TELFAST 120 MG FILM-COATED TABLETS

Active substance: FEXOFENADINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

• you have or ever had heart disease, since this
kind of medicine may lead to a fast or irregular
heart beat
TELFAST 120 mg
• you are elderly
film-coated tablets
If any of these apply to you, or if you are not
Fexofenadine hydrochloride
sure, tell your doctor before taking fexofenadine.
Other medicines and fexofenadine
Read all of this leaflet carefully before you
Tell your doctor or pharmacist if you are taking,
start taking this medicine because it contains
have recently taken or might take any other
important information for you.
• Keep this leaflet. You may need to read it again. medicines.
• If you have any further questions, ask your
Indigestion remedies containing aluminium and
doctor or pharmacist.
magnesium may affect the action of fexofenadine
• This medicine has been prescribed for you only. by lowering the amount of medicinal product
Do not pass it on to others. It may harm them,
absorbed.
even if their signs of illness are the same as yours. It is recommended that you leave about 2 hours
• If you get side effects, talk to your doctor or
between the time that you take fexofenadine and
pharmacist. This includes any possible side
your indigestion remedy.
effects not listed in this leaflet (see section 4).
Pregnancy and breast-feeding
What is in this leaflet:
Ask your doctor or pharmacist for advice before
1. What fexofenadine is and what it is used for
taking any medicine.
2. What you need to know before you take
Do not take fexofenadine if you are pregnant,
fexofenadine
unless necessary.
3. How to take fexofenadine
Fexofenadine is not recommended during breast4. Possible side effects
feeding.
5. How to store fexofenadine
Driving and using machines
6. Contents of the pack and other information
Fexofenadine is unlikely to affect your ability to
drive or operate machinery. However, you should
1. WHAT FEXOFENADINE IS AND WHAT IT IS
check that these tablets do not make you feel
USED FOR
sleepy or dizzy before driving or operating
The name of this medicine is Telfast 120 mg film- machinery.
coated tablets, referred to as Fexofenadine
3. HOW TO TAKE FEXOFENADINE
throughout this leaflet.
Always take this medicine exactly as your doctor
Fexofenadine is an antihistamine.
has told you.
It is used in adults and adolescents of 12 years
Check with your doctor or pharmacist if you are
and older to relieve the symptoms that occur
not sure.
with hay fever (seasonal allergic rhinitis) such as
sneezing, itchy, runny or blocked nose and itchy, For adults and children aged 12 years and over
red and watery eyes.
The recommended dose is one tablet (120 mg)
daily. Take your tablet with water before a meal.
2. WHAT YOU NEED TO KNOW BEFORE YOU
If you take more fexofenadine than you should
TAKE FEXOFENADINE
If you take too many tablets, contact your doctor
Do not take fexofenadine:
or the nearest hospital emergency department
• if you are allergic to fexofenadine or any of the immediately. Symptoms of an overdose in adults
other ingredients of this medicine (listed in
are dizziness, drowsiness, fatigue and dry mouth.
section 6).
If you forget to take fexofenadine
Warnings and precautions
Do not take a double dose to make up for a
Talk to your doctor or pharmacist before taking
forgotten tablet. Take the next dose at the usual
fexofenadine if:
time as prescribed by your doctor.
• you have problems with your liver or kidneys

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4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately and stop taking
fexofenadine 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.
Additional side effects (frequency not known:
cannot be estimated from the available data)
which may occur are:
• difficulty sleeping (insomnia)
• sleeping disorders
• bad dreams
• nervousness
• fast or irregular heart beat
• diarrhoea
• skin rash and itching
• hives
• serious allergic reactions which can cause
swelling of the face, lips, tongue or throat,
flushing, chest tightness, and difficulty
breathing.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side
effects, you can help provide more information
on the safety of this medicine.

5. HOW TO STORE FEXOFENADINE
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
This medicine does not require any special
storage condition.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What fexofenadine 120 mg contains
• The active substance is fexofenadine
hydrochloride. Each tablet contains 120 mg of
fexofenadine hydrochloride
• The other ingredients are:
○ Tablet core - microcrystalline cellulose,
pregelatinised maize starch, croscarmellose
sodium, magnesium stearate.
○ Film coating - hypromellose, povidone,
titanium dioxide (E171), colloidal anhydrous
silica, macrogol 400 and iron oxide (E172).
What fexofenadine 120 mg looks like and
contents of the pack
Fexofenadine 120 mg film-coated tablets are peach
coloured, capsule shaped tablets marked with
“012” on one side and a scripted “e” on the other.
Each blister pack contains 30 tablets.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi,
One Onslow Street, Guildford, Surrey, GU1 4YS,
UK.
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie,
30-36 Avenue Gustave Eiffel, 37100 Tours, France.
This leaflet was last updated in 01/2014

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If you stop taking fexofenadine
Tell your doctor if you want to stop taking
fexofenadine before you have finished your
course of treatment. If you stop taking
fexofenadine earlier than planned, your
symptoms may return.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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