Aspira Oral Granules 4mg

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

MONTELUKAST SODIUM

Tilgjengelig fra:

PHARMANIAGA MANUFACTURING BERHAD

INN (International Name):

MONTELUKAST SODIUM

Enheter i pakken:

28 Sachets

Produsert av:

PHARMANIAGA MANUFACTURING BERHAD

Informasjon til brukeren

ASPIRA ORAL GRANULES / ASPIRA CHEWABLE TABLET /
ASPIRA TABLET
Montelukast (4.0mg,5.0mg,10.0mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Aspira is used for
2.
How Aspira works
3.
Before you use Aspira
4.
How to use Aspira
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Aspira
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ASPIRA IS USED FOR
Aspira contains the active substances
Montelukast sodium. It is used for the
treatment
of
asthma
in
adults
and
children 12 months of age and older.
Aspira may also be used for relieving
day and night symptoms of seasonal
allergic rhinitis (hay fever) in adults
and children 2 years of age and older.
HOW ASPIRA WORKS
Aspira
is
a
leukotriene
receptor
antagonist
that
blocks
substances
called leukotrienes. Leukotrienes cause
narrowing and swelling of airways in
the
lungs.
By
blocking
leukotrienes,
Aspira improves asthma symptoms and
helps
control
asthma.
Aspira
also
improves hay fever symptoms.
BEFORE YOU USE ASPIRA
-
_When you must not use it _
Do not take Aspira if you or your child
is allergic to any medicine containing
Montelukast
or
any
of
the
other
ingredients
listed
at
the
end
of
this
leaflet.
_-Before you start to use it _
Tell
your
doctor
about
any
medical
problems or allergies you or your child
has now or has had.
Oral Aspira is not meant to treat acute
asthma
attacks.
If
an
attack
occurs,
follow the instructions your doctor has
given you or your child. Always have
your
inhaled
rescue
medicine
for
asthma attacks with you.
Do
not
take
acetyl-salicylic
acid
(aspirin)
or
anti-inflammatory
medicines
(also
known
as
non-
steroidal
anti-inflammatory
drugs
or
NSAIDs)
if
they
make
your
asthma
worse.
_Pregnancy and lactation _
Discuss with your doctor or pharmacist
first if you are pregnant or plan to get
pregnant or breastfeeding.
_-Taking other medicines _
Tell your doctor if you are taking any
other medicine, including any that you
buy
without
a
prescription
from
a
ph

Preparatomtale

FRONT
(L)297mm
(W)210mm
02
23.04.18
- Amend wording.
03
30.04.18
- Amend wording.
04
14.06.19
- Amend wording.
05
17.06.19
- Add ® beside Pharmaniaga logo.
06
19.06.19
- Remove the word "sodium"
07
25.06.19
- Amend wording.
08
02.07.19
- Amend wording.
09
19.12.19
- Amend wording.
10
01.09.2020
- Amend wording and revision date.
11
07.12.2020
- Amend wording.
12
10.12.2020
- Amend wording.
13
30.09.2021
- Amend wording and PRP from V11 artwork.
15
14
23.09.2022
- Amend wording and PRP.
07.12.2022
- Amend wording and PRP.
01
12.04.18
- Amend wording and PRP no.
VERSION NO.
DATE
REASON FOR CHANGE
ARTWORK LOG
artwork prepared by: cynthia yap
email: [e-mail] (Graphic Dept)
customer
PHARMANIAGA MANUFACTURING BERHAD
description
ASPIRA INSERT (FRONT)
PRP 0556.4/ PRP 0557.4/ PRP 0558.4 071222
size
attn
(L)297 X (W)210MM
date
07.12.2022
FOCUSPRINT
SDN BHD
DATE:
t: 603-8766 6030 f: 603-8766 6033 (Factory)
website: www.focusprint.com.my
1
PLEASE CHOP & SIGN FOR APPROVAL
colours
BLACK
IMPORTANT !
PLEASE NOTE THAT THIS COLOUR PRINT IS FOR VISUAL PURPOSE ONLY. OUTPUT
COLOUR MIGHT DIFFER IN ACTUAL PRODUCTION.
finishing
material
60G SIMILI
BACK
(L)297mm
(W)210mm
02
23.04.18
- Amend wording.
03
30.04.18
- Amend wording.
04
14.06.19
- Amend wording.
05
17.06.19
- Add ® beside Pharmaniaga logo.
06
19.06.19
- Remove the word "sodium"
07
25.06.19
- Amend wording.
08
02.07.19
- Amend wording.
09
19.12.19
- Amend wording.
10
01.09.2020
- Amend wording and revision date.
11
07.12.2020
- Amend wording.
12
10.12.2020
- Amend wording.
13
30.09.2021
- Amend wording and PRP from V11 artwork.
15
14
23.09.2022
- Amend wording and PRP.
07.12.2022
- Amend wording and PRP.
01
12.04.18
- Amend wording and PRP no.
VERSION NO.
DATE
REASON FOR CHANGE
ARTWORK LOG
artwork prepared by: cynthia yap
email: [e-mail] (Graphic Dept)
customer
PHARMANIAGA MANUFACTURING BERHAD
description
ASPIRA INSERT (BACK)
PRP 0556.4/ PRP 0557.4/ PRP 0558.4 071222
size
attn
(L)297 X (W)210MM
date
07.12.2022
FOCUSPRINT
SDN BHD
DATE:
t: 603-8766