Sverige - svenska - Läkemedelsverket (Medical Products Agency)
Package leaflet: Information for the user
Flaxxone Forspiro, 50 microgram/250 microgram/dose, inhalation powder, predispensed
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.
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. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Flaxxone Forspiro is and what it is used for
2. What you need to know before you use Flaxxone Forspiro
3. How to use Flaxxone Forspiro
4. Possible side effects
5. How to store Flaxxone Forspiro
6. Contents of the pack and other information
What Flaxxone Forspiro is and what it is used for
Flaxxone Forspiro is used to treat:
This medicine contains two active substances.
Salmeterol: a long-acting substance that widens the airways
Fluticasone: a corticosteroidwhich reduces swelling and inflammation in the lungs
What you need to know before you use Flaxxone Forspiro
Do not use Flaxxone Forspiro
if you are
to salmeterol, fluticasone or to the other ingredient of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Flaxxone Forspiro if you have:
heart disease, including an irregular or fast heartbeat
overactive thyroid gland
high blood pressure
low potassium in your blood
tuberculosis now or in the past, or other lung infections
Contact your doctor if you experience blurred vision or other visual disturbances.
Flaxxone Forspiro prevents the onset of breathlessness and wheezing. Please note that it does
not work when you are already breathless or wheezy.
If such a
occurs, you need to use a medicine which quickly widens the
airways, such as salbutamol.
Inform your doctor immediately if your asthma or breathing gets worse. You may find
you feel more wheezy
your chest feels tight more often
you need to use more of your fast acting airway widening inhaler
Continue to use Flaxxone Forspiro if any of these happen, but do not increase the number of
inhalations. Your chest condition may be getting worse and you could become seriously ill.
Talk to your doctor as you may need additional treatment.
Children and adolescents
Flaxxone Forspiro should not be used in children under the age of 12 years.
Other medicines and Flaxxone Forspiro
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
The following medicines can influence or be influenced by Flaxxone Forspiro:
medicines to treat high blood pressure, heart or other illnesses, with active substance names
ending with “olol” (beta-blockers), such as atenolol, propranolol and sotalol
medicines to treat viruses including some medicines for HIV, such as ritonavir or cobicistat;
Your doctor may wish to monitor you carefully if you are taking these medicines.
medicines to treat infections, such as ketoconazole, itraconazole and erythromycin
corticosteroids taken by the mouth or injected: medicines to treat inflammation or prevent
organ transplant rejection
diuretics, also known as ‘water tablets’ used to treat high blood pressure
other bronchodilators (such as salbutamol)
xanthine medicines. These are often used to treat asthma.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will
assess whether you can take Flaxxone Forspiro during this time.
Driving and using machines
Flaxxone Forspiro is unlikely to impair your ability to drive or operate machinery.
Flaxxone Forspiro contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.
The amount of lactose in this medicine does not normally cause problems in people who are
How to use Flaxxone Forspiro
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose
for adults and children from 12 years
One inhalation twice daily
Your doctor will want to regularly check your asthma symptoms.
If your symptoms become controlled using Flaxxone Forspiro twice daily, your doctor may
reduce your dose to once daily:
once at night if you have night-time
once in the morning if you have daytime
Method of use
Use Flaxxone Forspiro every day as prescribed by your doctor, preferably
in the morning and/or in the evening.
After use, rinse your mouth with water.
Not using Flaxxone Forspiro properly or as prescribed may worsen your breathing difficulties.
For optimal therapy, you must use Flaxxone Forspiro daily, even if you don’t have any
Instructions for use
Your doctor, nurse or pharmacist should demonstrate how to use the inhaler and should check
your use regularly.
The inhaler contains 60 doses of powder medication in a coiled strip of foil. It has a dose
counter which shows you how many doses you have remaining counting down from 60 to 0.
When you have reached the last 10 doses the numbers will be on a red background.
The inhaler is not refillable – please dispose of the inhaler when it is empty and replace it with
a new one.
Before using the inhaler
Open the transparent side chamber door.
Remove the foil strip from the side chamber by carefully tearing away the full length
of strip against the ‘teeth’ of the side chamber as shown below.
Do not pull or tug
Close the side chamber door and dispose of the used strip.
As you use the inhaler the side chamber will gradually fill up with used strip. The foil
black bars don’t contain medication
. Eventually the numbered sections
of the strip will appear in the side chamber.
Do not let more than 2 sections of foil strip build up
in the side chamber as they
may cause the inhaler to jam. Tear the strip away carefully as shown above, and
dispose of it safely.
Using the inhaler
Hold the inhaler in your hands as seen in the pictures.
to reveal the mouthpiece.
Check the dose counter to see how many doses are left.
Prepare the dose
the edge of the
. Make sure the side chamber is closed.
: Only operate the white lever when you are ready to inhale a dose of your
medication. If you play with the white lever, you will waste doses.
white lever fully over
as far as it will go and
until it clicks
action moves a new dose into position with the number at the top.
white lever fully
so that it
back into its original
position. The inhaler is now ready for immediate use.
Away from the inhaler mouthpiece, breathe out as much as is comfortable
breathe directly into
the inhaler as this could affect the dose.
Hold the inhaler level with the
protective cap pointing downwards
Close your lips firmly around the mouthpiece.
in steadily and
through the inhaler, not through your nose.
Remove the inhaler from your mouth and
hold your breath for 5-10 seconds
long as you can without causing
Afterwards, breathe out slowly,
but not into the inhaler
Close the protective cap over the mouthpiece.
Rinse your mouth with water and spit it out. This may help to prevent you from getting
fungal infection in the mouth and becoming hoarse.
