Sverige - svenska - Läkemedelsverket (Medical Products Agency)
Package leaflet: Information for the user
Affera K-haler 50 microgram /5 microgram per actuation pressurised inhalation, suspension
Affera K-haler 125 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 <,or> pharmacist <or nurse>.
This medicine has been prescribed for you only. 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 <,or> pharmacist <or nurse>. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
is and what it is used for
What you need to know before you use
How to use
Possible side effects
How to store
Contents of the pack and other information
What <Invented name> is and what it is used for
pressurised inhalation, suspension is the full name of the product, however throughout
this leaflet it is referred to as
or simply as an inhaler, sometimes together with a reference
to a specific strength.
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 beta
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. The inhaler is breath-triggered (or breath-actuated) which
means that it will release these two active ingredients when you breath in through the mouthpiece.
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.
What you need to know before you use <Invented name>
Do not use <Invented name>
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 <,or> pharmacist <or nurse> before using this inhaler
Before treatment with this inhaler tell your doctor<, or> pharmacist <or 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
an abnormal bulging of a blood vessel wall (an aneurysm);
high blood pressure;
an overactive thyroid gland which can cause increased appetite, weight loss or sweating
low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm
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
Contact your doctor if you experience blurred vision or other visual disturbances.
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 <Invented name>
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
including medicines obtained without a prescription. If you use this inhaler with some other medicines the
effect of this inhaler or the other medicine may be altered.
Tell your doctor or pharmacist if you are taking:
medicines known as beta blockers (such as atenolol to treat high 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
medicines containing adrenaline or related substances (including other beta agonists like salbutamol or
beta antagonists including atenolol, metoprolol, propranolol, timolol). Additional long-acting beta
agonists should not be used together with this inhaler. If your asthma becomes worse between doses of
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
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);
some medicines may increase the effects of <Invented name> and your doctor may wish to monitor you
carefully if you are taking these medicines (including some medicines for HIV: ritonavir, atazanavir,
indinavir, nelfinavir, saquinavir or cobicistat);
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 might be pregnant or are planning to have a baby ask your
doctor or pharmacist for advice about using your inhaler. Your doctor will advise you if you should take
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.
<Invented name> 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.
How to use <Invented name>
Always use this inhaler exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist 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 has advised. If you are not sure about how much to take or how often to use your
inhaler please check with your doctor or pharmacist.
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.
<Invented name> 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, or pharmacist will show you how to use your inhaler properly. The inhaler is breath-
triggered (or breath-actuated) which means that it will automatically release the two active ingredients when
you breath in through the mouthpiece. The medicine is contained in an aerosol can which is hidden inside a
plastic casing. The plastic casing also has a counter to tell you how many puffs (actuations) are left . This
counter is colour coded. When there are less than 28 puffs (actuations) left it starts changing to red and you
should contact your doctor for a replacement inhaler. You should not use your inhaler when the counter
reads “0” or has turned completely red.
Before you use your inhaler for the first time or if it hasn’t been used for more than 3 days
If your inhaler is new or it hasn’t been used for more than 3 days then it must be ‘set up’ (primed) to ensure
it works properly and gives you the correct dose.
Always point the mouthpiece away from you when setting up (priming).
Follow the instructions to set up your inhaler.
As the mouthpiece is closed it will release one puff (actuation).
If you drop your inhaler or leave the mouthpiece cover open for more than 10 minutes, then your inhaler
needs to be triggered once before use as in steps 1 and 2 above.
If you expose your inhaler to freezing conditions you should leave it to warm at room temperature for 30
minutes then trigger once before use as in steps 1 and 2 above.
Your inhaler should always be shaken immediately before use.
Using your inhaler
If you feel you are getting breathless or wheezy while using
, you should continue to use
but go to see your doctor as soon as possible, as you may need additional treatment.
Once your asthma is well controlled your doctor may consider it appropriate to reduce the dose of
The inhaler should be shaken immediately before each puff (actuation) to ensure the contents of your
inhaler are evenly mixed.
Sit upright or stand. Breathe out as slowly and deeply as possible. See diagram 1.
Hold your inhaler upright, open the orange mouthpiece cover and put the mouthpiece in your mouth
with your lips around it. Do not bite the mouthpiece.
Breathe in slowly and deeply through the mouthpiece, which will automatically trigger the release of a
puff (actuation). While holding your breath, remove the inhaler from your mouth and close the
mouthpiece cover. Continue to hold your breath for as long as is comfortable. Do not breathe out into
the inhaler. See diagrams 2 and 3. If you see a ‘mist’ as you close the mouthpiece cover then you have
not taken your inhaler properly and will need to repeat the steps above.
For the second puff (actuation), hold the inhaler upright and repeat the steps 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 use more <Invented name> than you should
It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. 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 or pharmacist 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 or
pharmacist 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 <Invented name>
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 <Invented name>
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
Possible side effects
Like all medicines, this inhaler
can cause side effects, although not everybody gets them. Your doctor will
prescribe the lowest dose necessary to control your asthma which may reduce the possibility of side effects
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
your quick acting ‘reliever’ inhaler. Contact your doctor straight away. Your doctor will assess you and
may start you on a different course of treatment. You should carry your ‘reliever’ inhaler with you at all
may affect up to 1 in 100 people
Worsening of asthma.
An irregular heartbeat or palpitations.
Difficulty in sleeping.
Alteration in voice/hoarse voice.
Dry mouth, sore or irritated throat.
may affect up to 1 in 1,000 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
Thrush or other fungal infections in the mouth and throat.
Inflammation of the sinuses (sinusitis).
Chest pain associated with heart disease.
Coughing or shortness of breath.
Changes in taste.
A feeling of dizziness or ‘spinning’.
High blood pressure.
A feeling of unusual weakness.
Swelling of hands, ankles or feet.
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:
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.
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 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
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<,or> pharmacist <or nurse>. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the national reporting system.
By reporting side effects you can help provide more information on the safety of this medicine.
How to store <Invented name>
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 once 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.
Contents of the pack and other information
What <Invented name> contains
The active substances are fluticasone propionate and formoterol fumarate dihydrate. There are two different
strengths of inhaler available.
50 microgram/5 microgram per actuation
pressurised inhalation, suspension – only
Each puff (actuation) contains 50 micrograms fluticasone propionate and 5 micrograms formoterol fumarate
125 microgram/5 microgram per actuation
pressurised inhalation, suspension – only
Each puff (actuation) contains 125 micrograms fluticasone propionate and 5 micrograms formoterol
The other ingredients are:
Apaflurane HFA 227 (propellant)
What <Invented name> looks like and the contents of the pack
These inhalers are small aerosol cans sealed inside pale grey plastic casings with orange mouthpiece covers.
You cannot see the aerosol can inside the plastic casing. The aerosol cans contain a white to off-white
liquid suspension and are fitted with a metering valve. Each inhaler contains 120 puffs (actuations). There
is one inhaler in a pack. Multiple pack size is 3 x 1 inhaler (120 actuations).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
<To be completed nationally>
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last revised in 2019-03-14
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