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.
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:
1.
What Fexofenadine Hydrochloride Tablets are and what they are used for
2.
Before you take Fexofenadine Hydrochloride Tablets
3.
How to take Fexofenadine Hydrochloride Tablets
4.
Possible side effects
5.
How to store Fexofenadine Hydrochloride Tablets
6.
Further information

1.

WHAT FEXOFENADINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY
ARE 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 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).

2.

BEFORE YOU TAKE FEXOFENADINE HYDROCHLORIDE TABLETS

Do not take Fexofenadine Hydrochloride Tablets:
if you are allergic (hypersensitive) to fexofenadine hydrochloride or any of the other ingredients
of Fexofenadine Hydrochloride Tablets.
Take special care with Fexofenadine Hydrochloride Tablets:
if you are elderly.
if you have ever had heart problems.
if you have kidney or liver problems.
Ask your doctor for advice before taking this medicine.
Taking other medicines

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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 Tablets. The remedy may lower the amount of drug absorbed and the
action of Fexofenadine Hydrochloride Tablets may be effected.
If you are taking Fexofenadine Hydrochloride Tablets together with erythromycin (an antibiotic) or
ketoconazole (an antifungal medicine), the level of fexofenadine in your plasma may increase.
Allergy tests: If you are taking an allergy test this medicine must be discontinued three days before the
test.
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 Tablets with food and drink
Fexofenadine Hydrochloride Tablets should be taken with water before a meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy: You must only take Fexofenadine Hydrochloride Tablets according to your doctor’s
instructions.
Breast-feeding: If you are breast-feeding, you must try to avoid taking Fexofenadine Hydrochloride
Tablets. Please ask your doctor.
Driving and using machines
Trials have shown that Fexofenadine Hydrochloride Tablets do not cause drowsiness, and your ability
to drive should therefore not be affected while you are on treatment with Fexofenadine Hydrochloride
Tablets. However, there may be rare exceptions, so please ensure that you are alert before driving and
performing tasks demanding your full attention.

3.

HOW TO TAKE FEXOFENADINE HYDROCHLORIDE TABLETS

Always take Fexofenadine Hydrochloride Tablets 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 daily for adults and children 12 years or older.
Fexofenadine Hydrochloride 180 mg Tablets: For relief of symptoms of chronic idiopathic urticaria
(allergic skin condition).
The usual dose is one tablet daily for adults and children 12 years or older.
Take the tablets orally with water before a meal.
If you think the effects of Fexofenadine Hydrochloride Tablets are too strong or too weak, please
consult your doctor or pharmacist.
If you take more Fexofenadine Hydrochloride Tablets than you should

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Contact your doctor, emergency room or pharmacist if you have taken more Fexofenadine
Hydrochloride Tablets 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 Tablets
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 Hydrochloride Tablets can cause side effects although not everybody
gets them. The side effects described below have been experienced by people taking Fexofenadine
Hydrochloride Tablets
Tell your doctor immediately and stop taking Nefoxef 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 (experienced by between 1 in 10 and 1 in 100 patients):
• headache
• drowsiness
• nausea
• dizziness
Uncommon (experienced by between 1 in 100 and 1 in 1,000 patients):
• feeling tired or sleepy.

Additional side effects (frequency unknown) 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 reaction which can cause swelling of the
face, lips, tongue or throat, flushing, chest tightness and difficulty breathing.

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 TABLETS
Keep out of reach and sight of children. Do not use Fexofenadine Hydrochloride Tablets after the
expiry date which is stated on the carton. The expiry date refers to the last day of that month. This
medicinal product does not require 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 Hydrochloride Tablets contain
The active substance is fexofenadine hydrochloride.
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Each Fexofenadine Hydrochloride 120 mg Tablet contains 120 mg of fexofenadine hydrochloride,
which is equivalent to 112 mg of fexofenadine. The other ingredients are microcrystalline cellulose,
croscarmellose sodium, maize starch, povidone K30, magnesium stearate, hypromellose, 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,
which is equivalent to 168 mg of fexofenadine. The other ingredients are microcrystalline cellulose,
croscarmellose sodium, maize starch, povidone K30, magnesium stearate, hypromellose, titanium
dioxide (E171), macrogol 400, macrogol 4000 and iron oxide yellow (E172).
What Fexofenadine Hydrochloride Tablets look like and contents of the pack
Fexofenadine Hydrochloride 120 mg Tablets are peach coloured, oblong, biconvex and film-coated
tablets; plain on both sides. Fexofenadine Hydrochloride 180 mg Tablets are yellow coloured, oblong,
biconvex and film-coated tablets; plain on one side with a score line on the other.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Fexofenadine Hydrochloride Tablets come in packs of 7, 10, 15, 20, 30, 50, 100, 200 or 250 tablets;
not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Mylan
Potters Bar
Hertfordshire, EN6 1 TL
United Kingdom
Manufacturer(s):
Chanelle Medical
IDA Industrial Estate
Loughrea, Co. Galway
Ireland
Generics [UK] Limited
Potters Bar
Hertfordshire, EN6 1 TL
United Kingdom
Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
This leaflet was last approved in 10/2012

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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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