LAZINE 5MG TABLETS

Land: Maleisië

Taal: Engels

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

Werkstoffen:

LEVOCETIRIZINE DIHYDROCHLORIDE

Beschikbaar vanaf:

CAMBER LABORATORIES SDN. BHD.

INN (Algemene Internationale Benaming):

LEVOCETIRIZINE DIHYDROCHLORIDE

Eenheden in pakket:

30Tablet Tablets

Geproduceerd door:

"HETERO DRUGS LIMITED"

Bijsluiter

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LAZINE 5MG TABLETS
Levocetirizine dihydrochloride (5mg)
1
WHAT IS IN THIS LEAFLET
1.
What LAZINE
_ _
is used for
2.
How LAZINE
_ _
works
3.
Before you use LAZINE
4.
How to use LAZINE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of LAZINE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT LAZINE_ _IS USED FOR
LAZINE is used to treat the symptoms
of:
•
Allergic
rhinitis
(inflammation of
the
mucous
membrane inside
the
nose) including persistent allergic
rhinitis.
•
Long term hives of unknown cause.
HOW LAZINE WORKS
LAZINE contains the active ingredient
levocetirizine dihydrochloride.
LAZINE is an antiallergic medication. It
works
by
blocking
a
certain
natural
substance (histamine) that your body
makes during allergic reaction.
BEFORE YOU USE LAZINE
_-When you must not use it _
Do not take LAZINE if you have:
•
Allergy (hypersensitivity) to the
active ingredient levocetirizine
dihydrochloride, cetirizine,
piperazine or any of the ingredients
listed contained in the product.
•
Severe kidney impairment at less
than
10
ml/min
creatinine
clearance.
The
use
of
LAZINE
is
not
recommended for infants and children
under 6 years.
_Pregnancy and breastfeeding _
Ask
your
doctor
or
pharmacist
for
advice before taking any medicine. Tell
your doctor if you are pregnant, trying to
get pregnant or breastfeeding.
_-Before you start to use it _
Tell your doctor if you have been told by
your doctor that you have an intolerance
to
some
sugars.
This
tablet
contains
lactose.
_-Taking other medicines _
Tell your doctor or pharmacist if you are
taking
theophylline
(used
to
treat
asthma)
or
any
other
medicines
including those that you get without a
prescription.
HOW TO USE LAZINE
_-How much to use _
Always take LAZINE exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure.
The usual daily dose for:
•
Adults and children aged 6 years
old and above: 5mg (1 film-coated
t

Productkenmerken

LAZINE 5 MG TABLET (LEVOCETIRIZINE DIHYDROCHLORIDE TABLET 5MG)
Font: Time News Roman, size 7
DESCRIPTION AND COMPOSITION
: White film coated, scored, round shaped, standard concave tablets,
debossed with ‘161’ on one side and ‘H’ on the other side.
Each film coated tablet contains: Levocetirizine Dihydrochloride 5mg.
PHARMACODYNAMIC PROPERTIES:
Levocetirizine, the (R) enantiomer of cetirizine, is a potent and
selective antagonist of peripheral H1-receptors.
Binding studies revealed that levocetirizine has high affinity for
human H1-receptors (Ki= 3.2 nmol/l). Levocetirizine has an affinity
2-fold higher than that of
cetirizine (Ki = 6.3 nmol/l). Levocetirizine dissociates from
H1-receptors with a half-life of 115 ± 38 min. After single
administration, levocetirizine shows a
receptor occupancy of 90% at 4 hours and 57% at 24 hours.
Pharmacodynamic studies in healthy volunteers demonstrate that, at
half the dose, levocetirizine has comparable activity to cetirizine,
both in the skin and in the
nose.
The pharmacodynamic activity of levocetirizine has been studied in
randomised, controlled trials:
In a study comparing the effects of levocetirizine 5mg, desloratadine
5mg, and placebo on histamine-induced wheal and flare, levocetirizine
treatment resulted in
significantly decreased wheal and flare formation which was highest in
the first 12 hours and lasted for 24 hours, (p<0.001) compared with
placebo and
desloratadine.
The onset of action of levocetirizine 5 mg in controlling
pollen-induced symptoms has been observed at 1 hour post drug intake
in placebo-controlled trials in the
model of the allergen challenge chamber.
In vitro studies (Boyden chambers and cell layers techniques) show
that levocetirizine inhibits eotaxin-induced eosinophil
transendothelial migration through both
dermal and lung cells. A pharmacodynamic experimental study in vivo
(skin chamber technique) showed three main inhibitory effects of
levocetirizine 5 mg in
the first 6 hours of pollen- induced reaction, compared with placebo
in 14 ad