Telfast Allergy 120 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fexofenadine hydrochloride

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

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:

Not marketed

Authorization date:

2013-03-01

Patient Information leaflet

16/08/2021 11:39 - VISTAlink folder 4142241 - Page 1/7
_créé le_
_par_
_modifié le_
_par_
09/12/2020
DERIGNY C
14/06/2021
DERIGNY C
SANOFI
IRLANDE
_Laboratoires_
_Pays_
_Couleur_
_Nbre/Réf._
_Version N°_
_Type Article_
_Nom du produit_
_Référence article_
_Dosage_
_Quantité_
_N° version Logo/Name_
_N° version Country Ex._
_N° plan Dimensionnel_
_N° plan positionnement_
_Dimensions_
_Taille mini caractères_
_Code sécurité_
R790360
N.A.
CRIE-V1-10/09/2012
1-606251
606251-1A
150 X 210 MM
9 PTS
2
NOTICE TRIPLE
TAVANIC
R790360
250 MG & 500 MG
CPRS
1
PANTONE REFLEX BLUE U
_Numéro de pages_
1/6
PACKAGE LEAFLET: INFORMATION FOR THE USER
IS THIS LEAFLET HARD TO SEE OR READ?
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 Tavanic tablets are and what they are used for
2. What you need to know before you take Tavanic
tablets
3. How to take Tavanic tablets
4. Possible side effects
5. How to store Tavanic tablets
6. Contents of the pack and other information
1. WHAT TAVANIC TABLETS ARE AND WHAT THEY
ARE USED FOR
The name of your medicine is Tavanic tablets.
Tavanic tablets contain a medicine called
levofloxacin. This belongs to a group of medicines
called antibiotics. Levofloxacin is a ‘quinolone’
antibiotic. It works by killing the bacteria that
cause infections in your body.
TAVANIC TABLETS CAN BE USED TO TREAT
INFECTIONS OF THE:
• Sinuses
• Lungs, in people with long-term breathing
problems or pneumonia
• Urinary tract, including your kidneys or

Summary of Product characteristics

Health Products Regulatory Authority
14 July 2021
CRN00C59M
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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 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 fexofenadine hydrochloride 120mg 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.
Health Products Regulatory Authority
14 July 2021
CRN00C59M
Page 2 of 6
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