TELFAST 30MG FILM-COATED TABLETS

Active substance: FEXOFENADINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

62C0005

89024475
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2
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9pt su 10pt

89027342

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If any of these apply to your child, or if you are not sure,
always tell your doctor before giving Telfast to your child.

89027342

167 x 304,8 s

This leaflet was last approved in 02/2014

04/02/2014
IST. TELFAST 30MG GB I01

0101000010

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

Istruzione

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.

PACK. ITEM:

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 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.

Do not use Telfast after the expiry date which is stated on
the carton after EXP. The expiry date refers to the last day This medicinal product is authorised in the Member
of that month.
States of the EEA under the following names:
This medicinal product does not require any special
storage condition.
Belgium: Telfast 30 mg filmomhulde tabletten
Cyprus: Telfast
Medicines should not be disposed of via wastewater or
Denmark: Telfast, filmovertrukne tabletter 30 mg
household waste. Ask your pharmacist how to dispose of Finland: Telfast 30 mg tabletti, kalvopäällysteinen
medicines no longer required. These measures will help
Germany: Telfast 30 mg Filmtabletten
to protect the environment.
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

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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.

Manufacturer:
Sanofi-Aventis S.p.A.
S.S 17 Km 22 – Scoppito (AQ) – ITALY

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1.

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.

Keep out of the reach and sight of children.

Verificare la corrispondenza delle pellicole
con l’artwork approvato - la nostra
responsabilità è limitata al rifacimento
delle eventuali pellicole errate.

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)

Always use Telfast exactly as the doctor has told you.
You should check with your doctor or pharmacist if you
are not sure.

Arkhé S.a.s.

2. Before you use Telfast

3. How to use Telfast

Tel. 0862.404140
fax 0862.404140

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.

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.

GB: GREAT BRITAIN

1. What Telfast is and what it
is used for

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.

 Reflex Blue

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

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.

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
Tell your doctor immediately and stop treatment with
hydrochloride. Each tablet contains 30 mg of
Telfast if your child experiences swelling of the face, lips, fexofenadine hydrochloride.
tongue or throat and difficulty breathing, as these may
be signs of a serious allergic reaction.
The other ingredients are:
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
In adults, the following side effects have been reported:
(E171), colloidal anhydrous silica, macrogol, pink iron
oxide (E172) blend and yellow iron oxide (E172) blend.
Common side effects (occurring in less than 1 in 10 but
more than 1 in 100 patients): headache, drowsiness,
What Telfast 30 mg looks like and contents of the pack
feeling sick (nausea) and dizziness.
Telfast 30 mg film-coated tablets are round and peach
Uncommon side effects (occurring in less than 1 in 100
coloured, marked with “03” on one side and a scripted
but more than 1 in 1,000 patients): tiredness/sleepiness. “e” on the other.
Telfast is presented in blister packs. Each tablet is
Additional side effects (frequency unknown) which may
blistered.
occur are: difficulty sleeping (insomnia), sleeping
Telfast is available in packs of 1, 2, 4, 8, 10 or 15 (sample
disorders, bad dreams, nervousness, fast or irregular
only), 20, 30, 40, 50, 60, and 100 tablets per package.
heart beat, diarrhoea, skin rash and itching, hives,
Not all pack sizes are marketed.
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:
side effects not listed in this leaflet, please tell your
Sanofi, One Onslow Street, Guildford,
doctor or pharmacist.
Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
5. How to store Telfast

2 - Modifica testo reg.

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.

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.

6. Further information

1 - Prima realizzazione

Is this leaflet hard to see or read?
Phone 0845 372 7101

4. Possible side effects

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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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