Patient leaflet - Fexofenadine Hydrochloride 120 mg film-coated tablets
1. What Fexofenadine Hydrochloride Tablets is and what it is used for
Fexofenadine Hydrochloride Tablets contains fexofenadine hydrochloride, which is an antihistamine.
Fexofenadine Hydrochloride Tablets is 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.
2. What you need to know before you take Fexofenadine Hydrochloride Tablets
Do not take Fexofenadine Hydrochloride Tablets:
if you are allergic to fexofenadine 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 Hydrochloride Tablets if:
you have problems with your liver or kidneys · you have or ever had heart disease, since this kind of
medicine may lead to a fast or irregular heart beat · you are elderly
If any of these apply to you, or if you are not sure, tell your doctor before taking Fexofenadine Hydrochloride Tablets.
Other medicines and Fexofenadine Hydrochloride Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking apalutamide (a medicine to treat prostate cancer), as the effect of fexofenadine may be decreased.
Indigestion remedies containing aluminium and magnesium may affect the action of Fexofenadine Hydrochloride 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 Hydrochloride Tablets and your indigestion remedy.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Fexofenadine Hydrochloride Tablets if you are pregnant, unless necessary. Fexofenadine Hydrochloride Tablets is not recommended during breast-feeding.
Driving and using machines
Fexofenadine Hydrochloride Tablets is 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.
Fexofenadine Hydrochloride 120 mg Film-coated Tablets contains Lactose
Fexofenadine Hydrochloride 120 mg film-coated tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Fexofenadine Hydrochloride 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 (120 mg) daily. Take your tablet with water before a meal.
This medicine starts to relieve your symptoms within 1 hour and lasts for 24 hours.
If you use more Fexofenadine Hydrochloride Tablets than you should
If you takes 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 Hydrochloride 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 Hydrochloride Tablets
Tell your doctor if you want to stop taking Fexofenadine Hydrochloride Tablets before you have finished your course of treatment.
If you stop taking Fexofenadine Hydrochloride Tablets earlier than planned, your symptoms may return.
Version: 01
Dimension: 160 x 290 mm
Printing Colour: Black
1st Page: 4690
2nd Page: 4691
UK (Unit-V) Fexofenadine 120mg Leaflet
Supersede: 2072843 4690 4691 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 treatment with Fexofenadine Hydrochloride Tablets if you experiences · swelling of the face, lips, tongue or throat and
difficulty breathing, as these may be signs of a serious allergic reaction.
The following undesirable effects have been reported
in clinical trials, with an incidence similar to those observed in patient who did not receive the drug (placebo).
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.
- blurred vision
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Fexofenadine Hydrochloride 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 to protect the environment.
6. Contents of the pack and other information
What Fexofenadine Hydrochloride Tablets contains
The active substance is fexofenadine hydrochloride Each tablet contains 120 mg of fexofenadine hydrochloride. The other ingredients are:
- Tablet core: Lactose monohydrate, Low-substituted hydroxypropylcellulose, Pregelatinised starch, Colloidal anhydrous silica, Microcrystalline cellulose, Croscarmellose sodium, Magnesium stearate.
- Film-coating: Hypromellose, Povidone, Titanium dioxide, Iron oxide Red, Iron oxide Yellow, Silica, Colloidal Anhydrous and Macrogol 400.
What Fexofenadine Hydrochloride Tablets looks like and contents of the pack
Fexofenadine hydrochloride 120 mg film-coated tablets Peach coloured capsule shaped film-coated tablets, debossed as '120' on one side and 'FX'on other side.
Fexofenadine hydrochloride 120 mg film-coated tablets are available in Alu-PVC/PVdC, Alu/PVC/PE/ACLAR blisters of 10 and 30 tablets and HDPE bottle packs of 500 and 1000 tablets.
Marketing Authorisation Holder
Amarox Limited
Congress House, 14 Lyon Road
Harrow, HA1 2EN
United Kingdom
Manufacturer
MEDREICH PLC,
Warwick House,
Plane Tree Crescent,
Feltham TW13 7HF, UK
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
0203 972 0004 (UK only)
Please be ready to give the following information: Product name
Fexofenadine Hydrochloride 120 mg Film-coated Tablets
Reference number
PL 49445/0122
This leaflet was last revised in 04/2026
2107881