PATIENT INFORMATION LEAFLET

REACTINE Levocabastina 0.5 mg/ml Eye Drops in Suspension

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4).

You should consult your doctor if you get worse or do not improve after2 days.

1. What isREACTINE Levocabastinaand what it is used for

2. What you need to know before starting to useREACTINE Levocabastina

3. How to useREACTINE Levocabastina

4. Possible side effects

5. Storage ofREACTINE Levocabastina

6. Contents of the pack and additional information.

REACTINE Levocabastina 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.

Consult a doctor if symptoms worsen or do not improve after 2 days.

Do not use REACTINE Levocabastina

If you are allergic to levocabastina, or to any of the other components of this medication (including those 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 medication is primarily eliminated through the kidneys.

As with any eye preparation containing Chlorobutanol, propylene glycol, and esters, do not use soft contact lenses (hydrophilic) while being treated with REACTINE Levocabastina.

Interference with diagnostic tests :

If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc…), inform your doctor that you are using this medication as it may alter the results.

Use of REACTINE with other medications

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

No interactions of REACTINE Levocabastina have been reported with other medications, but in any case, it should be separated by at least 10 minutes from the administration of any other eye preparation.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery:

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

REACTINE Levocabastina contains chlorobutanol

This medication may cause eye irritation due to the presence of chlorobutanol, propylene glycol, and esters.

Avoid contact with soft contact lenses.

Remove contact lenses before application and wait at least 15 minutes before reinserting them.

May alter the color of soft contact lenses.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years old: 1 drop in each eye 2 times a day (every 12 hours). If symptom relief does not last for 12 hours, the number of applications may be increased to 3 or 4 times a day (every 6 or 8 hours) as needed.

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

Use in children:

This medication should not be used in children under 12 years old.

Method of use:

This medication is used topically (in the eyes).

Shake the bottle before use.

With clean hands, open the container carefully, ensuring the stopper and dropper do not come into contact with anything.

With your head tilted back, separate the lower eyelid downward, press the bottle carefully until 1 drop is released into the eye while looking upward. Blink to spread the drop across the eye.

The application of the eye drop should be performed with the utmost care, avoiding contact with the dropper (e.g., eyelids, fingers, etc.) as much as possible.

After each application, close the container tightly.

As this is a sterile medication, the following instructions are recommended:

- Each container should only be used by one patient.

- Once treatment is complete, discard the medication, even if the container is not fully used.

If you use moreREACTINE Levocabastinathan you should

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

If you forgot to use REACTINE Levocabastina

If you forgot to useREACTINE Levocabastina, do not use a double dose to compensate for the missed dose. If necessary, resume using the medication as indicated in the section 3. HOW TO USEREACTINE Levocabastina

Like all medications, REACTINE Levocabastina may produce adverse effects, although not all people may experience them.

- Frequent may affect up to 1 in 10 patients: eye pain, blurry vision

- Infrequent may affect up to 1 in 100 patients: swelling of the eyelid

- 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 skin areas),contact dermatitis, urticaria and reactions at the application site such as, sensation of burning in the eye, redness, irritation, inflammation, itching and eye pain and blurry vision.In very rare cases, some patients with significant alteration of the cornea (thin outer layer of the eye) have developed white patches on the cornea due to calcium accumulation during treatment.

Notification of Suspected Adverse Reactions

This allows for continuous monitoring of the benefit/risk ratio of the medication. It is essential to report suspected adverse reactions to the medication after its authorization. Healthcare professionals are invited to report suspected adverse reactions through the Spanish System of Pharmacovigilance of human medicines,

https: //www.notificaRAM.es

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Dispose of the medication 28 days after opening and removing the packaging seal.

Store below25 °C.

Medications should not be thrown away through drains or in the trash. Deposit empty containers and unused medications at thePharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition ofREACTINE Levocabastina

The active ingredient is Levocabastina.

Each milliliter contains 0.5 milligrams of levocabastina.

The other components (excipients) are: Benzalkonium chloride, Anhydrous disodium hydrogen phosphate, Monohydrate disodium dihydrogen phosphate, Hypromellose, Propylene glycol, Polysorbate 80, Disodium edetate, Water for injectable preparations c.s.

Appearance of the product and content of the packaging

REACTINE 0.5 mg/ml Levocabastinaeye drops in suspension are packaged in boxes containing a 5 ml plastic container with 4 ml of homogeneous white suspension.

Holder of the marketing authorization

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Responsible for manufacturing

FAMAR, S.A.

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

Telephone: 302109898500 Telefax: 302109888800

Last review date of this leaflet: February 2016

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es