Flaxxone Forspiro 50 mikrogram/250 mikrogram Inhalationspulver, avdelad dos

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)


Produktens egenskaper Produktens egenskaper (SPC)


Aktiva substanser:
flutikasonpropionat; salmeterolxinafoat
Tillgänglig från:
Sandoz A/S,
INN (International namn):
fluticasone propionate; salmeterol
50 mikrogram/250 mikrogram
Inhalationspulver, avdelad dos
laktosmonohydrat Hjälpämne; salmeterolxinafoat 73 mikrog Aktiv substans; flutikasonpropionat 250 mikrog Aktiv substans
Receptbelagda typ:
Salmeterol och flutikason
Förpacknings: Inhalator, 1 x 60 doser; Inhalator, 10 x 60 doser; Inhalator, 6 x 60 doser; Inhalator, 5 x 60 doser; Inhalator, 4 x 60 doser; Inhalator, 3 x 60 doser; Inhalator, 2 x 60 doser
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

Flaxxone Forspiro, 50 microgram/250 microgram/dose, inhalation powder, predispensed

salmeterol/fluticasone propionate

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

diabetes mellitus

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

breathlessness attack

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

lactose intolerant.


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

right before


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

the strip.

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

strips with

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.




the protective

cap downwards

to reveal the mouthpiece.

Check the dose counter to see how many doses are left.


Prepare the dose

Lift up

the edge of the

white lever

. 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.

Open: Move

white lever fully over

as far as it will go and

until it clicks

. This

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

. Never

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

or as

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

muscle weakness

aching joints

feeling shaky

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:

stomach pain

tiredness and loss of appetite, feeling sick

sickness and diarrhoea

weight loss

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

Flaxxone Forspiro

. 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:

Very Common,

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

muscle cramps

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 cough

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.

feeling worried

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.

disturbed sleep

chest pain

clouding of the eye lens (cataract)

allergic skin rash


may affect up to 1 in 1,000 people

breathing difficulties



gets worse

straight after using Flaxxone Forspiro.

Stop using

your Flaxxone Forspiro and use your fast-acting

airway widening inhaler to

help your breathing

. Tell your doctor

straight away.

abnormal production of certain hormones, particularly when using this medicine in high

doses over a long time

Signs are:

slowing of growth in children and adolescents

thinning of the bones

increased eye pressure (glaucoma)

weight gain

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.

blurred vision.

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

the national

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


Flaxxone Forspiro

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.

Pack sizes:

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

following names:


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]

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