Salmeterol/Fluticasone Sandoz 50 mikrogram/250 mikrogram/dos Inhalationspulver, avdelad dos

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

flutikasonpropionat; salmeterolxinafoat

Tillgänglig från:

Sandoz A/S

ATC-kod:

R03AK06

INN (International namn):

fluticasone propionate; salmeterol

Dos:

50 mikrogram/250 mikrogram/dos

Läkemedelsform:

Inhalationspulver, avdelad dos

Sammansättning:

laktosmonohydrat Hjälpämne; salmeterolxinafoat 73 mikrog Aktiv substans; flutikasonpropionat 250 mikrog Aktiv substans

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Salmeterol och flutikason

Produktsammanfattning:

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

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2015-05-21

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
Salmeterol/Fluticasone Sandoz, 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 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
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

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.
Salmeterol/Fluticasone Sando

Produktens egenskaper

Produktinformationen för Salmeterol/Fluticasone Sandoz 50
mikrogram/250 mikrogram/dos
inhalationspulver, avdelad dos, MTnr 50816, 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.
1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Salmeterol/Fluticasone Sandoz, 50 microgram/250 microgram/dose,
inhalation powder, predispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of {Salmeterol/Fluticasone Sandoz} provides:
For 50 microgram/250 microgram/dose, inhalation powder, predispensed:
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 233
micrograms of fluticasone propionate
Excipient with known effect: lactose monohydrate: 12.20 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION