HP-DESLORATADINE 5MG FILM-COATED TABLETS

Country: Malaysia

Language: English

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

Active ingredient:

DESLORATADINE

Available from:

MEDISPEC (M) SDN.BHD

INN (International Name):

DESLORATADINE

Units in package:

1 x 10 Tablets; 3 x 10 Tablets; 10 x 10 Tablets

Manufactured by:

Hainan Poly Pharm. Co., Ltd.

Patient Information leaflet

HP-DESLORATADINE 5MG FILM-COATED TABLETS
desloratadine (5mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_HP-Desloratadine_
is used
for
2.
How
_HP-Desloratadine_
works
3.
Before you use
_HP-Desloratadine_
4.
How to use
_HP-Desloratadine_
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
_HP-_
_Desloratadine_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _HP-DESLORATADINE_ IS USED FOR
_HP-Desloratadine_
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.
_HP-Desloratadine_
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 _HP-DESLORATADINE_ WORKS
_HP-Desloratadine_
is
an
anti-allergy
medicine
that
does
not
make
you
drowsy. It helps control your allergic
reaction and its symptoms.
BEFORE YOU USE _HP-DESLORATADINE_
-
_When you must not use it _
Do not use
_HP-Desloratadine_
if:
•
If
you
are
hypersensitivity
to
desloratadine,
to
any
of
the
excipients.
_ _
-
_Before you start to use it _
Talk
to
your
doctor
or
pharmacist
before
taking
_HP-Desloratadine_
if
you have medical or familial history
of seizures.
Efficacy
and
safety
of
_HP-_
_Desloratadine_
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
_HP-Desloratadine_
is
not recommended.
IMPORTANT INFORMATION ABOUT SOME OF
THE INGREDIENTS OF _HP-DESLORATADINE_
_HP-Desloratadine_
contain
lactose.
If
you have been told by your doctor that
you have an intoleranc

Summary of Product characteristics

HP-DESLORATADINE 5MG FILM-COATED TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg desloratadine.
PHARMACEUTICAL FORM
Film-coated, light blue, round tablets.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
HP- Desloratadine 5mg Film-Coated Tablets are indicated for the rapid
relief of symptoms associated
with allergic rhinitis, such as sneezing, nasal discharge and itching,
congestion/stuffiness, as well as
ocular itching, tearing and redness.
HP-Desloratadine 5mg Film-Coated 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 older): One
HP-Desloratadine 5mg Film-Coated Tablets
once a day regardless of mealtime. For oral use.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Efficacy and safety of HP-Desloratadine 5mg Film-Coated Tablets in
children under 12 years of age have
not been established.
Desloratadine should be administered with caution in patients with a
medical or family history of
seizures.
In particular, young children may be more susceptible to developing
new
seizures under desloratadine
treatment. Healthcare providers may consider discontinuing
desloratadine in patients who experience a
seizure while on treatment
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No effects on the ability to drive and use machines have been observed
(see Pharmacodynamic
properties).
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No clinically relevant interactions with HP-Desloratadine 5mg
Film-Coated Tablets were observed. There
was no effect of food or grapefruit juice on the disposition of
desloratadine.
HP-Desloratadine 5mg Film-Coated Tablets taken concomitantly with
alcohol did not potentiate the
performance impairing effects of alcohol
FERTILITY, PREGNANCY AND LACTATION
HP-Desloratadine 5mg Film-Co