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OXIS 6MICROGRAMS TURBOHALER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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Oxis® 6micrograms Turbohaler®/
Oxis® 6micrograms Turbuhaler®
(formoterol fumarate)
This product is available as either of the above names but will be referred
to as Oxis Turbohaler throughout the following:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• 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 only . Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1) What Oxis Turbohaler is and what it is used for
2) What you need to know before you use Oxis Turbohaler
3) How to use Oxis Turbohaler
4) Possible side effects
5) How to store Oxis Turbohaler
6) Contents of the pack and other information

1) What Oxis Turbohaler is and what it is used for
Oxis Turbohaler is an inhaler. It contains a medicine called formoterol. This
belongs to a group of medicines called ‘long-acting beta-agonists’ or
‘bronchodilators’.
It works by relaxing the muscles in your airways. This helps you to breathe
more easily. It starts to work within 1 to 3 minutes and the effects last up to
12 hours.
Your doctor has prescribed this medicine to treat asthma or chronic
obstructive pulmonary disease (COPD).
Asthma
Oxis Turbohaler is used to treat asthma in adults, adolescents and children
6 years and older.
For asthma, your doctor will prescribe two asthma inhalers:
Oxis Turbohaler and a separate ‘corticosteroid’ inhaler. These should be
used together.
• Oxis Turbohaler is used to help prevent asthma symptoms from
happening.
• Some people also use Oxis Turbohaler when they need extra doses for
relief of asthma symptoms, to make it easier to breathe again.
• Oxis Turbohaler can also be used before exercise to prevent asthma
symptoms caused by exercise.
Chronic obstructive pulmonary disease (COPD)
Oxis Turbohaler can also be used to treat the symptoms of COPD in
adults. COPD is a long-term disease of the airways in the lungs, which is
often caused by cigarette smoking.

2) What you need to know before you use Oxis Turbohaler
Do not use Oxis Turbohaler if:
• You are allergic (hypersensitive) to formoterol, or the other ingredients of
this medicine (listed in section 6).
Warning and precautions
Talk to your doctor or pharmacist before using Oxis Turbohaler if:
• You are diabetic. You may need some additional blood sugar tests while
you are using Oxis Turbohaler.
• You have high blood pressure or you have ever had a heart problem.
• You have problems with your thyroid gland.
• You have low levels of potassium in your blood. Your doctor may take
blood samples to check the levels of potassium in your blood.
• You have severe liver problems such as liver cirrhosis.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before using Oxis Turbohaler.
Other medicines and Oxis Turbohaler
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. This includes medicines that you buy
without a prescription and herbal medicines. This is because Oxis
Turbohaler can affect the way some medicines work and some medicines
can have an effect on Oxis Turbohaler.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
• Beta-blocker medicines (such as atenolol or propranolol for high blood
pressure), including eyedrops (such as timolol for glaucoma).
• Medicines for a fast or uneven heart beat (such as quinidine).
• Medicines like digoxin, often used to treat heart failure.
• Diuretics, also known as ‘water tablets’ (such as furosemide). These are
used to treat high blood pressure.
• Steroid medicines that you take by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline). These are
often used to treat asthma.
• Erythromycin (used to treat infections).
• Anti-histamines (such as terfenadine).
• Other substances that dilate the airways (bronchodilators, such as
salbutamol).
• Ephedrine (used to treat asthma or as a decongestant).
• Tricyclic anti-depressants (such as amitriptyline).
If any of the above applies to you, or if you are not sure, talk to your doctor
or pharmacist before using Oxis Turbohaler.
Also tell your doctor or pharmacist if you are going to have a general
anaesthetic for an operation or for dental work.

The addition of anticholinergics (such as tiotropium or ipratropium bromide)
to the treatment with Oxis Turbohaler, can help to open your airways even
more.
Pregnancy and breast-feeding
• If you are pregnant, or breast-feeding, think you may be pregnant, or are
planning to have a baby, ask your doctor for advice before taking this
medicine - do not use Oxis Turbohaler unless your doctor tells you to.
• If you get pregnant while using Oxis Turbohaler, do not stop using Oxis
Turbohaler but talk to your doctor immediately.
Driving and using machines
Oxis Turbohaler is not likely to affect you being able to drive or use any
tools or machines.
Oxis Turbohaler contains lactose
Oxis Turbohaler contains lactose, which is a type of sugar. If you have
been told by your doctor that you have an intolerance to some sugars, talk
to your doctor before using this medicine. The amount of lactose in this
medicine does not normally cause problems in people who are lactose
intolerant.
The excipient lactose contains small amounts of milk proteins, which may
cause allergic reactions.

