Reactine levocabastine 0.5 mg/ml eye drops suspension

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

REACTINE Levocabastin 0.5 mg/ml Eye Drops, suspension

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet (see section 4).

You should consult your doctor if your condition worsens or if you do not improve after 2 days.

Leaflet contents:

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

1. What REACTINE Levocabastine is and what it is used for

REACTINE Levocabastine belongs to a group of medicines called antiallergic agents.

It is indicated for the temporary relief of symptoms of allergic conjunctivitis such as tearing, itching, and redness of the eyes.

You should consult a doctor if symptoms worsen or do not improve after 2 days.

2. What you need to know before starting to use REACTINE Levocabastine

Do not use REACTINE Levocabastine

If you are allergic to levocabastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use REACTINE if you have any kidney disease, as the medicine is eliminated mainly through the kidneys.

As with any ophthalmic preparation containing benzalkonium chloride, propylene glycol, and esters, soft (hydrophilic) contact lenses must not be worn during treatment with REACTINE Levocabastine.

Interference with diagnostic tests:

If you are due to have any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are using this medicine, as it may affect the results.

Using REACTINE with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions between REACTINE Levocabastine and other medicines have been reported. However, in any case, at least 10 minutes should be left between the administration of REACTINE and any other ophthalmic preparation.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines:

After applying REACTINE, you may experience eye irritation, pain, inflammation, itching, redness, burning sensation, or blurred vision. Do not drive or operate machinery until these effects have disappeared.

REACTINE Levocabastine contains benzalkonium chloride

This medicine may cause ocular irritation because it contains benzalkonium chloride, propylene glycol, esters, and polysorbates.

Polysorbates may cause allergic reactions.

Avoid contact with soft contact lenses.

Remove contact lenses before applying the eye drops and wait at least 15 minutes before reinserting them.

May alter the color of soft contact lenses.

3. How to USE REACTINE Levocabastin

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents over 12 years of age: 1 drop in each eye twice daily (every 12 hours). If symptom relief does not last for 12 hours, the number of applications may be increased up to 3 or 4 times a day (every 6 or 8 hours) as needed.

Do not exceed 4 drops per eye per day (within 24 hours).

Use in children:

This medicine must not be used in children under 12 years of age.

Method of administration:

This medicine is administered by ophthalmic route (into the eyes).

Shake the bottle before use.

With freshly washed hands, open the container, taking care that the cap and dropper do not touch anything.

Tilt your head backwards, pull down the lower eyelid, and gently press the bottle to instill 1 drop into the conjunctival sac while looking upwards. Blink several times to spread the drop throughout the eye.

Eye drop administration must be performed with maximum care, avoiding contact with the dropper tip (e.g. eyelids, fingers, etc.) as much as possible.

Close the container tightly after each use.

Since this is a sterile medicine, the following instructions are recommended:

• each container must be used by only one patient

• after completion of treatment, discard the medicine even if the bottle has not been completely emptied.

If you use more REACTINE Levocabastin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to a medical center, or call the Toxicology Information Service (telephone: 91-562 04 20), indicating the medicine and the amount ingested.

If you forget to use REACTINE Levocabastin

If you forget to use REACTINE Levocabastin, do not use a double dose to make up for the missed dose. If necessary, resume using the medicine as indicated in section 3. HOW TO USE REACTINE Levocabastin.

4. Possible adverse effects

Like all medicines, REACTINE Levocabastin may cause adverse effects, although not everyone experiences them.

• Frequent – may affect up to 1 in 10 patients: eye pain, blurred vision
• Uncommon – may affect up to 1 in 100 patients: eyelid swelling
• Very rare – may affect up to 1 in 10,000 patients: palpitations, hypersensitivity, headache and eye pain, conjunctivitis, watery eyes, allergic reaction, angioedema (swelling of certain areas of the skin), contact dermatitis, urticaria, and application site reactions such as burning sensation in the eye, redness, irritation, inflammation, itching, eye pain, and blurred vision. In very rare cases, some patients with significant corneal abnormalities (the thin front layer of the eye) have developed whitish areas in the cornea due to calcium deposits during treatment.

Reporting suspected adverse reactions

This enables continued monitoring of the benefit-risk balance of the medicinal product. It is important to report suspected adverse reactions to the medicinal product after authorization. Healthcare professionals are encouraged to report suspected adverse reactions through the Spanish Pharmacovigilance System for human medicinal products,

https: //www.notificaRAM.es

5. Storage of REACTINE Levocabastine

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Discard the medicine 28 days after unsealing and opening the container.

Store below 25 °C.

Medicines must not be disposed of via wastewater or household waste. Return unused or expired containers and medicines to the Sigre collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of REACTINE Levocabastine

The active substance is Levocabastine.

Each millilitre contains 0.5 milligrams of levocabastine.

The other components (excipients) are: Benzalkonium chloride, Disodium phosphate, Sodium dihydrogen phosphate monohydrate, hypromellose, propylene glycol, polysorbate 80, disodium edetate, water for injections q.s.

Nature of the product and pack contents

REACTINE 0.5 mg/ml Levocabastine eye drops suspension is supplied in boxes containing one 5 ml plastic container with 4 ml of homogeneous white suspension.

Marketing Authorization Holder

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Manufacturer

FAMAR, S.A.

63, Agiou Dimitriou Str. (Alimos, Attica) - GR-17456 - Greece

Telephone: 302109898500 Fax: 302109888800

Date of the most recent revision of this leaflet: October 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es