SYNERRV FEXOFENADINE 180MG (FEXOFENADINE HYDROCHLORIDE TABLETS USP)

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

Fexofenadine hydrochloride

Verfügbar ab:

SYNERRV SDN BHD

INN (Internationale Bezeichnung):

Fexofenadine hydrochloride

Einheiten im Paket:

5 x 10 Tablets; 1 x 10 Tablets; 3 X 10 Tablets

Hergestellt von:

IND-SWIFT LIMITED

Gebrauchsinformation

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SYNERRV FEXOFENADINE 120MG
(FEXOFENADINE HYDROCHLORIDE 120MG
TABLETS USP)
SYNERRV FEXOFENADINE 180MG
(FEXOFENADINE HYDROCHLORIDE 180MG
TABLETS USP)
Fexofenadine hydrochloride (120mg & 180mg)
1
WHAT IS IN THIS LEAFLET
1.
What SYNERRV
FEXOFENADINE is used for
2.
How SYNERRV
FEXOFENADINE works
3.
Before you use SYNERRV
FEXOFENADINE
4.
How to use SYNERRV
FEXOFENADINE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
SYNERRV FEXOFENADINE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS SYNERRV
FEXOFENADINE USED FOR
SYNERRV FEXOFENADINE
(120mg & 180mg) is used in adult
and adolescents of 12 years and older
to relieve the symptoms that occur
with hay fever (seasonal allergic
rhinitis) such as sneezing, itchy,
watery or red eyes, and itchy or
runny nose.
Additionally, SYNERRV
FEXOFENADINE (180mg only) is
also used to relieve the symptoms of
long-term hives (chronic idiopathic
urticaria – a raised, itchy rash of
unknown cause)
HOW SYNERRV
FEXOFENADINE WORKS
SYNERRV FEXOFENADINE
contains Fexofenadine
hydrochloride, which is an
antihistamine. It works by blocking
the action of histamine in order to
treat allergy symptoms.
BEFORE YOU USE SYNERRV
FEXOFENADINE
_-When you must not use it _
Do not take SYNERRV
FEXOFENADINE if you are allergic
(hypersensitive) to Fexofenadine or
any of the other ingredients of this
medicine listed at the end of this
leaflet.
_-Before you start to use it _
Check with your doctor before taking
SYNERRV FEXOFENADINE if:
•
You have problems with
your liver or kidneys.
•
You are an elderly.
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking this
medicine.
_Pregnancy and breastfeeding: _
Tell your doctor before taking this
medicine if you:
•
Are pregnant or plan to get
pregnant.
•
Are breastfeeding or plan to
start breastfeeding.
Fexofenadine hydrochloride should
be used during pregnancy and
breastfeeding o

Fachinformation

DIMENSION: 130 X 250MM
PAPER SHOULD BE MAPLITHO (60 GSM)
BLACK
COMPOSITION:
Synerrv Fexofenadine 120 (Fexofenadine Hydrochloride 120 mg Tablets
USP)
Each film coated tablet contains:
Fexofenadine hydrochloride USP … 120 mg
Excipients: Lactose spray dried, Pregelatinized starch, Croscarmellose
sodium, Colloidal anhydrous silica, Magnesium stearate, Povidone
and Opadry pink 03B54819
Colours: Iron Oxide Red, Iron Oxide Yellow and Titanium Dioxide
Synerrv Fexofenadine 180 (Fexofenadine Hydrochloride 180 mg Tablets
USP)
Each film coated tablet contains:
Fexofenadine hydrochloride USP … 180 mg
Excipients: Lactose spray dried, Pregelatinized starch, Croscarmellose
sodium, Colloidal anhydrous silica, Magnesium stearate, Povidone
and Opadry pink 03B54819
Colours: Iron Oxide Red, Iron Oxide Yellow and Titanium Dioxide
DESCRIPTION:
_For 120mg: _Peach coloured, oblong shaped, biconvex film coated
tablets with both sides plain. The tablets are approximately 15.5 mm
in
length and 7 mm in breadth.
_For 180mg:_ Peach coloured, oblong shaped, biconvex film coated
tablets with both sides plain. The tablets are approximately 18 mm in
length and 8 mm in breadth.
DOSAGE FORM: Film Coated Tablets
PRESENTATION: 10's, 30's and 50's Tablets (1 x 10's, 3 x 10's & 5 x
10's Alu/PVC/PVdC Blister Strips)
PROPERTIES:
Fexofenadine, a pharmacologically active metabolite of Terfenadine, is
a non-sedating antihistamine with selective peripheral H1 receptor
antagonist with the chemical name (±)-4-[1
hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-, -dimethyl
benzeneacetic acid
hydrochloride. The molecular formula is C H NO HCL and its molecular
weight is 538.13.
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STRUCTURAL FORMULA:
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS:
Pharmacotherapeutic group: Antihistamines for systemic use, ATC Code:
R06AX26
Mechanism of Action
Fexofenadine hydrochloride is a non-sedating H antihistamine.
Fexofenadine is a pharmacologically active metabolite of Terfenadine.
1
Efficacy and Safety
Single and twice daily doses of Fexofenadine hydrochlori