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FLUTIFORM 250 MICROGRAM / 10 MICROGRAM PER ACTUATION PRESSURISED INHALATION SUSPENSION

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

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Package leaflet: Information for the user

Flutiform® 250 microgram /10 microgram
per actuation pressurised inhalation, suspension
(fluticasone propionate/formoterol fumarate)
The name of this product is Flutiform® 250
microgram / 10 microgram per actuation pressurised
inhlation, suspension but will be referred to as
Flutiform inhaler throughout this leaflet.
Also available as 50 microgram / 5 microgram and
125 microgram / 5 microgram.
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.
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

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.
Please note:- Flutiform pressurised inhalation,
Before treatment with this inhaler tell your doctor,
suspension is the product name, however
pharmacist or asthma nurse if you have:
throughout this leaflet it is shortened to Flutiform
• tuberculosis (TB) now or in the past. Symptoms
inhaler.
include a persistent cough often with blood
Sometimes this may refer to a specific strength.
streaked phlegm, fever, tiredness, loss of
Flutiform is an inhaler (a pressurised inhalation,
appetite, loss of weight and night sweats;
suspension) which contains two active ingredients:
• an infection of the lungs or chest;
• Fluticasone propionate which belongs to a group
• heart problems such as problems with the
of medicines called steroids. Steroids help to
blood flow to your heart or narrowing of
reduce swelling and inflammation in the lungs.
one of your heart valves (the aortic valve),
• Formoterol fumarate dihydrate which belongs
heart failure which can cause shortness of
to a group of medicines called long-acting beta2
breath or ankle swelling, a condition where the
agonists. Long-acting beta2 agonists are longheart muscle is enlarged (hypertrophic
acting bronchodilators which help the airways in
obstructive cardiomyopathy), an irregular
your lungs to stay open, making it easier for you to
heart beat (cardiac arrhythmias) or if you
breathe.
have been told that your heart trace is abnormal
(prolongation of the QTc interval);
Together these two active ingredients help to
improve your breathing. It is advised that you should • an abnormal bulging of a blood vessel wall
(an aneurysm);
use this medicine every day as directed by your
• diabetes;
doctor or asthma nurse.
• high blood pressure;
This medicine helps to prevent breathing
• an overactive thyroid gland which can cause
problems such as asthma and helps to stop you
increased appetite, weight loss or sweating
becoming breathless and wheezy. However, it
(thyrotoxicosis);
does not work if you are already having an asthma
• low blood levels of potassium which can cause
attack i.e. you are already breathless and wheezing.
muscle weakness, twitching or abnormal heart
You will need to use a fast acting ‘reliever’ medicine
rhythm (hypokalaemia);
such as salbutamol if this happens.
• 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.
1. What Flutiform inhaler is and what it is used for

• medicines used to treat viral infections
including HIV (for example ritonavir,
atazanavir, indinavir, nelfinavir or saquinavir);
• antibiotics (such as clarithromycin,
telithromycin or furazolidone);
Other medicines and Flutiform inhaler
• medicine to treat Parkinson’s disease
Tell your doctor, pharmacist or asthma nurse
(levodopa);
if you are taking, have recently taken or might take
• medicine to treat an underactive thyroid
any other medicines. If you use this inhaler with
gland (levothyroxine);
some other medicines the effect of this inhaler or the • medicine to treat Hodgkin’s disease
other medicine may be altered.
(procarbazine);
Tell your doctor, pharmacist or asthma nurse if you
• medicine to induce labour (oxytocin).
are taking:
• medicines known as beta-blockers (such as
If you are going to have an operation under a
atenolol to treat blood pressure, sotalol to treat
general anaesthetic, please tell the doctor at
an irregular heart beat, metoprolol to treat a
the hospital that you are using this inhaler.
fast heart beat or timolol eye drops to treat
Pregnancy and breastfeeding
glaucoma);
• certain other medicines used to treat asthma or
If you are pregnant or breastfeeding, think you may
breathing conditions (such as theophylline or
be pregnant or are planning to have a baby ask
aminophylline);
your doctor or asthma nurse for advice about using
• medicines containing adrenaline or related
your inhaler. Your doctor or asthma nurse will
substances (including other beta-agonists
advise you if you should take this medicine.
like salbutamol or beta-antagonists including
Driving and using machines
atenolol, metoprolol, propranolol, timolol).
This medicine is unlikely to affect your ability
Additional long-acting beta2 agonists should not
to drive or use machines.
be used together with this inhaler. If your asthma
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.













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);

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.

