TELFAST 30MG FILM-COATED TABLETS

Active substance: FEXOFENADINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

30 mg
film-coated tablets
Fexofenadine hydrochloride

Is this leaflet hard to see or read?
Phone 01483 505515
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.

4. Possible side effects
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 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.

6. Further information

Like all medicines, Telfast can cause side effects, although What Telfast 30 mg film-coated tablets contains
not everybody gets them.
The active substance of Telfast is fexofenadine
hydrochloride. Each tablet contains 30 mg of
Tell your doctor immediately and stop treatment with
Telfast if your child experiences swelling of the face, lips, fexofenadine hydrochloride.
tongue or throat and difficulty breathing, as these may
The other ingredients are:
be signs of a serious allergic reaction.
Tablet core: microcrystalline cellulose, pregelatinised
In clinical trials in children 6 to 11 years of age, the most starch, croscarmellose sodium, magnesium stearate.
common side effect was headache.
Film coating: hypromellose, povidone, titanium dioxide
(E171), colloidal anhydrous silica, macrogol, pink iron
In adults, the following side effects have been reported:
oxide (E172) blend and yellow iron oxide (E172) blend.
Common side effects (occurring in less than 1 in 10 but
What Telfast 30 mg looks like and contents of the pack
more than 1 in 100 patients): headache, drowsiness,
feeling sick (nausea) and dizziness.
Telfast 30 mg film-coated tablets are round and peach
coloured, marked with “03” on one side and a scripted
Uncommon side effects (occurring in less than 1 in 100
but more than 1 in 1,000 patients): tiredness/sleepiness. “e” on the other.
Telfast is presented in blister packs. Each tablet is
blistered.
Additional side effects (frequency unknown) which may
Telfast is available in packs of 1, 2, 4, 8, 10 or 15 (sample
occur are: difficulty sleeping (insomnia), sleeping
only), 20, 30, 40, 50, 60, and 100 tablets per package.
disorders, bad dreams, nervousness, fast or irregular
Not all pack sizes are marketed.
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 Marketing Authorisation Holder and Manufacturer
difficulty breathing.
If any of the side effects gets serious, or if you notice any Marketing Authorisation Holder:
Sanofi-aventis, One Onslow Street, Guildford,
side effects not listed in this leaflet, please tell your
Surrey, GU1 4YS, UK
doctor or pharmacist.
Tel: 01483 505515
Fax: 01483 535432
5. How to store Telfast
email:uk-medicalinformation@sanofi-aventis.com
Keep out of the reach and sight of children.
Manufacturer:
Do not use Telfast after the expiry date which is stated on Sanofi-Aventis S.p.A.
the carton after EXP. The expiry date refers to the last day S.S 17 Km 22 – Scoppito (AQ) – ITALY
of that month.
This medicinal product is authorised in the Member
This medicinal product does not require any special
States of the EEA under the following names:
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
to protect the environment.

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 approved in 09/2011

89024475

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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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