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 leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 04425/0158.


Telfast 180mg Tablets

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 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 fexofenadine is and what it is used for
2. What you need to know before you take fexofenadine
3. How to take fexofenadine
4. Possible side effects
5. How to store fexofenadine
6. Contents of the pack and other information

1. WHAT FEXOFENADINE IS AND WHAT IT IS USED FOR

The name of this medicine is Telfast 180 mg film coated tablets, referred to as Fexofenadine throughout this leaflet.

Fexofenadine is an antihistamine.

Fexofenadine 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 FEXOFENADINE

Do not take fexofenadine

  • 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 fexofenadine 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 heartbeat
  • you are elderly.

If any of these apply to you, or you are not sure, tell your doctor before taking fexofenadine.

Other medicines and fexofenadine

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 fexofenadine by lowering the amount of medicinal product absorbed.

It is recommended that you leave about 2 hours between the time that you take fexofenadine and your indigestion remedy.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Do not take fexofenadine if you are pregnant, unless necessary

Fexofenadine is not recommended during breastfeeding.

Driving and using machines

Fexofenadine 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 FEXOFENADINE

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.

This medicine starts to relieve your symptoms within 1 hour and lasts for 24 hours.

If you take more fexofenadine 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 fexofenadine

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 fexofenadine

Tell your doctor if you want to stop taking fexofenadine before you have finished your course of treatment.

If you stop taking fexofenadine 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 fexofenadine 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard 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 FEXOFENADINE

Keep this medicine out of the sight and reach of children.

Do not use fexofenadine after the expiry date which is stated on the carton. 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 fexofenadine 180 mg contains

  • The active substance is fexofenadine hydrochloride. Each tablets contains 180mg 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 fexofenadine 180 mg looks like and contents of the pack

Fexofenadine 180 mg film-coated tablets are peach coloured, capsule shaped tablets marked with ā€œ018ā€ on one side and a scripted ā€œeā€ on the other.

Each pack contains 30 tablets in blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi
410 Thames Valley Park Drive
Reading
Berkshire
RG6 1PT
UK
Tel: 0845 372 7101

Manufacturer

Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37100 Tours
France

This leaflet was last revised in 08/2019

1065016140 - 749328