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FEXOFENADINE HYDROCHLORIDE 120MG FILM-COATED TABLETS

Active substance(s): FEXOFENADINE HYDROCHLORIDE

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Package leaflet: Information for the user
Fexofenadine hydrochloride 120 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 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 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 hydrochloride 120 mg film-coated-tablets (called Fexofenadine throughout this leaflet)
contains fexofenadine hydrochloride, which is an antihistamine.
Fexofenadine 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 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.

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Reference: 23074 1.3.1.3 - Leaflet Text - PIL - 120mg - 2013-11-22 - 0000 - Fexofenadine - Article 45 4.3

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 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):

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Reference: 23074 1.3.1.3 - Leaflet Text - PIL - 120mg - 2013-11-22 - 0000 - Fexofenadine - Article 45 4.3




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
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 this medicine after the expiry date which is stated on the carton and blister after [to be
completed nationally]. 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 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, titanium dioxide (E171), colloidal anhydrous silica, macrogol
400 and iron oxide (E172).
What Fexofenadine 120 mg looks like and contents of the pack
Fexofenadine hydrochloride 120 mg film-coated tablets are peach coloured, modified capsule-shaped
tablets marked with “012” on one side and a scripted “e” on the other.

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Reference: 23074 1.3.1.3 - Leaflet Text - PIL - 120mg - 2013-11-22 - 0000 - Fexofenadine - Article 45 4.3

Fexofenadine is presented in PVC/PE/PVDC/Al blister packs packaged into cardboard boxes.
Fexofenadine 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 and Manufacturer
Marketing Authorisation Holder:
Sanofi-aventis, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi-aventis.com
Manufacturer responsible for batch release:
Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, 37 100 Tours, France
Sanofi Winthrop Industrie, 56 route de Choisy-au-Bac, 60205 Compiègne, France
Sanofi-Synthelabo Ltd, Edgefield Avenue, Fawdon, Newcastle upon Tyne, Tyne and Wear, NE3 3TT,
UK
This medicinal product is authorised in the Member states of the EEA under the following
names:
Denmark: Allegra
Finland: Allegra 120 mg kalvopäällysteiset tabletit
Ireland: Fexofenadine Hydrochloride 120 mg film coated tablets
Malta: Allegratab 120 mg film coated tablets
United Kingdom: Fexofenadine Hydrochloride 120 mg film coated tablets

This leaflet was last revised in November2013
 Sanofi-aventis, 2013

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Reference: 23074 1.3.1.3 - Leaflet Text - PIL - 120mg - 2013-11-22 - 0000 - Fexofenadine - Article 45 4.3

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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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