Fexofenadine Hydrochloride 120 mg 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 is and what it is used for
2. What you need to know before you take Fexofenadine Hydrochloride
3. How to take Fexofenadine Hydrochloride
4. Possible side effects
5. How to store Fexofenadine Hydrochloride
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 Hydrochloride 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.

Fexofenadine Hydrochloride 120 mg Film-Coated Tablet is not recommended for children less than 12 years of age.

In children from 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablet is the appropriate formulation for administration and dosing in this population.

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.

It is especially important to talk to your doctor before you take fexofenadine if you are also taking any of the following medicines:

• an antibiotic used to treat certain bacterial infections (erythromycin)
• an antifungal used to treat fungal infections (ketoconazole)

These medicines increase the amount of fexofenadine absorbed.

Indigestion remedies containing aluminium and magnesium may affect the action of fexofenadine, 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 and your indigestion remedy.

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 if you are pregnant, unless recommended by your doctor.

Fexofenadine hydrochloride is not recommended during breast-feeding.

Fexofenadine Hydrochloride is not recommended during breast-feeding.

Fexofenadine hydrochloride 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.

This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free’.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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 pharmacist 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.

If you stop taking Fexofenadine Hydrochloride your symptoms may return.

• 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 heartbeat
• 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

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 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 120 mg fexofenadine hydrochloride, which is equivalent to 112 mg of fexofenadine.

• The other ingredients are:

Tablet core: Croscarmellose sodium, lactose, lactose monohydrate, maize starch, silica, colloidal anhydrous, starch, pregelatinised, stearic acid

Tablet coating: Iron oxide red (E172), iron oxide yellow (E172), hypromellose type 2910 6 mPas (E464), macrogol 400 (E1521), titanium dioxide (E171)

Film-coated tablet

Peach-coloured, capsule shaped, bevel edge, biconvex film-coated tablets debossed with “FE” on one side and “120” on other side.

Fexofenadine Hydrochloride 120 mg Film-Coated Tablets are available blister packs containing 7, 10, 15, 20, 30, 50, 60 and 100 film-coated tablets.

Not all pack sizes may be marketed.