Buventol easyhaler

QR code to the website: www.oeh.fi/spl
To obtain information on how to use the Easyhaler inhaler, please scan this QR code. The same
information is also available on the website: www.oeh.fi/spl
Package leaflet: Information for the user
Buventol Easyhaler
100 micrograms/dose, powder for inhalation
200 micrograms/dose, powder for inhalation
Salbutamol
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Buventol Easyhaler is and what it is used for
2. Important information before using Buventol Easyhaler
3. How to use Buventol Easyhaler
4. Possible side effects
5. How to store Buventol Easyhaler
6. Contents of the pack and other information

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

Salbutamol belongs to a group of medicines called short-acting beta-2 agonists, which cause relaxation of the smooth muscles of the bronchi. It opens the airways and thus helps maintain airway patency. It relieves respiratory symptoms such as chest tightness, wheezing and cough. The effect of salbutamol begins within a few minutes and lasts for a short period (4 to 6 hours).
Buventol Easyhaler is indicated in adults and children over 6 years of age for symptomatic treatment of asthma attacks and asthma exacerbations, as well as for prevention of exercise-induced asthma attacks or asthma attacks triggered by anticipated exposure to allergens usually causing breathlessness.
In adults, the medicine is also indicated for symptomatic treatment of exacerbations of chronic obstructive pulmonary disease (COPD) with reversible airway obstruction.

2. Important information before using Buventol Easyhaler

When not to use Buventol Easyhaler

• if the patient is allergic to salbutamol, milk proteins, or any of the other ingredients of this medicine (listed in section 6).
• in cases of threatened miscarriage or for prevention of premature labor.

Warnings and precautions
Before starting treatment with Buventol Easyhaler, consult a doctor or pharmacist if the patient has:

• high blood pressure,
• any heart or blood vessel disease,
• problems with blood sugar levels, including diabetes,
• hyperthyroidism,
• low potassium levels in the blood. The doctor may recommend monitoring blood potassium levels during treatment with Buventol Easyhaler.

If the patient experiences shortness of breath or chest pain, medical advice should be sought immediately.
Buventol Easyhaler and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently taken, or planned to be taken.
In particular, inform the doctor if the patient is taking the following medicines:

• other medicines that relax smooth muscles of the airways,
• beta-blockers (e.g. propranolol) (used in the treatment of high blood pressure or other heart diseases),
• theophylline or aminophylline (used in the treatment of asthma or chronic obstructive pulmonary disease),
• medicines used to treat depression,
• diuretics,
• cardiac glycosides (medicines used in the treatment of heart diseases).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used in pregnant women, women planning pregnancy, or women who are breastfeeding, unless otherwise advised by a doctor.

Driving and operating machinery
There are no data available on the influence of this medicine on the ability to drive vehicles or operate machinery.

Buventol Easyhaler contains lactose
The medicine contains a small amount of lactose (milk sugar), which is unlikely to cause problems in patients with lactose intolerance. However, if the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

3. How to use Buventol Easyhaler

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The active substance of the medicine – salbutamol – is contained in the Easyhaler inhaler. The medicine is a dry powder intended for inhalation via the inhaler mouthpiece.

Buventol Easyhaler should be used when needed, not on a regular basis.

Recommended dose:

Adults:

• For the treatment of acute bronchospasm, 100 µg (micrograms) to 200 µg of salbutamol should be administered.
• For the prevention of asthma attacks triggered by physical exertion or anticipated exposure to allergens, 100 µg or 200 µg of salbutamol should be administered 15–30 minutes before physical exertion or anticipated allergen exposure.

Children over 6 years of age:

• For the treatment of acute bronchospasm, the initial recommended dose is 100 µg of salbutamol. The dose may be increased to 200 µg of salbutamol if necessary.
• For the prevention of asthma attacks triggered by physical exertion or allergens, 100 µg or 200 µg of salbutamol should be administered 15–30 minutes before physical exertion or anticipated allergen exposure.

Buventol Easyhaler is not indicated for use in children under 6 years of age.

The maximum daily dose (within 24 hours) for adults and children is 800 μg (8 inhalations of Buventol Easyhaler, 100 micrograms per inhalation, or 4 inhalations of Buventol Easyhaler, 200 micrograms per inhalation).

IT IS VERY IMPORTANT NOT TO USE Buventol Easyhaler IN HIGHER DOSES OR MORE FREQUENTLY THAN PRESCRIBED BY YOUR DOCTOR.

Important

If a patient's asthma is active (for example, frequent symptoms or exacerbations such as breathlessness interfering with speaking, eating, or sleeping, coughing, wheezing, chest tightness, or reduced physical performance), the patient should immediately inform their doctor. The doctor may initiate or increase the dose of a controller medication to maintain asthma symptoms under control, such as an inhaled corticosteroid.

