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FORMATRIS NOVOLIZER 12 MICROGRAMS PER ACTUATION INHALATION POWDER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE MICRONISED

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T5006274_p02.indd 1

▯▯

▯▯
▯▯
▯▯

Formatris Novolizer is also used for the
relief of symptoms such as wheezing,
shortness of breath and coughing in
patients with chronic obstructive pulmonary disease (COPD).
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE FORMATRIS NOVOLIZER
INHALATION POWDER
Do NOT use Formatris Novolizer if you
are allergic (hypersensitive) to formoterol or
the other ingredient of this medicine listed
in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before
using Formatris Novolizer.
Formatris Novolizer should not be used
(and is not sufficient) as the first treatment for asthma.

The NOVOLIZER can be refilled using
new cartridges* containing the active
substance and is thus ideally suited to
long-term usage (up to one year).
Do not shake the filled NOVOLIZER.
Please support your children in proper
handling of the device.
Make sure your NOVOLIZER is protected from moisture and heat and kept
clean at all times.

Formatris Novolizer should not be used to
treat an acute asthma attack or for relief of
acute symptoms of asthma. In these situations you should take your short-acting
bronchodilator, for example your salbutamol inhaler, also known as your blue
“reliever” inhaler, to treat an acute asthma
attack and you should contact your doctor
or asthma nurse straightaway.

*For information on other medicines which
can be used in the Novolizer dry powder
inhaler, please contact your doctor.
MEDA Pharma GmbH & Co. KG
Benzstr. 1, 61352 Bad Homburg (Germany)
Last Review February 2014

If you are an asthmatic patient, you should
also be receiveing treatment with a corticosteroid (an anti-inflammatory treatment for your asthma). Formatris Novolizer
must always be prescribed together with a
corticosteroid inhaler and it is important
that you continue taking the steroid inhaler
while you are taking Formatris Novolizer
inhalation powder. You should not
decrease the dose of your steroid inhaler
when you start taking Formatris Novolizer
inhalation powder without medical advice
even when your symptoms improve.

Should your symptoms continue or worsen
or the number of doses of formoterol you
need to take to control symptoms
increases, this usually indicates a worsening of disease, In these situations you
should contact your doctor or your asthma
nurse in order that your asthma and your
treatment can be re-assessed.
Children
This medicine is not recommended for use
in children below the age of 6.
Other medicines and Formatris
Novolizer
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other inhalers or other medicines.
In particular, this applies for:
▯▯ other B2agonists also known as bronchodilators e.g. salbutamol, salmeterol or
ephedrine
▯▯ xanthine derivatives used for the treatment of asthma (e.g. theophylline)
▯▯ steroid medicines (e.g. beclomethasone
dipropionate, fluticasone propionate, and
steroid tablets eg, prednisolone)
▯▯ diuretics or water tablets (e.g., furosemide)
▯▯ antihistamines (e.g. terfenadine, astemizole)
▯▯ digoxin used to treat heart disease.
▯▯ medicines for a rapid or irregular heart
beat (e.g. quinidine, disopyramide, procainamide)
▯▯ phenothiazines
(e.g. chlorpromazine)
used to treat mental illness or severe
nausea (feeling sick) and vomiting (being
sick)
▯▯ antibiotics (e.g. erythromycin)
▯▯ tricyclic antidepressants (e.g. amitriptyline)
▯▯ monoamine oxidade inhibitors taken
within the last 14 days (e.g. phenelzine)
▯▯ hormones (e.g. L-thyroxine, oxytocin)
▯▯ beta-blockers for high blood pressure or
angina (taken by mouth as e.g. atenolol,
metoprolol or as eye drops e.g. timolol)
▯▯

Some general anaesthetics may interact
with formoterol to cause irregular heart
rhythms and a fall in blood pressure.
Therefore, if you are having an operation, advise hospital staff that you are
taking Formatris Novolizer.

▯▯

As with other medicines of this type, if
formoterol is taken with alcohol, or with
medicines for Parkinson’s disease or
thyroid problems you may experience
an increase in heart rate (pulse).

Formatris Novolizer with food, drink and
alcohol
You should avoid drinking of alcohol
because you may experience an increase

03.06.15 15:16

Bemerkung/remark

Korrektur notwendig/
correction required

Datum /date: Unterschrift/signature:

additional NON PRINTING
Cutting

Formoterol is used to treat patients with
asthma already being treated with inhaled
corticosteroids (also known simply as steroids). Inhaled corticosteroid and formoterol taken together are long-term treatments for asthma and must be taken
regularly every day to prevent symptoms of
asthma occurring. Such as increasing
shortness of breath, wheezing, coughing.

