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FEXOFENADINE HYDROCHLORIDE180 MG FILM-COATED TABLETS

Active substance(s): FEXOFENADINE HYDROCHLORIDE

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Telfast® 180 mg film-coated tablets

2542
23.11.13[3]

(fexofenadine hydrochloride)
PATIENT INFORMATION LEAFLET
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.
Your medicine is available as the above name but will be referred to as
Telfast throughout this leaflet.
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 180mg 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.
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:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE TELFAST
Keep out of the sight and reach of children.
Do not use Telfast after the expiry date which is stated on the carton after
EXP. 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.
If the tablets become discoloured or show any other sign of deterioration,
seek the advice of your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Telfast contains
The active substance of Telfast is fexofenadine hydrochloride.
Each tablet contains 180 mg of fexofenadine hydrochloride, which is
equivalent to 168 mg of fexofenadine.
The other ingredients are microcrystalline cellulose, pregelatinised maize
starch, croscarmellose sodium, magnesium stearate, hypromellose,
povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400
and iron oxide (E172).
What Telfast looks like and contents of the pack
Telfast are peach coloured, capsule-shaped, film-coated tablet debossed
‘018’ on one side and a scripted ‘e’ on the other side.
Available in blister packs of 20 and 30 tablets.
Manufacturer and Product Licence Holder
Manufactured by Sanofi-Synthelabo Ltd, Edgefield Avenue, Fawdon,
Newcastle upon Tyne, UK.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2542

Leaflet revision and issue date: 23.11.13[3]
Telfast is a trademark of Aventisub II Inc

Fexofenadine Hydrochloride 180 mg
film-coated tablets

2542
23.11.13[3]

PATIENT INFORMATION LEAFLET
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.
Your medicine is available as the above name but will be referred to as
Fexofenadine throughout this leaflet.
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
Fexofenadine contains fexofenadine hydrochloride, which is an
antihistamine.
Fexofenadine 180mg 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 heart beat
- you are elderly
If any of these apply to you, or if 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 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.
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.
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, 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:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE FEXOFENADINE
Keep out of the sight and reach of children.
Do not use Fexofenadine after the expiry date which is stated on the carton
after EXP. 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.
If the tablets become discoloured or show any other sign of deterioration,
seek the advice of your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fexofenadine contains
The active substance of Fexofenadine is fexofenadine hydrochloride.
Each tablet contains 180 mg of fexofenadine hydrochloride, which is
equivalent to 168 mg of fexofenadine.
The other ingredients are microcrystalline cellulose, pregelatinised maize
starch, croscarmellose sodium, magnesium stearate, hypromellose,
povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400
and iron oxide (E172).
What Fexofenadine looks like and contents of the pack
Fexofenadine are peach coloured, capsule-shaped, film-coated tablet
debossed ‘018’ on one side and a scripted ‘e’ on the other side.
Available in blister packs of 20 and 30 tablets.
Manufacturer and Product Licence Holder
Manufactured by Sanofi-Synthelabo Ltd, Edgefield Avenue, Fawdon,
Newcastle upon Tyne, UK.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2542

Leaflet revision and issue date: 23.11.13[3]

Expand view ⇕

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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