Telfast 180mg film-coated Tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Fexofenadine hydrochloride

Dostopno od:

Imbat Limited

Koda artikla:

R06AX; R06AX26

INN (mednarodno ime):

Fexofenadine hydrochloride

Odmerek:

180 milligram(s)

Farmacevtska oblika:

Film-coated tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Other antihistamines for systemic use; fexofenadine

Status dovoljenje:

Authorised

Datum dovoljenje:

2008-09-05

Navodilo za uporabo

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELFAST
® 180MG FILM COATED TABLETS
(fexofenadine hydrochloride)
Your medicine is available using the above name, but will be
referred to as Telfast throughout this leaflet.
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 is used in adults and adolescents of 12 years and older
to relieve the symptoms that occur with long term allergic
skin reactions (chronic idiopathic urticaria) such as itching,
swelling and rashes.
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 alumini

Lastnosti izdelka

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 (equivalent
to 168mg of fexofenadine)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-Coated Tablet.
_Product imported from UK:_
Peach, capsule-shaped, film-coated tablet debossed with an ‘e’ on
one side and ‘018’ on the other .
4 CLINICAL PARTICULARS
As per PA0540/078/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/078/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet core:_
Microcrystalline Cellulose
Pregelatinised Maize Starch
Croscarmellose Sodium
Magnesium Stearate
_Film coat:_
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 for this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Overlabelled cardboard outer containing blister strips. Pack size 30.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDI