Neolor 5- Desloratadine Tablets USP 5 mg

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

DESLORATADINE

Dostępny od:

UNIMED SDN BHD

INN (International Nazwa):

DESLORATADINE

Sztuk w opakowaniu:

1 X 10 Tablets

Wyprodukowano przez:

Zydus Lifesciences Limited

Ulotka dla pacjenta

NEOLOR 5
Desloratadine Tablet USP 5mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET:
1.
What is used for
NEOLOR 5
2.
How
NEOLOR 5
works
3.
Before you use
NEOLOR 5
4.
How to use
NEOLOR 5
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
NEOLOR
5
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT NEOLOR 5
IS USED FOR:
NEOLOR 5 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).
NEOLOR 5 is also used to relieve the
symptoms
associated
with
urticaria
(a
skin
condition
caused
by
an
allergy).
These
symptoms
include
itching
and
hives.
HOW NEOLOR 5 WORKS
NEOLOR 5 is an
anti-allergy medicine
that does not make you drowsy. It helps
control
your
allergic
reaction
and
its
symptoms.
BEFORE YOU USE NEOLOR 5
-
_When you must not use it_
_ _
Do not take NEOLOR 5 if you:
Have
•
If you are allergic to Desloratadine or
any of the other ingredients of this
medicine
(listed
in
section
“Ingredients”)
_ _
-
Before you start to use it
Do not take NEOLOR 5 if:
•
If you have medical or family history
of seizures.
•
Efficacy and safety of NEOLOR 5 in
children under 12 years of age have not
been established.
-
_Pregnancy and Lactation _
_ _
•
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 NEOLOR 5 is not
recommended
-
_Taking other medicines _
_ _
Tell your doctor or pharmacist if you
are taking, have recently taken or might
take any other medicines. This includes
medicines
obtained
without
a
prescription,
herbal
medicines
and
supplements.
However,
there
are
no
known
interactions of NEOLOR 5 with other
medicines.
HOW TO USE
NEOLOR 5
-
_How much to use _
Adults and adolescents (12 years of age
and older): ta

Charakterystyka produktu

1. NAME OF THE MEDICINAL PRODUCT
NEOLOR 5
Desloratadine Tablets USP 5mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains:
Desloratadine USP
5mg
Excipients
q.s.
Colours: Iron Oxide Yellow, Iron Oxide Red, Titanium Dioxide
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film Coated Tablet
DESLORATADINE TABLETS USP 5MG: Pink colored, biconvex, round shaped,
film
coated tablet plain on both side. The tablet should be free of all
physical defects.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desloratadine 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.
Desloratadine tablets for the relief of symptoms associated with
chronic idiopathic
urticaria such as the relief of itching and the size and number of
hives.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and Adolescents (12 years of age and older):
One Desloratdine 5 mg film coated tablet once a day regardless of
mealtime.
METHOD OF ADMINISTRATION
For oral use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Efficacy and safety of Desloratadine 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.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No clinically relevant interactions with Desloratadine tablets were
observed in
clinical trials. There was no effect of food or grapefruit juice on
the disposition
of desloratadine.
Desloratadine tablets taken concomitantly with alcohol d