XYZAL 5MG FILM COATED TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Levocetirizine Dihydrochloride

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

Levocetirizine Dihydrochloride

Unit dalam pakej:

50 Tablets; 50 Tablets

Dikeluarkan oleh:

UCB FARCHIM S.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
XYZAL FILM COATED TABLET
Levocetirizine dihydrochloride (5 mg)
WHAT IS IN THIS LEAFLET
1.
What XYZAL is used for
2.
How XYZAL works
3.
Before you use XYZAL
4.
How to use
XYZAL
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of XYZAL
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
11.
Serial Number
WHAT XYZAL IS USED FOR
Xyzal is used to treat the symptoms of:
•
Allergic rhinitis (inflammation of the
mucous membrane inside the nose)
including persistent allergic rhinitis
•
Chronic idiopathic urticaria (a raised,
itchy rash of unknown cause)
HOW XYZAL WORKS
Xyzal contains the active ingredient
levocetirizine dihydrochloride
Xyzal is an antiallergic medication. It
works by blocking a certain natural
substance (histamine) that your body
makes during an allergic reaction.
BEFORE YOU USE XYZAL
-
_When you must not use it_
_ _
Do not take Xyzal
•
if you are allergic (hypersensitive) to
the active substance, levocetirizine
dihydrochloride, cetirizine, hydroxyzine
or to an antihistamine, or any of the
other ingredients of Xyzal (see section
PRODUCT DESCRIPTION
)
•
if you have a severe kidney impairment
with creatinine clearance below 10
ml/min.
The use of Xyzal is not recommended for
infants and children under 6 years.
_Pregnancy and breastfeeding _
Ask your doctor or pharmacist for advice
before taking any medicine. Tell your
doctor if you are pregnant, trying to get
pregnant or breastfeeding. Levocetirizine
is excreted in human milk. Talk to your
doctor or pharmacist before taking this
medicine if you are breastfeeding.
-
_Before you start to use it_
_ _
Tell your doctor if you have any of the
following conditions:
•
If you have difficulties emptying your
bladder due to factors such as spinal
cord lesion or prostatic hyperplasia
(enlargement of the prostate gland).
•
If you have been told by your doctor
that you have an intolerance to some
sugars. This tablet contains lactose.
•
If you have ep

Ciri produk

[GSK logo]
XYZAL
LEVOCETIRIZINE DIHYDROCHLORIDE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Levocetirizine dihydrochloride, 5 mg, film-coated tablet_
Film-coated tablet containing 5 mg of levocetirizine dihydrochloride
EXCIPIENTS
_Levocetirizine dihydrochloride, 5 mg, film-coated tablet _
Microcrystalline cellulose, Lactose monohydrate, Colloidal anhydrous
silica, Magnesium
stearate, Hypromellose, Titanium dioxide, Macrogol 400
PHARMACEUTICAL FORM
_Levocetirizine dihydrochloride, 5 mg, film-coated tablet _
White to off-white, oval, film-coated tablet with a Y logo on one
side.
CLINICAL INFORMATION
INDICATIONS
Levocetirizine is indicated for the symptomatic treatment of allergic
rhinitis (including
persistent allergic rhinitis) and chronic idiopathic urticaria.
DOSAGE AND ADMINISTRATION
_Levocetirizine dihydrochloride, 5 mg, film-coated tablet _
The film-coated tablet must be taken orally, swallowed whole with
liquid and may be taken
with or without food. It is recommended to take the daily dose in one
single intake.
_Duration of use _
Intermittent allergic rhinitis (symptoms < 4 days/week or for less
than 4 weeks a year) has to
be treated according to the disease and its history; it can be stopped
once the symptoms have
disappeared and can be restarted again when symptoms reappear.
In case of persistent allergic rhinitis (symptoms > 4 days/week or for
more than 4 weeks a
year), continuous therapy can be proposed to the patient during the
period of exposure to
allergens.
There is clinical experience with the use of levocetirizine for
treatment periods of at least 6
months. In chronic urticaria and chronic allergic rhinitis, there is
clinical experience of use of
cetirizine (racemate) for up to one year.
ROUTE OF ADMINISTRATION
For oral use.
ADULTS AND ADOLESCENTS 12 YEARS AND ABOVE
_Levocetirizine dihydrochloride, 5 mg, film-coated tablet _
The daily recommended dose is 5 mg (1 film-coated tablet).
CHILDREN
_Children aged 6 to 12 years _
_Levocetirizine dihydrochloride, 5 mg, film-coated tablet _
The daily recommend