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FLUTIFORM 125 MICROGRAM /5 MICROGRAM INHALER

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

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Driving and using machines

Package leaflet: Information for the user

This medicine is unlikely to affect your ability to drive or use machines.

Flutiform inhaler contains ethanol (alcohol) and sodium cromoglicate

Flutiform® 125 microgram/5 microgram Inhaler
(fluticasone propionate/formoterol fumarate)

This medicine contains very small amounts of ethanol (alcohol), i.e 1.00 mg per actuation
(puff).

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.

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.

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.

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.

WHAT FLUTIFORM INHALER IS AND WHAT IT IS USED FOR

Please note:- Flutiform 125 microgram /5 microgram Inhaler 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 long-acting bronchodilators which help the
airways in your lungs to stay open, making it easier for you to breathe.

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.

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.

Aerosol Can

2.

Counter

Actuator

WHAT YOU NEED TO KNOW BEFORE YOU USE FLUTIFORM INHALER

Do not use Flutiform inhaler if you:


Mouthpiece
Mouthpiece cover

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.

Diagram 1

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.

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.

Other medicines and Flutiform inhaler

Perform steps 2 to 5 below, slowly.

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.

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

Diagram 2

1.
2.
3.

Remove the mouthpiece cover (see Diagram 2) and check that your inhaler is clean and
free from any dust.
The inhaler should be shaken immediately before releasing each puff (actuation) to ensure
the contents of your inhaler are evenly mixed.
Sit upright or stand. Breathe out as far as is comfortable and as slowly and as deeply as
possible.

Diagram 3

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.

Page 1 of 2

4.

5.

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.
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).












Diagram 4

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-excitment 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:





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.

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.










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.

Reporting of side effects

Caring for your 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.
If your doctor tells you to stop using Flutiform inhaler, please take it back to your pharmacist to
be destroyed. Only keep this if the doctor tells you to.
If the medicine becomes discoloured or show any signs of deterioration, you should seek the
advice of your doctor or pharmacist.
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 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.

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).

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Flutiform inhaler contains

The active substances are fluticasone propionate and formoterol fumarate dihydrate.
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 (exactuator) of approximately 115 micrograms of fluticasone propionate and 4.5 micrograms of
formoterol fumarate dihydrate.

What Flutiform inhaler looks like and the contents of the pack

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.

Flutiform inhaler is white with a grey integrated dose indicator which indicates the number of
actuations (puffs) remaining and a light grey mouthpiece cover. The actuator contains a
pressurised metal canister which contains the white to off white liquid suspension.

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.

The inhaler is contained in a foil pouch. There is one inhaler in each pack.
Each inhaler contains 120 actuations. Pressurised inhalation suspension.

Manufacturer:

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, Hoelelaken, The Netherlands.

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.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland,
NE42 6PX.
PL: 21828/0678

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.

Flutiform® is a registered trade mark of Jagotec AG.
Aerochamber Plus™ is a trademark of Trudell Medical International.

Other information

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.

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please
call the 01302 365000 and ask for Regulatory Department.
You will need to give details of the product name and reference number.
These are as follows:
Product name: Flutiform 125 microgram/5 microgram Inhaler
Reference number: 21828/0678

Rare: may affect up to 1 in 1000 people








POM

Leaflet revision and issue dated: 03.05.16

Uncommon: may affect up to 1 in 100 people











HOW TO STORE FLUTIFORM INHALER

The other ingredients are:
• Sodium cromoglicate
• Ethanol
• Apaflurane HFA 227 (propellant)

If you forget to use Flutiform inhaler

4.

5.

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.

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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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