LEVOREACT 0.5 MG/ML NASAL SPRAY, SUSPENSION 10 ML BOTTLE

Name
LEVOREACT 0.5 mg/ml nasal spray, suspension
Levocabastine hydrochloride


What is it and what is it for?
LEVOREACT is a nasal spray that contains levocabastine hydrochloride, an active ingredient belonging to the antihistamine class, which helps narrow the blood vessels in the nose, reducing swelling of the mucosa.

LEVOREACT is indicated in adults and children over 3 years of age to treat inflammation of the nose due to allergies (allergic rhinitis), which can cause: sneezing, runny nose, itching and a feeling of stuffiness.


What you need to know before taking the medicine
Do not use LEVOREACT if:
• are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• is pregnant, unless specifically indicated by your doctor.


Warnings and precautions
Talk to your doctor or pharmacist before using LEVOREACT:
• if you have severe kidney problems (renal failure).

Children and adolescents
LEVOREACT is indicated for children over 3 years of age.
The safety and efficacy of LEVOREACT in children under 3 years of age have not been established.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using LEVOREACT and contact your doctor immediately if you experience any of the following conditions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat, severe itching of the skin, with red rashes or blisters, with possible sudden drop in blood pressure, possible signs of an allergic reaction.

Tell your doctor if you notice:
Very common side effects (may affect more than 1 in 10 people)
• heachache.

Common side effects (may affect up to 1 in 10 people)
• dizziness, drowsiness;
• nausea;
• fatigue, pain;
• inflammation of the paranasal sinuses (sinusitis);
• sore throat, nosebleed, cough.

Uncommon side effects (may affect up to 1 in 100 people)
• feeling of heart in the throat (palpitation);
• malaise;
• breathing problems (dyspnea);
• allergy (hypersensitivity);
• redness, pain, dryness or discomfort in the nose, feeling of stuffiness (congestion).

Rare side effects (may affect up to 1 in 1,000 people)
• increased heart rate (tachycardia);
• swelling or burning of the nose.

Unknown side effects (it is not possible to establish their frequency)
• swelling of the eyes;
• severe difficulty breathing (bronchospasm).

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.