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FLUTIFORM 250MICROGRAM/10MICROGRAM PER ACTUATION PRESSURISED INHALATION SUSPENSION

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

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Package leaflet: Information for the user

Flutiform®
250microgram/10microgram
per actuation pressurised
inhalation, suspension
(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 250microgram/
10microgram per actuation pressurised inhalation,
suspension but will be referred to as Flutiform throughout
this leaflet. Please note that the leaflet also contains
information about other strengths Flutiform
50microgram/5microgram and Flutiform
125microgram/5microgram per actuation pressurised
inhalation, suspension.
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 betaantagonists 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 anti-psychotics);
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.

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.

Driving and using machines
This medicine is unlikely to affect your ability to drive or
use machines.

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.

Flutiform contains ethanol (alcohol) and sodium
cromoglicate
This medicine contains very small amounts of ethanol
(alcohol), i.e 1.00mg 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.

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.

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.

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 250microgram /
10microgram).
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.

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).

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.

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.

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
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, 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 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 heart beat 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 heart beat.
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, overexcitment 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
Keep out of the sight and reach of children.
Do not store above 25°C. Do not refrigerate or freeze.
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.
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 ingredients in Flutiform are fluticasone
propionate and formoterol fumarate dihydrate.
Each metered dose (ex-valve) contains 250micrograms of
fluticasone propionate and 10micrograms of formoterol
fumarate dihydrate. This is equivalent to a delivered dose
(ex-actuator) of approximately 230micrograms of
fluticasone propionate and 9micrograms of formoterol
fumarate dihydrate.
The other ingredients are sodium cromoglicate, 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: Mundipharma DC B.V., De Wel 20,
NL-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® 250microgram/10microgram per actuation
pressurised inhalation, suspension;
POM
PL 18799/2922
Leaflet date: 31.03.2016

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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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