Levozal Tablet 5mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVOCETIRIZINE DIHYDROCHLORIDE

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Nama Antarabangsa):

LEVOCETIRIZINE DIHYDROCHLORIDE

Unit dalam pakej:

10x 10 Tablets; 50x10 Tablets

Dikeluarkan oleh:

IDAMAN PHARMA MANUFACTURING SDN BHD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
LEVOZAL TABLET 5MG
Levocetirizine dihydrochloride (5mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Levozal Tablet 5mg is
used for
2.
How
Levozal
Tablet
5mg
works
3.
Before
you
use
Levozal
Tablet 5mg
4.
How to use Levozal Tablet
5mg
5.
While you are using Levozal
Tablet 5mg
6.
Side effects
7.
Storage
and
disposal
of
Levozal Tablet 5mg
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT LEVOZAL TABLET 5MG IS
USED FOR
Levozal Tablet 5mg is used to
treat the symptoms:
•
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
LEVOZAL
TABLET
5MG
WORKS
Levozal Tablet 5mg contains the
active
ingredient
levocetirizine
dihydrochloride.
Levozal
Tablet
5mg
is
an
antiallergic medication. It works
by
blocking
a
certain
natural
substance (histamine) that your
body
makes
during
allergic
reaction.
BEFORE YOU USE LEVOZAL TABLET
5MG
_-When you must not use it _
Do not take Levozal Tablet 5mg
if you are: -
•
Allergy (hypersensitive) to the
active substance levocetirizine
dihydrochloride,cetirizine,hydr
-oxyzine,piperazine derivatives
or any of the excipients listed
contains in the product
•
Severe renal impairment at less
than
10
ml/min
creatinine
clearance.
The use of Levozal Tablet 5mg 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 or
have
any
of
the
following
medical conditions: -
•
If
you
have
difficulties
emptying your bladder due to
factors
such
as
spinal
cord
lesion or prostatic hyperplasia
(enlargement
of
t

Ciri produk

CONTRAINDICATIONS
Levocetirizine is contraindicated in:
• hypersensitivity to levocetirizine, to cetirizine, to hydroxyzine,
to any piperazine derivatives
or any of the excipients contained in the product.
• severe renal impairment at less than 10 ml/min creatinine
clearance.
• rare
hereditary
problems
of
galactose
intolerance,
the
Lapp
lactase
deficiency
or
glucose-galactose malabsorption.
WARNINGS AND PRECAUTIONS
Do not exceed the stated dose.
_ALCOHOL_
Precaution is recommended with intake of alcohol.
_RISK OF URINARY RETENTION_
Caution should be taken in patients with predisposing factors of
urinary retention (e.g. spinal
cord lesion, prostatic hyperplasia) as levocetirizine may increase the
risk of urinary retention.
_RISK OF SEIZURE AGGRAVATION_
Caution should be taken in patients with epilepsy and patients at risk
of convulsion as
levocetirizine may cause seizure aggravation.
_ALLERGY SKIN TESTS_
Response to allergy skin tests are inhibited by antihistamines and a
wash-out period (of 3 days)
is required before performing them.
_WITHDRAWAL SYNDROME_
Pruritus may occur when levocetirizine is stopped even if those
symptoms were not present
before treatment initiation. The symptoms may resolve spontaneously.
In some cases, the
symptoms may be intense and may require treatment to be restarted. The
symptoms should
resolve when the treatment is restarted.
_EXCIPIENT: LACTOSE_
This medical product contains lactose. Patients with rare hereditary
problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not take this
medicine.
INTERACTIONS WITH OTHER MEDICAMENTS
No interaction studies have been performed with levocetirizine
(including no studies with
CYP3A4 inducers); studies with the racemate compound cetirizine
demonstrated that there were
no
clinically
relevant
adverse
interactions
antipyrine
(with
antipyrine
pseudoephedrine,
cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and
diazepam).
_THEOPHYLLINE_
A small decrease in the clearance of cetiri