Levoreact

Patient Information Leaflet

LEVOREACT 0.5 mg/ml nasal spray, suspension

Levocabastine hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What LEVOREACT is and what it is used for
2. What you need to know before using LEVOREACT
3. How to use LEVOREACT
4. Possible side effects
5. How to store LEVOREACT
6. Package contents and other information

1. What LEVOREACT is and what it is used for

LEVOREACT is a nasal spray containing levocabastine hydrochloride, an active substance belonging to the class of antihistamines, which helps to constrict the blood vessels in the nose, thereby reducing swelling of the mucosa.
LEVOREACT is indicated in adults and children over 3 years of age for the treatment of nasal inflammation due to allergies (allergic rhinitis), which may cause sneezing, runny nose, itching, and nasal congestion.

2. What you need to know before using LEVOREACT

Do not use LEVOREACT if:

• you are allergic (hypersensitive) to the active substance 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 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.

Other medicines and LEVOREACT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as certain drugs may affect the proper functioning of LEVOREACT.
In particular, inform your doctor or pharmacist if you are taking:

• oxymetazoline, a decongestant medicine used to relieve nasal congestion.

Pregnancy, breastfeeding and fertility
Do not use LEVOREACT during pregnancy or breastfeeding, unless specifically advised by your doctor.
If you suspect you are pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
LEVOREACT may cause drowsiness. Make sure you do not experience this adverse effect before driving or operating machinery.

LEVOREACT contains:

• 40 mg of propylene glycol per usual dose, equivalent to 0.57 mg/kg for a 70 kg adult and 2 mg/kg for a 20 kg child.
• 0.08 mg of benzalkonium chloride per usual dose, equivalent to 0.001 mg/kg for a 70 kg adult and 0.004 mg/kg for a 20 kg child. Benzalkonium chloride may cause irritation and swelling inside the nose, especially if used for prolonged periods.

3. How to take LEVOREACT

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.

Adults and children over 3 years of age
Unless otherwise indicated by your doctor or pharmacist, use 2 sprays of LEVOREACT in each nostril, twice daily. In more severe cases, the stated dose may be repeated up to 3–4 times daily.

Method of administration
LEVOREACT is administered by nasal route. Clean the nose thoroughly before administration to ensure proper delivery. Always shake the bottle before each use.

1. Remove the protective cap. Press the pump one or two times until a consistent spray is obtained. The spray is now ready for use.
2. Hold the bottle as shown in the figure. Tilt your head slightly forward. Close one nostril firmly and insert the nozzle into the other nostril.
3. Spray twice; while spraying, breathe in gently through the same nostril. Repeat the procedure for the other nostril.
4. After use, replace the protective cap on the bottle.

LEVOREACT treatment should continue only for the time necessary for symptoms to resolve.
Caution: Use only for short-term treatment. Consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.
Do not use LEVOREACT in children under 3 years of age, as the safety and efficacy of LEVOREACT in children below 3 years have not been established.

If you take more LEVOREACT than you should, inform your doctor immediately or go to the nearest hospital.
If the contents of the bottle are accidentally ingested, mild sedation may occur. In such a case, contact your doctor and drink plenty of water or other non-alcoholic fluids to reduce the likelihood of adverse effects.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop using LEVOREACT and contact your doctor immediately if you experience any of the following:

• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat, severe itching of the skin with red rash or blisters, possibly accompanied by a sudden drop in blood pressure, possible signs of an allergic reaction.

Inform your doctor if you notice any of the following while taking 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 sinuses (sinusitis);
• sore throat, nosebleed, cough.

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

• sensation of pounding heartbeat (palpitations);
• malaise;
• breathing problems (dyspnoea);
• allergy (hypersensitivity);
• redness, pain, dryness or irritation in the nose, sensation of blocked nose (congestion).

Rare side effects (may affect up to 1 in 1000 people)

• increased heart rate (tachycardia);
• swelling or burning sensation in the nose.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• swelling of the eyes;
• severe breathing difficulties (bronchospasm).

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

5. How to store LEVOREACT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store LEVOREACT above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LEVOREACT contains
The active substance is: levocabastine hydrochloride.
1 ml of nasal spray, suspension contains: 0.54 mg levocabastine hydrochloride (equivalent to 0.5 mg of
levocabastine).
The other components are: propylene glycol, monohydrate sodium phosphate, anhydrous disodium phosphate,
hydroxypropylmethylcellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water.
Description of the appearance of LEVOREACT and contents of the pack
This medicine is a suspension, available in a 10 ml bottle equipped with a pump spray and a protective cap.
Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina Km 23.500, 00071 Santa Palomba - Pomezia (Rome)
Manufacturer
Janssen Pharmaceutica N.V., Turnhoutseweg, 30, B-2340 Beerse (Belgium)