TELFAST 30MG FILM-COATED TABLETS

Active substance: FEXOFENADINE HYDROCHLORIDE

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516582_Nt TELFAST 30MG GB.qxp_FORMAT 210x170mm-RL.qxd 19/06/14 11:46 Page1

PACKAGE LEAFLET:
INFORMATION FOR THE USER

30 mg
Fexofenadine hydrochloride

0845 372 7101
Read all of this leaflet carefully before your child starts
taking this medicine.
• 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 your child. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as your child’s.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Telfast is and what it is used for
2. Before you use Telfast
3. How to use Telfast
4. Possible side effects
5. How to store Telfast
6. Further information
1. What Telfast is and what it
is used for
Telfast contains fexofenadine hydrochloride, which is an
antihistamine.
Telfast 30 mg is used in children 6 to 11 years old 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. Before you use Telfast
Do not use Telfast
if your child is allergic (hypersensitive) to fexofenadine or
any of the other ingredients of Telfast (see section 6 for a
full list of ingredients)
Take special care with Telfast
if your child has liver or kidney problems
if your child has or ever had heart disease, since this
medicine may lead to a fast or irregular heart beat
If any of these apply to your child, or if you are not sure,
always tell your doctor before giving Telfast to your child.

Taking other medicines
Please tell your doctor or pharmacist if your child is taking or
has recently taken any other medicines, including medicines
obtained without a prescription.
Indigestion remedies containing aluminium and magnesium
may affect the action of Telfast, by lowering the amount of
medicinal product absorbed.
It is recommended that 2 hours are left between the time that
your child takes Telfast and the indigestion remedy.
Pregnancy and breast-feeding
This medicine is for use in children 6 – 11 years of age.
However, the following information should be noted
regarding the safe use of this medicine.
Ask your doctor or pharmacist for advice before giving any
medicine.
Telfast should not be taken during pregnancy, unless necessary.
Telfast is not recommended during breast-feeding.
Driving and using machines
Telfast is unlikely to affect ones ability to drive or use
machines. However, you should check that these tablets do
not make your child feel sleepy or dizzy.
Do not let your child drive or operate machinery if they are
affected.
3. How to use Telfast
Always use Telfast exactly as the doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
For children aged 6 to 11 years of age
The recommended dose is one tablet (30 mg) twice daily.
The tablet should be taken with water.
If you use more Telfast than you should
If your child takes too many tablets, contact your doctor or the
nearest hospital emergency department immediately.
Symptoms of an overdose are dizziness, drowsiness, fatigue
and dry mouth.
If you forget to use Telfast
Do not give a double dose to make up for a forgotten tablet.
Give the next dose at the usual time as prescribed by the
doctor.
If you stop using Telfast
Tell your doctor if you want your child to stop taking Telfast
before the course of treatment has finished.
If treatment with Telfast is stopped earlier than planned, the
symptoms may return.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

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4. Possible side effects

What Telfast 30 mg looks like and contents of the pack

Like all medicines, Telfast can cause side effects, although not
everybody gets them.

Telfast 30 mg film coated tablets are round and peach
coloured, marked with “03” on one side and a scripted “e” on
the other.

Tell your doctor immediately and stop treatment with Telfast
if your child experiences swelling of the face, lips, tongue or
throat and difficulty breathing, as these may be signs of a
serious allergic reaction.

Telfast is presented in blister packs. Each tablet is blistered.
Telfast is available in packs of 1, 2, 4, 8, 10, or 15 (sample
only), 20, 30, 40, 50, 60, and 100 tablets per package.
Not all pack sizes are marketed.

In clinical trials in children 6 to 11 years of age, the most
common side effect was headache.

Marketing Authorisation Holder and Manufacturer

In adults, the following side effects have been reported:
Common side effects (occurring in less than 1 in 10 but more
than 1 in 100 patients): headache, drowsiness, feeling sick
(nausea) and dizziness.
Uncommon side effects (occurring in less than 1 in 100 but
more than 1 in 1,000 patients): tiredness/sleepiness.
Additional side effects (frequency unknown) 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.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. How to store Telfast
Keep out of the reach and sight of children.
Do not use Telfast 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.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
protect the environment.
6. Further information

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,
37 100 Tours, France
This medicinal product is authorised in the Member states
of the EEA under the following names:
Belgium: Telfast 30 mg filmomhulde tabletten
Cyprus: Telfast
Denmark: Telfast, filmovertrukne tabletter 30 mg
Finland: Telfast 30 mg tabletti, kalvopäällysteinen
Germany: Telfast 30 mg Filmtabletten
Iceland: Telfast 30 mg filmuhúðaðar töflur
Ireland: Telfast 30 mg film coated tablets
Italy: Telfast 30 mg compresse rivestite con film
Luxembourg: Telfast 30 mg filmomhulde tabletten
Malta: Telfast 30 mg film coated tablets
Norway: Telfast 30 mg filmdrasjerte tabletter
Poland: Telfast 30
Portugal: Telfast 30, comprimidos revestidos por película
Spain: Telfast 30 mg comprimidos recubiertos con película
Sweden: Telfast 30 mg filmdragerade tabletter
United Kingdom: Telfast 30 mg film coated tablets
This leaflet was last revised in June 2014
© Sanofi, 2014

What Telfast 30 mg film-coated tablets contains

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The active substance of Telfast is fexofenadine hydrochloride.
Each tablet contains 30 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, pink iron oxide (E172)
blend and yellow iron oxide (E172) blend.

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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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