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OXIS 12 MICROGRAMS TURBOHALER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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ASSESSED AGAINST UK PIL DATED MARCH 2016

By austino at 9:41 am, Sep 28, 2016

Mock-up

The addition of anticholinergics (such as tiotropium or ipratropium bromide) to the treatment
with Oxis Turbohaler, can help to open your airways even more.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxis® 12 Micrograms Turbohaler®
(formoterol fumarate dihydrate)

Pregnancy, breast-feeding and fertility


Your medicine is available using the name Oxis 12 Micrograms Turbohaler but will be referred to
as Oxis Turbohaler throughout the leaflet.
Read all of this leaflet carefully before you start using 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 aged 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.



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.




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)




2.



WHAT YOU NEED TO KNOW BEFORE YOU USE OXIS TURBOHALER

Do not use Oxis Turbohaler:


If you are allergic (hypersensitive) to formoterol, or any of the other ingredients of this
medicine (listed in section 6).

Warnings 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.

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

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.

Chronic obstructive pulmonary disease (COPD)

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.



The recommended dose is 1 inhalation, once or twice a day.
Your doctor may increase this to 2 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 inhalation when they happen.
A total daily dose of more than 4 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 6 inhalations a day. Do not use more
than 6 inhalations in total in 24 hours.
Do not take more than 3 inhalations at any one time.

Children and adolescents (6 to 17 years)







The recommended dose is 1 inhalation 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 inhalation when they happen.
A total daily dose of more than 2 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 4 inhalations a day. Your
child should not use more than 4 inhalations in total in 24 hours.
Your child should not have more than 1 inhalation 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 1 inhalation before exercise.
A total daily dose of more than 4 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 6 inhalations a day. Do not use more
than 6 inhalations in total in 24 hours.
Do not take more than 3 inhalations at any one time.

Children and adolescents (6 to 17 years)





Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an
operation or for dental work.
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The recommended dose is 1 inhalation before exercise.
A total daily dose of more than 2 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 4 inhalations a day. Your
child should not use more than 4 inhalations in total in 24 hours.
Your child should not have more than 1 inhalation at any one time.

Chronic obstructive pulmonary disease (COPD)






Preparing your new Oxis Turbohaler

Before using your new Oxis Turbohaler for the first time, you
need to prepare it for use as follows:
• Unscrew the white cover and lift it off. You may hear a rattling
sound.


If you stop using Oxis Turbohaler

Only to be used by adults (aged 18 years and above).
The recommended dose is 1 inhalation 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 4 inhalations a day.
Do not take more than 2 inhalations at any one time.

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.

4.

If the following happens to you, stop using Oxis Turbohaler and talk to your
doctor immediately:

Mouthpiece



Indicator








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 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.

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.

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

Hold your Oxis Turbohaler upright with the turquoise grip at
the bottom.
Grip



POSSIBLE SIDE EFFECTS

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

Trembling or shaking. If these effects occur, they are usually mild and usually disappear as
you continue to use Oxis Turbohaler.
Headache.
Feeling dizzy.
Nausea (feeling sick).
Muscle cramps.

Uncommon (may affect up to 1 in 100 people)


Palpitations (awareness of your heart beating). If this effect occurs, it is usually mild and
usually disappears as you continue to use Oxis Turbohaler.
Disturbed sleep.
Fast heart beat.
Allergic reactions such as rash, itching and bronchospasm.
Low level of potassium in your blood.
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.
Uneven heart beat.
Chest pain or tightness in the chest (angina pectoris).

1.

Unscrew the white cover and lift it off. You may hear a rattling sound.











2.

Hold your Turbohaler upright with the turquoise grip at the bottom.

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

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.

By reporting side effects you can help provide more information on the safety of this medicine.

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.

How to take an inhalation

Every time you need to take an inhalation, follow the instructions below.

7.

If you are to take a second inhalation, repeat steps 2 to 6.

8.

Replace the cover tightly after use.

Feeling restless or agitated.

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 effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

5.










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.

6.

HOW TO STORE OXIS TURBOHALER

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C.
Keep container tightly closed on your Oxis Turbohaler when you are not using it.
Do not use a damaged Oxis Turbohaler.
Do not use after the expiry date printed on the carton or inhaler. The expiry date refers to
the last day of that month.
If your doctor tells you to stop taking the medicine, please take it back to the pharmacist for
safe disposal. Only keep the medicine if your doctor tells you to.
If the medicine becomes discoloured or shows signs of deterioration, you should seek the
advice of your pharmacist.
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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Oxis Turbohaler contains

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.

The active substance is formoterol fumarate dihydrate.
Each dose contains 12 micrograms of formoterol fumarate dihydrate of which you can inhale
9 micrograms.
Oxis Turbohaler also contains lactose.

When to start using a new Turbohaler

What Oxis Turbohaler looks like and contents of the pack





The dose indicator tells you how many doses are left in the Turbohaler, starting with 60
doses when it is full.
When you first see a red mark at the edge of the indicator window, shown in the diagram
below in grey, there are approximately 20 doses left. When the red mark reaches the
bottom of the indicator window, shown in the diagram below in grey, you must start using
your new Turbohaler.

Oxis Turbohaler is a multi-dose dry powder inhaler made of plastic materials, which works by
breathing in (inhaling) through the mouthpiece. The colour of the turning grip is dark greenblue. On the bottom of the turning grip, a braille code for identification of formoterol is
embossed. The contents are white to off-white rounded granules. The inhalation powder is white
in colour.
Each Oxis Turbohaler contains 60 actuations.

Manufacturer

Your medicine is manufactured by: AstraZeneca AB, S-151 85 Södertälje, Sweden.
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 your 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.

Your medicine is procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0207

POM

To listen to or request a copy of this leaflet in Braille, large print or audio please call
01302 365000 and ask for Regulatory Department.

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 heart beat.

Please be ready to give the following information:
Product name
Oxis 12 Micrograms Turbohaler
Reference number
21828/0207

If you forget to use Oxis Turbohaler

Oxis® and Turbohaler® are registered trademarks of AstraZeneca group of companies.

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.

Leaflet revision date: 29.07.16

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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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