3) How to use Oxis Turbohaler
• Always use this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure..
• Do not increase the dose of Oxis Turbohaler prescribed by your doctor
without talking to your doctor first.
• If you are using Oxis Turbohaler regularly for asthma or COPD you
should continue to use your medicine, even if you have no symptoms.
Important information about your asthma or COPD symptoms
If you feel you are getting breathless or wheezy while using Oxis
Turbohaler, you should continue to use Oxis Turbohaler but go to see your
doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:
• Your breathing is getting worse or you often wake up at night with
asthma.
• You start getting chest tightness.
• You are not getting relief from your current dose.
• You need to take more than your usual dose for more than two days in a
week.
• You need to use your Turbohaler more often than usual before exercise.
These signs could mean that your asthma or COPD is not being properly
controlled and you may need different or additional treatment immediately.
Asthma
Oxis Turbohaler should not be used in children under 6 years of age.
Adults (18 years and above)
• The recommended dose is 1 or 2 inhalations, once or twice a day.
• Your doctor may increase this to 4 inhalations, once or twice a day.
• Some people also use Oxis Turbohaler as a ‘reliever inhaler’. If you get
asthma symptoms, the usual dose is 1 or 2 inhalations when they
happen.
• A total daily dose of more than 8 inhalations is not normally needed. This
includes the inhalations that you take every day, when you get asthma
symptoms and before exercise. However, your doctor may allow you to
take up to 12 inhalations a day. Do not use more than 12 inhalations in
total in 24 hours.
• Do not take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)
• The recommended dose is 2 inhalations, once or twice a day.
• Some children also use Oxis Turbohaler as a ‘reliever inhaler’. If your
child gets asthma symptoms, the usual dose is 1 or 2 inhalations when
they happen.
• A total daily dose of more than 4 inhalations is not normally needed. This
includes the inhalations that your child takes every day, when they get
asthma symptoms and before exercise. However, your doctor may allow
your child to take up to 8 inhalations a day. Your child should not use
more than 8 inhalations in total in 24 hours.
• Your child should not have more than 2 inhalations at any one time.
Your doctor (or asthma nurse) will help you to manage your asthma. Once
your asthma is well controlled your doctor may consider it appropriate to
gradually reduce the dose of Oxis Turbohaler.
Asthma caused by exercise
If you or your child have asthma symptoms caused by exercise, your
doctor may advise you or your child to use Oxis Turbohaler before
exercise as well. Oxis Turbohaler should not be used in children under 6
years of age.
Adults (18 years and above)
• The recommended dose is 2 inhalations before exercise.
• A total daily dose of more than 8 inhalations is not normally needed. This
includes the inhalations that you take every day, when you get asthma
symptoms and before exercise. However, your doctor may allow you to
take up to 12 inhalations a day. Do not use more than 12 inhalations in
total in 24 hours.
• Do not take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)
• The recommended dose is 1 or 2 inhalations before exercise.

• A total daily dose of more than 4 inhalations is not normally needed. This
includes the inhalations that your child takes every day, when they get
asthma symptoms and before exercise. However, your doctor may allow
your child to take up to 8 inhalations a day.
Your child should not use more than 8 inhalations in total in 24 hours.
• Your child should not have more than 2 inhalations at any one time.
Chronic obstructive pulmonary disease (COPD)
• Only to be used by adults (aged 18 years and above).
• The recommended dose is 2 inhalations once or twice a day.
• Your doctor may advise you to take extra doses for relief of your COPD
symptoms.
• You should not have more than 8 inhalations a day.
• Do not take more than 4 inhalations at any one time.

If you use more Oxis Turbohaler than you should
If you use more Oxis Turbohaler than you should, contact your doctor or
pharmacist for advice immediately. The following effects may happen:
trembling, headache or a rapid heartbeat.
If you forget to use Oxis Turbohaler
• If you forget to take a dose, take it as soon as you remember. However,
if it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you stop using Oxis Turbohaler
Do not stop using Oxis Turbohaler without talking to your doctor.
If you have any further questions on using your Turbohaler, ask your
doctor, nurse or pharmacist.

Preparing your new Oxis Turbohaler Inhaler
Before using your new Oxis Turbohaler for the first time, you need to
prepare it for use as follows.

4) Possible side effects

• Unscrew the white cover
and lift it off. You may hear
a rattling sound.
• Hold your Oxis Turbohaler
upright with the turquoise
grip at the bottom.
• Turn the turquoise grip as
far as it will go in one
direction. Then turn it as far
as it will go in the other
direction (it does not matter
which way you turn it first).
You should hear a click
sound.
• Do this again, turning the
turquoise grip in both
directions.
• Your Oxis Turbohaler is
now ready for use.

If the following happens to you, stop using Oxis Turbohaler and talk
to your doctor immediately:
• Bronchospasm (tightening of the muscles in the airways which causes
sudden wheezing) after inhaling your medicine. This happens very
rarely, may affect up to 1 in 10,000 people.

