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ABRIFF 50 MICROGRAM /5MICROGRAM PER ACTUATION PRESSURISED INHALATION

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

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Package leaflet: Information for the user

Abriff® 50 microgram /5 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.
®

The name of your medicine is Abriff 50 microgram /
5 microgram per actuation pressurised inhalation, suspension,
but will be referred to as Abriff inhaler in this leaflet.
What is in this leaflet:
1. What Abriff inhaler is and what it is used for
2. What you need to know before you use Abriff inhaler
3. How to use Abriff inhaler
4. Possible side effects
5. How to store Abriff inhaler
6. Contents of the pack and other information

1. What Abriff inhaler is and what it is used for
Abriff 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 Abriff
inhaler
Do not use Abriff 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 Abriff 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 Abriff 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.
Abriff 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 Abriff 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
(Abriff 250 microgram /10 microgram).
Abriff 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.

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
Abriff inhaler, you should continue to use Abriff 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
Abriff inhaler.
Perform steps 2 to 5 below, slowly.

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.

Uncommon: may affect up to 1 in 100 people
• Worsening of asthma.
• Headache.
• Shaking.
• An irregular heartbeat or palpitations.
• Dizziness.
• Difficulty sleeping.
• Alteration in voice/hoarse voice.
• Dry mouth, sore or irritated throat.
• Rash.

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).

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, overexcitement 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.

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 Abriff 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 Abriff 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 Abriff 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, lightheadedness 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 Abriff
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.

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.
How
to store
5. How
toCelebrex
store Abriff

inhaler

Keep out of the sight and reach of children.
Do not use this inhaler after the expiry date which is stated on
the label, foil pouch and carton after EXP. The expiry date refers
to the last day of that month.
Do not store above 25°C.
Do not refrigerate or freeze.
If the inhaler is exposed to freezing conditions it must be allowed
to warm at room temperature for 30 minutes then primed before
use (see section 3 "How to use ...").
Do not use the inhaler if it has been removed from the foil pouch
for more than 3 months, or if the dose indicator reads ‘0’.
Do not expose to temperatures higher than 50°C.
The aerosol can contains a pressurised liquid so do not
puncture, break or burn the can even when apparently empty.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other information
What Abriff inhaler contains
Each metered dose (ex-valve) contains 50 micrograms of
fluticasone propionate and 5 micrograms of formoterol fumarate
dihydrate. This is equivalent to a delivered dose (ex-actuator) of
approximately 46 microgram of fluticasone propionate and
4.5 microgram of formoterol fumarate dihydrate.
Also contains:
• sodium cromoglicate,
• anhydrous ethanol and
• apaflurane HFA 227 (propellant).
What Abriff inhaler looks like and the contents of the pack
These inhalers are small aerosol cans containing a 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.
There is one inhaler in a pack.
Each inhaler contains 120 puffs (actuations).
The device has a counter which tells you the number of blisters
remaining. It counts down from 120 to 0. When the counter
shows 0, your inhaler is empty and should be disposed of.
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 & repackaged by PL holder:
Kosei Pharma UK Limited, 956 Buckingham Avenue, Slough
Trading Estate, Slough, SL1 4NL, UK
®

Abriff 50 microgram /5 microgram per actuation
pressurised inhalation, suspension

POM

PL 39352/0332
®

Abriff is a registered trademark of Mundipharma AG.
Leaflet date: 26/02/2016

Package leaflet: Information for the user

Flutiform® 50 microgram /5 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.
®

The name of your medicine is Flutiform 50 microgram /
5 microgram per actuation pressurised inhalation, suspension,
but will be referred to as Flutiform inhaler in this leaflet.
What is in this leaflet:
7. What Flutiform inhaler is and what it is used for
8. What you need to know before you use Flutiform inhaler
9. How to use Flutiform inhaler
10. Possible side effects
11. How to store Flutiform inhaler
12. Contents of the pack and other information

1. What Flutiform inhaler is and what it is used
for is an inhaler (a pressurised inhalation, suspension)
Flutiform
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).
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.

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.

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.

Uncommon: may affect up to 1 in 100 people
• Worsening of asthma.
• Headache.
• Shaking.
• An irregular heartbeat or palpitations.
• Dizziness.
• Difficulty sleeping.
• Alteration in voice/hoarse voice.
• Dry mouth, sore or irritated throat.
• Rash.

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).

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, overexcitement 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.

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.
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, lightheadedness 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.

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.
How
to store
5. How
to Celebrex
store Abriff

inhaler

Keep out of the sight and reach of children.
Do not use this inhaler after the expiry date which is stated on
the label, foil pouch and carton after EXP. The expiry date refers
to the last day of that month.
Do not store above 25°C.
Do not refrigerate or freeze.
If the inhaler is exposed to freezing conditions it must be allowed
to warm at room temperature for 30 minutes then primed before
use (see section 3 "How to use ...").
Do not use the inhaler if it has been removed from the foil pouch
for more than 3 months, or if the dose indicator reads ‘0’.
Do not expose to temperatures higher than 50°C.
The aerosol can contains a pressurised liquid so do not
puncture, break or burn the can even when apparently empty.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other information
What Flutiform inhaler contains
Each metered dose (ex-valve) contains 50 micrograms of
fluticasone propionate and 5 micrograms of formoterol fumarate
dihydrate. This is equivalent to a delivered dose (ex-actuator) of
approximately 46 microgram of fluticasone propionate and
4.5 microgram of formoterol fumarate dihydrate.
Also contains:
• sodium cromoglicate,
• anhydrous ethanol and
• 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 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.
There is one inhaler in a pack.
Each inhaler contains 120 puffs (actuations).
The device has a counter which tells you the number of blisters
remaining. It counts down from 120 to 0. When the counter
shows 0, your inhaler is empty and should be disposed of.
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 & repackaged by PL holder:
Kosei Pharma UK Limited, 956 Buckingham Avenue, Slough
Trading Estate, Slough, SL1 4NL, UK
®

Flutiform 50 microgram /5 microgram per actuation
pressurised inhalation, suspension

POM

PL 39352/0332
®

Flutiform is a registered trademark of Jagotec AG.
Leaflet date: 26/02/2016

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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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