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SALBULIN MDPI NOVOLIZER 100 MICROGRAMS / DOSE INHALATION POWDER

Active substance: SALBUTAMOL SULPHATE

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T5006025

PACKAGE LEAFLET: INFORMATION FOR THE USER

NOVOLIZER®

SALBULIN® MDPI
100 micrograms/dose inhalation powder
Salbutamol
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.

What is in this leaflet
1. WHAT SALBULIN MDPI NOVOLIZER IS
AND WHAT IT IS USED FOR.
2. WHAT YOU NEED TO KNOW BEFORE
USING SALBULIN MDPI NOVOLIZER.
3. HOW TO USE SALBULIN MDPI
NOVOLIZER.
4. POSSIBLE SIDE-EFFECTS.
5. HOW TO STORE SALBULIN MDPI
NOVOLIZER.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION.
7. INSTRUCTIONS FOR USING THE
NOVOLIZER DEVICE.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE SALBULIN MDPI
NOVOLIZER
DO NOT take Salbulin MDPI Novolizer
if:
• you are allergic (hypersensitive) to
salbutamol, lactose or milk protein
Warnings and precautions
Talk to your doctor before using
Salbulin MDPI Novolizer if you can
answer ‘yes’ to any of the
following questions:

• do you have any heart or circulatory
problems, particularly a recent heart
attack or angina?
• do you suffer from high blood
pressure?
• have you been told you have an
aneurysm (a swelling or dilation of a
blood vessel)?
• do you have an overactive thyroid
gland?
• do you suffer from diabetes which is
difficult to control?
• do you have a tumour near your
kidney (a phaeochromocytoma)?
• are you about to have an operation
requiring a general anaesthetic?
• are you taking any other medicines
and/or inhalers for your asthma
either prescribed by a doctor or
bought from a pharmacy?
Seek medical advice if you experience
chest pain or other symptoms of
worsening of your heart disease.
Your doctor may wish to alter your
treatment or monitor your condition
more closely if any of the above apply
to you.

1. WHAT SALBULIN MDPI NOVOLIZER IS
AND WHAT IT IS USED FOR

Other medicines and Salbulin MDPI
Novolizer

Salbulin MDPI Novolizer is indicated in
adults, adolescents and children aged 6 to
12 years.

Treatment with salbutamol may cause
hypokalaemia (low potassium in your
blood) which can be aggravated by some
other drugs. These include other drugs for
asthma, such as xanthine derivatives
(e.g. theophylline) or steroids
(e.g. prednisolone), or drugs for other
conditions such as water tablets
(e.g. frusemide) or digoxin. You must
mention to your doctor if you are taking
any of these drugs, as your doctor may
want to take a blood sample to monitor
your potassium levels.

Salbulin MDPI Novolizer is a powder
for inhalation containing the active
substance salbutamol.
Salbutamol belongs to a group of
anti-asthmatic drugs known as
bronchodilators which are used to relieve
symptoms such as chest tightness,
wheezing or cough caused by asthma or
other conditions. Salbutamol can also be
used to prevent asthma symptoms
brought on by exercise and other
'triggers' such as pollen.
For instructions for using the Novolizer
Inhaler Device, see section 7 on the
reverse side of this leaflet.

T5006025_p03.indd 1

If you are taking beta-blockers (e.g. atenolol)
for high blood pressure or angina, or
antidepressants (e.g. moclobemide,
phenelzine, amitriptyline, clomipramide or
imipramine) you should also tell your
doctor.
Some general anaesthetics may interact
with salbutamol to cause heart problems

and decrease blood pressure. Therefore, if
you are having an operation, advise
hospital staff that you are taking Salbulin
MDPI Novolizer.
Tell you doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines including inhalers and
even those medicines not prescribed by
your doctor and bought without a
prescription.
Salbulin MDPI Novolizer with
food and drink
Food and drink are not known to alter the
effectiveness of Salbulin MDPI Novolizer
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 or pharmacist for advice before
taking this medicine.
If taken during pregnancy salbutamol will
pass through the placenta and may cause
the heart rate of the foetus (unborn baby)
to increase. However, there is no evidence
that salbutamol causes any malformations.
Salbutamol also passes into a mother’s
milk and may cause some side effects in a
breast-fed infant (see section 4 below).
Driving and using machines
No studies on the ability to drive and use
machines have been performed.
Salbulin MDPI Novolizer contains milk
sugar (lactose).
You should not take Salbulin MDPI
Novolizer if you are allergic to lactose.

