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FLUTIFORM 125 MICROGRAMS/5 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SUSPENSION

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

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Package leaflet: Information for the user

Flutiform® 125 micrograms/5
micrograms per actuation
pressurised inhalation,
suspension
Flutiform® 250 micrograms/10
micrograms per actuation
pressurised inhalation,
suspension
(fluticasone propionate/formoterol fumarate)
The name of your medicine is Flutiform 125
micrograms/5 micrograms per actuation pressurised
inhalation, suspension or Flutiform 250 micrograms/10
micrograms per actuation pressurised inhalation,
suspension but will be referred to as Flutiform
throughout this leaflet. This product is available in
different strengths.
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
1. WHAT FLUTIFORM INHALER IS AND WHAT
IT IS USED FOR
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 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 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.
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.
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.
3. HOW TO USE FLUTIFORM INHALER
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).

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.
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.

Flutiform inhaler 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.

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.

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 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.

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).

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.
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

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.
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.

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.
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, 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 INHALER
Keep this medicine 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. 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.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Flutiform inhaler contains:
Flutiform 125 micrograms/5 micrograms per actuation
pressurised inhalation, suspension:
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.
Flutiform 250 micrograms/10 micrograms per actuation
pressurised inhalation, suspension:
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
 Heptafluoropropane HFA 227 (propellant)
What Flutiform inhaler looks like and the contents of
the pack
The inhaler is a white with a grey integrated dose
indicator and a light grey mouthpiece cover containing a
white to off-white liquid suspension.
Manufacturer
Flutiform inhalers are manufactured by Bard
Pharmaceuticals Limited, Cambridge Science Park,
Milton Road, Cambridge CB4 0GW, UK and
Mundipharma Pharmaceuticals DC B.V., De Wel 20,
NL-3871 M.V, Hoelelaken, Holland.
Procured from within the EU and repackaged in the UK
by the Parallel Import Product Licence holder: CD
Pharma Ltd, Unit 3 Manor Point, Manor Way,
Borehamwood, Herts WD6 1EE.
Flutiform 125 micrograms/5 micrograms per
actuation pressurised inhalation, suspension
PL 20492/0528
Flutiform 250 micrograms/10 micrograms per
actuation pressurised inhalation, suspension
PL 20492/0529
POM
Flutiform is a registered trademark.
Date of preparation: 12th August 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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