Affera K-haler 125 mikrogram/5 mikrogram/puff Inhalationsspray, suspension

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)


Produktens egenskaper Produktens egenskaper (SPC)


Aktiva substanser:
flutikasonpropionat; formoterolfumaratdihydrat
Tillgänglig från:
Mundipharma AB
INN (International namn):
fluticasone propionate; formoterol
125 mikrogram/5 mikrogram/puff
Inhalationsspray, suspension
formoterolfumaratdihydrat 5 mikrog Aktiv substans; flutikasonpropionat 125 mikrog Aktiv substans; etanol, vattenfri Hjälpämne
Receptbelagda typ:
Förpacknings: Inhalator, 3 x 120 puffar; Inhalator, 120 puffar
Bemyndigande status:
Tillstånd datum:

Dokument på andra språk

Bipacksedel Bipacksedel - engelska


Produktens egenskaper Produktens egenskaper - engelska


Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska


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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


<Invented name>

is and what it is used for

What you need to know before you use

<Invented name>

How to use

<Invented name>

Possible side effects

How to store

<Invented name>

Contents of the pack and other information


What <Invented name> is and what it is used for

Please note:-

<Invented name>

pressurised inhalation, suspension is the full name of the product, however throughout

this leaflet it is referred to as

<Invented name>

or simply as an inhaler, sometimes together with a reference

to a specific strength.

<Invented name>

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


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.

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.


What you need to know before you use <Invented name>

Do not use <Invented name>

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 <,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


liver problems.

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

<Invented name>

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

this medicine.

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

<Invented name>

, you should continue to use

<Invented name>

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

<Invented name>

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

asthma attack.


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

<Invented name>

and use

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).

Fast heartbeat.

Chest pain associated with heart disease.

Muscle spasms.

Coughing or shortness of breath.



Changes in taste.

A feeling of dizziness or ‘spinning’.

Abnormal dreams.


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

Blurred vision.

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.

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 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

fumarate dihydrate.

The other ingredients are:

Sodium cromoglicate


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:

Affera K-haler:




This leaflet was last revised in 2019-03-14

Other sources of information

To view the interactive training tool visit XXXX

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