As with other inhaled medicines there is a
risk of paradoxical bronchospasm (acute
wheezing or shortness of breath or a feeling of tightness in the chest or severe
coughing immediately after using the Formatris Novolizer). If this occurs do not take
any more puffs from the Formatris
Novolizer. You should talk immediately with
your doctor.

Page 1 of 2
Typopharma # 118002

1. WHAT FORMATRIS NOVOLIZER
INHALATION POWDER IS AND WHAT
IT IS USED FOR
Formatris Novolizer is a powder for inhalation containing formoterol. Formoterol
belongs to a group of medicines known as
long-acting B2  agonists. B2  agonists relax
the muscles in the airways in your lungs
and by doing this open up your airways so
that you can breathe more easily. They
give long-lasting relief (up to 12  hours) of
symptoms such as wheezing, shortness of
breath and coughing.

If any of the above apply to you, you must
tell your doctor. He/she may wish to alter
your treatment or monitor your condition
more closely.

Sec. Edge Marks

2. USAGE:
1. Whenever possible,
sit or stand while
inhaling. When using
the NOVOLIZER al-­
ways keep it horizontal. First remove
the protective cap (←).
2. Completely depress
the coloured dosage button. A loud
double click will be
heard
and
the
colour of the control
window will change from red to green.
Then release the coloured button.
The  colour green in the control window
indicates that the NOVOLIZER is ready
for use.
3. 
Breathe out deeply
(but not into the
Dry
NOVOLIZER
Powder
Inhaler).
Put your lips tightly
around the mouthpiece, inhale the powder
with a deep breath, during this breath a
loud click should be heard, which indicates
that you have breathed in strongly enough
and correctly. Then hold the breath for a
few seconds and continue to breathe out
slowly through the nose. If you need to
take another dose repeat steps 2 and 3.

3. CLEANING:
The NOVOLIZER Dry Powder Inhaler should
be cleaned at regular intervals, but at least
every time the cartridge is changed.
Remove protective cap
and mouthpiece
First remove the protective cap. Then grasp
the mouthpiece and
turn it briefly counterclockwise (↑) until it becomes loose. Then
remove (←).
Cleaning
Now
turn
the
NOVOLIZER upside
down. Grasp the loose
dispensing slide and
move it forwards (←)
and upwards (↑). Any remaining powder can
be removed by tapping lightly.
Clean the mouthpiece, the dispensing slide
and the powder inhaler with a soft and dry lintfree cloth.
Do NOT use water or detergent.
Assembly – Insert dispensing slide
After cleaning insert
the dispensing slide by
sliding down at an
angle (() and press
into position (↓).
Turn the inhaler back over.
Assembly – Fit mouthpiece and protective cap
Insert the mouthpiece
with the pin into the
groove on the left and
turn to the right until it
snaps into place. Finish by replacing the
protective cap.
Notes
▯▯ The Patient Information Leaflet describes
how the drug works. Please read it through
carefully before using the inhaler for the
first time.
▯▯ The NOVOLIZER which comes with various
active substances does not use any propellants and is designed for refilling. This
makes the NOVOLIZER a very environmentally friendly product.
▯▯ It is not possible to overdose with the
NOVOLIZER. Even if the button is pressed
several times, no more powder is available
for inhalation. Only press the button when
you really want to inhale. If you cannot
manage to inhale correctly after several
attempts, consult your doctor.

247 x 340 mm
MMC

Remove the protective
aluminium foil from the
cartridge cylinder and
take out the new cartridge.This should be
done just before using the cartridge. The
colour coding on the cartridge must correspond to the colour of the dosage button.
The small red disc on the bottom of the cartridge cylinder is a drying agent which should
be disposed of after removal of the cartridge.
First filling:
Insert the cartridge
into the NOVOLIZER
Dry Powder Inhaler
with the dosage counter facing the mouthpiece (↓). Do not press the dosage button
while inserting the cartridge.
Refilling:
Note: The NOVOLIZER Dry Powder Inhaler
should be cleaned every time the cartridge is
exchanged after removal of empty cartridge.
If you have already used the NOVOLIZER Dry
Powder Inhaler, first remove the empty cartridge and then insert the new one (↓). Do not
press the dosage button while inserting the
cartridge.
Replace the cap into
the side guides from
above (↓) and push
down flat towards the
coloured dosage button until it snaps into place (→).
The NOVOLIZER is
now filled and ready
for use.
You can leave the
cartridge
­
in
the
NOVOLIZER dry powder inhaler until it is used up or for up to
6  months after insertion. Remember to
replace the cartridge every 6 months even if it
is not empty. The cartridge is used up if you
see a hatched “0” in the middle of the control
window. Then a new cartridge has to be
inserted. The cartridges can only be used in
the original Novolizer dry powder inhaler.

