Dasselta 5 mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DESLORATADINE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

DESLORATADINE

Unit dalam pakej:

1x10's tablet Tablets; 10x10's tablet Tablets

Dikeluarkan oleh:

KRKA, d.d., Novo mesto

Risalah maklumat

DASSELTA FILM-COATED TABLETS
Desloratadine (5 mg)
_ _
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What _Dasselta _is used for
2.
How _Dasselta_ works
3.
Before you use _Dasselta_
4.
How to use _Dasselta_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Dasselta_
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT _DASSELTA_ IS USED FOR
_Dasselta_ contains desloratadine which
is
an
antihistamine.
_Dasselta_
is
an
antiallergy medicine that does not make
you
drowsy.
It
helps
control
your
allergic reaction and its symptoms.
_Dasselta_
is
indicated
for
adults
and
adolescents (12 years of age and older).
HOW _DASSELTA_ WORKS
_Dasselta_ tablets are indicated for the
rapid
relief
of
symptoms
associated
with allergic rhinitis such as sneezing,
nasal
discharge,
itching,
congestion/stuffiness, as well as ocular
itching, tearing and redness.
_Dasselta_ tablets are also indicated for
the relief of symptoms associated with
chronic idiopathic urticaria such as the
relief
of
itching
and
the
size
and
number of hives.
BEFORE YOU USE _DASSELTA_
_ _
_When you must not use it _
If you are allergic to desloratadine, to
any
of
the
other
ingredients
of
this
medicine (listed in Product Description)
or to loratadine.
_Pregnancy and lactation _
If you are pregnant or breast-feeding,
think
you
may
be
pregnant
or
are
planning
to
have
a
baby,
ask
your
doctor or pharmacist for advice before
taking this medicine.
If you are pregnant or nursing a baby,
taking _Dasselta_ is not recommended.
_ _
_Before you start use it _
If
you
have
poor
kidney,
_Dasselta_
should be used with caution. If this
applies to you, or if you are not sure,
please check with your doctor before
taking _Dasselta_.
_ _
_Use in children and adolescents _
Efficacy and safety of _Dasselta_ tablets
in children under 12 years of age have
not been established.
_Dasselta_
contains
lactose.
Patients
with
rare
hereditary
problems
of
galactose intolerance, the Lapp lactase
deficiency
or
gl

Ciri produk

1.3.1
Desloratadine
SPC, Labeling and Package Leaflet
MY
SmPCPIL155458_1
26.08.2020 – Updated: 26.08.2020
Page 1 of 4
DASSELTA
_Desloratadine_
NAME OF THE MEDICINAL PRODUCT
Dasselta 5 mg film-coated tablets
COMPOSITION
Each tablet contains 5 mg desloratadine.
PRODUCT DESCRIPTION
Dasselta film-coated tablets are light blue, round with beveled edges.
THERAPEUTIC INDICATIONS
Dasselta tablets are indicated for the rapid relief of symptoms
associated with allergic rhinitis, such as
sneezing, nasal discharge, itching, congestion/stuffiness, as well as
ocular itching, tearing and redness.
Dasselta tablets are also indicated for the relief of symptoms
associated with chronic idiopathic
urticaria, such as the relief of itching and the size and number of
hives.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents (12 years of age and over): One Dasselta 5 mg
film-coated tablet once a day
regardless of mealtime for the relief of symptoms associated with
allergic rhinitis (including
intermittent and persistent allergic rhinitis) and urticaria.
For oral use.
Intermittent allergic rhinitis (presence of symptoms for less than 4
days per week or for less than 4
weeks) should be managed in accordance with the evaluation of
patient’s disease history and the
treatment could be discontinued after symptoms are resolved and
reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or
more per week and for more than 4
weeks), continued treatment may be proposed to the patients during the
allergen exposure periods.
CONTRAINDICATIONS
Hypersensitivity to the active substance, to any of the excipients or
to loratadine.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In the case of severe renal insufficiency, Dasselta should be used
with caution.
Dasselta contains lactose. Patients with rare hereditary problems of
galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption should not take
this medicine.
CONFIDENTIAL
Dasselta 5 mg film-coated tablets
MODULE Part I
VOL