Prospect: information for the user

Bilina 0.5 mg/ml eye drop suspension

Levocabastine

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Bilina and for what it is used

2. What you need to know before using Bilina

3. How to use Bilina

4. Possible adverse effects

5. Conservation of Bilina

6. Contents of the package and additional information

Bilina 0.5 mg/mlcolirio in suspension contains levocabastine which is an antihistamine used for the symptomatic treatment of allergic conjunctivitisin adults and in children and adolescents from 4 years of age to less than 18 years of age.

Levocabastine is a highly selective antagonist of H1histamine receptors. After application to the eyes, almost immediately and for hours, relief of symptoms of allergic conjunctivitis (pruritus, redness, eyelid inflammation, tearing)..

Do not use Bilina

• If you are allergic (hypersensitive) to levocabastine or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Bilina.

Children and adolescents

• The safety and efficacy of this medication have not been established in children under 4 years old.
• Bilina should only be used to treat children and adolescents from 4 to less than 18 years old.

Use of Bilina with other medications

Not described.

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, do not use Bilina as there have been no safety studies in pregnant women and Bilina passes into breast milk. Consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Bilina does not cause drowsiness, nor does it interfere with psychomotor activity. Adverse reactions such as eye irritation, pain, swelling, itching, redness, burning sensation, watery eyes, and blurred vision have been reported with Bilina eye drops that may affect vision. Therefore, caution is recommended for driving and operating machinery after applying Bilina eye drops.

Bilina eye drops contain benzalkonium chloride

This medication contains 15 mg of benzalkonium chloride in each ml.

Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you feel an unusual sensation, burning, or pain in the eye after using this medication.

This medication contains 14.04 mg of phosphates in each ml.

If you have severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

1) Dosage

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults and children and adolescents 4 years of age or less than 18 years of age

The recommended dose is 1 drop of Bilina in each eye, 2 times a day. The dose can be increased up to 1 drop in each eye, 3 or 4 times a day. Treatment should be continued until symptoms are eliminated.

Use in children under 4 years of age

The safety and efficacy of this medication have not been established.No data are available.

Seniors

No data are available on the use of levocabastine in seniors.

2) Usage Instructions

Before first use of Bilina, remove the seal from the container and note the date of opening on the box.

Follow these steps:

1. Shake the container well before removing the cap
2. Incline your head as far back as possible
3. Press the bottle and carefully pour 1 drop into the inner corner of the eye. Pull the lower eyelid down while keeping your head inclined back so that the drops can reach the area between the eye and the eyelid. Try to blink to spread the drops across the eye.
4. Repeat step 3 for the other eye.

Do not touch the bottle to the eye to avoid introducing impurities into the remaining liquid.Do not use the drops more than 1 month after opening the bottle for the first time.

Treatment should be continued until symptoms improve.

If you use more Bilina than you should

If you accidentally ingest the contents of a container, you may feel drowsy. In this case, it is recommended to drink plenty of non-alcoholic liquids to accelerate the elimination of the medication through the kidneys and contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Bilina

Do not apply an additional drop to the eye to compensate for the missed dose.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Bilina may cause adverse effects, although not everyone will experience them.

The frequency of the possible adverse effects listed below is defined using the following convention:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

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

Frequency not known (cannot be estimated from available data)

The adverse effects observed with Bilina are:

Common adverse effects (affecting between 1 and 10 in 100 patients) may include:

• Reaction at the site of administration such as burning/itching in the eyes, eye irritation

Very rare adverse effects (affecting less than 1 in 10,000 patients) may include:

• A particular type of allergic reaction characterized by swelling of the lips, tongue, eyelids (angioneuritic edema) or other allergic reactions (anaphylaxis, hypersensitivity) such as, for example, urticaria and difficulty breathing
• Eye pain
• Conjunctivitis
• Swelling of the eyelids
• Swelling of the eyes
• Swelling of the eyelids
• Swelling of the eyes
• Swelling of the eyes
• Swelling of the eyes
• Swelling of the eyes
• Urticaria
• Headache
• Palpitations

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out ofthe sight and reach of children.

Do not usethis medicationafter the expiration datethat appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Dispose of within 28 days after the first opening of the packaging.

Do not store at a temperature above25°C.

Medicines should not be thrown down the drain or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment..

Composition of Bilina

• The active principle is levocabastine. Each milliliter of Bilina contains 0.5 milligrams of levocabastine.
• The other components (excipients) are benzalkonium chloride, propylene glycol, anhydrous sodium phosphate, monosodium phosphate, hypromellose, polysorbate 80, disodium edetate, and water for injectable preparations.

Appearance of the product and contents of the packaging

Bilina is presented in the form of a suspension eye drop, sterile, white in color in a plastic dropper bottle containing 4 ml of suspension eye drop.

Holder of the marketing authorizationand responsible for manufacturing

Holder of the marketing authorization

EstevePharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing

Famar, S.A.

Agiou Dimitriou 63

Alimos Attiki

17456 Greece

Date of the last review of this leaflet: September 2020

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