Levoreact ophthalmic

Package leaflet: Information for the patient

LEVOREACT OFTALMICO 0.05% eye drops, 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 need more information or advice, consult your pharmacist.
• If you experience any 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 improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What LEVOREACT OFTALMICO is and what it is used for

LEVOREACT OFTALMICO is an eye drop that contains levocabastine hydrochloride, an active substance belonging to the class of antihistamines, which helps reduce allergy symptoms.
LEVOREACT OFTALMICO is used to treat allergic conjunctivitis (inflammation of the eye due to allergies, which may cause: redness, itching, tearing, and eyelid swelling).

2. What you need to know before using LEVOREACT OFTALMIC

Do not use LEVOREACT OFTALMIC if:
you are allergic to the active substance or to any of the other ingredients of this medicine (listed
in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using LEVOREACT OFTALMIC.

Other medicines and LEVOREACT OFTALMIC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.

Pregnancy, breast-feeding and fertility
If you suspect you are pregnant, are planning a pregnancy, or are breast-feeding, consult your
doctor or pharmacist before using this medicine.
Do not use LEVOREACT OFTALMIC during pregnancy unless specifically instructed by your doctor.

Driving and using machines
LEVOREACT OFTALMIC may cause eye irritation, pain, redness, swelling, itching, burning sensation, tearing, and blurred vision. Caution is advised when driving or using machinery after application of LEVOREACT OFTALMIC.

LEVOREACT OFTALMIC contains:

• Propylene glycol: This medicine contains 6 mg of propylene glycol per usual dose, corresponding to 0.086 mg/kg in a 70 kg adult male and 0.3 mg/kg in a 20 kg child.
• Benzalkonium chloride: This medicine contains 0.018 mg of benzalkonium chloride per usual dose, corresponding to 0.00026 mg/kg in a 70 kg adult male and 0.0009 mg/kg in a 20 kg child. Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience unusual eye sensations, burning, or pain after using this medicine, speak with your doctor.
• Phosphate buffer: This medicine contains 1.68 mg of phosphate buffer per usual dose, equivalent to 0.024 mg/kg in a 70 kg adult and 0.084 mg/kg in a 20 kg child. If you have severe damage to the outer transparent layer of the eye (cornea), phosphates may very rarely cause opaque corneal spots due to calcium accumulation during treatment.

3. How to use LEVOREACT OFTALMICO

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop of LEVOREACT OFTALMICO per eye, twice daily. The dose may be increased to 1 drop up to 3–4 times daily.
Method of administration
LEVOREACT OFTALMICO is a medicine for the eyes (eye drops).
At the first use of the eye drops, completely remove the closure ring from the bottle.

1. Shake the bottle vigorously. Remove the protective cap.

2. Tilt your head backward as much as possible.
3. Press the bottle and carefully apply 1 drop into the inner corner of the eye. Then pull down the lower eyelid, keeping your head tilted backward, so that the drop reaches the space between the lower part of the eye and the lower eyelid. The eyelid will blink automatically, spreading the drop over the entire eye.
4. Repeat for the other eye.

Do not let the bottle tip touch the eye to prevent contamination of the remaining liquid. Do not swallow the eye drops.
Treatment with LEVOREACT OFTALMICO should be continued only for the period necessary for symptoms to resolve. Caution: Use only for short-term treatment.
If you use more LEVOREACT OFTALMICO than you should, inform your doctor immediately or go to the nearest hospital.
If the contents of the bottle are accidentally swallowed, sedation may occur. If this happens, contact your doctor and drink plenty of water or other non-alcoholic liquids.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using LEVOREACT OFTALMICO and contact your doctor immediately if you experience any of the following conditions, which may be signs of an allergic reaction:

• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat, possibly with a sudden drop in blood pressure;
• severe itching of the skin, with red skin rash or blisters.

Other side effects:
Common side effects (may affect up to 1 in 10 people)

• eye reactions such as burning or sensation of burning, irritation;
• eye pain, blurred vision;
• headache.

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

• swelling of the eyelids.

Very rare side effects (may affect up to 1 in 10,000 people)

• eye reactions such as redness, itching.

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

• sensation of pounding heartbeat (palpitations);
• hives, skin inflammation triggered by contact with specific substances (contact dermatitis);
• eye swelling, tearing, eye redness due to hyperemia;
• inflammation of the eye (conjunctivitis) or eyelids (blepharitis).

Reporting of side effects
If you experience any side effect, including those 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/segnalazioni-reazioni-avverse".
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LEVOREACT OFTALMICO

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 above 25°C.
After first opening, LEVOREACT OFTALMICO must be used within one month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What LEVOREACT OFTALMICO contains
The active substance is: levocabastine hydrochloride.
1 ml of eye drops, suspension contains: 0.54 mg levocabastine hydrochloride (equivalent to 0.5 mg of levocabastine).
The other components are: propylene glycol, monosodium phosphate monohydrate, disodium hydrogen
phosphate anhydrous, hypromellose 2910, polysorbate 80, benzalkonium chloride, disodium edetate,
water for injections.
Description of the appearance of LEVOREACT OFTALMICO and contents of the pack
This medicine is a suspension, available in a 5 ml bottle with a screw cap. The bottle
contains 4 ml of suspension, equivalent to approximately 120 drops.
Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina Km 23,500, 00071 Santa Palomba - Pomezia (Rome)
Manufacturer
Famar S.A., Agiou Dimitriou 63, Alimos Attiki 17456 Greece