Salmeterol Neolab 25 micrograms per metered dose pressurised inhalation suspension

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Salmeterol

Dostupno od:

Fannin Limited

ATC koda:

R03AC; R03AC12

INN (International ime):

Salmeterol

Doziranje:

25 microgram(s)

Farmaceutski oblik:

Pressurised inhalation, suspension

Područje terapije:

Selective beta-2-adrenoreceptor agonists; salmeterol

Status autorizacije:

Not marketed

Datum autorizacije:

2011-07-22

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
Salmeterol Neolab 25micrograms per metered dose pressurised inhalation
suspension.
(as xinafoate)
The name of this medicine is Salmeterol Neolab 25 micrograms per
actuation pressurised
inhalation suspension which will be referred to as Salmeterol Neolab
25 micrograms inhalation
throughout this leaflet.
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.
1.
WHAT SALMETEROL NEOLAB 25 MICROGRAMS INHALATION
SUSPENSION IS AND WHAT IT IS USED FOR
•
Salmeterol Neolab 25 micrograms inhalation suspension contains the
medicine
salmeterol. It is a long-acting bronchodilator. It helps the airways
in the lungs to stay
open. This makes it easier for air to get in and out. The effects can
usually be noticed
within 10 to 20 minutes and last for 12 hours or more.
•
The doctor has prescribed Salmeterol Neolab 25 micrograms inhalation
suspension to
help prevent breathing problems. These could be caused by asthma.
Taking Salmeterol
Neolab 25 micrograms inhalation suspension regularly will prevent
asthma attacks
including asthma brought on by exercise or at night.
•
Taking Salmeterol Neolab 25 micrograms inhalation suspension regularly
will also help
prevent breathing problems caused by other chest illnesses such as
chronic obstructive
pulmonary disease (COPD).
•
Salmeterol Neolab 25 micrograms inhalation suspension helps to stop
breathlessness and
wheezing coming on. It does not work once you are breathless or
wheezy. If that
happens you need to use a fast-acting “reliever” medicine, such as

Svojstava lijeka

Health Products Regulatory Authority
12 March 2019
CRN008KJ6
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salmeterol Neolab 25 micrograms per metered dose pressurised
inhalation suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex-valve) contains 25 micrograms salmeterol (as
xinafoate). This is equivalent to a delivered dose
(ex-actuator) of 21 micrograms salmeterol (as xinafoate).
Excipient(s):
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
Pressurised aluminium canister containing a white suspension sealed
with a metering valve, with a mid-green polypropylene
actuator and a pale green polypropylene dust cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Regular symptomatic add-on treatment of reversible airways obstruction
in patients with asthma, including those with
nocturnal asthma, who are inadequately controlled on inhaled
corticosteroids in accordance with current treatment guidelines.
Treatment of chronic obstructive pulmonary disease (COPD).
Prevention of exercise-induced asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For inhalation use .
Salmeterol Neolab 25 micrograms should be used regularly. The full
benefits of treatment will be apparent after several doses
of the medicinal product. As there may be adverse reactions associated
with excessive dosing with this class of medicinal
product, the dosage or frequency of administration should only be
increased on medical advice.
Recommended Doses:
_ASTHMA_
_Adults and adolescents 12 years and older:_
Two actuations of 25 micrograms salmeterol twice daily.
In asthma patients with more severe airways obstruction up to four
inhalations of 25 micrograms of salmeterol twice daily may
be of benefit.
_Children below twelve years of age:_
The safety and efficacy of Salmeterol Neolab 25 micrograms have not
been demonstrated in children. The refore Salmeterol
Neolab 25 micrograms should not be used in children below twelve years
of age.
_COPD_