Telfast 120mg film-coated Tablets

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

FEXOFENADINE HYDROCHLORIDE

متاح من:

Sanofi Malta Limited

ATC رمز:

R06AX26

INN (الاسم الدولي):

FEXOFENADINE HYDROCHLORIDE

الشكل الصيدلاني:

FILM-COATED TABLET

تركيب:

FEXOFENADINE HYDROCHLORIDE 120 mg

نوع الوصفة الطبية :

POM

المجال العلاجي:

ANTIHISTAMINES FOR SYSTEMIC USE

الوضع إذن:

Authorised

تاريخ الترخيص:

2005-11-15

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
TELFAST 120 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 an
antihistamine.
Telfast 120 mg is used in adults and adolescents of 12 years
and older to relieve the symptoms that occur with hay fever
(seasonal allergic rhinitis) such as sneezing, itchy, runny or
blocked nose and itchy, red and watery eyes.
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 recommended that

خصائص المنتج

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 8
1.
NAME OF THE MEDICINAL PRODUCT
Telfast 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 120 mg of fexofenadine hydrochloride, which is
equivalent to 112 mg of
fexofenadine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Peach, modified capsule-shaped, film-coated tablet of 6.1 x 15.8 mm
debossed with “012" on
one side and a scripted “e” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Telfast 120 mg is indicated in adults and children 12 years and older
for the relief of
symptoms associated with seasonal allergic rhinitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dose of fexofenadine hydrochloride for adults is 120
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
120 mg once daily taken before a meal.

Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride 120 mg has not
been studied in
children under 12.
In children from 6 to 11 years of age: fexofenadine hydrochloride 30
mg tablet is the
appropriate formulation for administration and dosing in this
population.
_Special populations _
Studies in special risk groups (elderly, renally or hepatically
impaired patients) indicate that
it is not necessary to adjust the dose of fexofenadine hydrochloride
in these patients.
Page 3 of 8
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with most new medicinal products 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