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FLUTIFORMO 250 MICROGRAM/10 MICROGRAM PER ACTUATION PRESSURISED INHALATION SUSPENSION

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Flutiform®
250 microgram/10 microgram per actuation
pressurised inhalation, suspension /
Flutiformo®
250 microgram/10 microgram 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.
 Your medicine is available using either of the above names but will be
referred to as Flutiform inhaler throughout the remainder of the leaflet.
 This product is also available in other strengths.
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
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 longacting 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).

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.

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.

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.

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 colour 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.

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.

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.

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 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
Like all medicines, this inhaler can cause side effects, although not
everybody gets them.

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.
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.
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.

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.

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

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-excitement or irritability. These effects
are more likely to occur in children.

What Flutiform looks like and contents of the pack
White to off white liquid suspension in an aluminium pressurised canister in
a white actuator with a grey integrated dose indicator and light grey
mouthpiece cover. Supplied in a foil pouch.
Each Flutiform inhaler contains 120 actuations. There is one inhaler in a
pack.






Keep out of the sight and reach of children.
Do not store above 25oC.
Use within 3 months of opening the foil pouch.
Do not refrigerate or freeze.
The canister contains a pressurised liquid. Do not expose to
temperatures higher than 50oC. Do not puncture, break or burn even
when apparently empty.
If the inhaler is exposed to freezing conditions, it must be left at room
temperature for 30 minutes and activated before use (see section 3 ‘How
to use Flutiform inhaler’). 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 use this inhaler after the expiry date which is stated on the carton.
The expiry date refers to the last day of the month.
If your medicine shows any signs of deterioration, return it to your
pharmacist.
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
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 anhydrous and
apaflurane HFA 227.

Manufactured by
Bard Pharmaceuticals Limited, Cambridge Science Park, Milton Road,
Cambridge, CB4 0GW, UK
or
Mundipharma Pharmaceuticals DC B.V., De Wel 20, NL-3871 M.V,
Hoevelaken, The Netherlands.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
PL: 33532/0651

POM

Leaflet dated 22nd March 2016
Leaflet coded XXXXXXXXXX
FLUTIFORM® is a registered trademark of Jagotec AG.
FLUTIFORMO® is a registered trademark of Mundipharma AG.
AEROCHAMBER® and AEROCHAMBER PLUS® are registered trademarks
of Trudell Medical International.
To request a copy of this leaflet in Braille, large print or audio please call
01922 745 645 and ask for the Regulatory Department.

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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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