TELFAST 180 TABLET

Држава: Јужноафричка Република

Језик: Енглески

Извор: South African Health Products Regulatory Authority (SAHPRA)

Доступно од:

Opella Healthcare South Africa (Pty) Ltd

Дозирање:

See ingredients

Фармацеутски облик:

TABLET

Састав:

EACH TABLET CONTAINS FEXOFENADINE HYDROCHLORIDE 180 mg

Статус ауторизације:

Registered

Датум одобрења:

1999-08-02

Информативни летак

Page 1 of 5
APPROVED PATIENT INFORMATION LEAFLET FOR TELFAST 180 TABLETS
SCHEDULING STATUS:
S1
TELFAST 180 TABLETS
Active ingredient fexofenadine hydrochloride
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
TELFAST 180 is available without a doctor’s prescription.
Nevertheless, you will still need to use TELFAST 180 carefully to get
the
BEST RESULTS FROM IT.
•
Keep this leaflet. You may need to read it again.
•
Do not share TELFAST 180 with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
WHAT IS IN THIS LEAFLET
1.
WHAT TELFAST 180 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TELFAST 180
3.
HOW TO TAKE TELFAST 180
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TELFAST 180
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT TELFAST 180 IS AND WHAT IT IS USED FOR
TELFAST 180 belongs to a group of medicines called antihistamines.
TELFAST 180 is used in adults and adolescents of 12 years and older
to relieve the symptoms that occur with long term allergic skin
reactions (chronic idiopathic urticaria) such as itching, swelling and
Rashes and hay fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TELFAST 180
Do not take TELFAST 180:
•
If you are allergic to fexofenadine hydrochloride or any of the other
Page 2 of 5
Ingredients in this medicine (listed in section 6)
•
If you are pregnant or think that you may be pregnant and if
you are breastfeeding your baby
WARNINGS AND PRECAUTIONS
SPECIAL CARE SHOULD BE TAKEN WITH TELFAST 180:
•
If you have problems with your liver or kidneys
•
If you are elderly
If any of these apply to you, or if you are not sure, tell your doctor
or
pharmacist or healthcare provider before taking TELFAST 180
OTHER MEDICINES AND TELFAST 180
Tell your doctor, pharmacist or health care provider if you are
taking or have recently taken or might take any other medicines.
Indigestion medicines containing aluminium and magnesium may
affect the action of TELFAST 180 by lo

Карактеристике производа

Page 1 of 6
APPROVED PROFESSIONAL INFORMATION FOR TELFAST 180 TABLETS
SCHEDULING STATUS:
S1
PROPRIETARY NAME AND DOSAGE FORM:
TELFAST 180 tablets
COMPOSITION:
TELFAST 180:
Fexofenadine base 168 mg (as fexofenadine hydrochloride 180 mg) per
tablet.
INACTIVE INGREDIENTS:
Colloidal anhydrous silica, croscarmellose sodium, hypromellose,
macrogol, magnesium
stearate, microcrystalline cellulose, pregelatinised maize starch,
povidone, titanium dioxide, pink
and yellow iron oxide.
Sugar free.
CATEGORY AND CLASS:
A 5.7.1 Antihistaminics
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
Fexofenadine hydrochloride is a pharmacologically active metabolite of
terfenadine and is a
non-sedating selective histamine H
1
-receptor antagonist.
Fexofenadine exhibits an antihistaminic effect beginning within one
hour, achieving maximum
effect at 6 hours and lasting 24 hours. There was no evidence of
tolerance to these effects
after 28 days of dosing.
PHARMACOKINETIC PROPERTIES:
_Absorption:_
Page 2 of 6
Fexofenadine is absorbed into the body following oral administration,
with T
max
occurring at
approximately 1 - 3 hours post dose. The mean C
max
value was approximately 494 ng/ml
following the administration of a 180 mg dose once daily.
_Distribution:_
Fexofenadine is 60 – 70 % plasma protein bound.
_Biotransformation and elimination:_
Fexofenadine undergoes negligible metabolism, as it was the only major
compound identified
in urine and faeces of animals and
man. The plasma concentration profiles of fexofenadine
follow a bi-exponential decline with a terminal elimination half-life
ranging from 11 to 15 hours
after multiple dosing. The single and multiple dose pharmacokinetics
of fexofenadine are
linear between 40 mg and 240 mg taken daily. The major route of
elimination is believed to
be via biliary excretion while up to 10 % of ingested dose is excreted
unchanged through the
urine.
EFFECT OF AGE:
In older subjects (≥ 65 years old), peak plasma levels of
fexofenadine were 99 % greater than
those observed in normal volunteers (