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Flaxxone Forspiro

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Package leaflet: Information for the user


Flaxxone Forspiro, 50 microgram/500 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.


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


1What Flaxxone Forspiro is and what it is used for


Flaxxone Forspiro is used to treat:

This disease is characterized by continuous breathing difficulties caused by narrowed airways, often accompanied with coughing and phlegm. This medicine reduces the number of flare ups of COPD symptoms.



This medicine contains two active substances.


2What you need to know before you use Flaxxone Forspiro


Do not use Flaxxone Forspiro

if you are allergic 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:


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 attackoccurs, 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 that:

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

Asthma:

Flaxxone Forspiro should not be used in children under the age of 12 years.


COPD:

Flaxxone Forspiro should not be used in children and adolescents.


Other medicines and Flaxxone Forspiro

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines can influence or be influenced by Flaxxone Forspiro:


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 Forspiroduring 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.


3How 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.


Asthma

The recommended dose for adults and children from 12 years is:


One inhalation twice daily


Your doctor will want to regularly check your asthma symptoms.


Chronic obstructive pulmonary disease

The recommended dose for adultsis:


One inhalation twice daily


If your symptoms become controlled using Flaxxone Forspiro twice daily, your doctor may reduce your dose to once daily:


Method of use

Use Flaxxone Forspiroevery day as prescribed by your doctor, preferably right before mealtime 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 symptoms.


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