FEXALLEGRA*10FC TAB 120MG

Fexallegra 120 mg film-coated tablets
Fexofenadine hydrochloride

What it is and what it is used for
Fexallegra is an orally administered medicine containing fexofenadine hydrochloride, a non-drowsy antihistamine that is used to treat certain forms of allergy.
Fexallegra 120 mg is used in adults and adolescents aged 12 years and over for the treatment of irritation or inflammation of the nasal mucous membranes caused by allergy (allergic rhinitis). This medicine relieves symptoms caused by this allergy, such as sneezing, nasal itching, runny or blocked nose; itching and irritation of the eyes (redness and watering).

What you need to know before taking the medicine
Do not take Fexallegra
- if you are allergic to fexofenadine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Fexallegra.
Take special care if:
- you suffer from liver or kidney problems; in particular, if you suffer from severe kidney problems (severe renal insufficiency), you can only take the medicine under medical supervision;
- you suffer or have suffered from heart or circulatory diseases, as this type of medicine can cause a fast or irregular heartbeat;
- you are elderly;
- you are pregnant or breastfeeding, as you must consult your doctor (see Pregnancy and breastfeeding).

Children and adolescents
This medicine should not be taken by children under 12 years of age (see Use in children and adolescents).

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 Fexallegra if you experience:
• swelling of the face, lips, tongue or throat and difficulty breathing, as these signs may be indicative of a severe allergic reaction.
The following side effects have been reported in clinical studies in adults with a frequency similar to that observed in patients who did not receive the drug (placebo):

Common (may affect up to 1 in 10 people)
• headache,
• drowsiness,
• feeling unwell (nausea),
• dizziness.

Uncommon (may affect up to 1 in 100 people)
• fatigue.

The following side effects have been reported in post-marketing surveillance:

Not known frequency (frequency cannot be estimated from the available data)
• difficulty falling asleep (insomnia),
• sleep disturbances,
• nightmares,
• nervousness,
• fast or irregular heartbeat,
• diarrhoea,
• skin abnormalities (rash), also with small swellings and itching (urticaria),
• severe allergic reactions that can cause swelling of the face, lips, tongue or throat and difficulty breathing,
• blurred vision.

Reporting of side effects
If you get any side effects, including any 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/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.