Fexofenadine Hydrochloride 120 Mg Film-Coated Tablets
Telfast® 120 mg film-coated tablets 18-11^
(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 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
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 (120 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 120 mg of fexofenadine hydrochloride, which is equivalent to 112 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 '012' 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 20636/2541
Leaflet revision and issue date: 18.11.13[2]
Telfast is a trademark of Aventisub II Inc.
2541
18.11.13|2]
Fexofenadine Hydrochloride 120 mg film-coated tablets
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 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 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 (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 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 120 mg of fexofenadine hydrochloride, which is equivalent to 112 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 '012' 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 20636/2541
Leaflet revision and issue date: 18.11.13[2]