Telfast 120mg film-coated tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Fexofenadine hydrochloride

Prieinama:

PCO Manufacturing Ltd.

ATC kodas:

R06AX; R06AX26

INN (Tarptautinis Pavadinimas):

Fexofenadine hydrochloride

Dozė:

120 milligram(s)

Vaisto forma:

Film-coated tablet

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

Other antihistamines for systemic use; fexofenadine

Autorizacija statusas:

Authorised

Leidimo data:

2010-10-29

Pakuotės lapelis

_ _
_ _
_ _
_ _
_ _
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELFAST
® 120 MG FILM-COATED TABLETS
Fexofenadine hydrochloride
IS THIS LEAFLET HARD TO SEE OR READ?
IN IRELAND 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 Telfast is and what it is used for
2.
What you need to know before you take Telfast
3.
How to take Telfast
4.
Possible side effects
5.
How to store Telfast
6.
Contents of the pack and other information
1.
WHAT TELFAST IS AND WHAT IT IS USED FOR
Telfast contains fexofenadine hydrochloride, which is an
antihistamine.
Telfast 120 mg 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
DO NOT TAKE TELFAST

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 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.
OTHER MEDICINES AND TELFAST
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Indigestion remedies containing alumin

Prekės savybės

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 a 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 a scripted ‘e’ on the other
side.
4 CLINICAL PARTICULARS
As per PA0540/078/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/078/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet Core_
Microcrystalline cellulose
Pregelatinised maize starch
Croscarmellose sodium
Magnesium Stearate
_Film coating_
Hypromellose
Povidone
Titanium dioxide (E171)
Colloidal anhydrous silica
Macrogol 400
Iron oxide (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_9_
_/_
_0_
_8_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_9_
_3_
_9_
_8_
_2_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
30 tablets in blisters, presented in an overlabelled outer carton
6.6 SPECIAL PRECAUTIONS FOR