Eklira Genuair 322 mcg Inhalation Powder

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

Aclidinium Bromide

Verfügbar ab:

ASTRAZENECA SDN. BHD.

INN (Internationale Bezeichnung):

Aclidinium Bromide

Einheiten im Paket:

1units Units

Hergestellt von:

Industrias Farmaceuticas Almirall, S.A. (IFA)

Gebrauchsinformation

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
EKLIRA GENUAIR 322 MCG
INHALATION POWDER
322MCG ACLIDINIUM (375 MCG ACLIDINIUM BROMIDE)
1
WHAT IS IN THIS LEAFLET
1.
What Eklira Genuair is
used for
2.
How Eklira Genuair works
3.
Before you use Eklira
Genuair
4.
How to use Eklira Genuair
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
Eklira Genuair
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT EKLIRA GENUAIR IS USED
FOR
Eklira Genuair is indicated to
help open the airways and
relieve symptoms of COPD, a
serious, long-term lung disease
characterised by breathing
difficulties. Regular use of
Eklira Genuair can help you
when you have ongoing
shortness of breath related to
your disease and will help you
to minimise the effects of the
disease on your everyday life.
HOW EKLIRA GENUAIR WORKS
The active ingredient of Eklira
Genuair is aclidinium bromide,
which belongs to a group of
medicines called
bronchodilators.
Bronchodilators relax airways
and help keep bronchioles
open.
Eklira Genuair is a dry powder
inhaler that uses your breath to
deliver the medicine directly
into your lungs. This makes it
easier for chronic obstructive
pulmonary disease (COPD)
patients to breathe.
BEFORE YOU USE EKLIRA
GENUAIR_ _
_When you must not use it _
Do not use Eklira Genuair
-
if you are allergic to
aclidinium bromide or any of
the other ingredients of this
medicine
_Before you start to use it _
Talk to your doctor, pharmacist
or nurse before using Eklira
Genuair:
-
if you have had heart
problems recently.
-
if you see halos around lights
or coloured images
(glaucoma).
-
if you have an enlarged
prostate, problems passing
urine, or a blockage in your
bladder
Eklira Genuair is indicated for
maintenance treatment and
should not be used to treat a
sudden attack of breathlessness
or wheezing. If your COPD
symptoms (breathlessness,
wheezing, cough) do not
improve or get worse you
should contact your doctor for
advice as soon as possible.
Dry mouth, which has been
observed

Fachinformation

1. NAME OF THE MEDICINAL PRODUCT
Eklira Genuair 322 mcg inhalation powder
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose leaving the mouthpiece) contains 375 mcg aclidinium bromide
equivalent to 322 mcg of aclidinium. This corresponds to a metered dose of 400 mcg
aclidinium bromide equivalent to 343 mcg aclidinium.
Excipients with known effect:
Each delivered dose contains approximately 12 mg lactose (as monohydrate ).
For the full list of excipients, se e section 6.1.
3. PHARMACEUTICAL FORM
Inhalation powder.
White or almost white powder in a white inhaler with an integral dose indicator and a green
dosage button.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Eklira Genuair is indicated as a mai ntenance bronchodilator treatment to relieve symptoms in
adult patients with chronic obstructive pulmonary disease (COPD).
4.2 Posology and method of administration
Posology
The recommended dose is one inhalation of 322 micrograms aclidinium twice daily.
If a dose is missed the next dose should be taken as soon as possible. However, if it is nearly
time for the next dose, the missed dose should be skipped.
Elderly
No dose adjustments are required for elderly patients (see section 5.2).
Renal impairment
No dose adjustments are required for patients with renal impairment (see section 5.2).
Hepatic impairment
No dose adjustments are required for patients with hepatic impairment (see section 5.2).
Paediatric population
There is no relevant use of Eklira Ge nuair in children and adolescents (under 18 years of age)
in the indication of COPD.
Method of administration
For inhalation use.
Patients should be instructed on how to administer the product correctly as the Genuair
inhaler may work differently from inh alers the patients may have used previously. It is
important to instruct the patients to carefully read the Instructions for Use in the Package
Insert, which is packed together with each inhaler.