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FLUTIFORM 125 MICROGRAM/5 MICROGRAM PER ACUTATION PRESSURISED INHALATION SUSPENSION

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

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Package leaflet: Information for the user
Flutiform® 125 microgram/5 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 by using the above name but will be referred
to as Flutiform inhaler throughout the leaflet. Flutiform inhaler 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 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
tumour 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 ketoconazole 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.

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.

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.

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

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.

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, over-excitement 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 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. EXP: 08-2020 means that you should not use the
inhaler after the last day of that month i.e. August 2020.
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.
If the inhaler fails to work properly or shows signs of any deterioration
you should seek the advice of your pharmacist who will tell you what to
do.
6. Contents of the pack and other information
What Flutiform inhaler contains
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 actuation) of approximately 115
micrograms of fluticasone propionate and 4.5 micrograms of 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
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 inhaler contains 120 puffs (actuations). There is one inhaler in a
pack.
Manufacturers: Bard Pharmaceuticals Limited,
Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, UK
Mundipharma DC B.V., De Wel 20, NL-3871 MV,
Hoevelaken, The Netherlands
Procured within the EU.
Product Licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD.
POM
PL 19065/0503
This leaflet was revised on 02/03/2016

E0503/1
®FLUTIFORM is a registered trade mark of Jagotec AG®
AEROCHAMBER and AEROCHAMBER PLUS are registered trade
marks of Trudell Medical International

If you require this leaflet in large print please contact 01355 574450
Ask for Regulatory Department. Quote PL 19065/0503

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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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