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TELFAST 120 MG FILM-COATED TABLETS

Active substance(s): FEXOFENADINE HYDROCHLORIDE

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650720_NT. TELFAST 120MG RL S1 GB.qxp_FORMAT 210x170mm-RL.qxd 09/09/16 14:46 Page1

Package leaflet: Information for the user

TELFAST 120 mg film-coated tablets
Fexofenadine hydrochloride

0845 372 7101
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 aluminium and magnesium
may affect the action of Telfast, by lowering the amount of
medicinal product absorbed.
It is recommended that you leave about 2 hours between the
time that you take Telfast and your indigestion remedy.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take Telfast if you are pregnant, unless necessary.
Telfast is not recommended during breast-feeding.
Driving and using machines
Telfast is unlikely to affect your ability to drive or operate
machinery. However, you should check that these tablets do
not make you feel sleepy or dizzy before driving or operating
machinery.
3. How to take Telfast
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
For adults and children aged 12 years and over
The recommended dose is one tablet (120 mg) daily.
Take your tablet with water before a meal.
This medicine starts to relieve your symptoms within 1 hour
and lasts for 24 hours.
If you take more Telfast than you should
If you take too many tablets, contact your doctor or the
nearest hospital emergency department immediately.
Symptoms of an overdose in adults are dizziness, drowsiness,
fatigue and dry mouth.
If you forget to take Telfast
Do not take a double dose to make up for a forgotten tablet.
Take the next dose at the usual time as prescribed by your doctor.
If you stop taking Telfast
Tell your doctor if you want to stop taking Telfast before you
have finished your course of treatment.
If you stop taking Telfast earlier than planned, your
symptoms may return.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
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 Telfast if
you experience:
- swelling of the face, lips, tongue or throat and difficulty
breathing, as these may be signs of a serious allergic
reaction.

650720_NT. TELFAST 120MG RL S1 GB.qxp_FORMAT 210x170mm-RL.qxd 09/09/16 14:46 Page2

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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.
UK:
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
Ireland:
You can also report side effects directly via HPRA
Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie
Malta:
You can also report side effects directly via ADR Reporting
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Telfast
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 after EXP. 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 Telfast 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 K30, titanium
dioxide (E171), colloidal anhydrous silica, macrogol 400,
red iron oxide (E172) and yellow iron oxide (E172).


What Telfast 120 mg looks like and contents of the pack
Telfast 120 mg film-coated tablets of 6.1 x 15.8 mm are
peach coloured, capsule shaped tablets marked with “012”
on one side and a scripted “e” on the other.
Telfast is presented in blister packs. Each tablet is blistered.
Telfast is available in packs of 2 (sample only), 7, 10, 15, 20,
30, 50, 100 and 200 (as 10x20) tablets per package.
Not all pack sizes are marketed.
Marketing Authorisation Holder:
In the UK:
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
In Ireland:
sanofi-aventis Ireland Ltd., T/A SANOFI
Citywest Business campus, Dublin 24, Ireland
Tel: 00353 (0) 1 403 5600
Fax: 00353 (0) 1 403 5601
email: IEmedinfo@sanofi.com
Manufacturer
Sanofi Winthrop industrie,
30-36 Avenue Gustave Eiffel,
37100 Tours, France
This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria: Allegra 120 mg Filmtabletten
Belgium: Allegra tab 120 mg filmomhulde tabletten
Croatia: Allegra 120 mg filmom obložene tablete
Czech Republic: Allegra 120 mg
Denmark: Telfast, filmovertrukne tabletter 120 mg
Estonia: Allegra
Finland: Telfast 120 mg tabletti, kalvopäällysteinen
Germany: Telfast 120 mg-Filmtabletten
Greece: Allegra
Ireland: Telfast 120 mg film-coated tablets
Italy: Telfast 120 mg compresse rivestite con film
Latvia: Allegra 120 mg apvalkotās tabletes
Lithuania: Allegra 120 mg plėvele dengtos tabletės
Luxembourg: Allegra tab 120 mg comprimés pelliculés
Portugal: Telfast 120, comprimidos revestidos por película
Romania: Telfast 120 mg comprimate filmate
Slovenia: Telfast 120 mg filmsko obložene tablete
Slovakia: Allegra 120 mg
Spain: Telfast 120 mg comprimidos recubiertos con película
Sweden: Allegra
United Kingdom: Telfast 120 mg film-coated tablets
This leaflet was last revised in 09/2016

*650720*

Uncommon side effects (may affect up to 1 in 100 people):
- tiredness/sleepiness.



650720

Common side effects (may affect up to 1 in 10 people):
- headache
- drowsiness
- feeling sick (nausea)
- dizziness.

650720_NT. TELFAST 120MG RL S1 GB.qxp_FORMAT 210x170mm-RL.qxd 09/09/16 14:46 Page3

For Sanofi use only

Code :
Update :
Local code :
Old PM code :

650720
V1 - 09/SEP./2016
N.A.
619879

Name :

NT. TELFAST 120MG
RL S1

Country :

GB

Plant :
Supplier code :

TOURS
N.A.

Format : 210 x 170 mm - Rouleau - Simple
Sens de déroulement :
Recto Intérieur_4A (Portrait) - Verso Ext. : 4B

Technical Data

Plant barcode : *650720*
Colours : 2
- Noir PMS Black U
- Bleu PMS REFLEX BLUE U
Fonts : OceanSansPRO SAN (8Pt à 100%) - Arial (bullet points ○) L39HrP24Dh (Code 39)

Approvals

Layout of Cutting :
TN_LCG_NTRL_13c
Technical Constraint : PLANTYPE-NTRL-2015_S-DB (CAB/Verso ext.)

Colours may note reproduce accurately on this proof.
You should refer to Pantone references for accurate colour match.

Nature du changement/Reason for change :
- Regulatory text:
Add sentence in 'how to take telfast'
Change name of BE and LU product

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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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