Fexofenadine Hydrochloride 120mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fexofenadine hydrochloride 120mg 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 120mg Film-coated Tablets are and what they are used for
2. What you need to know before you take Fexofenadine hydrochloride 120mg Film-coated Tablets
3. How to take Fexofenadine hydrochloride 120mg Film-coated Tablets
4. Possible side effects
5. How to store Fexofenadine hydrochloride 120mg Film-coated Tablets
6. Contents of the pack and other information
1. WHAT FEXOFENADINE HYDROCHLORIDE 120MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Fexofenadine hydrochloride 120mg film-coated Tablets contain Fexofenadine hydrochloride, which is an antihistamine.
Fexofenadine hydrochloride 120mg film-coated Tablets are used in adults and adolescents of 12 years and older to relieve the symptoms that occur with hay fever (seasonal allergic rhinitis) such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes.
Fexofenadine Hydrochloride 120mg 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 120MG 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
T alk 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
T ell 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 120mg 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 120MG 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 (120mg) 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.
T ell 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 120MG 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 120mg of Fexofenadine hydrochloride; equivalent to 112mg 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 120mg film-coated Tablets look like and contents of the pack
Fexofenadine hydrochloride 120mg film-coated tablets are pink coloured, oval, tablets marked with "FXF" on one side and "120" 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 120mg film-coated Tablets: PL08553/0273
This leaflet was last revised in 07/2014