at least 1 minute between each puff.
A further dose should not be taken
within 4 hours.
For prevention of exercise-induced
asthma and wheezing before contact
with a ‘trigger’: 2 puffs should be
taken 10-15 minutes before exercise or
contact with the ‘trigger’.
Maximum daily dose: 8 puffs
Use in children 6 -12 years of age
For relief of symptoms: Start with
1 puff; if needed the dose may be
increased to 2 puffs. You should leave
at least 1 minute between each puff.
A further dose should not be taken
within 4 hours.
For prevention of exercise-induced
asthma and wheezing before contact
with a ‘trigger’: 1 puff should be taken
10-15 minutes before exercise or
contact with the ‘trigger’. If needed
this may be increased to 2 puffs.
Maximum daily dose: 4 puffs
Children below 6 years of age
Salbulin MDPI Novolizer is not
recommended for use in children
below the age of 6 because there is
insufficient information on safety and
effectiveness in this age group.
You must not take more puffs than
your doctor advises. If your asthma is
getting worse you should discuss
your treatment with your doctor, as
you may need additional medicine
for your chest condition. The
following may indicate your asthma
is getting worse:

Normally, the content of lactose in a
single dose does not cause any problems
in persons with lactose intolerance.
If you are concerned that you may have an
intolerance, you must talk to your doctor.

• You find that you need more puffs
than usual
• Relief of your chest tightness is not
sufficient
• You notice that the relief is not
lasting as long

3. HOW TO USE SALBULIN MDPI
NOVOLIZER

IF YOUR BREATHING SUDDENLY
BECOMES WORSE OR YOU ARE
UNABLE TO TRIGGER THE NOVOLIZER
DEVICE YOU MUST CONTACT YOUR
DOCTOR IMMEDIATELY.

Always use this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are unsure.
The label should remind you of how many
actuations (puffs) to take and how often
you should take them. Do not take more
than your doctor has told you to. Your
doctor or nurse should also have shown
you how to use the Novolizer Device, but
please read the instructions for using this
device carefully before taking this
medicine. These instructions can be found
on the reverse of this leaflet.
The following information about the use
of Salbulin MDPI Novolizer applies unless
your doctor has instructed otherwise.
Please also note that if you are changing
from another salbutamol inhaler to
Salbulin MDPI Novolizer you may find
that you have to adjust your dose.
Use in adults and adolescents above
12 years of age
For relief of symptoms: Start with
1 puff; if needed the dose may be
increased to 2 puffs. You should leave

