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FLUTIFORM 250 MICROGRAM /10 MICROGRAM INHALER

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

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Rare: may affect up to 1 in 1000 people
• An increase in the amount of sugar in your
blood. If you are diabetic you may need to
check your blood sugar more often and adjust
your usual diabetic treatment. Your doctor may
need to monitor you more closely.
• Thrush or other fungal infections in the mouth
and throat.
• Inflammation of the sinuses (sinusitis).
• Fast heartbeat.
• Chest pain associated with heart disease.
• Muscle spasms.
• Coughing or shortness of breath.
• Diarrhoea.
• Indigestion.
• Changes in taste.
• A feeling of dizziness or ‘spinning’.
• Abnormal dreams.
• Agitation.
• Itchy skin.
• High blood pressure.
• A feeling of unusual weakness.
• Swelling of hands, ankles or feet.
Not Known Frequency cannot be estimated
from the available data
• Sleeping problems, depression or feeling
worried, aggression, anxiety, restlessness,
nervousness, over excitment or irritability.
These effects are more likely to occur in
children.
The following side effects are associated with
formoterol fumarate but they have not been
reported during clinical trials with this inhaler:
• Low blood levels of potassium which can cause
muscle weakness, twitching or abnormal heart
rhythm.
• An abnormal heart trace potentially leading to
an abnormal heart rhythm (QTc interval
prolongation).
• High levels of lactic acid in the blood.
• Feeling sick.
• Muscle pain.
Inhaled steroids can affect the normal production
of steroid hormones in your body, particularly if
you use high doses for a long time. The effects
include:
• changes in bone mineral density (thinning of
the bones);
• cataracts (clouding of the lens in the eye);
• glaucoma (increased pressure in the eye);
• bruising or thinning of the skin;
• an increased chance of catching an infection;
• slowing of the rate of growth of children and
adolescents;
• a round (moon shaped) face;
• an effect on the adrenal gland (a small gland
next to the kidney) which means you may have
symptoms such as weakness, tiredness,
difficulty in coping with stress, abdominal pain,
loss of appetite, weight loss, headache,
dizziness, very low blood pressure, diarrhoea,
feeling or being sick or fits.
These effects are much less likely to happen with
inhaled steroids than with steroid tablets.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 FLUTIFORM INHALER
Keep out of the sight and reach of children.
Do not store above 25°C. Do not refrigerate or
freeze. If the inhaler is exposed to freezing
conditions it must be allowed to warm at room
temperature for 30 minutes then primed before
use (see section 3 “How to use…”). Do not use
the inhaler if it has been removed from the foil
pouch for more than 3 months, or if the dose
indicator reads ‘0’. Do not expose to temperatures
higher than 50°C. The aerosol can contains a
pressurised liquid. Do not puncture, break or burn
even when apparently empty.
Do not use this medicine after the expiry date
which is stated on the carton after EXP.
The expiry date refers to the last day of that
month.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Flutiform inhaler contains
The active substances are fluticasone propionate
and formoterol fumarate dihydrate.
Each metered dose (ex-valve) contains 250
micrograms of fluticasone propionate and
10 micrograms of formoterol fumarate dihydrate.
This is equivalent to a delivered dose
(ex-actuator) of approximately 230 micrograms of
fluticasone propionate and 9.0 micrograms of
formoterol fumarate dihydrate.
The other ingredients are: sodium cromoglicate,
ethanol and apaflurane HFA 227 (propellant).
What Flutiform inhaler looks like and contents
of the pack
This inhaler is a small aerosol can fitted with a
metering valve and containing a white to off white
liquid suspension. The aerosol can is inserted into
grey and white plastic dispenser (actuator) with a
light grey mouthpiece cover. This actuator also
has a dose indicator.
Each inhaler contains 120 puffs (actuations).
There is one inhaler in a pack.
Manufacturer and Licence Holder
This medicine is manufactured by Mundipharma
DC B.V., De Wel 20, NL-3871 MV, Hoevelaken,
Holland and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.

POM PL 15184/1636

Flutiform 250
microgram/10
microgram inhaler

Flutiform is is a registered trademark of
Mundipharma AG.
Leaflet revision date: 21/03/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 1636/210316/1/F
PATIENT INFORMATION LEAFLET
Flutiform ® 250 microgram/10 microgram inhaler

(fluticasone propionate / formoterol fumarate)

