FEXALLEGRA 120 MG FILM-COATED TABLETS 10 TABLETS IN PVC/PVDC/AL BLISTER

Name
Fexallegra 120 mg film-coated tablets
Fexofenadine hydrochloride


What is it and what is it used for?
Fexallegra is an oral medicine containing fexofenadine hydrochloride, a non-drowsy antihistamine used to treat some types of allergies.
Fexallegra 120 mg is used in adults and adolescents aged 12 years and older to treat irritation or inflammation of the nasal mucosa caused by allergies (allergic rhinitis). This medicine relieves symptoms caused by this allergy, such as sneezing, itchy nose, runny or stuffy nose; and itchy and irritated eyes (redness and watery eyes).


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:
- suffer from liver or kidney problems; in particular, if you suffer from severe kidney problems (severe renal insufficiency), you may only take the medicine under medical supervision;
- suffer or have suffered from heart or blood circulation diseases, as this type of medicine may cause a rapid or irregular heartbeat;
- he is an elderly person;
- you are pregnant or breastfeeding, as you should 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 taking Fexallegra if you experience:
• swelling of the face, lips, tongue or throat and difficulty breathing, as these signs may be indicative of a serious allergic reaction.
The following side effects have been reported in clinical studies conducted in adults and 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)
• heachache,
• drowsiness,
• feeling of being unwell (nausea),
• dizziness.

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

The following adverse reactions have been reported in post-marketing surveillance:

Frequency unknown (frequency cannot be estimated from the available data)
• difficulty falling asleep (insomnia),
• sleep disorders,
• nightmares,
• nervousness,
• rapid or irregular heartbeat,
• diarrhea,
• skin abnormalities (rash), even with small bumps and itching (hives),
• serious allergic reactions that may cause swelling of the face, lips, tongue or throat and difficulty breathing,
• blurred vision.

Reporting of side effects
If you experience 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.