TELFAST 180MG TABLET

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

FEXOFENADINE HCL

Dostupné s:

DKSH MALAYSIA SDN BHD

INN (Mezinárodní Name):

FEXOFENADINE HCL

Jednotky v balení:

50Tablet Tablets

Výrobce:

PT AVENTIS PHARMA

Informace pro uživatele

_ _
_ Consumer Medication Information Leaflet (RiMUP) _
TELFAST
®
180 MG TABLET
Fexofenadine Hydrochloride (180 mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Telfast 180 mg is used for
2.
How Telfast 180 mg works
3.
Before you use Telfast 180 mg
4.
How to use Telfast 180 mg
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Telfast 180
mg
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
TELFAST
180
MG
IS
USED
FOR
Telfast 180 mg are 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.
Telfast 180 mg is also used to relieve
the
symptoms
of
long-term
hives
(chronic idiopathic urticaria - a raised,
itchy rash of unknown cause).
HOW TELFAST 180 MG WORKS
Telfast 180 mg contains fexofenadine
hydrochloride,
which
is
an
antihistamine. It works by blocking the
action of histamine in order to treat
allergy symptoms.
BEFORE YOU USE TELFAST 180 MG
-
_When you must not use it _
Do
not
take
Telfast
180
mg
in
following cases:
•
in children less than 12 years of age
due to the lack of safety and efficacy
data
•
if you have a history of allergy to any
of the ingredients of this medicine
-
_Before you start to use it _
CHECK
WITH
YOUR
DOCTOR
BEFORE
TAKING TELFAST 180 MG IF:
•
You have problems with your liver or
kidneys
•
You are an elderly
If you are unsure of anything, it is
essential that you ask your doctor or
pharmacist for advice.
_Pregnancy and breastfeeding _
If you are pregnant or breast-feeding,
think
you
may
be
pregnant
or
are
planning
to
have
a
baby,
ask
your
doctor or pharmacist for advice before
taking this medicine.
Do
not
take
this
medicine
during
pregnancy unless you are advised to do
so by your doctor.
If you discover that you are pregnant
during treatment, talk to your doctor.
Only your doctor will be able to decide
whether
it
is
necessary
to
continue
treatment.
It is unclear as to whether this med

Charakteristika produktu

MY/TEL[phone]/FR SmPC0621
Page 1 of 5
TELFAST
®
Fexofenadine HCl
180 mg
[SANOFI logo]
1. NAME OF THE MEDICINAL PRODUCT
Telfast 180 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fexofenadine hydrochloride 180.00 mg
For one film-coated tablet.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Telfast 180 mg is 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.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria
_Adults and Children 12 Years and Older: _
The recommended dose of TELFAST tablets is 180 mg once daily with
water. A
dose of 60 mg once daily is recommended as the starting dose in
patients with
decreased renal function.
_At-risk subjects: _
Studies conducted in at-risk adult patients (impaired renal or hepatic
function)
show that it is not necessary to adjust the posology of fexofenadine
hydrochloride in these patients.
METHOD OF ADMINISTRATION
Oral use.
4.3. CONTRAINDICATIONS
History of hypersensitivity to any of the ingredients.
Children less than 12 years of age due to the lack of safety and
efficacy data.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with cardiovascular disease or a history of cardiovascular
disease should
be alerted to the fact that antihistamines as a therapeutic group have
been
associated with the undesirable effects tachycardia and palpitations
(see
section 4.8).
MY/TEL[phone]/FR SmPC0621
Page 2 of 5
There are limited data on administration in the elderly and patients
with kidney
or liver failure. Fexofenadine hydrochloride should be used with
caution in these
patients (see section 4.2).
EXCIPIENT WITH KNOWN EFFECT:
This medicinal product contains less than 1 mmol sodium (23 mg) per
tab