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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.

•    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. Do not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

•    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.

In this leaflet:

T| What Fexofenadine

hydrochloride is and what it is used for

"21 Before you take Fexofenadine hydrochloride

"3 How to take Fexofenadine hydrochloride Possible side effects of Fexofenadine hydrochloride

^1 How to store Fexofenadine hydrochloride

"6 Further information

3 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).

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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).

J BEFORE YOU TAKE FEXOFENADINE HYDROCHLORIDE Do not take Fexofenadine hydrochloride :

•    if you are allergic (hypersensitive) to 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 :

•    if you are elderly.

•    if you have kidney or liver problems. Ask your doctor for advice before taking this medicine.

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.

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.

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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

Fexofenadine hydrochloride should be taken with water.

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.

Driving and using machines

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.

3| HOW TO TAKE FEXOFENADINE HYDROCHLORIDE

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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Fexofenadine 120mg & 180mg film-coated tablets PIL - UK			colours/plates:
			1. Black
^actav/s creating value In pharmaceuticals t 00441271311400 f 00441271311449	item no: AAAF7935	dimensions: 170 x 210	2.
	print proof no: 4	pharmacode:	3.
			4.
	origination date: I&O8.I3	min pt size:	5.
@ artworkstudio@actavis.co.uk	originated by: DR		6.
approved for print/date	revision date: 21.11.13	Technical Approval	Non Printing Colours
			1.
	revised by: DR	date sent: 16 08.13
			2.
	supplier: Chanelle	technically app. date: 22.°8.13	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 you forget to take Fexofenadine hydrochloride

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.

POSSIBLE SIDE EFFECTS

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 l00 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.

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.

J 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.

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.

A FURTHER INFORMATION

What Fexofenadine hydrochloride contains

The active substance is fexofenadine hydrochloride.

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, film-coated tablets, plain on both sides. Fexofenadine hydrochloride 180 mg tablets are yellow coloured, oblong, film-coated tablets, 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

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last approved in August 2013

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

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Fexofenadine 120mg & 180mg film-coated tablets PIL - UK			colours/plates:
			1. Black
Actavis creating value In pharmaceuticals t 00441271311400 f 00441271311449	item no: AAAF7935	dimensions: 170 x 210	2.
	print proof no: 4	pharmacode:	3.
			4.
	origination date: 1A°8.13	min pt size:	5.
@ artworkstudio@actavis.co.uk	originated by: DR		6.
approved for print/date	revision date: 21.11.13	Technical Approval	Non Printing Colours
			1.
	revised by: DR	date sent: 16 08.13
			2.
	supplier: Chanelle	technically app. date: 22.08.13	3.
* Please note Any technica		he technical approval is provided by the supplier and is valid on the date indicated chanages made by the supplier after approval are not the responsibility of the Artwork Studio