Skip to Content

FLUTIFORM 50 MICROGRAM / 5 MICROGRAM PER ACTUATION PRESSURISED INHALATION SUSPENSION

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

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Flutiform® 50 microgram /5 microgram,
125 microgram /5 microgram and
250 microgram /10 microgram
per actuation pressurised inhalation, suspension
fluticasone propionate/formoterol fumarate dihydrate
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

FLUTIFORM INH PIL UK 582557 V3.indd 2

1. What Flutiform inhaler is and what it is used for
Please note:- Flutiform pressurised inhalation,
suspension is the product name, however throughout
this leaflet it is shortened to Flutiform inhaler.
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 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).
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).
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.
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 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.
Diagram 2

Mouthpiece
Mouthpiece
cover

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.

19/06/2015 09:06

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.

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).

FLUTIFORM INH PIL UK 582557 V3.indd 3

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.

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.
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
The active substances are fluticasone propionate
and formoterol fumarate dihydrate. There are three
different strengths of inhaler available. Each puff
(actuation) contains either 50 micrograms fluticasone
propionate and 5 micrograms formoterol fumarate
dihydrate, 125 micrograms fluticasone propionate
and 5 micrograms formoterol fumarate dihydrate
or 250 micrograms fluticasone propionate and
10 micrograms formoterol fumarate dihydrate.
The other ingredients are:
• Sodium cromoglicate
• Ethanol
• 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. Each inhaler contains 120 puffs
(actuations). There is one inhaler in a pack.
Marketing Authorisation Holder:
Napp Pharmaceuticals Limited, Cambridge Science
Park, Milton road, Cambridge, CB4 0GW,
UK.
Manufacturer:
Bard Pharmaceuticals Limited, Cambridge Science
Park, Milton road, Cambridge, CB4 0GW,
UK.
This leaflet is also available in large print, Braille or as
an audio CD. To request a copy, please call the RNIB
Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and
reference number.
These are as follows:
Product name: Flutiform inhaler
Reference number: 16950/0167
This leaflet was last revised in June 2015
Distributed by Napp Pharmaceuticals Ltd. under licence
from Jagotec AG.
® FLUTIFORM is a registered trade mark of Jagotec AG
and is used licence.
AEROCHAMBER and AEROCHAMBER PLUS are
registered trade marks of Trudell Medical International.
NAPP and the ‘NAPP’ logo are registered trade marks
of the Napp Pharmaceutical Group.
© 2012 – 2015 Napp Pharmaceuticals Limited.

19/06/2015 09:06

Expand view ⇕

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.

Hide