Dezal Tablet 5mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DESLORATADINE

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DESLORATADINE

Unit dalam pakej:

3x10tablet Tablets; 10x10tablet Tablets; 1x10 Tablets

Dikeluarkan oleh:

Actavis Ltd.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
DEZAL TABLET 5MG
Desloratadine (5 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Dezal is used for
2.
How Dezal works
3.
Before you use Dezal
4.
How to take Dezal
5.
While you are using Dezal
6.
Side Effects
7.
Storage
and
Disposal
of
Dezal
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT DEZAL IS USED FOR
Dezal
relieves
symptoms
associated with allergic rhinitis
(inflammation
of
the
nasal
passages caused by an allergy,
for
example,
hay
fever
or
allergy
to
dust
mites).
These
symptoms
include
sneezing,
runny
or
itchy
nose,
itchy
palate, and itchy, red or watery
eyes.
Dezal is also used to relieve the
symptoms
associated
with
urticaria
(a
skin
condition
caused
by
an
allergy).
These
symptoms
include
itching
and
hives.
Relief of these symptoms lasts a
full
day
and
helps
you
to
resume
your
normal
daily
activities and sleep.
HOW DEZAL WORKS
Dezal is an antiallergy medicine
that does not make you drowsy.
It
helps
control
your
allergic
reaction and its symptoms.
BEFORE YOU USE DEZAL
_-When you must not take it_
Do
not
use
Dezal
if
you
are
allergic
(hypersensitive)
to
desloratadine,
to
any
of
the
other ingredients of Dezal or to
loratadine.
_-Before you start to take it _
Efficacy and safety of Dezal 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
Dezal
is
not
recommended.
_ _
_-Taking other medicines _
There are no known interactions
of Dezal with other medicines.
Tell
your
doctor
if
you
are
taking
any
other
medicines,
including
any
that
you
buy
without
a
prescription
from
a
pharmacy,
supermarket
or
health food shop.
HOW TO TAKE DEZAL
_-How much to take _
Adults
and
adolescents
(12
years of age and older): take one
tablet once a day.
_-When to take it _
Swallow the tablet whole with
water, with or without food.
_-How long to take it _
Y

Ciri produk

PRODUCT NAME
Dezal Tablet 5mg
COMPOSITION
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each tablet contains 5mg desloratadine
PRODUCT DESCRIPTION
5mg tablet: Blue, round, 6mm, biconvex, film-coated
tablets with “LT” debossed on one face.
PHARMACOLOGY
Actions: Desloratadine is a non-sedating long-acting
histamine antagonist with potent, selective peripheral
H
1
-receptor antagonist activity. It has demonstrated
anti-allergic, antihistaminic and anti-inflammatory
activity.
Pharmacodynamics: After oral administration,
desloratadine selectively blocks peripheral histamine
H
1
- receptors because the drug is effectively excluded
from entry to the central nervous system (CNS).
In addition to antihistaminic activity, desloratadine
has demonstrated anti-allergic and anti-inflammatory
activity.
Desloratadine does not readily penetrate the CNS.
At the recommended dose of 5mg daily, there was
no excess incidence of somnolence. Desloratadine
tablet even at a dose of 7.5 mg daily, did not
affect psychomotor performance. A single dose of
desloratadine 5 mg did not affect standard measures
of flight performance including exacerbation of
subjective sleepiness or tasks related to flying.
In adult and adolescent patients with seasonal allergic
rhinitis (SAR), Desloratadine tablet, was effective in
relieving symptoms eg, sneezing, nasal discharge
and itching, congestion/stuffiness, as well as ocular
itching, tearing and redness, and itching of palate.
Desloratadine tablet effectively controlled symptoms
for 24 hrs.
PHARMACOKINETICS
Desloratadine plasma concentrations can be detected
within 30 min of desloratadine administration.
It is well absorbed with maximum concentration
achieved after approximately 3 hrs; the terminal
phase half-life is approximately 27 hrs. The degree
of accumulation of desloratadine was consistent with
its half-life (approximately 27 hrs) and a once-daily
dosing frequency. In adults and adolescents, the
bioavailability of desloratadine was dose proportional
over the range of 5-20 mg.
Desloratadine is moderat