Mouthpiece
Indicator

Grip

How to take an inhalation
Every time you need to take an inhalation, follow the instructions below.
1. Unscrew the white cover and lift it off.
2. Hold your Turbohaler upright with the turquoise
grip at the bottom.
3. Do not hold the mouthpiece when you load your
Turbohaler. To load your Turbohaler with a dose,
turn the turquoise grip as far as it will go in one
direction. Then turn it as far as it will go in the
other direction (it does not matter which way you
turn it first). You should hear a click sound. Your
Turbohaler is now loaded and ready to use. Only
load your Turbohaler when you need to use it.
4. Hold your Turbohaler away from your mouth. Breathe out gently (as far
as is comfortable). Do not breathe out through your Turbohaler.
5. Place the mouthpiece gently between your teeth.
Close your lips. Breathe in as deeply and as hard as you can through
your mouth. Do not chew or bite on the mouthpiece.
6. Remove your Turbohaler from your mouth.
Then breathe out gently. The amount of medicine that is inhaled is very
small. This means you may not be able to taste it after inhalation. If you
have followed the instructions, you can still be confident that you have
inhaled the dose and the medicine is now in your lungs.
7. If you are to take a second inhalation, repeat steps 2 to 6.
8. Replace the cover tightly after use.
Do not try to remove or twist the mouthpiece. It is fixed to your Turbohaler
and must not be taken off. Do not use your Turbohaler if it has been
damaged or if the mouthpiece has come apart from your Turbohaler.
As with all inhalers, caregivers should ensure that children prescribed Oxis
Turbohaler use correct inhalation technique, as described above.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week with a dry
tissue. Do not use water or liquids.
When to start using a new Turbohaler
• The dose indicator tells you how many does are left in the
Turbohaler, starting with 60 doses when full.
• The dose indicator is marked in intervals of 10 doses.
Therefore, it does not show every dose. When you first see
a red mark at the edge of the indicator window, there are
approximately 20 doses left. For the last 10 doses, the background of the
dose indicator is red. When the ‘0’ on the red background has reached
the middle of the window, you must start using your new
Turbohaler.
Note:
• The grip will still twist and ‘click’ even when your
Turbohaler is empty.
• The sound that you hear as you shake your Turbohaler is
produced by a drying agent and not the medicine.
Therefore the sound does not tell you how much medicine
is left in your Turbohaler.
• If you load you Oxis Turbohaler more than once by mistake before taking
your dose, you will still only receive one dose. However, the dose
indicator will register all the loaded doses.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Other possible side effects:
Common (may affect up to 1 in 10 people)
• Palpitations (awareness of your heart beating), trembling or shaking. If
these effects occur, they are usually mild and usually disappear as you
continue to use Oxis Turbohaler.
• Headache
Uncommon (may affect up to 1 in 100 people)
• Feeling restless or agitated.
• Disturbed sleep.
• Fast heart beat.
• Muscle cramps.
Rare (may affect up to 1 in 1,000 people)
• Uneven heart beat.
• Nausea (feeling sick).
• Low level of potassium in your blood.
• Allergic reactions such as rash, itching and bronchospasm.
Very rare (may affect up to 1 in 10,000 people)
• Chest pain or tightness in the chest (angina pectoris).
• An increase in the amount of sugar (glucose) in your blood.
• Taste changes, such as an unpleasant taste in the mouth.
• Changes in your blood pressure.
• Feeling dizzy.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Oxis Turbohaler
• Keep out of the sight and reach of children.
• Oxis Turbohaler should be stored below 30°C. Store with the cover
properly replaced after use.
• Do not use after the expiry date printed on the Oxis Turbohaler label or
carton. The expiry date refers to the last day of that month.
• Always be sure to dispose of your used Turbohaler responsibly, since
some of the medicine will remain inside it. Medicines should not be
disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines that are no longer required. This will help to
protect the environment.
• If your inhaler fails to work properly or show signs of deterioration you
should seek the advice of your pharmacist who will tell you what to do.

6) Contents of the pack and other information
What Oxis Turbohaler contains
The active substance is formoterol fumarate dihydrate.
Each dose contains 6 micrograms of formoterol fumarate dihydrate of
which you can inhale 4.5 micrograms.
The other ingredient is lactose monohydrate (which contains milk proteins).
What Oxis Turbohaler looks like and contents of the pack
Oxis 6 Turbohaler is an inhaler containing your medicine.
The Turbohaler has a light greenish-blue turning grip and white plastic
body and cover.
Oxis Turbohaler contains 60 actuations.
PL 10383/0700

Oxis 6 micrograms Turbohaler/
Oxis 6 micrograms Turbuhaler

POM

Who makes and repackages your medicine?
Your medicine is manufactured by AstraZeneca AB, Sodertalje, Sweden.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, Unit 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 20.07.2015
Oxis®, Turbohaler® and Turbuhaler® are registered trademarks of
AstraZeneca AB, Sweden.

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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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