Patient Leaflet Updated 10-Feb-2022 | Orion Pharma (UK) Limited
Easyhaler Salbutamol 100mcg and 200mcg
Package leaflet: Information for the user
Easyhaler Salbutamol Sulfate
100 and 200 micrograms/dose inhalation powder
salbutamol sulfate (salbutamol)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Easyhaler Salbutamol is and what it is used for
2. What you need to know before you use Easyhaler Salbutamol
3. How to use Easyhaler Salbutamol
4. Possible side effects
5. How to store Easyhaler Salbutamol
6. Contents of the pack and other information
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:
Warnings and precautions
Talk to your doctor, nurse or pharmacist before using Easyhaler Salbutamol if you have any of the following:
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:
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:
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:
Other side effects
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
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
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
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
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in November 2021
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.
QR code to 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
Step 1: SHAKE
SHAKE x 3-5
Important points to remember
Step 2: CLICK
CLICK x 1
Important points to remember
Step 3: INHALE
INHALE
Important points to remember
If you need to take another inhalation, please repeat the steps 1-3 Shake-Click-Inhale.
After you have used the inhaler:
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.
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:
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
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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+44 (0)1635 520 300