What is in this leaflet:
1. 
What Formatris Novolizer inhalation
powder is and what it is used for
2. What you need to know before you use
Formatris Novolizer inhalation powder
3. How to use Formatris Novolizer inhalation powder
4. Possible side effects
5. How to store Formatris Novolizer inhalation powder
6. Contents of the pack and other information

Freigabe/release

1. PREPARATION:
The NOVOLIZER is a breath actuated Dry
Powder Inhaler makes inhaling simple and
reliable. Its straightforward use, fast cartridge
replacement and simple cleaning are easy
and quickly done.
Place the NOVOLIZER Dry Powder Inhaler in
front of you. Lightly press together the ribbed
surfaces on both sides of the cap, move the
cap forwards (←) and lift off (↑).

Take special care and talk to your
doctor before using Formatris Novolizer
if you have
▯▯ any heart disease,
▯▯ blood pressure problems,
▯▯ diabetes,
▯▯ an overactive thyroid gland e.g. thyrotoxicosis or
▯▯ problems with adrenal glands e.g. phaeochromocytoma.

1. proof 26.05.2015 mz
2. proof 03.06.2015 vm
3. proof
4. proof
5. proof
6. proof

Control window

If you need to take an extra treatment, e.g.
your blue “reliever” to prevent exerciseinduced asthma symptoms more frequently
than you would usually do so, or several
times a week, this may be a sign that your
asthma control is not good enough. Therefore you should contact your doctor or
asthma nurse so that your asthma and your
treatment can be reassessed.

Meda Manufacturing GmbH, Köln
Code
––
Fontsize 8/9 pt
technical 7 pt
Used Font Nimbus Sans
Colours
black, p3275c

Protective cap

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 further questions, please
ask your doctor or your pharmacist.
– 
This medicine has been prescribed
for you. 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.

Meda
Order File
N/A
contract manufacturer:
MMC

Cartridge cylinder

12 micrograms per actuation inhalation powder
(formoterol)

4. Check that the colour of the control window
has changed back to red, which also indicates that you have breathed in strongly
enough and correctly. Replace the protective cap on the mouthpiece – the inhalation
procedure is now complete.
The number in the top window indicates the
number of inhalations left. The numeric scale
60-0 is shown in steps of 10. If the click sound
and change of the colour did not appear,
please repeat the procedure as described
above. When “0” appears in the middle of the
counter window the cartridge must be
replaced with a new one.
NOTE: The coloured dosage button should
only be pressed immediately before breathing in.
Taking a double dose or taking more than one
dose at a time is not possible with the
NOVOLIZER. The click sound and the change
of the colour in the control window indicate
that you have breathed in strongly enough
and correctly. If the colour of the control window does not change back to red, the inhalation (puff) should be repeated. If inhalation is
not completed correctly after several attempts,
then you should consult your doctor.

Formatris 12 2x60Dos
T5006274
––
GB

Sliding
cap

Dosage
button

Product
Material No.
Replaced No.
Country
Code No.
Dimension
Drawing No.

Dosage counter

T5006274

Cartridge

Formatris Novolizer ®

T5006274

Package leaflet: Information for the patient

INSTRUCTIONS FOR USE Novolizer ®

Use in children 6 years and older:
The usual dose for children is 1 puff in the
morning and 1  puff again in the evening.
For more severe asthma your doctor may
prescribe 2 puffs twice daily.
The maximum daily dose is 4 puffs (2 puffs
inhaled twice daily).
The regular daily dose should not exceed
2 puffs, however, occasionally up to a maximum of 4  puffs may be allowed within a
24-hours period.
Use in children below 6 years of age:
Formatris Novolizer is not recommended
for use in children under the age of 6 years
as insufficient experience is available in
this age group.
COPD (chronic obstructive pulmonary
disease):
Adults (including older people) and adolescents over 12 years of age:
The usual dose is 1 puff in the morning and
1 puff again at night.
The daily dose for regular use should not
exceed 2 puffs.
If necessary, additional puffs above those
prescribed for regular therapy may be used
for relief of symptoms, up to a maximum
total daily dose of 4 puffs. More than 2 puffs
should not be taken on any single occasion.
Method of Administration
For inhalation use. The powder should be
inhaled through your mouth into your lungs.
Inhale as shown in the ‘Instructions for
Use’ on the back of this leaflet.
If you use more Formatris Novolizer
than you should
The symptoms of an overdose are the
same as the more common side effects

