Telfast 180mg film-coated Tablets

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

FEXOFENADINE HYDROCHLORIDE

متاح من:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC رمز:

R06AX26

INN (الاسم الدولي):

FEXOFENADINE HYDROCHLORIDE

الشكل الصيدلاني:

FILM-COATED TABLET

تركيب:

FEXOFENADINE HYDROCHLORIDE 180 milligram(s)

نوع الوصفة الطبية :

POM

المجال العلاجي:

ANTIHISTAMINES FOR SYSTEMIC USE

الوضع إذن:

Authorised

تاريخ الترخيص:

2005-11-15

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELFAST 180 MG FILM-COATED TABLETS
FEXOFENADINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Telfast is and what it is used for
2.
What you need to know before you take Telfast
3.
How to take Telfast
4.
Possible side effects
5.
How to store Telfast
6.
Contents of the pack and other information
1.
WHAT TELFAST IS AND WHAT IT IS USED FOR
Telfast contains fexofenadine hydrochloride, which is a non-drowsy
antihistamine.
Telfast 180 mg 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TELFAST
DO NOT TAKE TELFAST
•
if you are allergic to fexofenadine or any of the other ingredients of
this medicine (listed in
section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Telfast if:
•
you have problems with your liver or kidneys
•
you have or ever had heart disease, since this kind of medicine may
lead to a fast or irregular
heart beat
•
you are elderly
If any of these apply to you, or if you are not sure, tell your doctor
before taking Telfast.
OTHER MEDICINES AND TELFAST
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines.
Indigestion remedies containing aluminium and magnesium may affect the
action of Telfast by
lowering the amount of medicinal product absorbed.
It is reco

خصائص المنتج

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Telfast 180 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 180 mg of fexofenadine hydrochloride, which is
equivalent to 168 mg of
fexofenadine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Peach, capsule-shaped, film-coated tablet debossed with “018” on
one side and a scripted “e” on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Telfast 180 mg is indicated in adults and children 12 years and older
for the relief of symptoms
associated with chronic idiopathic urticaria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dose of fexofenadine hydrochloride for adults is 180
mg once daily taken before a
meal.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
_Paediatric population _
•
Children aged 12 years and over
The recommended dose of fexofenadine hydrochloride for children aged
12 years and over is 180 mg
once daily taken before a meal.
_ _
•
Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride 180 mg has not
been studied in children under
12.
_Special populations _
Studies in special risk groups (older people, renally or hepatically
impaired patients) indicate that it is
not necessary to adjust the dose of fexofenadine hydrochloride in
these patients.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
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4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
There is only limited data in the older people and renally or
hepatically impaired patients.
Fexofenadine hydrochloride should be administered with care in these
special groups (see section
4.2).
Patients with a history of or ongoing cardiovascular disease should be
warned that, antihistamines as a
medicine class, have been associated with the adverse reactions,
tachycardia and palpitations (see
section 4.8)