number of doses left. The counter turns every five activations. When the dose counter turns red, it means there are 20 doses left. If you do not have a new Easyhaler inhaler, you should contact your doctor to get a new prescription. When the counter shows 0, you should replace the Easyhaler inhaler. If you are using the protective packaging, you should keep it and place the new inhaler in it.

Remember

• 1. Shaking, 2. Clicking, 3. Inhalation.
• After taking a dose, rinse your mouth with water and spit it out and (or) brush your teeth.
• Do not let the inhaler get wet, and protect it from moisture.

If you have any further questions about using this medicine, you should ask your doctor or pharmacist.