Allerzal F.C. Tablet 5mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVOCETIRIZINE DIHYDROCHLORIDE

Boleh didapati daripada:

Md Healthcare Sdn Bhd

INN (Nama Antarabangsa):

LEVOCETIRIZINE DIHYDROCHLORIDE

Unit dalam pakej:

500 Tablets; 10 Tablets; 100 Tablets

Dikeluarkan oleh:

STANDARD CHEM & PHARM CO LTD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ALLERZAL F.C. TABLET 5MG
Levocetirizine dihydrochloride 5mg
1
WHAT IS IN THIS LEAFLET
1.
What Allerzal F.C. Tablet 5mg
is used for
2.
How Allerzal F.C. Tablet 5mg
works
3.
Before you use
Allerzal F.C.
Tablet 5mg
4.
How to use Allerzal F.C. Tablet
5mg
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Allerzal F.C. Tablet 5mg
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT ALLERZAL F.C. TABLET 5MG IS
USED FOR
Levocetirizine 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
ALLERZAL
F.C.
TABLET
5MG
WORKS
Allerzal
contains
the
active
ingredient,
levocetirizine
dihydrochloride. Allerzal is an anti-
allergic
medication.
It
works
by
blocking a certain natural substance
(histamine) that your body makes
during an allergic reaction.
BEFORE
YOU
USE
ALLERZAL
F.C.
TABLET 5MG
_When you must not use it _
Do not use Allerzal:
•
If
you
are
allergic
(hypersensitive)
to
levocetirizine
dihydrochloride,
any other related substance, or
any of the other ingredients of
Allerzal
(refer
to
PRODUCT
DESCRIPTION section);
•
If
you
have
a
severe
kidney
impairment
with
creatinine
clearance below 10 ml/min.
The
use
of
Allerzal
is
not
recommended for children under 6
years.
Pregnancy and lactation
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 _
You should tell your doctor if:
•
You have difficulties emptying
your bladder due to factors such
as
spinal
cord
or
prostatic
hyperplasia (enlargement of the
prostate gland);
•
You
have
been
told
by
your
doctor
that
you
have
an
intol

Ciri produk

_ALLERZAL F.C. TABLET 5MG _
_Proposed package Insert (PI) _
1.
NAME OF THE MEDICINAL PRODUCT
Allerzal F.C. Tablet 5mg
2.
PHARMACEUTICAL FORM AND STRENGTH
Film-coated tablet: White to off-white, oblong and biconvex tablet;
engraved with “293” on one
surface and “STD” on the other surface, containing 5mg of
Levocetirizine Dihydrochloride.
List of excipients include: microcrystalline cellulose, lactose
(spray-dried), magnesium stearate,
hydroxypropylmethyl cellulose, polyethylene glycol 400, and titanium
dioxide.
3.
THERAPEUTIC INDICATION
Levocetirizine is indicted for the symptomatic treatment of allergic
rhinitis (including persistent
allergic rhinitis) and chronic idiopathic urticaria.
4.
POSOLOGY AND METHOD OF ADMINISTRATION
It must be taken orally, swallowed whole with liquid and may be taken
with or without food.
_Adults and adolescents 12 years and above: _
The recommended dose is 5mg once daily (1 film-coated tablet).
_Children aged 6 to 12 years: _
The recommended dose is 5mg once daily (1 film-coated tablet).
_Elderly: _
Adjustment of the dose is recommended in elderly patients with
moderate to severe renal impairment
(see Patients with renal impairment below).
_Adult patients with renal impairment: _
The dosing intervals must be individualized according to renal
function. Refer to the following table
and adjust the dose as indicated. To use this dosing table, an
estimate of the patient’s creatinine
clearance (CL
cr
) in ml/min is needed. The CL
cr
(ml/min) may be estimated from serum creatinine
(mg/dl) determination using the following formula:
CL
cr
= [140 – age (years)] x weight (kg)
(x 0.85 for women)
72 x serum creatinine (mg/dl)
Dosing Adjustments for Patients with Impaired Renal Function:
GROUP
CREATININE CLEARANCE (ML/MIN)
DOSAGE AND FREQUENCY
Normal
≥
80
1 tablet once daily
Mild
50 – 79
1 tablet once daily
Moderate
30 – 49
1 tablet once every 2 days
Severe
<
30
1 tablet once every 3 days
End-stage renal disease
-
Patients undergoing dialysis
<
10
Contra-indicated
In paediatric pa