Telfast 180 mg film-coated tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Fexofenadine hydrochloride

Предлага се от:

Opella Healthcare France SAS T/A Sanofi

АТС код:

R06AX; R06AX26

INN (Международно Name):

Fexofenadine hydrochloride

дозиране:

180 milligram(s)

Лекарствена форма:

Film-coated tablet

Терапевтична област:

Other antihistamines for systemic use; fexofenadine

Статус Оторизация:

Marketed

Дата Оторизация:

1997-11-11

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
TELFAST 180 MG FILM-COATED TABLETS
Fexofenadine hydrochloride
IS THIS LEAFLET HARD TO SEE OR READ?
IN IRELAND PHONE [phone] FOR HELP
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.
If you are taking apalutamide (a medicine to treat prostate cancer),
as the ef

Данни за продукта

Health Products Regulatory Authority
25 August 2023
CRN00DR85
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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 tablets.
Peach, modified 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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
There is limited data in the elderly and renally or hepatically
impaired patients. Fexofenadine hydrochloride should be
administered with care in these special groups (see section 4.2).
Health Products Regulatory Authority
25 August 2023
CRN00DR85
Page 2 of 6
Patients with a history of or ongoing cardiovascular disease should be
warned that, antihistamines as a medicine class, have
b