If a patient feels that the medicine is not working as well as usual, they should inform their doctor as soon as possible (for example, if higher doses are needed to relieve breathing difficulties, or if asthma symptoms do not subside within at least 3 hours after using the inhaler), as asthma may be worsening and another medication may be required.

If a patient uses Buventol Easyhaler more than twice a week to relieve asthma symptoms, excluding prophylactic use before physical exertion, this indicates poorly controlled asthma and increases the risk of severe asthma attacks (exacerbations), which may lead to serious complications, be life-threatening, or even fatal. The patient should contact their doctor promptly to reassess the asthma treatment regimen.

If a patient is using a daily anti-inflammatory lung medication, such as an inhaled corticosteroid, it is important to continue using it regularly, even if they feel better.

If a patient feels that the effect of Buventol Easyhaler is too strong or too weak, they should consult their doctor.

Instructions for using the inhaler are provided at the end of this leaflet.

Overdose of Buventol Easyhaler

If more of the medicine is taken than recommended, symptoms such as increased heart rate and tremor may occur. These symptoms should resolve spontaneously within a few hours, but the patient should inform their doctor or pharmacist. Additionally, hypokalaemia (low potassium levels) and increased blood glucose may occur, along with symptoms suggestive of lactic acidosis (elevated blood lactate levels), such as abdominal pain, increased lung ventilation (rapid breathing), shortness of breath despite reduced wheezing, cold hands and feet, irregular heartbeat, and increased thirst.

Missed dose of Buventol Easyhaler

If a dose of Buventol Easyhaler is missed, the next dose should be taken at the usual time, or the medicine should be taken before symptoms of breathlessness occur. The doctor may recommend taking the medicine regularly every day or only when symptoms such as breathlessness or shallow breathing occur.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If the patient experiences any of the following symptoms, the use of Buventol Easyhaler must be discontinued immediately and medical advice must be sought without delay:

• Uncommon (may affect up to 1 in 100 people): itching, rash, skin redness, swelling of the eyelids, lips, face or larynx, wheezing, low blood pressure or collapse. These may be symptoms of a severe hypersensitivity reaction (anaphylactic reaction or angioedema).
• Rare (may affect up to 1 in 1,000 people): worsening of wheezing and increased breathlessness (paradoxical bronchospasm) immediately after using the inhaler.

Other possible adverse reactions:
Common (may affect up to 1 in 10 people)

• headache
• increased heart rate, palpitations (awareness of heartbeat, faster or stronger than usual)
• peripheral vasodilation
• tremor

Uncommon (may affect up to 1 in 100 people)

• dryness of the oral mucosa, irritation of the oral and pharyngeal mucosa – rinsing the mouth and throat after inhalation helps prevent irritation

Rare (may affect up to 1 in 1,000 people)

• decreased blood potassium levels
• anxiety
• dizziness
• insomnia
• hyperactivity in children
• cough
• muscle cramps
• muscle pain

Very rare (may affect up to 1 in 10,000 people)

• sensation of irregular heartbeat

Frequency unknown (cannot be estimated from available data)

• myocardial ischaemia (may present, for example, as chest pain)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Buventol Easyhaler

Keep the medicine out of the sight and reach of children.
Store below 25 °C.
Before first use, the medicine should be stored in its original packaging.
After opening the aluminium foil pack, protect the medicine from moisture. It is recommended to store the inhaler in a protective container.
If the inhaler becomes damp, it should be replaced with a new one.
The inhaler should be replaced 6 months after opening the foil pack. To help remember the date of opening, write it down in the box below:
Do not use Buventol Easyhaler after the expiry date stated on the packaging following:
Expiry (EXP). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Buventol Easyhaler contains

• The active substance is salbutamol in the form of salbutamol sulfate.
  Buventol Easyhaler, 100 micrograms/inhalation dose:
  One metered dose contains 100 micrograms (µg) of salbutamol as 120.5 µg of salbutamol sulfate.
  One delivered dose contains 90 micrograms (µg) of salbutamol as 108.5 µg of salbutamol sulfate.

Buventol Easyhaler, 200 micrograms/inhalation dose:
One metered dose contains 200 micrograms (µg) of salbutamol as 241 µg of salbutamol sulfate.
One delivered dose contains 180 micrograms (µg) of salbutamol as 217 µg of salbutamol sulfate.

• Other ingredient: lactose monohydrate (contains milk proteins).

