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FLUTIFORM 125MICROGRAM/5MICROGRAM INHALER

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

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Package leaflet: Information for the user
®

Flutiform
125 microgram/5 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.
The name of your medicine is Flutiform
125 microgram/5 microgram Inhaler but will be
referred to as Flutiform throughout this leaflet. Please
note that the leaflet also contains information about
other strengths such as Flutiform 50 microgram/
5 microgram and Flutiform 250 microgram/
10 microgram Inhaler.
What is in this leaflet:
1. What Flutiform is and what it is used for
2. What you need to know before you use Flutiform
3. How to use Flutiform
4. Possible side effects
5. How to store Flutiform
6. Contents of the pack and other information

1. What Flutiform is and what it is used
for
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
Do not use Flutiform 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
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 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.
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 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.

Flutiform 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.

3. How to use Flutiform
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).
Flutiform should not be used in children under 12
years of age.

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.

Aerosol can
Actuator
Counter

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.
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.
Using your inhaler
If you feel you are getting breathless or wheezy
while using Flutiform, you should continue to use
Flutiform 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.
Perform steps 2 to 5 below, slowly.

Mouthpiece
Mouthpiece
cover

Diagram 2

Diagram 1
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.

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.

Diagram 4

3. Sit upright or stand. Breathe out as far as is
comfortable and as slowly and as deeply as
possible.

Diagram 3

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.

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.
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).

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. 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.
• Replace the mouthpiece cover.
• Do not put the metal canister into water.
If you use more Flutiform 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.
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
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.
If you stop using Flutiform
It is very important that you take this inhaler
everyday 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, lightheadedness 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
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.
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.ukyellowcard
By reporting side effects, you can help provide
more information on the safety of this medicine.

5. How to store Flutiform
Keep out of the sight and reach of children.
Do not use this inhaler after the expiry date which is
stated on the foil pouch and carton label after ‘Exp’.
The expiry date refers to the last day of that month.
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 Flutiform’). 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 so do
not puncture, break or burn the can even when
apparently empty.
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 contains
The active substances are fluticasone propionate
and formoterol fumarate dihydrate.
Each metered dose (ex-valve) contains 125
micrograms of fluticasone propionate and
5 micrograms of formoterol fumarate dihydrate.
This is equivalent to a delivered dose (ex-actuator)
of approximately 115 micrograms of fluticasone
propionate and 4.5 micrograms of formoterol
fumarate dihydrate.
The other ingredients are: sodium cromoglycate,
ethanol and Apaflurane HFA 227 (as propellant).
What Flutiform looks like and the contents of
the pack
The actuator is white with a grey integrated dose
indicator (which indicates the number of actuations
(puffs) remaining) and a light grey mouthpiece
cover. The actuator contains a pressurised canister
which contains the white to off white liquid
suspension. The inhaler is contained in a foil pouch.
Each inhaler contains120 puffs (actuations). There
is one inhaler in a pack.
Manufacturer by: Bard Pharmaceuticals Limited,
Cambridge Science Park, Milton Road, Cambridge
CB4 0GW, UK.
Or
Mundipharma DC B.V., De Wel 20,
3871 MV Hoevelaken, The Netherlands.
Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Flutiform® 125 microgram/5 microgram Inhaler;
PL 18799/2827
Leaflet date: 15.03.2016
POM

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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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