Xynoz Tablet 5mg

Страна: Малайзия

Език: английски

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

Активна съставка:

DESLORATADINE

Предлага се от:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Международно Name):

DESLORATADINE

Броя в опаковка:

10 Tablets

Произведено от:

IDAMAN PHARMA MANUFACTURING SDN BHD

Листовка

_Consumer Medication Information Leaflet (RiMUP)_
_ _
XYNOZ
TABLET 5MG
Desloratadine 5 mg
Desloratadine 5mg
WHAT IS IN THIS LEAFLET
1.
What
_Xynoz Tablet _
is
used for
2.
How
_Xynoz Tablet _
works
_3._
_ _
Before you use
_Xynoz _
_Tablet_
_ _
_4._
_ _
How to use
_Xynoz Tablet_
_ _
_5._
_ _
While you are using
_Xynoz _
_Tablet_
_ _
6.
Side effects
7.
Storage and Disposal of
_Xynoz Tablet _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT
_XYNOZ TABLET _
IS
USED FOR
_Xynoz Tablet _
relieves symptoms
of allergic reaction. These
symptoms include sneezing,
runny, blocked and itchy nose.
_Xynoz Tablet _
is also used to
relieve the symptoms of a skin
allergic reaction (urticaria). These
symptoms include itching and
hives.
HOW
_XYNOZ TABLET _
WORKS
_Xynoz Tablet _
is an antiallergy
medicine that does not make
you drowsy. It helps control
your allergic reaction and its
symptoms.
BEFORE YOU USE
_XYNOZ TABLET_
_ _
_ _
_-_
_ _
_When you must not use it_
_ _
Do not use
_Xynoz Tablet _
if
you are allergic
(hypersensitive) to
desloratadine, to any of the
other ingredients of
_Xynoz _
_Tablet _
or to loratadine.
_-_
_ _
_Before you start to use it _
Talk to your doctor or
pharmacist before taking
_Xynoz Tablet _
if you have
medical or familial history
of seizures.
Efficacy and safety of
_Xynoz Tablet _
in children
under 12 years of age have
not been established.
PREGNANCY AND BREAST-
FEEDING
Ask your doctor or pharmacist
for advice before taking any
medicine during pregnancy and
breast-feeding.
If you are pregnant or nursing a
baby, taking
_Xynoz Tablet _
is not
recommended.
_-_
_ _
_Taking other medicines_
_ _
There are no known interactions
of
_Xynoz Tablet _
with other
medicines.
Tell your doctor or pharmacist if
you are taking, have recently
taken or might take any other
medicines.
TAKING
_XYNOZ TABLET _
WITH FOOD
AND DRINK
_Xynoz Tablet _
may be taken with
or without a meal.
HOW TO USE
_XYNOZ TABLET_
_ _
_ _
_-_
_ _
_How much to use_
_ _
Adults and adolescents (12
years of age

Данни за продукта

COMPOSITION
Each film coated tablet contains Desloratadine 5 mg.
PRODUCT DESCRIPTION
Light blue, round film-coated tablet marked with ‘D5’ on one side
and plain on the other.
PHARMACODYNAMICS
Desloratadine is a non-sedating long-acting histamine antagonist with
potent, selective
peripheral H1-receptor antagonist activity. Desloratadine has
demonstrated antiallergic,
antihistaminic and anti-inflammatory activities. After oral
administration, desloratadine
selectively blocks peripheral histamine H1-receptors because the drug
is effectively
excluded from entry to the central nervous system.
Based on reported data, desloratadine inhibits the broad cascade of
events that initiate and
propagate allergic inflammation, including:
the release of proinflammatory cytokines including IL-4, IL-6, IL-8,
IL-13;
the release of important proinflammatory chemokines such as RANTES
(Regulated
upon Activation, Normal T-cell Expressed and Secreted);
superoxide anion production by activated polymorphonuclear
neutrophils;
eosinophil adhesion and chemotaxis;
the expression of the adhesion molecules such as P-selectin;
IgE-dependent release of histamine, prostaglandin (PGD2), and
leukotriene (LTC4);
the acute allergic bronchoconstrictor response and allergic cough in
animal models.
At the recommended adult dose of 5 mg daily, there was no excess
incidence of
somnolence and not affect standard measures of flight performance
including exacerbation
of subjective sleepiness or task related to flying. Also, Xynoz tablet
at a dose of 7.5 mg
daily does not affect psychomotor performance. Based on reported data,
at a dose 20 mg
daily for 14 days resulted in no statistical or clinical
cardiovascular effect. At a dose 45 mg
daily for 10 days, no prolongation of the QTc interval was reported.
No clinically relevant changes in desloratadine plasma concentrations
were observed when
taken
concomitantly
with
ketoconazole,
erythromycin,
azithromycin,
fluoxetine
and
cimetidine.
Based on literature, co-administration of alcohol did not increase the
alc