T5006274_p02.indd 2

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.
By reporting side effects you can help provide more information on the safety of this
medicine.
5. HOW TO STORE FORMATRIS
NOVOLIZER INHALATION POWDER
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.
Storage conditions
Store the cartridge in the original package
until required for use.
After opening the cartridge container and
inserting into the Novolizer device, store

The other ingredient is lactose monohydrate (milk sugar). Formatris Novolizer
12  micrograms per actuation inhalation
powder contains 11.488  mg of lactose per
puff.
What Formatris Novolizer looks like and
contents of the pack
Formatris Novolizer inhalation powder, contains a white powder in a cartridge and is
available in the following packs:
Original sales packs:
1  powder inhaler and 1  cartridge with at
least 60 puffs
1  powder inhaler and 2  cartridges with at
least 60 puffs each
Refill packs:
1 cartridge with at least 60 puffs
2 cartridges with at least 60 puffs each
3 cartridges with at least 60 puffs each
Not all pack sizes may be marketed.
Marketing Authorization Holder
MEDA Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
United Kingdom
Manufacturer:
VEMEDIA Manufacturing B.V.
Verrijn Stuartweg 60,
NL-1112 AX Diemen,
The Netherlands

Bemerkung/remark

Korrektur notwendig/
correction required

Datum /date: Unterschrift/signature:
Freigabe/release

additional NON PRINTING
Cutting

Formatris Novolizer 12  micrograms per
actuation inhalation powder is a dry powder for inhalation. The active substance is
formoterol.
One puff contains 8.36  micrograms formoterol (as fumarate dihydrate).

Asthma Lifestyle Advice
Asthma can be controlled in different ways.
Your doctor will work with you to decide on
a treatment plan which best suits your individual needs and which should help to
reduce your asthma symptoms and the
number of asthma attacks.
There are also ways that you can help
yourself, such as:
▯▯ Try to avoid or reduce contact with things
that may trigger an asthma episode, for
example, animal fur, smoking (including
passive smoking), moulds, pollen and
house dust mites.
▯▯ If you know that exercise is a trigger for
your asthma, make sure that you have
followed your doctor’s instructions before
starting any exercise.
▯▯ Be honest with your doctor or asthma
nurse about how asthma affects you
day-to-day and develop with them a
treatment plan that suits your particular
lifestyle. Remember to take your asthma
medication as your doctor has instructed.
▯▯ If you have any worries about your medication, discuss this with your local pharmacist, asthma nurse or doctor.

Page 2 of 2
Typopharma # 118002

List of all other side effects:
Common side effects (may affect up to 1 in
10 people):
Headache, tremor and palpitations-fast and
sometimes irregular heart beat.
Uncommon side effects (may affect up to
1 in 100 people):
Agitation, restlessness, difficulty sleeping,
muscle cramps and irritation of the throat.
Rare side effects (may affect up to 1  in
1,000 people):
Rapid or irregular heart beat, nausea (feeling sick), changes in potassium levels that
may cause muscle weakness, nervousness
and wheeziness.
Very rare side effects (may affect up to 1 in
10,000 people):
Increased risk of severe heart rhythm
abnormality in sensitive patients, hyperglycaemia (increase in blood glucose),
unusual taste, dizziness, and changes in
blood pressure

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Formatris Novolizer 12  micro­
grams per actuation inhalation powder
contains

This leaflet was last revised in February
2014

(alternative:
MEDA Manufacturing GmbH
Neurather Ring 1
D-51063 Cologne
Tel: (+49)-221-6472-0
Fax: (+49)-221-6472-696
Alternative:
MEDA Pharma GmBH & Co. KG
Benstraße 1
D-61352 Bad Homburg
Tel: (+49)-6172-888-01
Fax: (+49)-6172-888-2740
This medicinal product is authorized in
the Member States of the EEA under the
following names:
Austria:
Novolizer Formoterol Meda 12 Mikrogramm
Pulver zur Inhalation
Belgium and Luxembourg:
Novolizer Formoterol 12  microgrammes,
poudre pour inhalation
Germany:
Formoterol Novolizer 12  Mikrogramm, Pulver zur Inhalation

03.06.15 15:16

Sec. Edge Marks

Asthma:
Adults (including older people) and adolescents over 12 years of age:
The usual dose for adults is 1  puff in the
morning and 1  puff again in the evening.
For more severe asthma your doctor may
prescribe 2 puffs twice daily.
The maximum daily dose is 4 puffs (2 puffs
inhaled twice daily).

