TELFAST 180 MG FILM-COATED TABLETS

Active substance: FEXOFENADINE HYDROCHLORIDE

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554825_Nt TELFAST 180MG P1 GB.qxp_FORMAT 210x170mm-RL.qxd 23/05/14 15:47 Page1

Package leaflet: Information for the user

TELFAST 180 mg film-coated tablets
Fexofenadine hydrochloride

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 180 mg is used in adults and adolescents of 12 years
and older to relieve the symptoms that occur with long term
allergic skin reactions (chronic idiopathic urticaria) such as
itching, swelling and rashes.
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
Ask your doctor or pharmacist for advice before taking any
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 (180 mg) daily.
Take your tablet with water before a meal.
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.

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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:
Reports may be made by following the links to the online
reporting option accessible from the IMB homepage, or by
completing the downloadable report form also accessible
from the IMB website, which may be completed manually
and submitted to the IMB via freepost, to the following
address: FREEPOST, Pharmacovigilance Section, Irish
Medicines Board, Kevin O’Malley House, Earlsfort Centre,
Earlsfort Terrace, Dublin 2. Tel: +353 1 6764971,
Fax: +353 1 6762517, Website: www.imb.ie,
e-mail: imbpharmacovigilance@imb.ie
Malta:
ADR Reporting, The Medicines Authority, Post-Licensing
Directorate, 203 Level 3, Rue D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
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.

6. Contents of the pack and other information
What Telfast 180 mg contains
● The active substance is fexofenadine hydrochloride. Each
tablet contains 180 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 Telfast 180 mg looks like and contents of the pack
Telfast 180 mg film-coated tablets are peach coloured,
capsule shaped tablets marked with “018” 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), 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:
Belgium: Telfast 180 mg filmomhulde tabletten
Denmark: Telfast, filmovertrukne tabletter 180 mg
Finland: Telfast 180 mg tabletti, kalvopäällysteinen
Germany: Telfast 180 mg
Ireland: Telfast 180 mg film coated tablets
Italy: Telfast 180 mg compresse rivestite con film
Luxembourg: Telfast 180 mg filmomhulde tabletten
Portugal: Telfast 180, comprimidos revestidos por película
Spain: Fexofenadina Sanofi 180 mg comprimidos recubiertos
con película
Sweden: Telfast 180 mg filmdragerade tabletter
United Kingdom: Telfast 180 mg film coated tablets
This leaflet was last revised in 04/2014

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

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.

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

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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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