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OXIS TURBOHALER 12MCG INHALATION POWDER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE / FORMOTEROL FUMARATE DIHYDRATE / FORMOTEROL FUMARATE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxis® Turbohaler® 12mcg Inhalation Powder
(formoterol fumarate)
Your medicine is known as the above but will be referred to as
Oxis Turbohaler throughout the remainder of this 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.
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 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 eye drops (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, breast-feeding and fertility
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 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.



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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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