FEXOFENADINE 120 MG FILM-COATED TABLETS

Active substance: FEXOFENADINE HYDROCHLORIDE

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L:
W:

300mm
190 mm

Pharma Code (top to bottom
on the front face when reading the
text design right way up):

PANTONE® GREEN

n/a

BLACK

3rd Party Code: LA4111

FEXOFENADINE 120 MG FILM-COATED
TABLETS
FEXOFENADINE 180 MG FILM-COATED
TABLETS
Fexofenadine hydrochloride

Talk to your doctor before you take Fexofenadine
if:
• you are going to take an allergy test. You must
stop taking this medicine three days before the
test.

Taking other medicines:
Please tell your doctor or pharmacist if you are
taking or have recently taken other medicines,
Read all of this leaflet carefully before you start
including medicines obtained without a
using this medicine.
• Keep this leaflet. You may need to read it again. prescription.
• If you have any further questions, ask your
It is especially important to talk to your doctor
doctor or pharmacist.
• This medicine has been prescribed for you. Do before you take Fexofenadine if you are also
taking any of the following medicines:
not pass it on to others. It may harm them,
even if their symptoms are the same as yours. • erythromycin, an antibiotic used to treat certain
bacterial infections
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, • ketoconazole, used to treat fungal infections
• lopinavir/ritonavir, used to treat HIV infection.
please tell your doctor or pharmacist.
PACKAGE LEAFLET:
INFORMATION FOR THE USER

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 of Fexofenadine
5. How to store Fexofenadine
6. Further information

1 WHAT FEXOFENADINE IS AND WHAT IT

These medicines increase the amount of
Fexofenadine absorbed, and so may increase any
side effects you may suffer.
Indigeston remedies containing aluminium and
magnesium may affect the action of Fexofenadine
by lowering the amount of drug absorbed. If you
are taking any such indigestion remedies, it is
recommended that you leave about 2 hours
between the time that you take Fexofenadine and
your indigestion remedy.

IS USED FOR

Taking Fexofenadine with food and drink
Fexofenadine hydrochloride, the active ingredient Fexofenadine should be taken with water.
in your medicine, belongs to the group of
Pregnancy and breast-feeding
medicines known as antihistamines.
Ask your doctor or pharmacist for advice before
Fexofenadine 120 mg tablets are approved for the taking any medicine.
Pregnancy: Take Fexofenadine during pregnancy
relief of symptoms such as sneezing, running
nose and nose itch, eye itch, tearing and flushing, only if your doctor considers it to be strictly
which typically occur in connection with hay fever necessary.
Breast-feeding: It is not recommended to take
(allergic rhinitis).
Fexofenadine if you are breast-feeding.
Fexofenadine 180 mg tablets are approved for the
relief of symptoms such as flushing, oedema and Driving and using machines
It is unlikely that Fexofenadine will affect your
itching, which occur in connection with the
ability to drive or use machines. However, there
allergic skin condition called chronic idiopathic
may be rare exceptions, so please ensure that you
urticaria (CIU).
are alert before driving or performing tasks
demanding your full attention.

2 BEFORE YOU TAKE FEXOFENADINE
Do NOT take Fexofenadine if you:
• are allergic (hypersensitive) to fexofenadine
hydrochloride or any of the other ingredients of
this medicine.
The efficacy and safety of fexofenadine
hydrochloride has not been studied in children
under 12. This medicine is not recommended for
children under 12 years of age.
Take special care with Fexofenadine:
Tell your doctor before you start to take this
medicine if you:
• are elderly
• have kidney or liver problems
• if you have a history of or ongoing heart
disease, because taking this kind of medicine
may lead to a fast or irregular heart beat.
Ask your doctor for advice before taking this
medicine.

3 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.
Fexofenadine 120 mg Tablets:
For relief of symptoms of hay fever (allergic
rhinitis):
The usual dose is one tablet once daily for adults
and children 12 years and older.
Fexofenadine 180 mg Tablets:
For relief of symptoms of chronic idiopathic
urticaria (allergic skin condition):
The usual dose is one tablet once daily for adults
and children 12 years and older.
Take the tablets with water.

If you think the effects of Fexofenadine are too
strong or too weak, please consult your doctor or
pharmacist.
If you take more Fexofenadine than you should
Contact your doctor, emergency room or
pharmacist if you have taken more Fexofenadine
than stated in this leaflet or more than your
doctor has prescribed. Symptoms of overdose
include dizziness, feeling drowsy, feeling tired and
a dry mouth.
If you forget to take Fexofenadine
If you forget to take a dose, take it as soon as you
remember it unless it is nearly time for your next
dose. Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of
this product, ask your doctor or pharmacist

4 POSSIBLE SIDE EFFECTS
Like all medicines, Fexofenadine can cause side
effects although not everybody gets them.
The side effects described below have been
experienced by people taking fexofenadine and
they are listed as either common, uncommon or
rare.
Common (affecting fewer than one person in 10
but more than one person in 100):
• Headache
• Drowsiness
• Nausea
• Dry mouth
• Dizziness.
Uncommon (affecting fewer than one person in
100 but more than one person in 1,000):
• Feeling tired
• Difficulty sleeping
• Nervousness
• Sleep disturbances
• Bad dreams
• Irregular and/or fast heartbeat.
Rare (affecting fewer than one person in 1,000 but
more than one person in 10,000):
• Allergic skin reactions such as eczema
• Hives and itching
• Unexpected swelling (oedema)
• Chest tightness
• Shortness of breath
• Flushing.
Seek medical advice if symptoms of anaphylactic
reactions (for example swelling or difficulty
breathing) or serious skin reactions occur.
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.

• This medicinal product does not require any
special storage conditions.
• 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.

6

FURTHER INFORMATION

What Fexofenadine contains:
The active substance is fexofenadine
hydrochloride
• Each Fexofenadine 120 mg tablet contains
120 mg of fexofenadine hydrochloride
equivalent to 112 mg of fexofenadine.
• The other ingredients are microcrystalline
cellulose, croscarmellose sodium, maize starch,
povidone, magnesium stearate. The tablet coat
contains hypromellose (E464), titanium dioxide
(E171), macrogol 400, macrogol 4000, iron
oxide yellow (E172) and iron oxide red (E172).
• Each Fexofenadine 180 mg tablet contains
180 mg of fexofenadine hydrochloride
equivalent to 168 mg of fexofenadine.
• The other ingredients are microcrystalline
cellulose, croscarmellose sodium, maize starch,
povidone, magnesium stearate. The tablet coat
contains hypromellose (E464), titanium dioxide
(E171), macrogol 400, macrogol 4000 and iron
oxide yellow (E172).
What Fexofenadine looks like and contents of the
pack:
Fexofenadine 120 mg tablets are peach coloured,
oblong, film-coated tablets, plain on both sides.
Fexofenadine 180 mg tablets are yellow coloured,
oblong, film-coated tablet, plain on one side with
a central break-line on the other.
Fexofenadine 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
Marketing Authorisation holder: TEVA UK Limited,
Eastbourne, BN22 9AG.
Company responsible for manufacture:
Chanelle Medical, Loughrea, Co. Galway, Ireland.
Product licence number(s)
Fexofenadine 120 mg Film-Coated Tablets:
PL 00289/1030
Fexofenadine 180 mg Film-Coated Tablets:
PL 00289/1031
This leaflet was last revised: April 2010

5 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 and blister.
• The expiry date refers to the last day of that
month.

85846-V
LA4111

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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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