Telfast Allergy 120 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FEXOFENADINE HYDROCHLORIDE

Available from:

Opella Healthcare France SAS T/A Sanofi 157 avenue Charles de Gaulle, 92200 Neuilly-sur-Seine , France

ATC code:

R06AX26

INN (International Name):

FEXOFENADINE HYDROCHLORIDE 120 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

FEXOFENADINE HYDROCHLORIDE 120 mg

Prescription type:

OTC

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2013-01-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TELFAST ALLERGY 120 MG FILM-COATED TABLETS
_fexofenadine hydrochloride _
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE + 353 1 403 5600 FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1.
What Telfast Allergy is and what it is used for
2.
What you need to know before you take Telfast Allergy
3.
How to take Telfast Allergy
4.
Possible side effects
5.
How to store Telfast Allergy
6.
Contents of the pack and other information
1. WHAT TELFAST ALLERGY IS AND WHAT IT IS USED FOR
Telfast Allergy 120 mg film-coated tablets (called Telfast Allergy
throughout this leaflet) contains
fexofenadine hydrochloride, which is a non-drowsy antihistamine.
Telfast Allergy is used in adults and adolescents of 12 years and
older 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 YOU TAKE TELFAST ALLERGY
DO NOT TAKE TELFAST ALLERGY
•
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 Allergy 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 Allergy.
OTHER

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Telfast Allergy 120 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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 tablet.
Peach, modified capsule-shaped, film-coated tablet of 6.1 x 15.8 mm
debossed with ‘012’ on one
side and a scripted ‘e’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Telfast Allergy 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 Telfast Allergy 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.
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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. Telfast Allergy
should be administered with care in these special groups (see section
4.2).
Patients with a history of or ongoing cardiovascular dis