Instructions for use
Read this leaflet very carefully prior to use and
Always use this inhaler exactly as your doctor,
follow the instructions for use in the text and
pharmacist or asthma nurse has told you. Check
diagrams below. Your doctor, pharmacist or asthma
with your doctor, pharmacist or asthma nurse if you nurse will show you how to use your inhaler
are not sure. You should use your inhaler regularly
properly. The medicine is contained in an aerosol
i.e. two actuations (puffs) in the morning and two
can (see Diagram 1) which sits inside a plastic
actuations (puffs) in the evening every day to get the dispenser (also known as an actuator). The
most benefit from your inhaler, unless your doctor
actuator also has a counter to tell you how many
tells you otherwise or advises you to stop. Do not
puffs (actuations) are left after it has been primed.
take more than the prescribed dose. Your doctor
The counter is also coloured coded. It starts off
may have prescribed your inhaler for a different
green then, when there are less than 50 puffs
indication other than asthma/or at a different dose
(actuations) left it changes to yellow and when there
from that normally prescribed and as described in
are less than 30 puffs (actuations) left it changes to
this leaflet. You should always use your inhaler
red.
exactly as your doctor or asthma nurse has advised.
If you are not sure about how much to take or how
When this is getting near to zero, you should
often to use your inhaler please check with your
contact your doctor or asthma nurse for a
doctor, pharmacist or asthma nurse.
replacement inhaler. Do not use your inhaler
when the counter reads zero.
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 inhaler should not be used in children
under 12 years of age.
3. How to use Flutiform inhaler

Variation 3 - To update the manufacturers details.
This version replaces PIL dated 9 August 2016, previously assessed
against UK PIL dated June 2015.
A Chohan 9 September 2017

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 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.

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
1. Remove the mouthpiece cover (see Diagram
works properly and gives you the correct dose.
2) and check that your inhaler is clean and
free from any dust.

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.

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.

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 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.
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.

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.
4. Possible side effects
• Replace the mouthpiece cover.
Like all medicines, this inhaler can cause side
• Do not put the metal canister into water.
effects, although not everybody gets them.
Your doctor or asthma nurse will prescribe the
If you use more Flutiform inhaler than you
lowest dose necessary to control your asthma
should
which may reduce the possibility of side effects
It is important that you take your dose as stated on
occurring.
the pharmacist’s label or as advised by your doctor
All medicines can cause allergic reactions,
or asthma nurse. You should not increase or
decrease your dose without seeking medical advice. although serious allergic reactions are reported
rarely. Tell your doctor immediately if you get
If you take more of your medicine than you should,
contact your doctor, pharmacist or asthma nurse for any sudden swelling of the eyelids, face, throat,
tongue or lips, rash or itching especially those
advice. You may suffer from severe chest pain
covering your whole body, symptoms such as
(angina), high or low blood pressure, a headache,
muscle cramps, difficulty in sleeping, nervousness, a dizziness, light-headedness or fainting or any
sudden changes in your breathing pattern such
dry mouth, a loss of appetite, seizures, fits or
convulsions. You may feel shaky, light headed, faint, as increased wheezing or shortness of breath.
As with other inhalers, your breathing may worsen
tired, sick or generally unwell. You may also notice
immediately after using your inhaler. You may
changes in the rate of your heart beat and your
notice an increase in wheezing and shortness of
blood may have low levels of potassium or an
breath. If this happens stop using your Flutiform
increase in the amount of sugar in your blood. You
inhaler and use your quick acting ‘reliever’
may also suffer from symptoms such as abdominal
inhaler. Contact your doctor or asthma nurse
pain, being sick, weight loss, decreased level of
straight away. Your doctor or asthma nurse will
consciousness (which could make you feel drowsy
assess you and may start you on a different
or confused) or a low blood sugar level.
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.

5. How to store Flutiform inhaler
Keep out of the sight and reach of children.
Do not use this inhaler after the expiry date which is
stated on the label, foil pouch and carton 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…”). 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 protect the environment.
If your inhaler shows any signs of deterioration,
please contact your doctor or pharmacist who will
tell you what to do.
6. Contents of the pack and other information

What Flutiform inhaler contains
The active substances are fluticasone propionate
and formoterol fumarate.
Reporting of side effects
Each metered dose (ex-valve) contains
If you get any side effects, talk to your doctor,
250 micrograms fluticasone propionate and
pharmacist or nurse. This includes any possible side 10 micrograms formoterol fumarate.
effects not listed in this leaflet. You can also report
This is equivalent to a delivered dose (ex-actuator)
side effects directly via the Yellow Card Scheme at: of approximately 230 microgram of fluticasone
www.mhra.gov.uk/yellowcard
propionate and 9.0 microgram of formoterol
By reporting side effects you can help provide more fumarate dihydrate.
information on the safety of this medicine.

The other ingredients are:
• sodium cromoglicate
• ethanol anhydrous
• apaflurane HFA 227 (propellant)
What Flutiform inhaler looks like and the
contents of the pack
These inhalers are small aerosol cans containing
a white to off white liquid suspension fitted with a
metering valve. The aerosol cans are inserted into
grey and white plastic dispensers (actuators) with a
light grey mouthpiece cover. The actuator has a
counter to tell you how many puffs (actuations) are
left after it has been primed. Each inhaler contains
120 puffs (actuations). There is one inhaler in a
pack.
Manufacturer
Mundipharma DC B.V., Leuderend 16, 3832 RC
Leusden, The Netherlands.
Procured from within the EU and repackaged by
by PL holder
PilsCo Ltd, 10-16 Colvilles Place, East Kilbride,
G75 0SN.
POM
PL 39467/0263
®
Flutiform 250 microgram /10 microgram per
actuation pressurised inhalation, suspension
This leaflet was last revised on 25/08/2017

® FLUTIFORM is a registered trade mark of
Jagotec AG.
® AEROCHAMBER and AEROCHAMBER PLUS
are registered trade marks of Trudell Medical
International.

PIL0263.2

+ Expand Transcript

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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