If you have asthma your doctor may have
instructed you on the use of a peak-flow
meter. It is important to monitor your
asthma and the effectiveness of the
asthma treatments you have been given.
If you inhale more doses than you
should
If you take more puffs than recommended
you may notice that your heart beats
faster than usual and you may feel shaky.
These effects usually wear off in a few
hours, but you should contact your doctor
immediately.
If you need to see another doctor or
go to hospital
If you see any other doctor or have to go
to hospital for any reason, you should
take all your inhalers and any other
medicines with you including those
bought without a prescription. If you
have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Salbulin MDPI
Novolizer can cause side effects, although
not everybody gets them.
The common side effects (may affect up to
1 in 10 people) you are most likely to notice
when using Salbulin MDPI Novolizer include:
unpleasant or unusual taste, irritation of
the throat and mouth causing a cough,
shakiness (usually in the hands), dizziness,
restlessness, headache, sweating and
feeling sick. Muscle cramp can also occur,
but this is rare (may affect up to 1 in 1,000
people). These effects, if noticed will usually
wear off within 2 weeks of treatment.
Very rarely (may affect up to 1 in 10,000
people) inflammation of the kidney and a
drop in blood platelets can occur.
Sometimes some people may notice their
heart beating faster or unevenly
(palpitations), or feeling faint. These occur
only rarely with inhaled salbutamol, but if
you are affected tell your doctor.
Very rarely, some people may experience
chest pain (due to heart problems such as
angina). Tell your doctor as soon as
possible, but do not stop using this
medicine unless told to do so.
As with all inhalers it is possible for
the powder to make you wheezy
immediately after inhalation. This
occurs rarely. If this happens you
must call your doctor immediately.
Allergic reactions to salbutamol,
although very rare, have been
reported. These include: rash, skin
problems, swelling of the face, lips,
eyes and throat, wheeziness, low
blood pressure and collapse. If you
notice any of these reactions contact
your doctor immediately.
Children using this medicine may rarely
become hyperactive or excitable. They
may also suffer sleep disturbance or
hallucinations, although this is very rare.
Lactose-monohydrate contains small
amounts of milk proteins and can
therefore cause allergic reactions.
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects no listed in this leaflet.
5. HOW TO STORE SALBULIN MDPI
NOVOLIZER
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the label, the carton
and the cartridge container. The expiry
date refers to the last day of that month.
The cartridges containing Salbulin MDPI
Novolizer should be kept in their sealed
outer container until required for use.
When the Novolizer device is in-use it
should be stored in a dry place to ensure
that the powder cartridge inside is
protected from moisture. Regardless of
whether the cartridge is empty or not
after 6 months a new cartridge should be
inserted. It is recommended that you keep
a record of when you replace the
cartridges to help you remember when

you will need to insert a new one.
The Novolizer device should be replaced
after 2000 inhalations. Therefore, a
maximum of 10 cartridges should be used
with one device. In any event it is
recommended that you replace this device
at least once a year.
Do not store above 30°C.
Store in original package.
Protect from moisture.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Salbulin MDPI Novolizer contains
Salbulin MDPI Novolizer is a dry powder
for inhalation. The active substance is
salbutamol. Each actuation (puff) contains
100 micrograms of salbutamol (as
sulphate). The other ingredient is
Lactose monohydrate.
What Salbulin MDPI Novolizer looks
like and contents of pack
The following packs may be available:
An Original sales pack which contains a
Salbulin MDPI Novolizer dry powder
inhaler device and a Salbulin MDPI
Novolizer drug cartridge sealed in a
plastic container with aluminium foil.
Each cartridge contains 200 inhalations
(puffs).
A Refill pack which contains either 1 or 2
Salbulin MDPI Novolizer drug cartridges
sealed in a plastic container with aluminium
foil. These are for use with the Salbulin
MDPI Novolizer dry powder inhaler
device. Each refill cartridge contains 200
inhalations (puffs).
A Hospital pack with pack of 10 of
original sales packs
Not all pack sizes may be marketed.
The Manufacturer of this product is:
Meda Pharma GmbH & Co. KG
Benzstraße 1
D-61352 Bad Homburg, Germany
or
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
NL-1112 AX Diemen, The Netherlands
or
Meda Manufacturing GmbH
Neurather Ring 1
D-51063 Cologne, Germany
The Marketing Authorisation Holder
is:
Meda Pharmaceuticals Ltd
Skyway House, Parsonage Road, Takeley,
Bishop's Stortford, CM22 6PU
United Kingdom
This medicinal product is authorised in
the Member States of the EEA under the
following names:
United Kingdom: Salbulin® MDPI Novolizer®,
100 micrograms/dose inhalation powder
Germany: Salbutamol MDPI Novolizer®,
100 Mikrogramm/Dosis Pulver zur
Inhalation.

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7. INSTRUCTIONS FOR USING THE NOVOLIZER DEVICE
Cartridge

Dosage Counter

Lid

Button

Protective cap

Using the Novolizer Device
1. When using the Novolizer Device always
keep it horizontal. Remove the protective
cap, by lightly squeezing the sides and sliding
forwards ( ).

·
·

Introduction
The Novolizer Device is a breath-actuated dry powder inhaler. It helps to make
inhaling simple and reliable. It includes safety features to ensure that you take the
correct dose and it is also environmentally friendly as it does not use
chlorofluorocarbon (CFC) propellants. The following instructions for using the
Novolizer Device are brief and easy to understand, but it is recommended that
children use this device under the supervision of an adult.
Please note that the Novolizer Device supplied for use with
Salbulin MDPI Novolizer must only be used with this medicine.