Wipe the outside of the mouthpiece with a clean, dry tissue if necessary.
Do not attempt to take the inhaler apart to clean it or for any other purpose!
Do not use water or wet wipes to clean the inhaler parts as dampness can affect the
Never insert a pin or other sharp objects into the mouthpiece, or any other part, as this
could damage the inhaler!
If you use more Flaxxone Forspiro than you should
Contact your doctor or pharmacist.
Overdose symptoms are:
rapid heart beat
If you have used larger doses for a long persiod of time, you should talk to your doctor or
pharmacist for advice. This is because larger doses of Flaxxone Forspiro may reduce the
ammount of steroid hormones produced by the adrenal gland.
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 forget to use Flaxxone Forspiro
Do not take a double dose to make up for a forgotten dose. Use your next dose when it is due.
If you stop using Flaxxone Forspiro
Do not stop or suddenly reduce your dose of Flaxxone Forspiro without your doctor’s
permission as this could cause your breathing problems to worsen and very rarely side effects
could occur. These include:
tiredness and loss of appetite, feeling sick
sickness and diarrhoea
headache or drowsiness
low levels of sugar in your blood
low blood pressure and seizures
Very rarely, if you get an infection or at times of extreme stress (such as after a serious
accident or if you have surgery), you may get similar side effects. To prevent these symptoms
ocuring, your doctor may prescribe extra corticosteroids (like prednisolone).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions: you may notice your breathing suddenly gets worse after using
. You may be very wheezy and cough. You may also notice itching, a rash
(hives) and swelling (usually of the face, lips, tongue, or throat) , or you may suddenly feel
your heart beating very fast or you feel faint and light headed (which may lead to collapse or
loss of consciousness).
If you get these effects or if they happen suddenly after using
Flaxxone Forspiro, tell your doctor straight away.
Allergic reactions to Flaxxone Forspiro
are uncommon (they may affect up to 1 in 100 people).
Other side effects can occur with the following frequencies:
may affect more than 1 in 10 people
This usually gets better as treatment continues.
increased number of colds in patients with COPD
may affect up to 1 in 10 people
thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue and
hoarse voice and throat irritation.
Rinsing your mouth out with water and spitting it out immediately and/or brushing your
teeth after each inhalation may help. Your doctor may prescribe an anti-fungal medication to
treat the thrush.
aching, swollen joints and muscle pain
The following side effects have also been reported in patients with Chronic Obstructive
Pulmonary Disease (COPD)
Pneumonia (infection of the lung)
Tell your doctor if you have any of the following while taking Flaxxone Forspiro, they could
be symptoms of a lung infection:
increase in mucous production
change in mucous colour
increased breathing difficulties
bruising and fractures throughout the body
inflammation of the sinuses
low potassium level in the blood (you may get an uneven heartbeat, muscle weakness and/or
may affect up to 1 in 100 people
very fast heartbeat (tachycardia)
feeling shaky and a fast or uneven heartbeat (palpitation)
This is usually harmless and decreases during therapy.
This effect mainly occurs in children.
increased blood sugar level
If you have diabetes, more frequent blood sugar monitoring and possible adjustment of
your diabetic medicines may be required.
clouding of the eye lens (cataract)
allergic skin rash
may affect up to 1 in 1,000 people
straight after using Flaxxone Forspiro.
your Flaxxone Forspiro and use your fast-acting
airway widening inhaler to
help your breathing
. Tell your doctor
abnormal production of certain hormones, particularly when using this medicine in high
doses over a long time
slowing of growth in children and adolescents
thinning of the bones
increased eye pressure (glaucoma)
rounded, moon shaped face (Cushing’s Syndrome).
Your doctor will check you regularly for any of these side effects, ensuring you are on the
lowest dose possible.
behavioural changes, such as being unusually active and irritable
These effects mainly occur in children.
irregular heartbeat or heart gives an extra beat
Tell your doctor, but do not stop using Flaxxone Forspiro unless told to do so.
a fungal infection in the oesophagus (gullet), which might cause difficulties in
Frequency not known
, but may also occur
depression or aggression
These effects mainly occur in children.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via
reporting system listed in Appendix V.
By reporting side effects you can help provide more
information on the safety of this medicine.
How to store Flaxxone Forspiro
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not use this medicine after the expiry date which is stated on the label and carton after
EXP. The expiry date refers to the last day of that month.
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
Contents of the pack and other information
What Flaxxone Forspiro contains
Flaxxone Forspiro 50/250 microgram inhalation powder, predispensed:
The active substances are salmeterol and fluticasone. Each metered dose of Flaxxone
Forspiro provides 50 micrograms of salmeterol (as salmeterol xinafoate) and 250
micrograms of fluticasone propionate.Corresponding with a delivered dose of:
45 micrograms of Salmeterol (as salmeterol xinafoate) and 233micrograms of fluticasone
The other ingredient is lactose monohydrate.
What Flaxxone Forspiro looks like and contents of the pack
In the purple plasticdry-powder inhalation device, 60 doses of powder blend are contained
in an aluminium blister.
Each dose is pre-dispensed.
1, 2, 3, 4, 5, 6 or 10 devices containing 60 doses
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
Airflusal Forspiro 50 microgram/250 microgram/dosis inhalatiepoeder,
Airflusal Forspiro 50 mcg / 250 mcg poudre pour inhalation en récipient
Flaxxone Forspiro, 50 mikrogram/250 mikrogram inhalationspulver
This leaflet was last revised in
20 February 2018.
[To be completed nationally]
Marknadsförs ej för närvarande.