What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 04425/0157.

Telfast 120mg film-coated tablets

Package leaflet: Information for the user

TELFAST 120 mg film-coated tablets

Fexofenadine hydrochloride

Is this leaflet hard to see or read?

In the UK Phone 0845 372 7101 for help

In Ireland Phone 01 403 5600 for help

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 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

  • 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

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.

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 (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.

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.

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.

UK:

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland:

You can also report side effects directly via

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

Malta:

You can also report side effects directly via

ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

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.

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.

6. Contents of the pack and other information

What Telfast 120 mg contains

  • The active substance is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride.
  • The other ingredients are:
    • Tablet core: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, magnesium stearate.
    • Film coating: hypromellose, povidone K30, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400, red iron oxide (E172) and yellow iron oxide (E172).

What Telfast 120 mg looks like and contents of the pack

Telfast 120 mg film-coated tablets of 6.1 x 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 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

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 obložene tablete

Czech Republic: Allegra 120 mg

Denmark: Telfast, filmovertrukne tabletter 120 mg

Estonia: Allegra

Finland: Telfast 120 mg tabletti, kalvopäällysteinen

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 apvalkotās tabletes

Lithuania: Allegra 120 mg plėvele dengtos tabletės

Luxembourg: Allegra tab 120 mg comprimés pelliculés

Portugal: Telfast 120, comprimidos revestidos por película

Romania: Telfast 120 mg comprimate filmate

Slovenia: Telfast 120 mg filmsko obložene tablete

Slovakia: Allegra 120 mg

Spain: Telfast 120 mg comprimidos recubiertos con película

Sweden: Allegra

United Kingdom: Telfast 120 mg film-coated tablets

This leaflet was last revised in 09/2016

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