Easyhaler Salbutamol Sulfate 100 micrograms per actuation inhalation powder – patient leaflet, side effects, dosage

1. What Easyhaler^® Salbutamol is and what it is used for

What is Easyhaler Salbutamol?

Easyhaler Salbutamol is a “reliever” inhaler. The active ingredient

is salbutamol, an asthma medicine, which opens up the airways.

Salbutamol has a quick effect and a short duration of action

(4 to 6 hours).

What is Easyhaler Salbutamol used for?

Salbutamol is used to relieve symptoms of asthma and other

asthma-like conditions such as chest tightness, wheezing and

coughing in adults and children aged 4 years and over. It is also

used for prevention of asthma symptoms brought on by exercise

or a known allergen exposure that cannot be avoided.

2. What you need to know before you use Easyhaler^® Salbutamol

Do not use Easyhaler Salbutamol:

• if you are allergic to salbutamol or the other ingredient of this

  medicine (listed in section 6), which is lactose (which contains

  small amounts of milk protein)

• if you unexpectedly go into early labour (premature labour) or

  threatened abortion

Warnings and precautions

Talk to your doctor, nurse or pharmacist before using Easyhaler

Salbutamol if you have any of the following:

• any diseases affecting the heart or blood vessels
• any infection in your lungs
• overactivity of the thyroid gland
• low levels of potassium in your blood
• diabetes

• hereditary problems of galactose intolerance, the Lapp lactase

  deficiency or glucose-galactose malabsorption, you should not

  take this medicine.

Other medicines and Easyhaler Salbutamol

Tell your doctor or pharmacist if you are taking, have recently taken

or might take any other medicines.

In particular it is important to tell your doctor if you are currently

taking any of the following medicines:

• medicines for your breathing problems for example

  theophylline or aminophylline (xanthines)

• corticosteroids
• beta-blockers for your blood pressure e.g. propranolol
• medicines for depression

• water tablets (diuretics) and other medicines for heart

  problems

If you already use “preventor” medication e.g. inhaled

corticosteroid, it is important to continue using it regularly, even if

you feel better.

Pregnancy and breast-feeding

Easyhaler Salbutamol should not be used if you are pregnant or

breast-feeding, think you may be pregnant or are planning to have

a baby, unless you are advised to do so by your doctor. Ask your

doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Easyhaler Salbutamol will normally not affect your ability to drive or

operate machinery (no formal studies have been carried out).

However, if you experience side effects such as dizziness,

increased or uneven heart rate, muscle cramps or muscle pain or if

you feel a bit shaky, your ability to drive or operate machinery may

be affected.

Easyhaler Salbutamol contains lactose

Lactose contains small amounts of milk proteins, which may cause

allergic reaction. If you have been told that you do not tolerate

certain kinds of sugars, contact your doctor before taking this

medicine. The amount of lactose in Easyhaler Salbutamol

(less than 10 mg per dose) does not normally cause problems in

lactose intolerant people.

3. How to use Easyhaler^® Salbutamol

You will be shown how to use the Easyhaler by your doctor or

asthma nurse. Always use this medicine exactly as your doctor

or asthma nurse has told you. Check with your doctor or asthma

nurse if you are not sure how to use the Easyhaler, how many puffs

(actuations) to take or how often to take it.

IMPORTANT-contact your doctor immediately if:

• you need to use this “reliever” inhaler more often than usual
• you need to use your “reliever” more than twice a week
• your wheeziness or chest tightness is worse than usual.

Easyhaler Salbutamol should be used as required rather than

regularly.

If your asthma is active (for example you have frequent symptoms

or flare ups, such as breathlessness that makes speaking, eating or

sleeping difficult, cough, wheezing, tight chest or limited physical

ability), you should tell your doctor right away who may start or

increase a medicine to control your asthma such as an inhaled

corticosteroid.

Tell your doctor as soon as possible if your medicine does not

seem to be working as well as usual (for example you need higher

doses to relieve your breathing problems or your inhaler fails to give

relief for at least 3 hours) as your asthma may be getting worse and

you may need a different medicine.

