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FEXOFENADINE HYDROCHLORIDE 180 MG FILM-COATED TABLETS

Active substance(s): FEXOFENADINE HYDROCHLORIDE / FEXOFENADINE HYDROCHLORIDE / FEXOFENADINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

FEXOFENADINE HYDROCHLORIDE 120 mg FILM-COATED TABLETS
FEXOFENADINE HYDROCHLORIDE 180 mg FILM-COATED TABLETS
Fexofenadine hydrochloride

Fexofenadine hydrochloride 180 mg
Read all of this leaflet carefully
tablets is used in adults and adolescents
before you start using this medicine
of 12 years and older to relieve the
because it contains important
symptoms that occur with long
information for you.
term allergic skin reactions( chronic
• 
Keep this leaflet. You may need to
idiopathic urticaria) such as itching,
read it again.
swelling and rashes
• 
If you have any further questions,
ask your doctor or pharmacist.
What you need to know
• 
This medicine has been prescribed 2 
before you take Fexofenadine
for you only. Do not pass it on to
hydrochloride
others. It may harm them, even if
Do not take Fexofenadine
their signs of illness are the same as
hydrochloride :
yours.
• if you are allergic to fexofenadine or
• 
If you get any of the side effects,
any of the other ingredients of this
talk to your doctor or pharmacist.
medicine (listed in section 6)
This includes any possible side
effects not listed in this leaflet, (see
Warnings and precautions
section 4).
Talk to your doctor or pharmacist before

In this leaflet:
What Fexofenadine
1 
hydrochloride is and what it is
used for
What you need to know
2 
before you take Fexofenadine
hydrochloride
How to take Fexofenadine
3 
hydrochloride
Possible side effects of
4 
Fexofenadine hydrochloride
How to store Fexofenadine
5 
hydrochloride
Contents of the pack and other
6 
information
What Fexofenadine
1 

hydrochloride is and what it is
used for

Fexofenadine hydrochloride contains
Fexofenadine hydrochloride which is an
antihistamine.
Fexofenadine hydrochloride 120 mg
tablets is used in adults and adolescents
of 12 years and older to relieve the
symptoms that occur with hay fever
(seasonal allerigic rhinitis) such as
sneezing, itchy, running or blocked nose
and itchy, red and watery eye).

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BBBA0767

and ritonavir combination, the level
of fexofenadine in your plasma may
increase. It is possible that the side
effects may increase.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
Do not take Fexofenadine hydrochloride
if you are pregnant, unless necessary.
Fexofenadine hydrochloride is not
recommended during breast-feeding.
Driving and using machines
Fexofenadine hydrochloride 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.

taking Fexofenadine hydrochloride if:
• you have problems with your liver or
kidneys.
• you have or ever had heart disease,
How to take Fexofenadine
since this kind of medicine may lead to 3 
hydrochloride
a fast or irregular heart beat.
Always take this medicine exactly as
• you are elderly.
your doctor has told you. Check with
your doctor or pharmacist if you are
If any of these apply to you, or if you are
not sure.
not sure, tell your doctor before taking
Fexofenadine hydrochloride.
For adult and children aged 12 years
and over:
Other medicines and FEXOFENADINE
HYDROCHLORIDE
Fexofenadine hydrochloride 120 mg
Tablets: The recommended dose is one
Tell your doctor or pharmacist if you are
tablet (120 mg) daily. Take your tablet
taking, have recently taken or might
with water before a meal.
take any other medicines.
Indigestion remedies containing
aluminium or magnesium, may
affect the action of Fexofenadine
hydrochloride by lowering the amount
of medicinal product absorbed.
It is recommended that you leave about
2 hours between the time that you take
Fexofenadine hydrochloride and your
indigestion remedy
If you are taking fexofenadine together
with erythromycin or ketoconazole,
or with a single dose of lopinavir

Fexofenadine hydrochloride 180 mg
Tablets: The recommended dose is one
tablet (180 mg) daily. Take your tablet
with water before a meal.
If you take more Fexofenadine
hydrochloride than you should
If you take too many tablets, contact
your doctor, or the nearest hospital
emergency department immediately.