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, pharmacist or asthma nurse.
• 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,
pharmacist or asthma nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
Your medicine is called Flutiform 250
microgram/10 microgram inhaler and will be
referred to as Flutiform inhaler throughout the rest
of this leaflet.
Please note that the leaflet also contains
information about the other strengths of medicine
Flutiform 50 microgram / 5 microgram per
actuation pressurised inhalation, suspension and
Flutiform 125 microgram / 5 microgram per
actuation pressurised inhalation, suspension
What is in this leaflet:
1. What Flutiform inhaler is and what it is used for
2. What you need to know before you use
Flutiform inhaler
3. How to use Flutiform inhaler
4. Possible side effects
5. How to store Flutiform inhaler
6. Contents of the pack and other information
1. WHAT FLUTIFORM INHALER IS AND WHAT
IT IS USED FOR
Please note:- Flutiform pressurised inhalation,
suspension is the product name, however
throughout this leaflet it is shortened to Flutiform
inhaler. Sometimes this may refer to a specific
strength. Flutiform is an inhaler (a pressurised
inhalation, suspension) which contains two active
ingredients:
• Fluticasone propionate which belongs to a group
of medicines called steroids. Steroids help to
reduce swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate which belongs
to a group of medicines called long-acting beta2
agonists. Long-acting beta2 agonists are
long-acting bronchodilators which help the
airways in your lungs to stay open, making it
easier for you to breathe.
Together these two active ingredients help to
improve your breathing. It is advised that you
should use this medicine every day as directed by
your doctor or asthma nurse.
This medicine helps to prevent breathing
problems such as asthma and helps to stop
you becoming breathless and wheezy.
However, it does not work if you are already
having an asthma attack i.e. you are already
breathless and wheezing. You will need to use
a fast acting ‘reliever’ medicine such as
salbutamol if this happens.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE FLUTIFORM INHALER
Do not use Flutiform inhaler if you:
• are allergic to fluticasone propionate, formoterol
fumarate or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or asthma nurse
before using this inhaler.
Before treatment with this inhaler tell your doctor,
pharmacist or asthma nurse if you have:
• tuberculosis (TB) now or in the past. Symptoms
include a persistent cough often with blood
streaked phlegm, fever, tiredness, loss of
appetite, loss of weight and night sweats;
• an infection of the lungs or chest;

• heart problems such as problems with the blood
flow to your heart or narrowing of one of your
heart valves (the aortic valve), heart failure
which can cause shortness of breath or ankle
swelling, a condition where the heart muscle is
enlarged (hypertrophic obstructive
cardiomyopathy), an irregular heart beat
(cardiac arrhythmias) or if you have been told
that your heart trace is abnormal (prolongation
of the QTc interval);
• an abnormal bulging of a blood vessel wall (an
aneurysm);
• diabetes;
• high blood pressure;
• an overactive thyroid gland which can cause
increased appetite, weight loss or sweating
(thyrotoxicosis);
• low blood levels of potassium which can cause
muscle weakness, twitching or abnormal heart
rhythm (hypokalaemia);
• poor adrenal gland function (if your adrenal
gland is not working properly you may have
symptoms such as headaches, weakness,
tiredness, abdominal pain, loss of appetite,
weight loss, dizziness, very low blood pressure,
diarrhoea, feeling or being sick or fits) or a tumor
of the adrenal gland (phaeochromocytoma);
• liver problems.
If you are going to have an operation or are
extremely stressed, please tell your doctor as you
may need additional steroid treatment to control
your asthma.
Other medicines and Flutiform inhaler
Tell your doctor, pharmacist or asthma nurse if you
are taking, have recently taken or might take any
other medicines. If you use this inhaler with some
other medicines the effect of this inhaler or the
other medicine may be altered.
Tell your doctor, pharmacist or asthma nurse if you
are taking:
• medicines known as beta-blockers (such as
atenolol to treat blood pressure, sotalol to treat
an irregular heart beat, metoprolol to treat a
fast heart beat or timolol eye drops to treat
glaucoma);
• certain other medicines used to treat asthma or
breathing conditions (such as theophylline or
aminophylline);
• medicines containing adrenaline or related
substances (including other beta-agonists like
salbutamol or beta-antagonists including
atenolol, metoprolol, propranolol, timolol).
Additional long-acting beta2 agonists should not
be used together with this inhaler. If your asthma
becomes worse between doses of Flutiform
inhaler then you should use your quick acting
‘reliever’ inhaler for immediate relief;
• medicines to treat allergic reactions
(antihistamines);
• medicines to treat high blood pressure or fluid
build up by increasing the amount of urine
produced (diuretics);
• medicines used to treat heart failure (such as
digoxin);
• medicines to treat abnormal heart rhythms (such
as quinidine, disopyramide, procainamide);
• medicines to treat symptoms of depression or
mental disorders such as monoamine oxidase
inhibitors (for example phenelzine and
isocarboxazid), tricyclic antidepressants (for
example amitriptyline and imipramine), or you
have taken any of these types of medicine in the
last two weeks;
• medicines used to treat psychiatric or mental
disorders (phenothiazines or antipsychotics);
• other medicines containing steroids;
• antifungal medicines (such as ketaconazole
or itraconazole);
• medicines used to treat viral infections including
HIV (for example ritonavir, atazanavir, indinavir,
nelfinavir or saquinavir);
• antibiotics (such as clarithromycin, telithromycin
or furazolidone);
• medicine to treat Parkinson’s disease
(levodopa);



medicine to treat an underactive thyroid gland
(levothyroxine);
• medicine to treat Hodgkin’s disease
(procarbazine);
• medicine to induce labour (oxytocin).
If you are going to have an operation under a
general anaesthetic, please tell the doctor at the
hospital that you are using this inhaler.