Most important side effects
▯▯ as with all inhalers it is possible for the
powder to make you wheezy immediately after inhalation. This occurs rarely
(may affect up to 1 in 1,000 people).
▯▯ rarely an allergic reaction may result in a
condition known as angioneurotic
oedema which is a swelling of the face,
lips, eyes, and throat. If any of these
allergic reactions occur you must stop
taking Formatris Novolizer immediately
and contact your doctor.
▯▯ very rarely (may affect up to 1  in
10,000  people) severe chest pain
(angina pectoris) can occur

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 protect the environment.

247 x 340 mm
MMC

The recommended dose is:

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Possible side effects are listed below
according to their frequency. If you are not
sure what the side effects below are, ask
your doctor to explain them to you.

The Novolizer should be cleaned at regular
intervals, but at least every time the cartridge is changed. Instructions on how to
clean the device can be found in the
instructions for use on the back of this leaflet.

1. proof 26.05.2015 mz
2. proof 03.06.2015 vm
3. proof
4. proof
5. proof
6. proof

3. HOW TO USE FORMATRIS
NOVOLIZER INHALATION POWDER
Always use this medicine exactly as your
doctor or asthma nurse has told you.
Check with your doctor or pharmacist if you
are not sure. 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 or asthma
nurse told you to. Formatris Novolizer is for
inhalation use. It should be inhaled through
your mouth into your lungs. If the person
taking this medicine is a child, treatment
should be supervised by an adult. The
child should be shown how to use the
inhaler correctly and may need the help of
an adult to use the inhaler.Please read the
instructions for using this device carefully
before taking this medicine.

If you feel sick or very shaky or if you have
an unusually fast heart beat, your Formatris Novolizer dose may be too high. Tell
your doctor as soon as possible.
Once your symptoms are controlled your
doctor may decide to reduce the dose of
Formatris Novolizer inhalation powder
gradually so that your asthma is treated
with the lowest effective dose.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

Note: The Novolizer device should be
replaced after 2000  inhalations (puffs).
Therefore, a maximum of 33  cartridges
containing 60 single doses should be used
with this device (within a single year).

Meda Manufacturing GmbH, Köln
Code
––
Fontsize 8/9 pt
technical 7 pt
Used Font Nimbus Sans
Colours
black, p3275c

Formatris Novolizer contains milk sugar
(lactose)
Normally, the content of lactose in a single
dose does not cause any problems in people with lactose intolerance. Milk sugar
(lactose) may contain small amounts of
milk protein.

Do not stop or reduce the dose of Formatris Novolizer or any other medicine
for your breathing just because you feel
better, without talking to your doctor
first. It is very important to use these
medicines regularly.

Information concerning the shelf-life
after first opening
Exchange the cartridge 6 months after first
opening.
Do not use the powder inhaler for more
than a year.

France:
Asmelor Novolizer 12 microgrammes/dose,
poudre pour inhalation
Ireland:
Novolizer Formoterol 12  micrograms/dose
inhalation powder
Italy:
Formoterolo ViatrisNovolizer 12  microgrammi/dose polvere per inalazione
Netherlands:
Formoterol Novolizer 12  microgram, inhalatiepoeder
Portugal:
Formoterol Novolizer 12 microgramas/dose,
pó para inalação
Spain:
Formatris Novolizer 12  microgramos/dosis,
polvo para inhalación

Meda
Order File
N/A
contract manufacturer:
MMC

Driving and using machines
Formatris Novolizer does not affect the
ability to drive or use machines.

If you forget to use Formatris Novolizer
inhalation powder
Take your dose as soon as you remember,
if it is nearly time for the next dose just take
the next dose at the usual time.
Do not take a double dose to make up for a
forgotten dose.

Formatris Novolizer in a dry place protected from moisture and below 25 °C.

Formatris 12 2x60Dos
T5006274
––
GB

Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Formoterol should only be used during
pregnancy (particularly during the first
three months and at the end of the pregnancy and during labour), after careful consideration and if there are no other safer
alternatives.
It is not known whether formoterol passes
into human breast milk. Therefore, administration of Formatris Novolizer during breastfeeding should only be considered if the
expected benefit to you is greater than any
possible risk to the child.

and might include tremor, headache, palpitations, feeling sick.
If any of these reactions occur you should
contact your doctor immediately.

Product
Material No.
Replaced No.
Country
Code No.
Dimension
Drawing No.

in heart rate (pulse). Food and other drinks
are not known to alter the effectiveness of
Formatris Novolizer.

Expand view ⇕

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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