Aesalfluca Forspiro 50 mikrogram/500 mikrogram Inhalationspulver, avdelad dos

Valsts: Zviedrija

Valoda: zviedru

Klimata pārmaiņas: Läkemedelsverket (Medical Products Agency)

Aktīvā sastāvdaļa:

flutikasonpropionat; salmeterolxinafoat

Pieejams no:

Sandoz A/S

ATĶ kods:

R03AK06

SNN (starptautisko nepatentēto nosaukumu):

fluticasone propionate; salmeterol

Deva:

50 mikrogram/500 mikrogram

Zāļu forma:

Inhalationspulver, avdelad dos

Kompozīcija:

laktosmonohydrat Hjälpämne; flutikasonpropionat 500 mikrog Aktiv substans; salmeterolxinafoat 73 mikrog Aktiv substans

Klase:

Apotek

Receptes veids:

Receptbelagt

Ārstniecības joma:

Salmeterol och flutikason

Autorizācija statuss:

Avregistrerad

Autorizācija datums:

2015-03-12

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
Aesalfluca 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.

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 Aesalfluca Forspiro is and what it is used for
2. What you need to know before you use Aesalfluca Forspiro
3. How to use Aesalfluca Forspiro
4. Possible side effects
5. How to store Aesalfluca Forspiro
6. Contents of the pack and other information
1.
WHAT AESALFLUCA FORSPIRO IS AND WHAT IT IS USED FOR
Aesalfluca Forspiro is used to treat:

asthma

chronic obstructive pulmonary disease (COPD)
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.

Salmeterol: a long-acting substance that widens the airways

Fluticasone: a corticosteroid which reduces swelling and inflammation
in the lungs
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AESALFLUCA FORSPIRO
DO NOT USE AESALFLUCA 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 Aesalfluca 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

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aesalfluca Forspiro, 50 microgram/500 microgram/dose, inhalation
powder, predispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of Aesalfluca Forspiro provides:
For 50 microgram/500 microgram/dose, inhalation powder, predispensed:
50 micrograms of salmeterol (as salmeterol xinafoate) and 500
micrograms of fluticasone propionate
Corresponding with a delivered dose of:
45 micrograms of Salmeterol (as salmeterol xinafoate) and 465
micrograms of fluticasone propionate
Excipient with known effect
lactose monohydrate: 11.95 mg per metered dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White, homogenous powder
The pre-dispensed powder, contained in blister, is delivered by a
purple plastic dry-powder inhalation
device.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ASTHMA_
Aesalfluca Forspiro is indicated in the regular treatment of asthma
where use of a combination product
(long-acting β
2
agonist and inhaled corticosteroid) is appropriate:

patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short acting
β
2
agonist
or

patients already adequately controlled on both inhaled corticosteroid
and long-acting β
2
agonist.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
Aesalfluca Forspiro is indicated for the symptomatic treatment of
patients with COPD, with a FEV
1
<60% predicted normal (pre-bronchodilator) and a history of repeated
exacerbations, who have
significant symptoms despite regular bronchodilator therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration:
Aesalfluca Forspiro is for inhalation use only.
Patients should be made aware that Aesalfluca Forspiro must be used
daily for optimum benefit, even
when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Aesalfluca Forspiro they are
receiving remains optimal and is only changed on medical advice.
THE DOS