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Continued over page

Fexofenadine Hydrocholride 120 mg and 180mg Film-coated tablets PIL UK
approved for print/date

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0767

Originator:
C.Grant
Origination Date: 15/05/17
Revision Date:
Revised By:

Dimensions:
170x210
Min Body Text Size: 7.7pt
Supplier:
IL/Chanelle Medical

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
15/05/17
Date received:

6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Symptoms of an overdose in adults are
dizziness,drowsiness, fatigue and dry
mouth.
If you forget to take Fexofenadine
hydrochloride
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.

• 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
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety
of this medicine.

If you stop taking Fexofenadine
hydrochloride
Tell your doctor if you want to stop
taking Fexofenadine hydrochloride
before you have finished your course of 5 
How to store Fexofenadine
treatment.
hydrochloride
If you stop taking Fexofenadine
Keep this medicine out of sight and
hydrochloride earlier than planned, your
reach of children.
symptoms may return.
Do not use this medicine after the expiry
If you have any further questions on the
date which is stated on the carton after
use of this medicine, ask your doctor or
EXP. The expiry date refers to the last
pharmacist.
day of that month.

Possible side effects of
4 

Fexofenadine hydrochloride

Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Tell your doctor immediately
and stop taking Fexofenadine
hydrochloride 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
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
• diarrhea
• skin rash and itching
• hives

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BBBA0767

This medicinal product does not require
any special storage conditions
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 to protect the
environment.

Contents of the pack and other
6 
information

What Fexofenadine hydrochloride
contains
• T he active substance is fexofenadine
hydrochloride.
Each Fexofenadine hydrochloride
120 mg tablet contains 120 mg of
fexofenadine hydrochloride
• The other ingredients are:
- Tablet core: microcrystalline
cellulose, croscarmellose sodium,
maize starch, povidone, magnesium
stearate.
- Tablet coat: hypromellose (E464),
titanium dioxide (E171), macrogol
400, macrogol 4000, iron oxide
yellow (E172) and iron oxide red
(E172).

- Tablet coat: hypromellose (E464),
titanium dioxide (E171), macrogol
400, macrogol 4000 and iron oxide
yellow (E172).
What Fexofenadine hydrochloride
looks like and contents of the pack
Fexofenadine hydrochloride 120 mg
tablets are peach coloured, oblong, filmcoated tablets, plain on both sides.
Fexofenadine hydrochloride 180 mg
tablets are yellow coloured, oblong,
film-coated tablet, plain on one side
with a central break-line on the other.
Fexofenadine hydrochloride come in
packs of 2, 7, 10, 15, 20, 30, 50, 100 or
200 tablets; not all pack sizes may be
marketed.
Marketing Authorisation Holder and
Manufacturer
Chanelle Medical, Loughrea, Co Galway,
Ireland
Distributed in UK by: Actavis UK Ltd
This medicinal product is authorised in
the Member States of the EEA under the
following names:
NAME OF NAME OF MEDICINAL
MEMBER PRODUCT
STATE
Denmark Histafast 120 mg,
filmovertrukne tabletter
Histafast 180 mg,
filmovertrukne tabletter
France
Fexofenadine BIOGARAN
120 mg, comprimé
pelliculé
Fexofenadine BIOGARAN
180 mg, comprimé
pelliculé
Italy
Fixodin 120 mg compresse
film-rivestite
Fixodin 180 mg compresse
film-rivestite
Poland
Fexofast 120 mg
Fexofast 180 mg
United
Fexofenadine
Kingdom hydrochloride 120 mg
film-coated tablets
Fexofenadine
hydrochloride 180 mg
film-coated tablets
This leaflet was last approved in 04/2017

Each Fexofenadine hydrochloride
180 mg tablet contains 180 mg of
fexofenadine hydrochloride
• The other ingredients:
- Tablet core: microcrystalline
cellulose, croscarmellose sodium,
maize starch, povidone, magnesium
stearate
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Actavis, Barnstaple, EX32 8NS, UK

Fexofenadine Hydrocholride 120 mg and 180mg Film-coated tablets PIL UK
approved for print/date

Proof Round

01

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0767

Originator:
C.Grant
Origination Date: 15/05/17
Revision Date:
Revised By:

Dimensions:
170x210
Min Body Text Size: 7.7pt
Supplier:
IL/Chanelle Medical

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
15/05/17
Date received:

6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Expand Transcript

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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