Package leaflet: Information for the user

Fexyna 120 mg film-coated tablets

fexofenadine hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet

What Fexyna is and what it is used for
What you need to know before taking Fexyna
How to take Fexyna
Possible side effects
How to store Fexyna
Contents of the pack and other information

1. What Fexyna is and what it is used for

Fexyna contains fexofenadine hydrochloride, which is a non-sedating antihistamine.
Fexyna 120 mg is used in adults and adolescents aged 12 years and older to relieve symptoms of allergic rhinitis (for example, hay fever) such as sneezing, nasal itching, runny or blocked nose, and itchy, red or watery eyes.

Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before taking Fexyna

Do not take Fexyna

if you are allergic to fexofenadine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Fexyna if:

you have liver or kidney problems;
you currently have or have previously had heart disease, as this type of medicine may cause rapid or irregular heartbeat;
you are elderly.

If any of these conditions apply to you, or if you are unsure, inform your doctor before taking Fexyna.
Children and adolescents
Fexyna is not recommended for children under 12 years of age.
For children aged 6 to 11 years: fexofenadine hydrochloride 30 mg tablets are the appropriate formulation for administration and dosing in this population.
Other medicines and Fexyna
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking apalutamide (a medicine used to treat prostate cancer), as the effect of fexofenadine may be reduced.
It is particularly important to talk to your doctor before taking fexofenadine if you are also taking any of the following medicines:

an antibiotic used to treat certain types of bacterial infections (erythromycin);
an antifungal used to treat fungal infections (ketoconazole).

These medicines increase the amount of fexofenadine absorbed.
Medicines used to treat digestive problems that contain aluminium and magnesium may affect the action of Fexyna, reducing the amount of medicine absorbed.
It is recommended to leave an interval of about 2 hours between taking Fexyna and taking medicines for digestive problems.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Fexyna during pregnancy unless recommended by your doctor.
Fexyna is not recommended during breastfeeding.
Driving and using machines
It is unlikely that Fexyna will affect your ability to drive or operate machinery. However, make sure that the tablets do not cause you drowsiness or dizziness before driving or operating machinery.
Fexyna contains lactose:
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Fexyna contains sodium:
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to take Fexyna

Dosage
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
For adults and children aged 12 years and older
The recommended dose is one tablet (120 mg) once daily.
Take the tablet with water before meals.
This medicine starts to relieve symptoms within 1 hour and lasts for 24 hours.
If you take more Fexyna than you should
If you take too many tablets, contact your doctor, pharmacist, or nearest emergency department immediately.
Symptoms of overdose in adults include dizziness, drowsiness, fatigue, and dry mouth.
If you forget to take Fexyna
Do not take a double dose to make up for a forgotten dose.
Take the next dose at the same time as usual, according to your regular schedule.
If you stop taking Fexyna
If you stop taking Fexyna, symptoms may return.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Immediately contact your doctor and stop treatment with Fexyna if you experience:

Swelling of the face, lips, tongue or throat, and breathing difficulties, as these signs may indicate a severe allergic reaction.

The following side effects were reported in clinical studies, with a frequency similar to that observed in patients who did not receive the drug (placebo):
Common side effects (may affect up to 1 in 10 people)

Headache.
Drowsiness.
Feeling unwell (nausea).
Dizziness.

Uncommon side effects (may affect up to 1 in 100 people)

Tiredness.
Lethargy.

Additional side effects that may occur (frequency not known: cannot be estimated from the available data):

Difficulty falling asleep (insomnia).
Sleep disorders.
Nightmares.
Nervousness.
Blurred vision.
Fast or irregular heartbeat.
Diarrhea.
Skin rash and itching.
Hives (urticaria).
Severe allergic reactions which may cause swelling of the face, lips, tongue or throat, hot flushes, chest tightness and breathing difficulties.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Fexyna

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste.
Return unused medicines to the pharmacist. This will help protect the environment.

6. Package contents and other information

What Fexyna contains

The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride, equivalent to 112 mg of fexofenadine.
The other components are:
Tablet core: Croscarmellose sodium, lactose, monohydrate lactose, maize starch, anhydrous colloidal silica, pregelatinized starch, stearic acid.
Tablet coating: Red iron oxide (E172), yellow iron oxide (E172), hypromellose 2910 6 mPas (E464), macrogol 400 (E1521), titanium dioxide (E171).

Description of the appearance of Fexyna and package contents
Film-coated tablets.

Film-coated, biconvex, peach-colored, capsule-shaped tablets with bevelled edges, marked with "FE" on one side and "120" on the other.
Fexyna 120 mg film-coated tablets are available in blister packs containing 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102 - 21047 Saronno (VA), Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19, Venda Nova, 2700-487 Amadora, Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Fexyna
Portugal: Fexofenadina Aurovitas