Levocetirizine Auxilto Film-coated Tablets 5mg

Land: Maleisië

Taal: Engels

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

Werkstoffen:

LEVOCETIRIZINE DIHYDROCHLORIDE

Beschikbaar vanaf:

STADPHARM SDN. BHD.

INN (Algemene Internationale Benaming):

LEVOCETIRIZINE DIHYDROCHLORIDE

Eenheden in pakket:

50 Tablets

Geproduceerd door:

Community Pharmacy Public Company Limited

Bijsluiter

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
LEVOCETIRIZINE AUXILTO
FILM-COATED TABLET
_ _
Levocetirizine dihydrochloride (5 mg)
Page no.1
WHAT IS IN THIS LEAFLET
1. What Levocetirizine Auxilto is used for
2. How Levocetirizine Auxilto works
3. Before you use Levocetirizine Auxilto
4. How to use Levocetirizine Auxilto
5. While you are using Levocetirizine
Auxilto
6. Side effects
7. Storage and disposal of Levocetirizine
Auxilto
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date and revision
11. Serial Number
WHAT LEVOCETIRIZINE AUXILTO IS USED FOR
Levocetirizine Auxilto is indicated for the
symptomatic treatment of allergic rhinitis
(including persistent allergic rhinitis) and
chronic idiopathic urticaria.
HOW LEVOCETIRIZINE AUXILTO WORKS
Levocetirizine Auxilto contains the active
ingredient Levocetirizine dihydrychloride.
Levocetirizine is the active
_R_
-enantiomer
of cetirizine, a second generation
antihistamine. The drug is selective
antagonism of histamine H1-receptors.
BEFORE YOU USE LEVOCETIRIZINE AUXILTO
_When you must not use it _
-
If you are allergic to Levocetirizine or
any ingredient in the formulation or to
cetirizine.
-
If you have a severe kidney impairment
with creatinine clearance below 10
ml/min or undergoing hemodialysis.
_Pregnancy and breastfeeding _
Pregnancy Category B.
_ _
Safety for use
drug pregnancy has not been established.
Levocetirizine is expected to be
distributed into milk (since cetirizine is
distributed into milk). The use
of levocetirizine in breast-feeding mother
is not recommended.
_ _
_Before you start to use it _
-
Talk to your doctor or pharmacist before
taking Levocetirizine Auxilto
-
If you are likely to be unable to empty
your bladder (due to conditions such as
a spinal cord injury or enlarged
prostate), ask your doctor for advice.
-
If you have an intolerance to some
sugars, inform your doctor before using
Levocetirizine Auxilto.
_Taking other medicines _
Tell your doctor or pharmacist if you are
taking, have recently taken or mig

Productkenmerken

LEVOCETIRIZINE AUXILTO
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each film-coated tablet contains Levocetirizine dihydrochloride 5 mg
PRODUCT DESCRIPTION
Biconvex, oval, white film coated tablet. One side has score and
letter “L” and “C” on each
side. Another side has figure “5”.
PHARMACODYNAMIC/PHARMACOKINETICS
PHARMACODYNAMIC
MECHANISM OF ACTION
Levocetirizine is the active R-enantiomer of cetirizine, a second
generation antihistamine. The drug
is selective antagonism of histamine H1-receptors and as a group, is
less sedating.
PHARMACOKINETICS
Levocetirizine is rapidly and extensively absorbed following oral
administration, with peak plasma
concentration usually attained in 0.9 hour. A high-fat meal reduces
peak plasma concentration by
about 36% and delays time to peak plasma concentration by about 1.25
hours, but does not affect
AUC. A high-fat meal delays drug absorption but completely absorbed.
The average apparent volume
of distribution is 0.4 L/kg. Levocetirizine is approximately 91 - 92%
bound to plasma proteins (mainly
albumin). The extent of metabolism of levocetirizine is less than 14%
of dose by aromatic oxidation,
N-dealkylation, O-dealkylation and taurine conjugation. Levocetirizine
is excreted in urine; 85.4% (via
glomerular filtration and active tubular secretion) and excreted in
the feces 12.9%. The elimination
half-life is 8 – 9 hours in adults.
INDICATION
Levocetirizine is indicated for the symptomatic treatment of allergic
rhinitis (including persistent
allergic rhinitis) and chronic idiopathic urticaria.
RECOMMENDED DOSE
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
d