If you use Easyhaler Salbutamol more than twice a week to treat

your asthma symptoms, not including preventive use before

exercise, this indicates poorly controlled asthma and may increase

the risk of severe asthma attacks (worsening of asthma) that can

have serious complications and may be life-threatening or even

fatal. You should contact your doctor as soon as possible to review

your asthma treatment.

If you use a medicine against inflammation of your lungs daily,

e.g., “inhaled corticosteroid”, it is important to continue using it

regularly, even if you feel better.

The recommended dose for Easyhaler Salbutamol 100 mcg is:

Adults, Older people and Adolescents aged 12 years and over:

For the relief of symptoms of acute asthma attack and intermittent

asthma the starting dose is one puff (100mcg) that may be

increased to two puffs (200mcg). To prevent symptoms before

exercise or contact with whatever triggers your asthma attack the starting dose is two puffs (200mcg) that may be increased to four puffs (400mcg).

Children aged 4 to 11 years:

For the relief of symptoms of acute asthma attack and intermittent asthma the dose is one puff (100mcg) as required. This may be increased to two puffs (200mcg) if required.

To prevent symptoms before exercise or contact with whatever triggers your asthma attack the dose is one puff (100mcg). This may be increased to two puffs (200mcg) if required. For regular treatment the dose is up to two puffs (200mcg) up to 4 times a day.

Children should always have adult supervision when using the Easyhaler

The maximum daily dose (in 24 hours) for both adults and children aged 4 years and over: 8 puffs of the 100 mcg (800 micrograms). The recommended dose for Easyhaler Salbutamol 200 mcg is:

Adults, Older people and Adolescents aged 12 years and over: For the relief of symptoms of acute asthma attack and intermittent asthma the starting dose is one puff (200mcg) that may be increased to two puffs (400mcg). To prevent symptoms before exercise or contact with whatever triggers your asthma attack the starting dose is one puff (200mcg) that may be increased to two puffs (400mcg).

Children aged 4 to 11 years:

For the relief of symptoms of acute asthma attack and intermittent asthma the dose is one puff (200mcg) as required. To prevent symptoms before exercise or contact with whatever triggers your asthma attack the dose is one puff (200mcg). For regular treatment the dose is one puff (200mcg) up to 4 times a day.

Children should always have adult supervision when using the Easyhaler

The maximum daily dose (in 24 hours) for both adults and children: 4 puffs of the 200 mcg (800 micrograms). If you use more Easyhaler Salbutamol than you should

If you have taken more puffs than recommended, you should contact your doctor immediately. You may notice that your heart is beating faster than usual and that you feel shaky. These effects usually wear off in a few hours.

If you forget to use Easyhaler Salbutamol

If you forget to take a dose do not worry. Take your next dose when it is due or if you become wheezy. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

The instructions on how to use the 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.

If you experience any of the following side effects, stop taking Easyhaler Salbutamol and seek immediate medical attention:

• itching, rash or reddened skin
• swelling of the eye lids, lips, face or throat
• low blood pressure or collapse
• increase in wheezing and shortness of breath immediately after dosing.

Other side effects

Common side effects (may affect up to 1 in 10 people)

• feeling a bit shaky
• increased or uneven heart rate
• increased blood flow to your extremities.

Uncommon side effects (may affect up to 1 in 100 people)

• headache.

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

• cough, mouth and throat irritation (these may be prevented by rinsing the mouth with water and spitting it out after inhalation)
• decrease in the level of potassium in your blood
• muscle cramps
• restlessness, dizziness, behavioural difficulties. Very rare side effects (may affect up to 1 in 10,000 people)
• angina (chest pain), heart attack (myocardial ischemia)
• sleep disturbances.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effect directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Easyhaler^® Salbutamol

• Keep this medicine out of the sight and reach of children.
• Before the first use store in the unopened foil bag.
• After opening the foil bag, do not store above 25°C and protect from moisture. It is recommended to keep the Easyhaler in its protective cover.
• If your Easyhaler Salbutamol gets damp, you will need to replace it with a new one.
• Replace your Easyhaler Salbutamol with a new one no later than 6 months after you open the foil bag. Write down the date you opened the bag to help you remember.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Easyhaler Salbutamol contains

• The active substance is salbutamol sulfate
• The other ingredient is lactose (which contains milk protein). What Easyhaler Salbutamol looks like and contents of the pack

White or almost white inhalation powder.