Inserting a cartridge
1. When you first get the Novolizer Device
you will need to put the cartridge containing
the medicine into the device. To do this,
gently squeeze the ribbed surfaces on both
sides of the lid. Move the lid forwards ( )
and off ( ).

2. Remove the protective aluminium foil from
the cartridge box and take out the new
cartridge. Only do this just before you need to
use the cartridge.

3. Insert the cartridge into the Novolizer
Device with the dosage counter facing the
mouthpiece ( ). Do not press the dosage
button while inserting the cartridge.

4. Replace the lid into the lid guides from
above ( ) and push down flat towards the
dosage button ( ) until it clicks into place.

5. The Novolizer Device is now filled and
ready for use. You can leave the cartridge in
the Novolizer Device until ‘0’ appears in the
middle of the counter window; however, you
must replace it with a new cartridge within 6
months of taking the cartridge out of its
sealed outer container.

6. When the cartridge needs replacing remove
the lid as described in step 1 and lift out the
used cartridge. Insert a new cartridge
following steps 2 to 5.

Replacement and Storage

1. You should clean your Novolizer Device
regularly, or at least whenever you change
the cartridge. To do this first remove the
protective cap. Then twist the mouthpiece
anticlockwise slightly ( ). It will become loose
and you can remove it ( ).

1. The Novolizer Device can be refilled using
new cartridges containing Salbulin MDPI
Novolizer. It is ideal for long-term usage, but
you must remember to replace your Novolizer
Device after 2000 puffs (10 cartridges). In
any event you must replace it within a year.
Make sure your Novolizer Device is protected
from moisture.
Remember to replace the cartridge every 6
months even if it is not empty.

This cartridge MUST be replaced when either:

Control window

Cartridge box

4.The loud click and the colour change from
green to red in the control window indicate
that you have inhaled correctly. The figures in
the top window show the number of
inhalations (puffs) remaining. Each inhalation
is counted, but please note that figures in the
top window count down in steps of 20 until
60 puffs remain and then in steps of 10 when
it is below 60.

Cleaning

2. To ‘prime‘ the Novolizer Device push down
hard on the large coloured button until it
stops ( ) (see picture). You will hear a loud
double click and the colour of the control
window will change from red to green. You
can now release the large button. The colour
green in the control window indicates that
the Novolizer Device is now primed and ready
to use. The large button should only be
pressed immediately before inhaling.

3. Breathe out deeply, but not into the
Novolizer Device. Put your lips around the
mouthpiece. Inhale the powder with a strong
deep breath. During this breath you should
hear a loud click. This click indicates that you
have breathed in strongly enough for the
Novolizer Device to work. Continue inhaling
as strongly and deeply as you can. Hold your
breath for a few seconds before breathing out
slowly through your nose. If you need to take
another dose repeat steps 2 and 3. Replace
the protective cap on the mouthpiece.

‘0’ appears in the middle of the
counter window or
every 6 months, even if the cartridge is
not empty.

Please note: if there is no click and the
colour in the control window does not
change please repeat the procedure as
described above. If you cannot manage
to inhale correctly after several attempts,
please consult your doctor, nurse or
pharmacist .

2. Now turn the Novolizer Device upside down.
Loosen the dispensing slide and move it
forwards ( ) and upwards ( ). Any remaining
powder can be removed from the dispensing
slide by tapping it lightly. Clean the mouthpiece,
the dispensing slide and the powder inhaler
with a soft and dry lint-free cloth.
DO NOT use water or detergent.

3. After cleaning, re-insert the dispensing slide
by sliding down at an angle ( ) and press
back into position ( ). You will hear a click as
it fits into position.

4. Insert the mouthpiece so that the small pin
fits into the groove on the Novolizer Device
just below the colour control window ( ).
Twist the mouthpiece clockwise ( ) so that it
clicks into place.
Finish by replacing protective cap.

® Meda GmbH & Co. KG
© Meda Pharmaceuticals Ltd.

T5006025_p03.indd 2

T5006025

This leaflet was last revised in in
This leaflet was last approved
September2007
December 2012

29.10.12 14:13

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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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