Salmeterol/Fluticasone Hexal 50 mikrogram/500 mikrogram/dos Inhalationspulver, avdelad dos

מדינה: שוודיה

שפה: שוודית

מקור: Läkemedelsverket (Medical Products Agency)

מרכיב פעיל:

flutikasonpropionat; salmeterolxinafoat

זמין מ:

Hexal AG

קוד ATC:

R03AK06

INN (שם בינלאומי):

fluticasone propionate; salmeterol

כמות:

50 mikrogram/500 mikrogram/dos

טופס פרצבטיות:

Inhalationspulver, avdelad dos

הרכב:

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

סיווג:

Apotek

סוג מרשם:

Receptbelagt

איזור תרפויטי:

Salmeterol och flutikason

leaflet_short:

Förpacknings: Inhalator, 1 x 60 doser; Inhalator, 2 x 60 doser; Inhalator, 3 x 60 doser; Inhalator, 4 x 60 doser; Inhalator, 5 x 60 doser; Inhalator, 6 x 60 doser; Inhalator, 10 x 60 doser

מצב אישור:

Avregistrerad

תאריך אישור:

2014-02-13

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
Salmeterol/Fluticasone Hexal, 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 Salmeterol/Fluticasone Hexal is and what it is used for
2. What you need to know before you use Salmeterol/Fluticasone Hexal
3. How to use Salmeterol/Fluticasone Hexal
4. Possible side effects
5. How to store Salmeterol/Fluticasone Hexal
6. Contents of the pack and other information
1.
WHAT SALMETEROL/FLUTICASONE HEXAL IS AND WHAT IT IS USED FOR
Salmeterol/Fluticasone Hexal 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 SALMETEROL/FLUTICASONE HEXAL
DO NOT USE SALMETEROL/FLUTICASONE HEXAL

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 Salmeterol/Fluticasone
Hexal if you have:

heart disease, including an irregular or fast heartbeat

overactive thyroid gland

high

מאפייני מוצר

Produktinformationen för Salmeterol/Fluticasone Hexal 50
mikrogram/500 mikrogram/dos,
inhalationspulver, avdelad dos MTnr 49084, gäller vid det tillfälle
då läkemedlet godkändes.
Informationen kommer inte att uppdateras eftersom läkemedlet inte
marknadsförs i Sverige.
Av samma anledning finns inte någon svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige
är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Salmeterol/Fluticasone Hexal,50 microgram/500 microgram/dose,
inhalation powder, predispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of {Salmeterol/Fluticasone Hexal}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_
Salmeterol/Fluticasone Hexalis indicated in the regular treatment of
asthma where use of a
combination product (long-acting beta-2-agonist and inhaled
corticosteroid) is appropriate:

patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short acting
beta-2-agonist
or

patients already adequately controlled on both inhaled corticosteroid
and long-acting beta-2-
agonist.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
Salmeterol