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EASYHALER FORMOTEROL 12 MICROGRAMS/DOSE INHALATION POWDER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Formoterol Easyhaler 12 micrograms/dose inhalation powder
Formoterol fumarate dihydrate
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Formoterol Easyhaler is and what it is used for
2. Before you use Formoterol Easyhaler
3. How to use Formoterol Easyhaler
4. Possible side effects
5. How to store Formoterol Easyhaler
6. Further information
1. WHAT FORMOTEROL EASYHALER IS AND WHAT IT IS USED FOR

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

What is Formoterol Easyhaler?

• itching, rash, reddened skin

Formoterol Easyhaler is an asthma medication that opens up the airways thus

• swelling of the eye lids, lips, face or throat

preventing and treating breathing symptoms such as wheezing, shortness of breath

• low blood pressure or collapse

and coughing.

• increase in wheezing, and shortness of breath shortly after dosing.

The active ingredient is formoterol. Formoterol powder is packed in an inhaler called

Other side effects

Easyhaler. You inhale the powder into your lungs through the mouthpiece of the

Common (affecting less than 1 person in 10 but more than 1 in 100):

inhaler.

• tremor

What is Formoterol Easyhaler used for?

• palpitations

It is used:

• headache

• together with inhaled corticosteroids to treat and prevent asthma symptoms

Uncommon (affecting less than 1 person in 100 but more than 1 in 1,000):

• to treat and prevent symptoms of chronic obstructive pulmonary disease (COPD)

• muscle cramps, muscle pain

The effect of formoterol begins within 1−3 minutes and lasts for approximately 12

• fast heart beat

hours.

• dizziness

2. BEFORE YOU USE FORMOTEROL EASYHALER

• sleeplessness
• feeling nervous, restlessness

Do not use Formoterol Easyhaler, if you are allergic (hypersensitive) to:

Rare (affecting less than 1 person in 1,000 but more than 1 in 10,000):

• formoterol

• irregular or uneven heart beat/extra beats

• lactose, which contains small amounts of milk protein.

• decrease in blood potassium level

Not to be given to children under the age of 6.

• mouth or throat irritation
• wheezing/shortness of breath

Take special care with Formoterol Easyhaler

• allergic reactions

Please tell your doctor before using Formoterol Easyhaler if you have any of the

• nausea (feeling sick)

following:
• heart problems
• high blood pressure
• diabetes (you may need some additional blood sugar tests when you start using
this medicine)
• low blood potassium level
• an overactive thyroid gland
• a tumour of the gland next to your kidneys (phaeochromocytoma)
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription, herbal remedies and
natural products.

Very rare (affecting less than 1 person in 10,000):
• taste disturbances
• increase in blood sugar
• chest pain or tightness
• heart condition (prolongation of the QT interval)
• changes in blood pressure
• dizziness
If any of the side effects become serious, or if you notice any side effects not
mentioned in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE FORMOTEROL EASYHALER
• Keep out of the reach and sight of children.

In particular you need to tell your doctor, if you are taking:

• Before the first use store in the unopened laminate pouch.

• monoamine oxidase (MAO) inhibitors e.g. moclobemide for depression. Do not take

• After opening the laminate pouch, do not store above 30°C and protect from

Formoterol Easyhaler, if you have taken MAO inhibitors within previous 14 days.

moisture. It is recommended to keep the Easyhaler in its protective cover.

• tricyclic antidepressants e.g. amitriptyline or imipramine.

• If your Formoterol Easyhaler gets damp, you will need to replace it with a new one.

• medicines for Parkinson’s disease e.g. selegiline and levodopa

• Replace your Formoterol Easyhaler with a new one no later than 4 months after

• medicines for heart conditions including an irregular heart beat or angina

you open the laminate pouch. Write down the date you opened the pouch to help

• medicines for hypertension

you remember: _____________

• beta blockers (either as tablets or eye drops)
• water tablets (diuretics)

Do not use the Easyhaler after the expiry date which is stated on the label and carton.

