Glencet M (Montelukast 10mg Levocetirizine dihydrochloride 5mg) Film-Coated Tablet

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

MONTELUKAST SODIUM; Levocetirizine Dihydrochloride

Dostępny od:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (International Nazwa):

MONTELUKAST SODIUM; Levocetirizine Dihydrochloride

Sztuk w opakowaniu:

14 Tablets

Wyprodukowano przez:

Glenmark Pharmaceuticals Limited

Ulotka dla pacjenta

1
_Consumer Medication Information Leaflet (RiMUP) _
_ _
GLENCET M FILM-COATED TABLETS
Montelukast and Levocetirizine Dihydrochloride Tablets (10mg + 5mg)
WHAT IS IN THIS LEAFLET
1.
What Glencet M is used for
2.
How Glencet M works
3.
Before you take Glencet
M
4.
How to take Glencet M
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Glencet M
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT GLENCET M IS USED FOR
Glencet
M
contains
the
active
ingredients Montelukast sodium and
Levocetirizine dihydrochloride.
Glencet M is used for the treatment
of
relief
of
symptoms
associated
with seasonal allergic rhinitis..
HOW GLENCET M WORKS
Montelukast
is
a
leukotriene
receptor antagonist that blocks
substances
called
leukotrienes.
Leukotrienes
cause
narrowing
and swelling of airways in the
lungs
and
also
cause
allergy
symptoms.
By
blocking
leukotrienes,
montelukast
improves
seasonal
allergy
symptoms (also known as hay
fever
or
seasonal
allergic
rhinitis).
Levocetirizine
is
a
potent
and
selective
antihistamine which blocks the
action
of
substance
called
histamine which is produced in
the
body
during
an
allergic
reaction.
BEFORE YOU TAKE GLENCET M
_-When you must not use it _
a)
If you are allergic to montelukast,
levocetirizine dihydrochloride,
cetirizine, hydroxyzine or any of the
other ingredients of this medicine.
b)
if you have a severe impairment
of kidney function (severe renal
failure with creatinine clearance
below 10 ml/min)
c)
if
you
have
rare
hereditary
problems
of
galactose
intolerance,
the
Lapp
lactase
deficiency or glucose-galactose
malabsorption.
_-_
_ _
_Before you start to use it _
_ _
Talk to your doctor or pharmacist
before taking Glencet M
_ _
_ _CHILDREN AND ADOLESCENTS
The use of Glencet M is not
recommended
in
children
less
than 18 years since this product
has not been studied.
_ _
_-Taking other medicines _
Tell your doctor or pharmacist if
you are taking or have recently
taken
or
might
take
any
other
medicines
including
those
obtained

Charakterystyka produktu

PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE
PE55457
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
Group
Normal renal function
Mildly decreased
renal function
Moderatelydecreasedrenal
function
Severelydecreasedrenal
function
End stage renal disease
(ESRD)
60 - < 90
30 - < 60
15 < 30
(not requiring
dialysis)
1 tablet once
every 3 days
Contra-indicated
1 tablet once
every 2 days
eGFR
(ml/min)
≥ 90
1 tablet once daily
1 tablet once daily
Dosage and
frequency
< 15
(requiring
dialysis
treatment)
35 mm
_For the use only of a registered Medicinal Practitioner or_
_ a hospital or a Laboratory_
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
INFORMATION FOR THE PHYSICIAN
1.
NAME OF THE MEDICINAL PRODUCT
GLENCET
M
(Montelukast
10mg
+
Levocetirizine
dihydrochloride 5mg) Film-coated Tablets
2.
Q U A L I T A T I V E
A N D
Q U A N T I T A T I V E
COMPOSITION
Each film coated tablet contains:
Montelukast sodium equivalent to Montelukast 10 mg
Levocetirizine Dihydrochloride 5 mg
Colours: Ferric Oxide Yellow USPNF, Ferric Oxide Red USPNF
& Titanium Dioxide USP
3.
PHARMACEUTICAL FORM
Yellow, round, biconvex, film coated tablets plain on both sides.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
GLENCET
M
(Montelukast
10mg
+Levocetirizine
dihydrochloride 5mg) Film-coated Tablets are indicated for the
relief of symptoms associated with seasonal allergic rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (≥18 years of age): The recommended dose is one tablet to
be taken orally, in the evening. The tablets should be swallowed
whole with or without food.
PAEDIATRIC AND ADOLESCENT (<18 YEARS OF AGE):
Since this
product has not been studied in the adolescent and paediatric
population this medicinal product is not recommended in this
age group.
PATIENTS WITH RENAL IMPAIRMENT:
No dose adjustment is needed
in patients with mild renal impairment (creatinine clearance
>79
ml/min).
For
patients
with
moderate
to
severe
renal
impairment (creatinine clearance <79 ml/min - >10ml/min), this
pro