Xafen 180 Tablets 180mg

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

FEXOFENADINE HCL

Tillgänglig från:

MYLAN HEALTHCARE SDN. BHD.

INN (International namn):

FEXOFENADINE HCL

Enheter i paketet:

10tablet Tablets

Tillverkad av:

Medreich Limited (Unit 3)

Bipacksedel

_Consumer Medication Information Leaflet (RiMUP) _
XAFEN
™ 180
Fexofenadine (180mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_Xafen _
is used for
2.
How
_Xafen _
works
_3._
_ _
Before you use
_Xafen _
_4._
_ _
How to use
_Xafen _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Xafen _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT _XAFEN _IS USED FOR

Relief of symptoms associated with
seasonal
allergic
rhinitis
such
as
sneezing,
rhinorrhea,
pruritus
and
lacrimation.

Relief of symptoms associated with
chronic idiopathic urticarial.

Relief of symptoms associated with
perennial allergic rhinitis.
HOW _XAFEN _WORKS
Fexofenadine
hydrochloride
is
a
non-
sedating H1 antihistamine. Fexofenadine
is a pharmacologically active metabolite
of terfenadine.
Human histamine wheal and flare studies
following single and twice daily doses of
fexofenadine hydrochloride demonstrate
that the drug exhibits an antihistaminic
effect beginning within one hour,
achieving maximum at 6 hours and
lasting 24 hours. There was no evidence
of tolerance to these effects after 28 days
of dosing. A positive dose-response
relationship between doses of 10 mg to
130 mg taken orally was found to exist.
In this model of antihistaminic activity, it
was found that doses of at least 130 mg
were required to achieve a consistent
effect that was maintained over a 24 hour
period.
BEFORE YOU USE _XAFEN _
-
_When you must not use it _
_Pregnancy and lactation _
There are no adequate data from the use
of fexofenadine hydrochloride in
pregnant women.
Limited animal studies do not indicate
direct
or
indirect
harmful
effects
with
respect to effects on pregnancy,
embryonal/foetal
development,
parturition
or
postnatal
development.
Fexofenadine hydrochloride should not
be used during pregnancy unless clearly
necessary.
LACTATION
There are no data on the content of human
milk
after
administering
fexofenadine
hydrochloride.
However,
when
terfenadine was administered to n

Produktens egenskaper

XAFEN 180
(
Fexofenadine Hydrochloride Tablets 180 mg
)
LABEL CLAIM
Each film tablet contains Fexofenadine Hydrochloride Ph.Eur 180 mg
equivalent 168 mg
of Fexofenadine.
DESCRIPTION
_Fexofenadine Hydrochloride Tablets 180 mg: _
Peach colored, Caplet shape film coated tablet, debossed as ‘180’
on one side and plain on
other side.
LIST
OF
EXCIPIENTS:
Silicified
Microcrystalline
Cellulose,
Mannitol,
Croscarmellose
Sodium, Magnesium Stearate, Hypromellose, Titanium Dioxide, Colloidal
Anhydrous
Silica, Talc, Macrogols, Iron oxide Red, Iron oxide Yellow.
THERAPEUTIC INDICATIONS
Indicated for the relief of symptoms associated with chronic
idiopathic urticaria and allergic
rhinitis in adults and children 12 years of age and older. Symptoms
treated effectively
include sneezing, rhinorrhea, itchy nose / palate / throat itchy /
watery red eyes.
POSOLOGY AND METHOD OF ADMINISTRATION
ALLERGIC RHINITIS
60 mg twice daily OR 120 mg once daily OR 180 mg once daily.
CHRONIC IDIOPATHIC URTICARIA
60 mg twice daily OR 180 mg once daily.
SPECIAL RISK GROUP
It is not necessary to adjust the dose of fexofenadine hydrochloride
in special risk groups
(elderly, renally or hepatically impaired patients).
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with most new drugs there is only limited data in the elderly and
renally or hepatically
impaired patients. Fexofenadine hydrochloride should be administered
with care in these
special groups.
Patients with a history of or ongoing cardiovascular disease should be
warned that,
antihistamines as a drug class, have been associated with the adverse
events, tachycardia
and palpitations.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Fexofenadine hydrochloride does not undergo hepatic biotransformation
and therefore will
not
interact
with
other
drugs
through
hepatic
mechanisms.
Co-administration
of
fexofenadine hydrochloride with erythromycin or ketoconazole has been
found to result in
a