Salmex 50 micrograms / 500 microgram/dose Inhalation Powder, pre-dispensed

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

SALMETEROL, FLUTICASONE PROPIONATE

متاح من:

Glenmark Pharmaceuticals Nordic AB Propellergatan 2 SE-211 15 Malmö, Sweden

ATC رمز:

R03AK06

INN (الاسم الدولي):

SALMETEROL 50 µg FLUTICASONE PROPIONATE 500 µg

الشكل الصيدلاني:

INHALATION POWDER, PRE-DISPENSED

تركيب:

SALMETEROL 50 µg FLUTICASONE PROPIONATE 500 µg

نوع الوصفة الطبية :

POM

المجال العلاجي:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

الوضع إذن:

Authorised

تاريخ الترخيص:

2018-11-05

نشرة المعلومات

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SALMEX 50 MICROGRAM/500 MICROGRAM/DOSE INHALATION POWDER,
PRE-DISPENSED
Salmeterol/fluticasone propionate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Salmex is and what it is used for
2.
What you need to know before you use Salmex
3.
How to use Salmex
4.
Possible side effects
5.
How to store Salmex
6.
Contents of the pack and other information
1.
WHAT SALMEX IS AND WHAT IT IS USED FOR
Salmex contains two medicines, salmeterol and fluticasone propionate:
•
Salmeterol is a long-acting bronchodilator. Bronchodilators help the
airways in the lungs to stay
open. This makes it easier for air to get in and out. The effects last
for at least 12 hours.
•
Fluticasone propionate is a corticosteroid which reduces swelling and
irritation in the lungs.
The doctor has prescribed this medicine to help prevent breathing
problems such as:
•
Asthma
•
Chronic Obstructive Pulmonary Disease (COPD), reduces the number of
flare ups of COPD
symptoms.
You must use Salmex every day as directed by your doctor. This will
make sure that it works properly
in controlling your asthma or COPD.
SALMEX HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER
SALMEX SHOULD NOT BE
USED TO RELIEVE A SUDDEN ATTACK OF BREATHLESSNESS OR WHEEZING. IF THIS
HAPPENS YOU NEED TO USE A
FAST-ACTING ‘RELIEVER’ (‘RESCUE’) INHALER, SUCH AS SALBUTAMOL.
YOU SHOULD ALWAYS HAVE YOUR FAST-
ACTING ‘RESCUE’ INHALER WITH YOU.
SALMEX SHOULD ONLY BE USED TO TREAT ASTHMA

خصائص المنتج

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Salmex 50 microgram/500 microgram/dose inhalation powder,
pre-dispensed
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of
47 micrograms of salmeterol (as salmeterol xinafoate) and 460
micrograms of
fluticasone propionate. This corresponds to a pre-dispensed dose of 50
micrograms of
salmeterol (as salmeterol xinafoate) and 500 micrograms fluticasone
propionate.
Excipient(s) with known effect:
Each dose contains lactose up to 12.9 milligram.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
Molded plastic inhaler containing a foil strip with 60 regularly
placed blisters.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
_Asthma_
SALMEX IS INDICATED FOR USE IN PATIENTS WITH SEVERE ASTHMA 12 YEARS OF
AGE AND
OLDER ONLY.
Salmex is indicated in the regular treatment of patients with
SEVERE
asthma where use
of a combination product (long-acting β2 agonist and inhaled
corticosteroid) is
appropriate:
-
patients not adequately controlled on a lower strength corticosteroid
combination
product
or
-
patients already adequately controlled on an inhaled corticosteroid in
a high strength
and a long-acting β2 agonist.
_Chronic Obstructive Pulmonary Disease (COPD)_
Salmex 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.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Salmex is indicated in adults and adolescents 12 years of age and
older only.
Salmex is not indicated for use in children younger than 12 years of
age.
Posology
Route of administration: Inhalation use.
Patients should be made aware that Salmex must be used daily for
optimum benefit,
even when asymptomatic.
Patients should be regularly reassessed by a doctor, so t