Telfast 120mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fexofenadine hydrochloride

Available from:

LTT Pharma Limited

ATC code:

R06AX; R06AX26

INN (International Name):

Fexofenadine hydrochloride

Dosage:

120 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antihistamines for systemic use; fexofenadine

Authorization status:

Authorised

Authorization date:

2010-01-29

Patient Information leaflet

TELFAST 120MG FILM-COATED TABLETS
fexofenadine hydrochloride
Indigestion remedies containing aluminium and magnesium may affect the
action of Telfast, by lowering the amount of medicinal product
absorbed.
It is recommended that you leave about 2 hours between the time that
you
take Telfast and your indigestion remedy.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may be pregnant or
are
planning to have a baby, ask your doctor or pharmacist for advice
before
taking this medicine.
Do not take Telfast if you are pregnant, unless necessary.
Telfast is not recommended during breast-feeding.
DRIVING AND USING MACHINES
Telfast is unlikely to affect your ability to drive or operate
machinery.
However, you should check that these tablets do not make you feel
sleepy
or dizzy before driving or operating machinery.
HOW TO TAKE TELFAST
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
FOR ADULTS AND CHILDREN AGED 12 YEARS AND OVER
The recommended dose is one tablet (120mg) daily.
Take your tablet with water before a meal.
This medicine starts to relieve your symptoms within 1 hour and lasts
for 24
hours.
IF YOU TAKE MORE TELFAST THAN YOU SHOULD
If you take too many tablets, contact your doctor or the nearest
hospital
emergency department immediately. Symptoms of an overdose in adults
are
dizziness, drowsiness, fatigue and dry mouth.
IF YOU FORGET TO TAKE TELFAST
Do not take a double dose to make up for a forgotten tablet.
Take the next dose at the usual time as prescribed by your doctor.
IF YOU STOP TAKING TELFAST
Tell your doctor if you want to stop taking Telfast before you have
finished
your course of treatment.
If you stop taking Telfast earlier than planned, your symptoms may
return.
If you have any further questions on the use of this medicine, ask
your
doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
TELL YOUR DOCTOR IMMEDIATELY AND

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telfast 120mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 120mg of fexofenadine hydrochloride, which is
equivalent to 112mg of fexofenadine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
_Product imported from the UK_
Peach, modified capsule-shaped, film-coated tablet debossed with
''012''
on one side and “e” on the other.
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 (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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