LEVOREACT*NASAL SPRAY 10ML 0.5MG

LEVOREACT 0.5 mg/ml nasal spray, suspension
Levocabastine hydrochloride

What it is and what it is used for
LEVOREACT is a nasal spray containing levocabastine hydrochloride, an active ingredient belonging to the antihistamine class, which helps constrict blood vessels in the nose, reducing mucosal swelling.

LEVOREACT is indicated in adults and children over 3 years of age for the treatment of nasal inflammation due to allergies (allergic rhinitis), which can cause: sneezing, runny nose, itching, and nasal congestion.

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

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

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 skin itching, with red rashes or blisters, with a possible sudden drop in blood pressure, possible signs of an allergic reaction.

Inform your doctor if you notice any of the following during treatment with LEVOREACT:
Very common side effects (may affect more than 1 in 10 people)
• headache.

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)
• sensation of heart racing (palpitation);
• malaise;
• breathing problems (dyspnoea);
• allergy (hypersensitivity);
• redness, pain, dryness or discomfort in the nose, feeling of nasal congestion.

Rare side effects (may affect up to 1 in 1000 people)
• increased heart rate (tachycardia);
• swelling or burning in the nose.

Side effects of unknown frequency (frequency cannot be estimated from the available data)
• eye swelling;
• severe difficulty breathing (bronchospasm).

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.