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FEXOFENADINE 120 MG FILM-COATED TABLETS

Active substance(s): FEXOFENADINE HYDROCHLORIDE / FEXOFENADINE HYDROCHLORIDE

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Transcript
Ref:

231-30-85846-W LEA FEXOFENADINE A/S TAB TUK
Version:

1

Trackwise Parent:

234437

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/1030-31.
TEVA UK Limited Licence. Packed at Chanelle Medical, Ireland.
V1: Text update.

F. P. Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

231-10-05571, 231-10-05581
TBC
LA4111
Univers
10 Pt

Dimensions:
L:
W:

300 mm
190 mm

18 November 2013
Child:

234445

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
:HPXVWUHFHLYHDFRS\RIDQ\UG3DUW\6XSSOLHU·V3URRIEHIRUHDSSURYDOWRSULQWZLOOEHJUDQWHG

FEXOFENADINE 120 MG FILM-COATED
TABLETS
FEXOFENADINE 180 MG FILM-COATED
TABLETS
Fexofenadine hydrochloride
0!#+!'% ,%!&,%4
).&/2-!4)/. &/24(% 53%2

Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you
s +EEP THIS LEAFLET9OU MAY NEED TO READ IT AGAIN
s )F YOU HAVE ANY FURTHER QUESTIONS ASK YOUR
DOCTOR OR PHARMACIST
s 4HIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY
$O NOT PASS IT ON TO OTHERS )T MAY HARM THEM
EVEN IF THEIR SIGNS OF ILLNESS ARE THE SAME AS
YOURS
s )F YOU GET ANY OF THE SIDE EFFECTS TALK TO YOUR
DOCTOR OR PHARMACIST4HIS INCLUDES ANY POSSIBLE
SIDE EFFECTS NOT LISTED IN THIS LEAFLET 3EE SECTION 
). 4()3 ,%!&,%4

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 of Fexofenadine
5. How to store Fexofenadine
6. Contents of the pack and other information

1 WHAT FEXOFENADINE IS AND WHAT IT

4ALK TO YOUR DOCTOR BEFORE YOU TAKE &EXOFENADINE IF
s 9OU ARE GOING TO TAKE AN ALLERGY TEST9OU MUST
STOP TAKING THIS MEDICINE THREE DAYS BEFORE THE
TEST
Other medicines and Fexofenadine
4ELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING
HAVE RECENTLY TAKEN OR MIGHT TAKE ANY OTHER
MEDICINES
)T IS ESPECIALLY IMPORTANT TO TALK TO YOUR DOCTOR
BEFORE YOU TAKE &EXOFENADINE IF YOU ARE ALSO
TAKING ANY OF THE FOLLOWING MEDICINES
s ERYTHROMYCIN AN ANTIBIOTIC USED TO TREAT CERTAIN
BACTERIAL INFECTIONS
s KETOCONAZOLE USED TO TREAT FUNGAL INFECTIONS
s LOPINAVIRRITONAVIR USED TO TREAT ()6 INFECTION
4HESE MEDICINES INCREASE THE AMOUNT OF
&EXOFENADINE ABSORBED AND SO MAY INCREASE ANY
SIDE EFFECTS YOU MAY SUFFER
)NDIGESTION REMEDIES CONTAINING ALUMINIUM AND
MAGNESIUM MAY AFFECT THE ACTION OF &EXOFENADINE
BY LOWERING THE AMOUNT OF DRUG ABSORBED )F YOU
ARE TAKING ANY SUCH INDIGESTION REMEDIES IT IS
RECOMMENDED THAT YOU LEAVE ABOUT 2 hours
BETWEEN THE TIME THAT YOU TAKE &EXOFENADINE AND
YOUR INDIGESTION REMEDY
Fexofenadine with food and drink
&EXOFENADINE SHOULD BE TAKEN WITH WATER

IS USED FOR

Pregnancy and breast-feeding
&EXOFENADINE HYDROCHLORIDE THE ACTIVE INGREDIENT )F YOU ARE PREGNANT OR BREAST FEEDING THINK YOU
IN YOUR MEDICINE BELONGS TO THE GROUP OF
MAY BE PREGNANT OR ARE PLANNING TO HAVE A BABY
MEDICINES KNOWN AS ANTIHISTAMINES
ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE
TAKING THIS MEDICINE
&EXOFENADINE  MG TABLETS ARE APPROVED FOR THE Pregnancy: 4AKE &EXOFENADINE DURING PREGNANCY
RELIEF OF SYMPTOMS SUCH AS SNEEZING RUNNING
ONLY IF YOUR DOCTOR CONSIDERS IT TO BE STRICTLY
NOSE AND NOSE ITCH EYE ITCH TEARING AND FLUSHING NECESSARY
WHICH TYPICALLY OCCUR IN CONNECTION WITH HAY FEVER Breast-feeding )T IS NOT RECOMMENDED TO TAKE
ALLERGIC RHINITIS 
&EXOFENADINE IF YOU ARE BREAST FEEDING
&EXOFENADINE  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 #)5 