What Buventol Easyhaler looks like and contents of the pack
White or almost white powder.
1 powder inhalator Easyhaler contains 200 doses.
The plastic powder inhalator Easyhaler is equipped with a mouthpiece and a dose counter, packed in a laminated aluminium foil pouch (PET/Al/PE) and placed in a cardboard box.
Pack sizes:

• 200 doses in a powder inhalator
• 200 doses in a powder inhalator with a protective case

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
For further information, contact the representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]
Detailed and up-to-date information about this medicinal product regarding its use is available by scanning with a smartphone the QR code indicated in the Patient Leaflet, on the outer packaging of the medicine, and on the label of the inhalator. The same information is also available on the website: www.oeh.fi/spl
QR code for the website: www.oeh.fi/spl

How to use the Easyhaler inhaler
Information about the Easyhaler inhaler
The Buventol Easyhaler inhaler may differ from inhalers previously used by the patient.
Therefore, it is very important to use it correctly, as incorrect use may result in the patient not receiving the proper amount of medicine. This could lead to worsening of the patient's condition or result in asthma or COPD (chronic obstructive pulmonary disease) not being properly treated.
The doctor, nurse, or pharmacist will show the patient how to use the inhaler correctly.
The patient should ensure they understand how to use the inhaler properly. If in doubt, contact the doctor, nurse, or pharmacist. As with all inhalers, caregivers should ensure that children prescribed Buventol Easyhaler use the correct inhalation technique as described below. Instructional videos are also available at: www.oeh.fi/spl

First use of the Easyhaler inhaler

The Easyhaler inhaler is supplied in a laminated foil sachet. The sachet should not be opened until the start of treatment, as it helps to keep the powder in the inhaler dry. When the patient is ready to start treatment, open the packaging and record the date of opening, for example in a calendar. The Buventol Easyhaler inhaler can be used for 6 months after removal from the foil sachet.

HOW TO USE THE INHALER CORRECTLY

Step 1: SHAKING Remove the mouthpiece cover. Holding the inhaler upright, shake it up and down from 3 to 5 times.	SHAKE 3 TO 5 TIMES	Important information to remember It is important to keep the inhaler in an upright position. If the inhaler is accidentally actuated during shaking, remove the powder from the mouthpiece as described below.
Step 2: ACTUATING Hold the inhaler upright, using your index finger and thumb. Press down on the inhaler until you hear a click, then release pressure until you hear a second click. This releases the medication dose. Only one actuation is possible.	ACTUATE ONCE	Important information to remember The inhaler will not actuate if the mouthpiece cover has not been removed. Only one actuation is allowed. If actuated more than once, remove powder from the mouthpiece, see below. To release the medication dose, press down before inhaling, but not at the same time. Keep the inhaler upright during actuation and inhalation to prevent powder from spilling out of the inhalation channel.
		before inhaling.
Step 3: INHALATION Hold the inhaler upright. Breathe normally. Place the mouthpiece in the mouth between the teeth and seal lips tightly around it. Take a strong and deep breath in. Remove the inhaler from the mouth, hold breath for at least 5 seconds, then breathe normally.	INHALATION	Important information to remember Ensure the entire mouthpiece is inside the mouth to allow proper delivery of medication to the lungs. Make sure the lips are tightly sealed around the mouthpiece. Do not exhale into the inhaler. This is important: it may cause blockage of the inhaler. If you do exhale into the inhaler, remove powder from the mouthpiece as described below.

If an additional inhalation is necessary, repeat the steps described in points 1–3
"Shake, Click, Inhale."
After using the inhaler:

• Replace the mouthpiece cover to prevent accidental activation of the inhaler.

How to remove powder from the mouthpiece If the inhaler has been accidentally actuated, actuated multiple times, or if you have exhaled into the inhaler, remove powder from the mouthpiece: Tap the mouthpiece on a table or your palm to remove the powder. Then restart the "Shake-Click-Inhale" steps.

Cleaning the Easyhaler inhaler
The inhaler should be kept 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.

Use of the Easyhaler inhaler in the protective packaging The inhaler can be used in the protective packaging, which will increase the product's durability. Before placing the inhaler into the protective packaging, ensure that the cap covers the mouthpiece of the inhaler to prevent accidental actuation. The inhaler may be used without removing it from the protective packaging.
Use as directed above: 1. Shaking, 2. Clicking, 3. Inhalation. Remember to: Hold the inhaler vertically during clicking and inhalation. Replace the cap on the mouthpiece after taking the dose to prevent accidental actuation of the inhaler.
Switching to a new Easyhaler inhaler The inhaler is equipped with a dose counter indicating the number of remaining doses. The counter rotates every five actuations. When the dose counter turns red, this indicates that 20 doses remain. If the patient does not yet have a new Easyhaler inhaler, they should contact their doctor to obtain a new prescription. When the counter shows 0, the Easyhaler inhaler should be replaced. If the patient is using a protective packaging, it should be kept and used for the new inhaler.

To remember

• 1. Shake, 2. Click, 3. Inhale.
• The inhaler must not get wet; protect it from moisture.

If you have any further questions regarding the use of this medicine, consult your
doctor or pharmacist.