FEXOFENADINE HYDROCHLORIDE 180 MG FILM-COATED TABLETS

Active substance: 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

Read all of this leaflet carefully
before you start using this medicine.
•  eep this leaflet. You may need to
K
read it again.
I
• f you have any further questions,
ask your doctor or pharmacist.
•  his medicine has been prescribed
T
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
I
• f 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.

Fexofenadine hydrochloride 180 mg
tablets are approved for the relief of
symptoms such as flushing, oedema and
itching, which occur in connection with
the allergic skin condition called chronic
idiopathic urticaria (CIU).

Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.

Taking Fexofenadine
hydrochloride with food and
drink

2 
BEFORE YOU TAKE
Fexofenadine
hydrochloride

In this leaflet:

1 
What Fexofenadine
hydrochloride is and what it is
used for
2 
Before you take Fexofenadine
hydrochloride
3 
How to take Fexofenadine
hydrochloride
4 
Possible side effects of
Fexofenadine hydrochloride
5 
How to store Fexofenadine
hydrochloride
6 
Further information
1 
WHAT Fexofenadine
hydrochloride IS AND
WHAT IT IS USED FOR

Fexofenadine hydrochloride, the active
ingredient in your medicine, belongs
to the group of medicines known as
antihistamines.
Fexofenadine hydrochloride 120 mg
tablets are approved for the relief of
symptoms such as sneezing, running
nose and nose itch, eye itch, tearing
and flushing, which typically occur
in connection with hay fever (allergic
rhinitis).

Fexofenadine hydrochloride should be
taken with water.

Do not take Fexofenadine
hydrochloride :

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice
before taking any medicine.
Pregnancy: Take Fexofenadine
hydrochloride during pregnancy only
if your doctor considers it to be strictly
necessary.
Breast-feeding: It is not recommended
to take Fexofenadine hydrochloride if
you are breast-feeding.

• f you are allergic (hypersensitive) to
i
fexofenadine hydrochloride or any of
the other ingredients of Fexofenadine
hydrochloride.
This medicine is not recommended for
children under 12 years of age.

Take special care with
Fexofenadine hydrochloride :

Driving and using machines

• f you are elderly.
i
i
• f you have kidney or liver problems.
Ask your doctor for advice before taking
this medicine.

It is unlikely that Fexofenadine
hydrochloride will affect your ability to
drive or use machines. However, there
may be rare exceptions, so please ensure
that you are alert before driving or
performing tasks demanding your full
attention.

Taking other medicines

If you are taking a remedy against an
upset stomach containing aluminium
or magnesium, it is recommended
that you leave about 2 hours between
the time that you take your remedy
and Fexofenadine hydrochloride. The
remedy may lower the amount of drug
absorbed and the action of Fexofenadine
hydrochloride may be effected.

3 
HOW TO TAKE Fexofenadine
hydrochloride

If you are taking fexofenadine together
with erythromycin or ketoconazole,
or with a single dose of lopinavir
and ritonavir combination, the level
of fexofenadine in your plasma may
increase. It is possible that the side
effects may increase.
Allergy Tests: If you are taking an allergy
test this medicine must be discontinued
three days before the test.

Always take Fexofenadine hydrochloride
exactly as your doctor has told you.
You should check with your doctor or
pharmacist if you are not sure.

Fexofenadine hydrochloride
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 hydrochloride
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.

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AAAF7935

Continued over page

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Fexofenadine 120mg & 180mg film-coated tablets PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:

AAAF7935
4
16.08.13

originated by:
approved for print/date

21.11.13

170 x 210

revised by:
supplier:

DR
Chanelle

2.
3.

pharmacode:

4.

min pt size:

5.
6.

DR

revision date:

dimensions:

Non Printing Colours

Technical Approval
date sent:

16 08.13

technically app. date:

22.08.13

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

If you think the effects of Fexofenadine
hydrochloride are too strong or too
weak, please consult your doctor or
pharmacist.

If you take more Fexofenadine
hydrochloride than you should

Contact your doctor, emergency room
or pharmacist if you have taken more
Fexofenadine hydrochloride 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 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.

5 
HOW TO STORE
Fexofenadine
hydrochloride

Keep out of reach and sight of children.
Do not use Fexofenadine hydrochloride
after the expiry date which is stated on
the carton and blister. The expiry date
refers to the last day of that month. This
medicinal product does not require any
special storage conditions.

If you forget to take Fexofenadine
hydrochloride

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 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.

6 
FURTHER INFORMATION

Like all medicines, Fexofenadine
hydrochloride 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 (experienced by between 1 in
10 and 1 in 100 people):
headache, drowsiness, nausea, dry
mouth and dizziness.
Uncommon (experienced by between 1
in 100 and 1 in 1,000 people):
feeling tired.
Other side effects include diarrhoea,
difficulty sleeping, nervousness, sleep
disturbances, bad dreams, allergic skin
reactions such as eczema, hives and
itching, unexpected swelling (oedema),
chest tightness, shortness of breath
and flushing. Also, the heart may beat
more quickly or irregularly. Seek medical
advice if symptoms of anaphylactic
reactions (for example swelling or
difficulty breathing) or serious skin
reactions occur.

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AAAF7935

Marketing Authorisation Holder and
Manufacturer
Chanelle Medical, Loughrea, Co Galway,
Ireland
Distributed in UK by: Actavis
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

France

What Fexofenadine
hydrochloride contains

The active substance is fexofenadine
hydrochloride.

4 
POSSIBLE SIDE EFFECTS

Fexofenadine hydrochloride come in
packs of 2, 7, 10, 15, 20, 30, 50, 100 or
200 tablets; not all pack sizes may be
marketed.

Each Fexofenadine hydrochloride
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 hydrochloride
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 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, filmcoated tablets, plain on one side with a
central break-line on the other.

Italy

Poland
United
Kingdom

Histafast 120 mg,
filmovertrukne tabletter
Histafast 180 mg,
filmovertrukne tabletter
Fexofenadine BIOGARAN
120 mg, comprimé
pelliculé
Fexofenadine BIOGARAN
180 mg, comprimé
pelliculé
Fixodin 120 mg
compresse film-rivestite
Fixodin 180 mg
compresse film-rivestite
Fexofast 120 mg
Fexofast 180 mg
Fexofenadine
hydrochloride 120 mg
film-coated tablets
Fexofenadine
hydrochloride 180 mg
film-coated tablets

This leaflet was last approved in
August 2013

If you would like a
leaflet with larger
text, please contact
01271 311257.

Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

Fexofenadine 120mg & 180mg film-coated tablets PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:

AAAF7935
4
16.08.13

originated by:
approved for print/date

21.11.13

170 x 210

revised by:
supplier:

DR
Chanelle

2.
3.

pharmacode:

4.

min pt size:

5.
6.

DR

revision date:

dimensions:

Non Printing Colours

Technical Approval
date sent:

16 08.13

technically app. date:

22.08.13

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

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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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