2 WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FEXOFENADINE

Do not take Fexofenadine if you:
s ARE ALLERGIC HYPERSENSITIVE TO FEXOFENADINE
HYDROCHLORIDE OR ANY OF THE OTHER INGREDIENTS OF
THIS MEDICINE ,ISTED IN SECTION  
4HE EFFICACY AND SAFETY OF FEXOFENADINE
HYDROCHLORIDE HAS NOT BEEN STUDIED IN CHILDREN
UNDER  4HIS MEDICINE IS NOT RECOMMENDED FOR
CHILDREN UNDER  YEARS OF AGE
Warnings and precautions:
4ALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING
&EXOFENADINE IF YOU
s ARE ELDERLY
s HAVE KIDNEY OR LIVER PROBLEMS
s HAVE A HISTORY OF OR ONGOING HEART DISEASE
BECAUSE TAKING THIS KIND OF MEDICINE MAY LEAD
TO A FAST OR IRREGULAR HEART BEAT

Driving and using machines
)T IS UNLIKELY THAT &EXOFENADINE WILL AFFECT YOUR
ABILITY TO DRIVE OR USE MACHINES (OWEVER THERE
MAY BE RARE EXCEPTIONS SO PLEASE ENSURE THAT YOU
ARE ALERT BEFORE DRIVING OR PERFORMING TASKS
DEMANDING YOUR FULL ATTENTION

3 HOW TO TAKE FEXOFENADINE
!LWAYS TAKE &EXOFENADINE EXACTLY AS YOUR DOCTOR
HAS TOLD YOU #HECK WITH YOUR DOCTOR OR
PHARMACIST IF YOU ARE NOT SURE
Fexofenadine 120 mg Tablets: &OR RELIEF OF
SYMPTOMS OF HAY FEVER ALLERGIC RHINITIS 
4HE RECOMMENDED DOSE IS ONE TABLET ONCE DAILY
FOR ADULTS AND CHILDREN  YEARS AND OLDER
Fexofenadine 180 mg Tablets: &OR RELIEF OF
SYMPTOMS OF CHRONIC IDIOPATHIC URTICARIA ALLERGIC
SKIN CONDITION 
4HE RECOMMENDED DOSE IS ONE TABLET ONCE DAILY FOR
ADULTS AND CHILDREN  YEARS AND OLDER
4AKE THE TABLETS WITH WATER
)F YOU THINK THE EFFECTS OF &EXOFENADINE ARE TOO
STRONG OR TOO WEAK PLEASE CONSULT YOUR DOCTOR OR
PHARMACIST

Ref:

231-30-85846-W LEA FEXOFENADINE A/S TAB TUK
Version:

1

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/1030-31.
TEVA UK Limited Licence. Packed at Chanelle Medical, Ireland.
V1: Text update.

F. P. Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

231-10-05571, 231-10-05581
TBC
LA4111
Univers
10 Pt

234437

Dimensions:
L:
W:

300 mm
190 mm

18 November 2013
Child:

234445

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
:HPXVWUHFHLYHDFRS\RIDQ\UG3DUW\6XSSOLHU·V3URRIEHIRUHDSSURYDOWRSULQWZLOOEHJUDQWHG