• erythromycin (used to treat infection)

Medicines should not be disposed of via wastewater or household waste. Ask your

• corticosteroids tablets (such as prednisolone)

pharmacist how to dispose of medicines no longer required. These measures will help

• medicines for respiratory problems e.g. theophylline or aminophylline

to protect the environment.

• medicines for allergies such as antihistamines
• medicines used to treat mental illnesses or severe nausea and vomiting such as
phenothiazines
• medicines for thyroid disorders e.g. levothyroxine
If you are going to have an anaesthetic tell your doctor or dentist that you are using
Formoterol Easyhaler

6. FURTHER INFORMATION
What Formoterol Easyhaler contains
- The active substance is formoterol fumarate dihydrate
- The other ingredient is lactose monohydrate (which contains small amounts of
milk protein)

Using Formoterol Easyhaler with food and drink

What Formoterol Easyhaler looks like and contents of the pack

If you drink alcohol whilst using Formoterol Easyhaler, you may experience an increase

White to yellowish white powder.

in heart rate.
Formoterol Easyhaler 12 micrograms/dose inhalation powder:
Pregnancy and breast-feeding

• 120 doses + protective cover

If you are pregnant, become pregnant or are planning to become pregnant, do not use

• 120 doses

Formoterol Easyhaler unless you are advised to do so by your doctor. Do not breast-

• 2 x 120 doses

feed, if you are using Formoterol Easyhaler.

(Protective cover is available separately)

Driving and using machines

Not all pack sizes may be marketed.

Formoterol Easyhaler should not affect your ability to drive or operate machinery.
However, if you experience side effects such as dizziness, your ability to drive or
operate machinery may be affected.

Marketing Authorisation Holder and Manufacturer
Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Important information about some of the ingredients of Formoterol Easyhaler

This medicinal product is authorised in the Member States of the EEA under

Formoterol Easyhaler contains lactose. If you have been told that you do not tolerate

the following names:

certain kinds of sugars, contact your doctor before taking this medicine.
3. HOW TO USE FORMOTEROL EASYHALER
See “Instructions for using your Easyhaler” at the end of this leaflet.
This leaflet was last updated in September 2011
Your doctor has prescribed a suitable dose for you. Follow your doctor’s instructions
carefully. Do not exceed the recommended doses.
Acute asthma attacks
If you get an acute asthma attack between Formoterol Easyhaler doses, you should
use a short-acting “reliever” inhaler.
Contact your doctor as soon as possible if you experience any of the following:
• wheezing, shortness of breath or coughing is worse than usually
• symptoms come back more quickly than usual
• you need to use a short-acting “reliever” inhaler more often than usually.
Adults (including the elderly) and adolescents (12 to 17 years):
Asthma:
Usually 1 dose (12 mcg) twice daily regularly. This may be increased to a maximum
2 doses (2 x 12 mcg) twice daily.
Chronic Obstructive Pulmonary Disease (COPD):
Usually 1 dose (12 mcg) twice daily regularly. The maximum daily dose is 2 doses per
day.
Children 6 years and above:
Asthma:
Usually 1 dose (12mcg) two times daily regularly. The maximum daily dose is 2 doses
per day.
If you use more Formoterol Easyhaler than you should
If you take too much Formoterol Easyhaler contact your doctor or asthma nurse.
Symptoms of overdose may include nausea, vomiting, headache, tremor and fast heart
beat.
If you forget to use Formoterol Easyhaler
Do not take a double dose to make up for the forgotten one. If you miss a dose, just
take one as soon as you remember. If it is almost time for your next dose, wait and
take the usual amount at the right time.
If you stop taking Formoterol Easyhaler
Do not stop or reduce the dose of Formoterol Easyhaler, inhaled corticosteroid or other
medicines for your breathing problems without talking to your doctor. It is important
to use these medicines regularly, even when you feel better. This medicine is normally
taken in the mornings and in the evenings.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Formoterol Easyhaler can cause side effects, although not
everybody will experience them. These side effects are often mild and may go away as
treatment continues. If they are severe or last for more than a few days, or if you are
worried about any of them, talk to your doctor.

