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OXIS TURBOHALER 12MCG INHALATION POWDER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OXIS® TURBOHALER® 12 MICROGRAMS
(formoterol fumarate dihydrate)
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 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 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 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)
• 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)
• Only to be used by adults (aged 18 years and above).
• The recommended dose is 1 inhalation once or
twice a day.

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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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