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.
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

1.

What Fexofenadine hydrochloride 180mg Film-coated Tablets are and what they are used for
Before you take Fexofenadine hydrochloride 180mg Film-coated Tablets
How to take Fexofenadine hydrochloride 180mg Film-coated Tablets
Possible side effects
How to store Fexofenadine hydrochloride 180mg Film-coated Tablets
Further information

WHAT FEXOFENADINE HYDROCHLORIDE 180MG FILM-COATED TABLETS ARE AND WHAT THEY ARE
USED FOR

Fexofenadine hydrochloride 180mg Film-coated Tablets contain Fexofenadine hydrochloride, which belongs to a group of medicines called
antihistamines.
Fexofenadine hydrochloride 180mg Film-coated tablets are used to get relief from swelling, reddening and itching associated with a medical
condition called chronic idiopathic urticaria (itching of raised bumps of the skin) in adults and children aged 12 years or over.
Fexofenadine Hydrochloride 180 mg film-coated tablets will also be referred to in this leaflet as Fexofenadine tablets

2.

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 Fexofenadine tablets listed in Section 6.
Take special care with Fexofenadine Tablets
You should consult your doctor before taking Fexofenadine tablets if you:

are pregnant or could be pregnant

are breast feeding

have kidney or liver impairment

are elderly

have a heart condition because antihistamines may increase the rate your heart beats and cause palpitations
Taking other medicines
Are you taking any of the following medicines? Please inform your doctor before taking fexofenadine tablets if you are taking any of the
following medicines:

Erythromycin (antibiotic)

Ketoconazole (anti-fungal)
Heartburn or indigestion medicines called antacids which contain magnesium or aluminium
Antacids that contain magnesium or aluminium (used in treatment of indigestion) may cause a lower amount of Fexofenadine to be
absorbed. If you are taking such medicines, it is recommended to take Fexofenadine tablets 2 hours after taking these medicines
Taking Fexofenadine Tablets with food and drink
Fexofenadine tablets should be taken before meals.
Pregnancy and breast-feeding
Inform your doctor if you are

Pregnant or likely to be pregnant

Breast feeding
Your doctor will advise you whether to take Fexofenadine tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Fexofenadine tablets are unlikely to affect your ability to drive or use machines. However, there may be rare exceptions to this, and if you
feel that you might be affected, please avoid driving or performing activities that require concentration. If you are taking Fexofenadine tablets
for the first time, you should be aware that your ability to drive or use machinery safely may be impaired

3.

HOW TO TAKE FEXOFENADINE HYDROCHLORIDE 180mg FILM-COATED TABLETS

Your doctor will advise you on when and how many Fexofenadine tablets you should take. Always take Fexofenadine tablets as your doctor
has told you. You should check with your doctor or pharmacist if you are not sure.
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Adults and for children aged 12 or over:
Take one tablet daily. Fexofenadine tablets should be swallowed whole with a glass of water.
Children under 12 years:
Not recommended for children under the age of 12 years.
If you take more Fexofenadine Tablets than you should
If you have accidentally taken more tablets than you should, contact your doctor or the nearest hospital immediately. Take this leaflet and the
pack of Fexofenadine tablets with you, if you can.
If you forget to take Fexofenadine Tablets
If you forget to take the tablets, take one as soon as possible unless it is time for the next dose. Do not take double the dose the next time to
make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop taking Fexofenadine Tablets
No special precautions are necessary if you stop taking Fexofenadine Tablets.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Fexofenadine Tablets can cause side effects, although not everybody gets them. Many side effects are usually mild and
the side effects and go away when you stop taking the tablets. The possible side effects include:
Common (at least 1 in 100 and less than 1 in 10 patients):
Headache, drowsiness, dizziness and nausea
Uncommon (at least 1 in 1000 and less than 1 in 100 patients)
Fatigue.
Not known (cannot be estimated from the available data):
Diarrhoea, nervousness; sleep disorders (such as nightmares and sleeplessness); racing pulse or palpitations; skin rash, eruption or hives,
itching; allergic symptoms such as swelling of the face, chest tightness, shortness of breath and flushing, contact your doctor immediately if
any or all of these signs are seen
If any of the side effects get 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 180MG FILM-COATED TABLETS

Keep out of the reach and sight of children.
Fexofenadine tablets does not require any special storage conditions and disposal
Keep Fexofenadine tablets in the original pack.
Do not use Fexofenadine hydrochloride 180mg Film-coated tablets after the expiry date stated on the carton and the blister after {EXP} The
expiry date refers to the last day of that month.

6.

FURTHER INFORMATION

What Fexofenadine Tablets contain
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 03B54504 is a film Coating agent 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 shaped tablets marked with “FXF” on one side and “180” on
the other side.
Your Fexofenadine tablets are packed in blister strips in cartons.
The cartons contain 20 or 30 tablets. Not all packs may be marketed.
Marketing Authorisation Holder Dr. Reddy’s Laboratories (UK) Ltd, 6 Riverview Road, Beverley, HU17 0LD, UK.
Fexofenadine hydrochloride 180mg film-coated tablets: PL08553/0274
Date of preparation: 02/2011.
Component code
Dr Reddy’s Laboratories (UK) Ltd.

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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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