Telfast 30 mg film-coated tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Fexofenadine hydrochloride

Fáanlegur frá:

Opella Healthcare France SAS T/A Sanofi

ATC númer:

R06A

INN (Alþjóðlegt nafn):

Fexofenadine hydrochloride

Skammtar:

30 milligram(s)

Lyfjaform:

Film-coated tablet

Lækningarsvæði:

ANTIHISTAMINES FOR SYSTEMIC USE

Leyfisstaða:

Not marketed

Leyfisdagur:

2004-02-10

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
TELFAST 30 MG FILM-COATED TABLETS
Fexofenadine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS 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 your child only. Do not pass it
on to others. It may
harm them, even if their signs of illness are the same as your
child’s.
-
If your child gets 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 your child uses Telfast
3.
How to use Telfast
4.
Possible side effects
5.
How to store Telfast
6.
Content 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 30 mg is used in children 6 to 11 years old 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 YOUR CHILD USES TELFAST
DO NOT USE TELFAST

if your child is 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 using Telfast if:

your child has liver or kidneys problems

your child has or ever had heart disease, since this medicine may lead
to a fast or
irregular heart beat
If any of these apply to your child, or if you are not sure, always
tell your doctor before giving
Telfast to your child.
OTHER MEDICINES AND TELFAST
Tell your doctor or pharmacist if your child is taking, has 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

Vara einkenni

Health Products Regulatory Authority
25 August 2023
CRN00DR85
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telfast 30 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of fexofenadine hydrochloride, which is
equivalent to 28 mg of fexofenadine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Peach round film-coated tablet debossed with “03” on one side and
a scripted “e” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Telfast 30 mg is indicated in children aged 6 to 11 for the relief of
symptoms associated with seasonal allergic rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
- _Children 6 to 11 years of age_
The recommended dose of fexofenadine hydrochloride in children aged 6
to 11 years is 30 mg twice daily.
- _Children under 6 years of age_
The efficacy of fexofenadine hydrochloride has not been established in
children under 6 years of age.
_Special populations_
The safety and efficacy of fexofenadine hydrochloride in renally or
hepatically impaired children have not been established (see
section 4.4 Special Warnings and Precautions for Use). Studies
conducted in adults in special risk groups (renally or hepatically
impaired patients) indicate that it is not necessary to adjust the
dose of fexofenadine hydrochloride in adults.
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
The safety and efficacy of fexofenadine hydrochloride in renally or
hepatically impaired children have not been established (see
section 4.2, Posology and Method of Administration). Fexofenadine
hydrochloride should be administered with caution in
these patients.
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
p