Saturday, 3 March 2012

Fexofenadine hydrocloride 120mg Film-coated Tablets






Telfast 120 mg



Film coated tablets


Fexofenadine hydrochloride



Read all of this leaflet carefully before you start 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 you.

    Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • 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.



In this leaflet:


  • 1. What fexofenadine is and what it is used for

  • 2. Before you take fexofenadine

  • 3. How to take fexofenadine

  • 4. Possible side effects

  • 5. How to store fexofenadine

  • 6. Further information




What Fexofenadine Is And What It Is Used For


The name of this medicine is Telfast 120mg Film Coated Tablets, referred to as Fexofenadine throughout this leaflet.


Fexofenadine is an antihistamine.


It 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.




Before You Take Fexofenadine



Do not take fexofenadine


  • if you are allergic (hypersensitive) to fexofenadine or any of the other ingredients (see section 6 for a full list of ingredients).



Take special care with fexofenadine


  • if you have problems with your liver or kidneys

  • if you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heartbeat

  • if you are elderly

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




Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


Indigestion remedies containing aluminium and magnesium may affect the action of fexofenadine, by lowering the amount of drug 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 breast-feeding.




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.





How To Take Fexofenadine


Always take fexofenadine exactly as your doctor has told you.


You should 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.




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 product, ask your doctor or pharmacist.




Possible Side Effects


Like all medicines, fexofenadine 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 (occurring in less than 1 in 10 but more than 1 in 100 patients): headache, drowsiness, feeling sick (nausea) and dizziness.


Uncommon side effects (occurring in less than 1 in 100 but more than 1 in 1,000 patients): difficulty sleeping (insomnia), tiredness/sleepiness, sleeping disorders, bad dreams, nervousness, fast or irregular heart beat and diarrhoea.


Rare side effects (occurring in less than 1 in 1,000 but more than 1 in 10,000 patients): skin rash and itching, hives, serious allergic reactions which can cause swelling of the face, lips, tongue or throat and difficulty breathing.


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.




How To Store Fexofenadine


Keep out of the reach and sight 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 medicinal product does not require any special storage condition.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What fexofenadine 120 mg contains


Fexofenadine 120 mg tablets contain 120 mg of fexofenadine hydrochloride as the active ingredient.


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 120 mg looks like and contents of the pack


Fexofenadine 120 mg film coated tablets are peach coloured, capsule shaped tablets marked with "012" on one side and "e" on the other.


Each blister pack contains 30 tablets.




Marketing Authorisation Holder and Manufacturer



Marketing Authorisation Holder



Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Tel: 01483 505515

Fax: 01483 535432

email: uk-medicalinformation@sanofi-aventis.com



Manufacturer



Sanofi Winthrop Industrie

30-36 Avenue Gustave Eiffel

37100 Tours

France




This leaflet was last updated in 05/2008


208634





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