Telfast 120 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Fexofenadine hydrochloride

Tilgjengelig fra:

Opella Healthcare France SAS T/A Sanofi

ATC-kode:

R06AX; R06AX26

INN (International Name):

Fexofenadine hydrochloride

Dosering :

120 milligram(s)

Legemiddelform:

Film-coated tablet

Terapeutisk område:

Other antihistamines for systemic use; fexofenadine

Autorisasjon status:

Marketed

Autorisasjon dato:

1997-11-11

Informasjon til brukeren

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 a non-drowsy
antihistamine.
Telfast 120 mg is used in adults and adolescents of 12 years and older
to relieve the symptoms
that occur with allergic rhinitis (for example hay fever), 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.
If you are taking apalutamide (a medicine to treat prostate cancer),
as the effect of fexofenadine may be
decreased.
Indigestion remedie

Preparatomtale

Health Products Regulatory Authority
26 March 2024
CRN00DWTL
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telfast 120 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated 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 tablets.
Peach, modified capsule-shaped, film-coated tablet of 6.1 x 15.8mm
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 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.
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
Health Products Regulatory Authority
26 March 2024
CRN00DWTL
Page 2 of 6
There is limited data in the elderly and renally or hepatically
impaired patients. Fexofenadine hydrochloride should be
administered with