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

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

flutikasonpropionat; salmeterolxinafoat

Dostopno od:

Sandoz A/S

Koda artikla:

R03AK06

INN (mednarodno ime):

fluticasone propionate; salmeterol

Odmerek:

50 mikrogram/500 mikrogram/dos

Farmacevtska oblika:

Inhalationspulver, avdelad dos

Sestava:

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

Razred:

Apotek

Tip zastaranja:

Receptbelagt

Terapevtsko območje:

Salmeterol och flutikason

Povzetek izdelek:

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

Status dovoljenje:

Avregistrerad

Datum dovoljenje:

2014-02-13

Navodilo za uporabo

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

Lastnosti izdelka

Produktinformationen för Salmeterol/Fluticasone Sandoz 50
mikrogram/500 mikrogram/dos
inhalationspulver, avdelad dos, MTnr 49086, 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 Sandoz,50 microgram/500 microgram/dose,
inhalation powder, predispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of {Salmeterol/Fluticasone Sandoz}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 Sandoz}is 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)_
{Sal