FEXOFENADINE HYDROCHLORIDE 180MG FILM-COATED TABLETS

Active substance: FEXOFENADINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Fexofenadine hydrochloride 180mg 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 hydrochloride 180mg Film-coated Tablets are and what they are used for
2. What you need to know before you take Fexofenadine hydrochloride 180mg Film-coated Tablets
3. How to take Fexofenadine hydrochloride 180mg Film-coated Tablets
4. Possible side effects
5. How to store Fexofenadine hydrochloride 180mg Film-coated Tablets
6. Contents of the pack and other information

1. WHAT FEXOFENADINE HYDROCHLORIDE 180MG FILM-COATED TABLETS
ARE AND WHAT THEY ARE USED FOR
Fexofenadine hydrochloride 180mg film-coated Tablets contain Fexofenadine hydrochloride, which is an
antihistamine.
Fexofenadine hydrochloride 180mg film-coated Tablets are used in adults and adolescents of 12 years
and older to relieve the symptoms that occur with long term allergic skin reactions (chronic idiopathic
urticaria) such as itching, swelling and rashes.
Fexofenadine hydrochloride 180 mg film-coated Tablets will also be referred to in this leaflet as
Fexofenadine tablets.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEXOFENADINE
HYDROCHLORIDE 180MG FILM-COATED TABLETS
Do not take Fexofenadine Tablets
If you are allergic to Fexofenadine hydrochloride 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 tablets if you:
have problems with your liver or kidneys
have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat
are elderly
If any of these apply to you, or if you are not sure, tell your doctor before taking Fexofenadine tablets.

Other medicines and Fexofenadine tablets
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
tablets, by lowering the amount of medicinal product absorbed.
It is recommended that you leave about 2 hours between the time that you take Fexofenadine tablets
and your indigestion remedy.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Fexofenadine hydrochloride 180mg Film-coated tablets if you are pregnant, unless
necessary. Fexofenadine tablets are not recommended during breast-feeding.

Driving and using machines
Fexofenadine tablets are 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 HYDROCHLORIDE 180MG
FILM-COATED TABLETS
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 (180mg) daily. Take your tablet with water before a meal.

If you take more Fexofenadine tablets 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 tablets
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 tablets
Tell your doctor if you want to stop taking Fexofenadine tablets before you have finished your course of
treatment. If you stop taking Fexofenadine tablets 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 tablets 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
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:
http://yellowcard.mhra.gov.uk/. By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE FEXOFENADINE HYDROCHLORIDE 180MG
FILM-COATED TABLETS
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 after EXP. 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 Tablets contain
The active substance is fexofenadine hydrochloride. Each film coated tablet contains 180mg of
Fexofenadine hydrochloride; equivalent to 168mg of Fexofenadine.
The other ingredients (Excipients) are:
Tablet core: Powdered Cellulose, Mannitol (E421), Maize starch, Croscarmellose Sodium, Colloidal
anhydrous Silica, Magnesium Stearate.
Tablet coating: Opadry Pink film-coating mixture containing Hypromellose (E464), Titanium dioxide
(E171), Macrogol 400, Allura Red AC Lake (FD&C Red #40) (E129), and Iron Oxide, Black (E172)
What Fexofenadine hydrochloride 180mg film-coated Tablets look like and contents of the pack
Fexofenadine hydrochloride 180mg film-coated Tablets are pink coloured, oval, tablets marked with
“FXF” on one side and “180” on the other side.
Fexofenadine tablets are packed in blister strips packaged in cartons.
The cartons contain 20 or 30 Tablets. Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd, 6 Riverview Road, Beverley, HU17 0LD, UK.
Fexofenadine hydrochloride 180mg film-coated Tablets: PL08553/0274
This leaflet was last revised in 07/2014

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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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