Fexofenadine hydrochloride 120mg film-coated Tablets

• 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.

1. What Fexofenadine hydrochloride 120 mg Film-Coated Tablets are and what they are used for
2. What you need to know before you take Fexofenadine hydrochloride 120 mg Film-Coated Tablets
3. How to take Fexofenadine hydrochloride 120 mg Film-Coated Tablets
4. Possible side effects
5. How to store Fexofenadine hydrochloride 120 mg Film-Coated Tablets
6. Contents of the pack and other information

• If you are allergic to fexofenadine or any of the other ingredients of this medicine listed in Section 6.

Talk 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.

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 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.

If you are pregnant or breastfeeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Fexofenadine hydrochloride 120 mg Film-Coated Tablets if you are pregnant, unless necessary. Fexofenadine Tablets are not recommended during breastfeeding.

Fexofenadine ablets 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.

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 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.

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.

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.

• swelling of the face, lips, tongue or throat, flushing, chest tightness 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
• blurred vision
• fast or irregular heart beat
• diarrhoea
• skin rash and itching
• hives.

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 website: 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.

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)

Fexofenadine hydrochloride 120 mg 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.