Easyhaler multidose powder inhaler contains 200 doses (puffs). Packages:

200 doses in plastic multidose powder inhaler

200 doses in plastic multidose powder inhaler and protective cover

A protective cover is also available separately.

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FIN-02200 Espoo

Finland

Manufacturer

Orion Corporation, Orion Pharma

Orionintie 1

02200 Espoo

Finland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Orion Pharma UK Ltd, 9^th Floor, The Blade, Abbey Square, Reading, RG1 3BE

Tel.: +44 1635 520 300

This leaflet was last revised in January 2026

Detailed and updated information on how to use this product is available by scanning this QR code (included also on outer carton and inhaler label) with a smartphone. The same information is also available on the following URL: www.oeh.fi/sgb.

120205-21

Scan this code or visit www.oeh.fi/sgb to see instructions on

how to use Easyhaler

www.oeh.fi/sgb

How to use the Easyhaler^® inhaler

About your Easyhaler

Easyhaler Salbutamol may be different to inhalers you have used in the past. Therefore it is very important that you use it properly as using incorrectly can lead to you not receiving the right amount of medicine. This could make you very unwell or could lead to your asthma not being treated as it should.

Your doctor, nurse or pharmacist will show you how to use your inhaler properly. Make sure you understand the correct way to use the inhaler. If you are unsure contact your doctor, nurse or pharmacist. As with all inhalers, caregivers should ensure that children prescribed Easyhaler Salbutamol use correct inhalation technique, as described below. You can also use the instruction video at www.oeh.fi/sgb.

When you first get your Easyhaler

The Easyhaler comes in a foil bag. Do not open the foil bag until you are ready to start using the

medicine as it helps to keep the powder dry in the inhaler.

When you are ready to start treatment open the bag and record the date e.g., in your calendar.

Use the inhaler within 6 months of removing from the foil bag.

HOW TO USE CORRECTLY

If you need to take another inhalation, please repeat the steps 1-3 Shake-Click-Inhale.

After you have used the inhaler:

• Put the dust cap back on the mouthpiece. It stops the inhaler going off by accident.

How to empty the powder from the mouthpiece

If you click the inhaler by accident, or if you might have clicked it more than once, or if you breathe out into it, empty the mouthpiece.

• Tap the mouthpiece to empty the powder onto a table top, or the palm of your hand.
• Then start again with steps Shake-Click-Inhale.

Cleaning the Easyhaler

Keep your inhaler dry and clean. If necessary you may wipe the mouthpiece of your inhaler with a dry cloth or tissue. Do not use water: the powder in the Easyhaler is sensitive to moisture.

Using the Easyhaler with a protective cover

You may use a protective cover with your inhaler. This helps to improve durability of the product. When you first insert your inhaler in the protective cover make sure the dustcap is on the inhaler as this stops it going off by accident. You can use the inhaler without removing it from the protective cover.

Follow the same instructions as above, 1. Shake – 2. Click – 3. Inhale.

Remember to:

• Keep the inhaler in the upright position when clicking it
• Replace the dustcap after taking the dose as this stops the inhaler going off by accident.

When to switch to a new Easyhaler

The dose counter shows the number of remaining doses. The counter turns after every 5th click. When the dose counter starts turning red, there are 20 doses left.

If you do not already have a new Easyhaler, contact your doctor for a new prescription. When the counter reaches 0 (zero), you need to replace the Easyhaler.

If you use the protective cover, you can keep it and insert your new inhaler into it.

Remember

• 1. Shake – 2. Click – 3. Inhale.
• Do not get your inhaler wet, protect it from moisture.

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

Inhaler

Mouthpiece

Dustcapp p

D