Patient leaflet - TELFAST 120 MG FILM-COATED TABLETS
1. what telfast is and what it is used for
Telfast contains fexofenadine hydrochloride, which is a non-drowsy 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
X 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
A you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat
A 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.
[as! 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.
Telfast contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
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.
VqV 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.
Turn Over
The following undesirable effects have been reported in clinical trials, with an incidence similar to those observed in patient who did not receive the drug (placebo).
Common side effects (may affect up to 1 in 10 people):
-
– headache
-
– drowsiness
-
– feeling sick (nausea)
-
– dizziness.
Uncommon side effects (may affect up to 1 in 100 people):
-
– tiredness/sleepiness.
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.
You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. 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.
What Telfast 120 mg looks like and contents of the pack
Telfast 120 mg film-coated tablets of 6.1 × 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 10×20) tablets per package. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi, 410 Thames Valley Park Drive
Reading, Berkshire, RG6 1PT, UK
Tel: 0800 035 2525
email:
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 oblozene tablete
Czech Republic: Allegra 120 mg
Denmark: Telfast, filmovertrukne tabletter 120 mg
Estonia: Allegra
Finland: Telfast 120 mg tabletti, kalvopaallysteinen
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 apvalkotas tabletes
Lithuania: Allegra 120 mg plevele dengtos tabletes Luxembourg: Allegra tab 120 mg comprimes pellicules Malta: Telfast 120 mg film-coated Tablets
Portugal: Telfast 120, comprimidos revestidos por peKcula
Romania: Telfast 120 mg comprimate filmate
Slovenia: Telfast 120 mg filmsko oblozene tablete
Slovakia: Allegra 120 mg
Spain: Telfast 120 mg comprimidos recubiertos con pekcula
Sweden: Allegra
United Kingdom: Telfast 120 mg film-coated tablets
This leaflet was last revised in 06/2021.
6. contents of the pack and other information
What Telfast 120 mg contains
- The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride.
- The other ingredients are:
SANOFI wj
Code :
Update :
Local code :
Old PM code:
Name :
Country :
821232
V2 – 22/JUN/2021
N.A.
781712
NT. TELFAST 120MG
RL B2
GB
Plant : TOURS
Supplier code : N.A.
Format : 210 × 170 mm – Rouleau – Simple
Sens de deroulement :
Recto Interieur_4A (Portrait) – Verso Ext. : 4B
Plant barcode : 821232
Colours : 2
2 - Noir PMS Black U
■| – Bleu PMS REFLEX BLUE U
Fonts : OceanSansPRO SAN (8Pt a 100%) – Arial (bullet points o) -L39HrP24Dh (Code 39)
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 :
A – Regulatory Change
CHLOE_PCP
Telfast 120 mg Tablets POM
UK ONLY PACK
Marketing Authorisation Transfer from Aventis Pharma Limited (Trading as Sanofi) to Opella Healthcare UK Limited (Trading as Sanofi).
ADDITIONAL CHANGES
Creation of UK stand alone artworks
Notification 61.3 (BROMI) to remove IE and MT details and to add renewal changes (before renewal approval)