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INSTRUCTIONS FOR USING YOUR EASYHALER
Formoterol Easyhaler is easy to use. Read through these instructions first. They tell you what you should do and what to look out for.
UNPACKING THE INHALER (Figures 1 and 2))

Figure 1

Figure 2

I

The inhaler (Figure 1) comes in a laminate pouch to keep the powder dry. Do not
open the pouch until you are ready to start using your Easyhaler.
A protective cover is optional. If you do not use the protective cover, move on to
section “Taking a dose from Formoterol Easyhaler”.
Open the protective cover and insert the inhaler into it (Figure 2). Make sure the dust
cap covers the mouthpiece of the Easyhaler (this stops the inhaler releasing medicine
by accident).
If you are not using the inhaler immediately, close the protective cover.
TAKING A DOSE FROM FORMOTEROL EASYHALER
If you use the protective cover with your Formoterol Easyhaler, open it.

Figure 3a

Figure 3b

Figure 4a

Figure 4b

Figure 5a

Figure 5b

Remove the dust cap.
A. Shake (Figure 3a or 3b)
Shake the inhaler vigorously up and down 3–5 times, to allow proper
powder flow and a correct dose. After shaking, hold the Easyhaler in the
upright position.
B. Click (Figure 4a or 4b)
Press the inhaler once between your finger and thumb until you hear a click,
and let it click back again to deliver powder into the inhalation channel
inside the mouthpiece. Keep holding the inhaler in the upright position.
If you think that you have clicked the Easyhaler more than once, see
“NOTE!” (Figure 6a or 6b) below.
C. Inhale (Figure 5a or 5b)
In the sitting or standing position
• breathe out normally (but NOT into the inhaler)
• place the mouthpiece in your mouth between your teeth and seal your
lips tightly around it
• take a strong and deep breath through the inhaler (Figure 5a or 5b)
• remove the inhaler from your mouth
• hold your breath for at least 5 seconds, then breathe normally.
Make sure that you do not breathe out into the inhaler, because it could clog
up the inhaler. If this happens, see “NOTE!” (Figures 6a or 6b) below.
If you have been prescribed more than one dose, pause for one minute and
repeat points A, B and C.
Put the dust cap back on the mouthpiece.
Close the protective cover, if you are using it.

NOTE! (Figures 6a or 6b)
Figure 6a

Figure 6b

If you click the inhaler by accident, or if you have clicked it more than once,
or if you breathe out into it, tap the mouthpiece to empty the powder onto
a table top or the palm of your hand (Figure 6a or 6b). This ensures proper
dosing. Then start again with steps A, B and C.
CLEANING
Clean the mouthpiece at least once a week with a clean dry cloth or tissue.
Do not use water or other liquids, the powder in the inhaler is sensitive to
moisture.
If you use the protective cover, you can take the inhaler out of it to wipe it.
When you are putting it back into its protective cover, put the dust cap on

Figure 7a

the mouthpiece to stop it releasing the medicine accidentally.
GETTING A NEW FORMOTEROL EASYHALER (Figures 7a, 7b and 8))
Replace your Easyhaler with a new one 4 months after you opened the
laminate pouch. Write down the date you opened the pouch to help you
remember.
The inhaler has a dose counter which shows how many doses are left
(Figure 7a or 7b). The counter turns after every fifth dose (actuation). When
the numbers turn red, there are 20 doses left. If you do not already have a
new inhaler, contact your doctor for a new prescription. When the counter
reaches 0, you need to replace the inhaler even though you can still observe
the powder in the clear window on the back of the inhaler (Figure 8).
Keep the protective cover for the next inhaler.

Figure 8

Figure 7b

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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