s 4HE EXPIRY DATE REFERS TO THE LAST DAY OF THAT
If you take more Fexofenadine than you should
MONTH
#ONTACT YOUR DOCTOR EMERGENCY ROOM OR
PHARMACIST IF YOU HAVE TAKEN MORE &EXOFENADINE s 4HIS MEDICINAL PRODUCT DOES NOT REQUIRE ANY
SPECIAL STORAGE CONDITIONS
THAN STATED IN THIS LEAFLET OR MORE THAN YOUR
s $O NOT THROW AWAY ANY MEDICINES VIA
DOCTOR HAS PRESCRIBED 3YMPTOMS OF OVERDOSE
WASTEWATER OR HOUSEHOLD WASTE !SK YOUR
INCLUDE DIZZINESS FEELING DROWSY FEELING TIRED AND
PHARMACIST HOW TO DISPOSE OF MEDICINES NO
A DRY MOUTH
LONGER REQUIRED4HESE MEASURES WILL HELP TO
PROTECT THE ENVIRONMENT
If you forget to take Fexofenadine
)F YOU FORGET TO TAKE A DOSE TAKE IT AS SOON AS YOU
REMEMBER IT UNLESS IT IS NEARLY TIME FOR YOUR NEXT
6 CONTENTS OF THE PACK AND OTHER
DOSE $O NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A
INFORMATION
FORGOTTEN DOSE
What Fexofenadine contains:
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF
4HE ACTIVE SUBSTANCE IS FEXOFENADINE
THIS PRODUCT ASK YOUR DOCTOR OR PHARMACIST
HYDROCHLORIDE
s %ACH &EXOFENADINE  MG TABLET CONTAINS  MG
4 POSSIBLE SIDE EFFECTS OF
OF FEXOFENADINE HYDROCHLORIDE EQUIVALENT TO
FEXOFENADINE
 MG OF FEXOFENADINE
s 4HE OTHER INGREDIENTS ARE MICROCRYSTALLINE
,IKE ALL MEDICINES &EXOFENADINE CAN CAUSE SIDE
CELLULOSE CROSCARMELLOSE SODIUM MAIZE STARCH
EFFECTS ALTHOUGH NOT EVERYBODY GETS THEM
POVIDONE MAGNESIUM STEARATE4HE TABLET COAT
4HE SIDE EFFECTS DESCRIBED BELOW HAVE BEEN
CONTAINS HYPROMELLOSE % TITANIUM DIOXIDE
EXPERIENCED BY PEOPLE TAKING FEXOFENADINE AND
% MACROGOL  MACROGOL  IRON
THEY ARE LISTED AS EITHER COMMON UNCOMMON OR
OXIDE YELLOW % AND IRON OXIDE RED % 
RARE
s %ACH &EXOFENADINE  MG TABLET CONTAINS  MG
Common MAY AFFECT UP TO  IN  PEOPLE 
OF FEXOFENADINE HYDROCHLORIDE EQUIVALENT TO
s (EADACHE
 MG OF FEXOFENADINE
s $ROWSINESS
s 4HE OTHER INGREDIENTS ARE MICROCRYSTALLINE
s .AUSEA
CELLULOSE CROSCARMELLOSE SODIUM MAIZE STARCH
s $RY MOUTH
POVIDONE MAGNESIUM STEARATE4HE TABLET COAT
s $IZZINESS
CONTAINS HYPROMELLOSE % TITANIUM DIOXIDE
% MACROGOL  MACROGOL  AND IRON
Uncommon MAY AFFECT UP TO  IN  PEOPLE 
OXIDE YELLOW % 
s &EELING TIRED
s $IFFICULTY SLEEPING
What Fexofenadine looks like and contents of the
s .ERVOUSNESS
pack:
s 3LEEP DISTURBANCES
&EXOFENADINE  MG TABLETS ARE PEACH COLOURED
s "AD DREAMS
OBLONG FILM COATED TABLETS PLAIN ON BOTH SIDES
s )RREGULAR ANDOR FAST HEARTBEAT
&EXOFENADINE  MG TABLETS ARE YELLOW COLOURED
OBLONG FILM COATED TABLETS PLAIN ON ONE SIDE WITH
Rare MAY AFFECT UP TO  IN   PEOPLE 
A CENTRAL BREAK LINE ON THE OTHER
s !LLERGIC SKIN REACTIONS SUCH AS ECZEMA
s (IVES AND ITCHING
&EXOFENADINE COME IN PACKS OF      
s 5NEXPECTED SWELLING OEDEMA
  OR  TABLETS
s #HEST TIGHTNESS
.OT ALL PACK SIZES MAY BE MARKETED
s 3HORTNESS OF BREATH
s &LUSHING
Marketing Authorisation Holder and Manufacturer
-ARKETING !UTHORISATION HOLDER4%6! 5+ ,IMITED
Not known FREQUENCY CANNOT BE ESTIMATED FROM %ASTBOURNE ". !'
THE AVAILABLE DATA 
s $IARRHOEA
Company responsible for manufacture:
#HANELLE -EDICAL ,OUGHREA #O 'ALWAY )RELAND
3EEK MEDICAL ADVICE IF SYMPTOMS OF ANAPHYLACTIC
REACTIONS FOR EXAMPLE SWELLING OR DIFFICULTY
Product licence number(s)
BREATHING OR SERIOUS SKIN REACTIONS OCCUR
&EXOFENADINE  MG &ILM #OATED4ABLETS
0, 
Reporting of side effects
&EXOFENADINE  MG &ILM #OATED4ABLETS
)F YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR
0, 
PHARMACIST OR NURSE4HIS INCLUDES ANY POSSIBLE
SIDE EFFECTS NOT LISTED IN THIS LEAFLET9OU CAN ALSO
This leaflet was last revised: October 2013
REPORT SIDE EFFECTS DIRECTLY VIA THE9ELLOW #ARD
3CHEME AT WWWMHRAGOVUKYELLOWCARD
"Y REPORTING SIDE EFFECTS YOU CAN HELP PROVIDE
MORE INFORMATION ON THE SAFETY OF THIS MEDICINE

5 HOW TO STORE FEXOFENADINE
s Keep out of the sight and reach of children.
s $O NOT USE THIS MEDICINE AFTER THE EXPIRY DATE
WHICH IS STATED ON THE CARTON AND BLISTER

 7
,!

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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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