Diagram 3

If you use more Flutiform inhaler than you
should
It is important that you take your dose as stated
on the pharmacist’s label or as advised by your
doctor or asthma nurse. You should not increase
or decrease your dose without seeking medical
advice.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you
may be pregnant or are planning to have a baby
ask your doctor or asthma nurse for advice about
using your inhaler. Your doctor or asthma nurse
will advise you if you should take this medicine.
Driving and using machines
This medicine is unlikely to affect your ability to
drive or use machines.

Diagram 1

Flutiform inhaler contains ethanol (alcohol)
and sodium cromoglicate
This medicine contains very small amounts of
ethanol (alcohol), i.e 1.00 mg per actuation (puff).
It also contains a very small amount of sodium
cromoglicate however patients who are currently
taking cromoglicate (used to treat asthma, allergic
rhinitis and allergic conjunctivitis) should continue
as normal.

Before you use your inhaler for the first time or
if it hasn’t been used for more than 3 days or if
it has been exposed to freezing conditions.
If your inhaler is new or it hasn’t been used for
more than 3 days then it must be ‘primed’ to
ensure it works properly and gives you the correct
dose.

3. HOW TO USE FLUTIFORM INHALER

If your inhaler has been exposed to freezing
temperatures it must be allowed to warm at room
temperature for 30 minutes then it must be
‘primed’ to ensure it works properly and gives you
the correct dose.

Always use this inhaler exactly as your doctor,
pharmacist or asthma nurse has told you. Check
with your doctor, pharmacist or asthma nurse if
you are not sure. You should use your inhaler
regularly i.e. two actuations (puffs) in the morning
and two actuations (puffs) in the evening every
day to get the most benefit from your inhaler,
unless your doctor tells you otherwise or advises
you to stop. Do not take more than the prescribed
dose. Your doctor may have prescribed your
inhaler for a different indication other than
asthma/or at a different dose from that normally
prescribed and as described in this leaflet. You
should always use your inhaler exactly as your
doctor or asthma nurse has advised.
If you are not sure about how much to take or how
often to use your inhaler please check with your
doctor, pharmacist or asthma nurse.
Adults and adolescents over 12 years of age
The usual dose is two inhalations twice a day, that
is two puffs (actuations) in the morning and two in
the evening. Your doctor will prescribe the dose
required to treat your asthma. Adolescents
should not use the highest strength inhaler
(Flutiform 250 microgram /10 microgram).

5.Breathe in slowly and deeply through your
mouth and, at the same time, press down on
the aerosol can to release one puff (actuation).
Continue to breathe in steadily and deeply
(ideally for about 4-5 seconds).

Diagram 4

Using your inhaler
If you feel you are getting breathless or wheezy
while using Flutiform inhaler, you should continue
to use Flutiform inhaler but go to see your doctor
or asthma nurse as soon as possible, as you may
need additional treatment. Once your asthma is
well controlled your doctor or asthma nurse may
consider it appropriate to gradually reduce the
dose of Flutiform inhaler.
Perform steps 2 to 5 below, slowly.

Flutiform inhaler should not be used in
children under 12 years of age.

6. While holding your breath, remove the inhaler
from your mouth. Continue to hold your breath
for as long as is comfortable. Do not breathe out
into the inhaler.
7. For the second puff (actuation), keep the
inhaler in a vertical position then repeat steps
2 to 6.
8. Replace the mouthpiece cover.
You can practise in front of a mirror. If you see a
‘mist’ from the top of the inhaler or around your
mouth when you use your inhaler then you may
not have inhaled your medicine properly. Take
another dose by repeating from Step 2 above.
Always rinse your mouth out, gargle with water
or brush your teeth after you have taken your
inhaler and spit out the residue. This may help
prevent you developing a sore mouth and throat
or a hoarse voice.
If you have weak hands it may be easier to hold
the inhaler in both hands placing both index
fingers on the aerosol can and both thumbs on the
base of the inhaler.

