DESTAVELL 5mg Film-coated Tablet

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

DESLORATADINE

Beszerezhető a:

IMEKS PHARMA SDN. BHD.

INN (nemzetközi neve):

DESLORATADINE

db csomag:

3 x 10 Tablets

Gyártó:

PT NOVELL PHARMACEUTICAL LABORATORIES.

Betegtájékoztató

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DESTAVELL 5MG FILM-COATED TABLET
Desloratadine 5mg
1
WHAT IS IN THE LEAFLET
1.
What
_DESTAVELL _
is used for
2.
How
_DESTAVELL _
works
3.
Before you use
_DESTAVELL_
4.
How to use
_DESTAVELL_
_ _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_DESTAVELL _
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT_ DESTAVELL _IS USED FOR
_DESTAVELL _
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.
_DESTAVELL_
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 _DESTAVELL _WORKS
_DESTAVELL _
is an antiallergy medicine that
does not make you drowsy. It helps control
your allergic reaction and its symptoms.
BEFORE YOU USE _DESTAVELL _
-
_When you must not use it _
Do not use
_DESTAVELL_
if you are allergic
(hypersensitive) to desloratadine, to any of
other ingredients of
_DESTAVELL _
or to
loratadine.
-
_Before you start to use it _
Talk to your doctor or pharmacist before
taking
_DESTAVELL _
if you have
_ _
medical or
familial history of seizures.
Efficacy and safety of
_DESTAVELL_
in
children under 12 years of age have not been
established.
PREGNANCY AND BREAST-FEEDING
• Ask your doctor or pharmacist for advice
before taking
_ DESTAVELL _
during pregnancy
and breast-feeding.
• If your pregnant or nursing a baby, taking
_DESTAVELL_
_ _
is not recommended.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF _DESTAVELL _
_DESTAVELL_
contain lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicinal product.
-
_Taking

Termékjellemzők

DESTAVELL 5MG FILM COATED TABLET
CONTENT
Each Destavell contains 5.0 mg of desloratadine.
DESCRIPTION
Blue film-coated tablet, round, convex, plain on one side and
breakline on
the other.
PHARMACODYNAMICS
Pharmacotherapeutic group: antihistamines.
H1 antagonist, ATC code: R06AX27
Desloratadine is a non-sedating, long-acting histamine antagonist with
selective
peripheral H1-receptor antagonist activity. After oral administration,
desloratadine selectively blocks peripheral histamine H1- receptors
because
the substance is excluded from entry to the central nervous system.
Desloratadine has demonstrated antiallergic properties including
inhibit the
release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and
IL-13 from
human mast cells/basophils, as well as inhibition of the expression of
the
adhesion molecule P-selectin on endothelial cells.
Desloratadine does not readily penetrate the central nervous system.
At the
recommended dose of 5 mg daily, there was no excess incidence of
somnolence as compared to placebo. Desloratadine given at a single
daily
dose of 7.5 mg did not affect psychomotor performance. Desloratadine 5
mg did not affect standard measures of flight performance including
exacerbation of subjective sleepiness or tasks related to flying.
In patients with allergic rhinitis (AR), Destavell was effective in
relieving
symptoms such as sneezing, nasal discharge and itching, as well as
ocular
itching, tearing and redness, and itching of palate. Destavell
effectively
controlled symptoms for 24 hours. Efficacy has not been clearly
demonstrated
in patients 12.17 years of age.
Destavell was effective in relieving pruritus and decreasing the size
and
number of hives by the end of the first dosing interval. The effects
were
sustained over the 24-hour dosing interval. Treatment with Destavell
also
significantly reduced interference with sleep and daytime function, as
measured by a four-point scale used to assess these variables.
Destavell was effective in alleviating the burden of seasonal allergic
rhinitis