TELFAST 180 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FEXOFENADINE HYDROCHLORIDE

Available from:

LTT Pharma Limited

ATC code:

R06AX26

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Dosage:

180 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

other antihistamines for systemic use

Authorization status:

Authorised

Authorization date:

2010-01-29

Patient Information leaflet

PREGNANCY AND BREAST-FEEDING
Ask your doctor or pharmacist for advice before taking any 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 (180mg) 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 STOP TAKING TELFAST IF YOU
EXPERIENCE:
*
swelling of the face, lips, tongue or throat and difficulty breathing,
as these
may be signs of a serious allergic reaction.
COMMON SIDE EFFECTS (may affect up to 1 in 10 people):
*
headache
*
drowsiness
*
feeling sick (nausea)
*
dizziness.
UNCOMMON SIDE EFFECTS (may affect up to 1 in 100 people):
*
tiredness
*
sleepiness.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU STA

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telfast 180mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 180mg of fexofenadine hydrochloride, which is equivalent to 168mg 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 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
As with most new medicinal products there is only limited data in the older people and renally or hepatically impaired
patients. Fexofenadine hydrochloride should be administered with care i