1.Remove the mouthpiece cover (see Diagram 2)
and check that your inhaler is clean and free
from any dust.
2. The inhaler should be shaken immediately
before releasing each puff (actuation) to ensure
the contents of your inhaler are evenly mixed.
3. Sit upright or stand. Breathe out as far as is
comfortable and as slowly and as deeply as
possible.
4.Hold your inhaler upright (as shown in Diagram
3) and put the mouthpiece in your mouth with
your lips around it. Hold the inhaler with your
thumb(s) on the base of the mouthpiece and
forefinger/index finger(s) on the top of the
inhaler. Do not bite the mouthpiece.

If you take more of your medicine than you should,
contact your doctor, pharmacist or asthma nurse
for advice. You may suffer from severe chest pain
(angina), high or low blood pressure, a headache,
muscle cramps, difficulty in sleeping, nervousness,
a dry mouth, a loss of appetite, seizures, fits or
convulsions. You may feel shaky, light headed,
faint, tired, sick or generally unwell. You may also
notice changes in the rate of your heart beat and
your blood may have low levels of potassium or an
increase in the amount of sugar in your blood. You
may also suffer from symptoms such as
abdominal pain, being sick, weight loss,
decreased level of consciousness (which could
make you feel drowsy or confused) or a low blood
sugar level.
If you have taken more than the prescribed dose
for a long period of time, you should talk to your
doctor, pharmacist or asthma nurse for advice.
This is because large doses may reduce the
amount of steroid hormones produced normally
by your adrenal glands (see section 4).
If you forget to use Flutiform inhaler
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.

To prime the inhaler
• Remove the mouthpiece cover and shake the
inhaler well.
• Point the mouthpiece away from you and
release one puff (actuation) by pressing down
on the aerosol can. This step should be
performed 4 times.
Your inhaler should always be shaken immediately
before use.

Diagram 2

Instructions for use
Read this leaflet very carefully prior to use and
follow the instructions for use in the text and
diagrams below. Your doctor, pharmacist or
asthma nurse will show you how to use your
inhaler properly. The medicine is contained in an
aerosol can (see Diagram 1) which sits inside a
plastic dispenser (also known as an actuator).
The actuator also has a counter to tell you how
many puffs (actuations) are left after it has been
primed. The counter is also coloured coded. It
starts off green then, when there are less than
50 puffs (actuations) left it changes to yellow and
when there are less than 30 puffs (actuations) left
it changes to red. When this is getting near to
zero, you should contact your doctor or asthma
nurse for a replacement inhaler. Do not use your
inhaler when the counter reads zero.

• Replace the mouthpiece cover.
• Do not put the metal canister into water.

If you have difficulty using your inhaler your doctor
or asthma nurse may give you a device called an
AeroChamber Plus® spacing device, to help you
to breathe your medicine into your lungs properly.
Your doctor, pharmacist or asthma nurse will
advise you how to use the AeroChamber Plus®
spacing device with your inhaler. The
AeroChamber Plus® spacing device will come
with instructions for use and with care and cleaning instructions which you must read carefully.
Caring for your inhaler
It is important that you follow these instructions
carefully and clean your inhaler weekly. To clean
your inhaler:
• Remove the mouthpiece cover.
• Do not remove the aerosol can from the
actuator.
• Wipe the inside and outside of the mouthpiece
and the actuator with a clean, dry cloth or tissue.

If you stop using Flutiform inhaler
It is very important that you take this inhaler every
day as directed by your doctor even if you feel
well as it will help to control your asthma. If you
want to stop using your inhaler talk to your doctor
first. Your doctor will tell you how to do this,
usually by decreasing the dose gradually so that
you do not trigger an asthma attack.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this inhaler can cause side
effects, although not everybody gets them.
Your doctor or asthma nurse will prescribe the
lowest dose necessary to control your asthma
which may reduce the possibility of side effects
occurring.
All medicines can cause allergic reactions,
although serious allergic reactions are reported
rarely. Tell your doctor immediately if you get
any sudden swelling of the eyelids, face, throat,
tongue or lips, rash or itching especially those
covering your whole body, symptoms such as
dizziness, light-headedness or fainting or any
sudden changes in your breathing pattern such
as increased wheezing or shortness of breath.
As with other inhalers, your breathing may worsen
immediately after using your inhaler. You may
notice an increase in wheezing and shortness of
breath. If this happens stop using your Flutiform
inhaler and use your quick acting ‘reliever’
inhaler. Contact your doctor or asthma nurse
straight away. Your doctor or asthma nurse will
assess you and may start you on a different
course of treatment. You should carry your
‘reliever’ inhaler with you at all times.
Uncommon: may affect up to 1 in 100 people
• Worsening of asthma.
• Headache.
• Shaking.
• An irregular heartbeat or palpitations.
• Dizziness.
• Difficulty in sleeping.
• Alteration in voice/hoarse voice.
• Dry mouth, sore or irritated throat.
• Rash.

Ref:1636/210316/1/B

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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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