GLENDES 5mg Tablets

Страна: Малайзия

Язык: английский

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

Активный ингредиент:

DESLORATADINE

Доступна с:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

ИНН (Международная Имя):

DESLORATADINE

Штук в упаковке:

3 x 10 Tablets

Производитель:

GLENMARK PHARMACEUTICALS LTD

тонкая брошюра

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
GLENDES
® 5MG TABLETS
Desloratadine 5mg
1
WHAT IS IN THIS LEAFLET
1.
What GLENDES is used for
2.
How GLENDES works
3.
Before you use GLENDES
4.
How to use GLENDES
5.
While you are using
6.
Side effects
7.
Storage and Disposal of
GLENDES
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT GLENDES IS USED FOR
GLENDES
_ _
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.
GLENDES
_ _
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 GLENDES WORKS
GLENDES
is
an
anti-allergy
medicine that does not make you
drowsy.
It
helps
control
your
allergic
reaction
and
its
symptoms.
BEFORE YOU USE GLENDES
_When you must not use it _
Do not use GLENDES if you are
allergic
(hypersensitive)
to
desloratadine, to any of the other
ingredients
of
GLENDES
or
to
loratadine.
_ _
_Before you start use it _
Talk to your doctor or pharmacist
before taking GLENDES
_ _
if you
have medical or familial history of
seizures
(uncontrolled
electrical
activity in the brain).
If you have poor kidney
function,
GLENDES
_ _
should be used with
caution. If this applies to you, or if
you are not sure, please check with
your
doctor
before
taking
GLENDES.
Use
caution
when
taking
GLENDES with alcohol.
_Use in children and adolescents _
Efficacy and safety of GLENDES
_ _
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
GLENDES IS NOT
RECOMMENDED

Характеристики продукта

SAME SIZE ARTWORK
LEAFLET SIZE : 170 mm x 225 mm
25 mm
34 mm
_For the use only of a Registered Medical Practitioner _
_or a Hospital or a Laboratory_
PE00000 MY
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
Manufactured by:
B/2, Mahalaxmi Chambers,
22 Bhulabhai Desai Road,
Mumbai - 400 026 (India).
At: Plot No. S 7, Colvale Industrial Estate,
Colvale, Bardez, Goa - 403 513, INDIA
® Registered Trade Mark
PRODUCT REGISTRATION HOLDER:
Glenmark Pharmaceuticals
(Malaysia) Sdn Bhd (660397-W)
D-31-02, Menara Suezcap 1,
No. 2, Jalan Kerinchi,
59200 Kuala Lumpur, Malaysia
®
GLENDES
5mg Tablets
Desloratadine
LABEL CLAIM
Each uncoated tablet contains: Desloratadine Ph. Eur. ….5 mg
PHARMACEUTICAL FORM
Tablets
Off-white to light pink, circular, Biconvex with 'L5' debossed on
one side and plain on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Glendes 5mg 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.
Glendes
5mg
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
Posology
_Adults and adolescents (12 years of age and older):_
One Glendes 5 mg tablet once a day regardless of mealtime. For
oral use.
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, desloratadine should
be used with caution.
Desloratadine should be administered with caution in patients
with medical or familial history of seizures, and mainly young
children, being more susceptible to develop new seizures under
desloratadine treatment. Healthcare providers may consider
discontinu