Package Leaflet: Information for the User

Vividrin 0.5 mg/ml eye drops in single-dose container

Azelastine hydrochloride

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• If you do not get better after 48 hours or get worse, consult your doctor.

1. What is Vividrin and what it is used for

2. What you need to know before using Vividrin

3. How to use Vividrin

4. Possible side effects

5. Storage of Vividrin

6. Contents of the pack and additional information

This medication contains azelastine hydrochloride, which belongs to a group known as antihistamines. Antihistamines prevent the effects of substances such as histamine that are produced by the body as part of an allergic reaction. Azelastine has been shown to reduce ocular inflammation.

This medication is used in the following situations:

• Treatment and prevention of eye disorders caused by hay fever (seasonal allergic conjunctivitis) in adults and children aged 4 years and above.
• Treatment of eye disorders caused by allergy to dust mites or pet hair(perennial allergic conjunctivitis)in adults and children aged 12 years and above.

This medicationis notsuited for the treatment of eye infections.

Do not use Vividrin:

If you are allergic to azelastine hydrochloride or to any of the other ingredients of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication:

• If you are unsure whether your eye symptoms are caused by an allergy. In particular, if they only affect one eye, if your vision has worsened, or if you have eye pain and no nasal symptoms, it may be an infection rather than an allergy
• If symptoms worsen or last more than 48 hours without significant improvement despite using this medication
• If you wear contact lenses

Children and adolescents

This medication should not be used in children under 4 years old for the treatment and prevention of eye disorders related to hay fever (seasonal allergic conjunctivitis).

This medication should not be used in children under 12 years old for the treatment of eye disorders caused by allergy to dust mites or pet hair (perennial allergic conjunctivitis).

Other medications and Vividrin

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

The effect of this medication on other medications is unknown.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

You may experience blurred vision for a short period of time immediately after applying this medication. If this occurs, wait until your vision returns before driving or operating machinery.

Follow exactly the administration instructions of this medication contained in this leaflet or indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Remember: this medication should only be applied to the eyes.

The recommended dose is:

Allergic conjunctivitis caused by hay fever (seasonal allergic conjunctivitis)

Use in adults and children aged 4 years and older.

The usual dose is one drop in each eye, in the morning and at night.

If you anticipate exposure to pollen, you can administer the usual dose of this medication as a preventive measure before going outside.

Allergic conjunctivitis caused by an allergy (perennial non-seasonal allergic conjunctivitis)

Use in adults and children aged 12 years and older.

The usual dose is one drop in each eye, in the morning and at night.

If your symptoms are severe, your doctor may increase the dose to one drop in each eye up to four times a day.

You should notice relief from allergic conjunctivitis symptoms within 15-30 minutes.

Method of administration (application of this medication eye drop)

To facilitate correct application of the eye drop, it may be helpful to sit in front of a mirror the first few times to see what you are doing.

1.Wash your hands.

2.Gently clean the area around your eyes with a tissue to remove any remaining moisture.

3.Separate a single-use container from the top of the strip (Fig.1) andopen it. Turn and separate the top of the single-use unit (without pulling it) (Fig.2).

4. Tilt your head back.

Fig.1 Fig.2

5.Gently pull the lower eyelid down.

6.Place a drop carefully in the middle of the lower eyelid. Make sure the container does not touch the eyeto avoid contamination (Fig.3).

Fig.3.

7.Release the lower eyelid and press the inner corner of the eye gently against the bridge of the nose. While pressing the nose with your finger, blink slowly a few times to allow the drop to spread across the surface of the eye.

8.Wipe away any excess medication with a tissue.

9.Repeat the procedure with the other eye.

Treatment duration

If possible, use this medication regularly until your symptoms have disappeared. If you stop using this medication, your symptoms are likely to reappear.

Do not use this medication for more than 6weeks.

If you use more Vividrin than you should:

If you administer too much Vividrin to your eye, it is likely that you will not experience any problems. If you have any doubts, consult your doctor. In case of accidental ingestion of this medication, contact your doctor immediately or visit the nearest hospital emergency department.

If you forget to use Vividrin

Use your eye drop as soon as you remember. Apply the next dose at the usual time. Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment with Vividrin

If you have any other doubts about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Mild irritation (burning, itching, tearing) in the eyes after using this medication. These effects should not last long.

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

Bitter taste in the mouth. This effect should disappear quickly, especially if you drink a refreshing beverage.

Rare adverse effects (may affect up to 1 in 10,000 people):

Allergic reaction (such as rash and itching).

Reporting Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the carton box and on the packaging, after «CAD».

Use the single-use packaging only once.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and the

medicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. This way, you will help protect the environment.

Do not store at a temperature above 25°C.

Composition of Vividrin

• The active ingredient is azelastine hydrochloride.

Each milliliter contains 0.5 mg of azelastine hydrochloride.

Each drop contains 0.018 mg of azelastine hydrochloride.

• The other components are:

Solution of sorbitol at 70% (non-crystallizable), hypromellose, disodium edetate, sodium hydroxide, and water for injectable preparations.

Appearance of Vividrin and contents of the package

This medication is an colorless and transparent solution that is presented in a single-dose LDPE transparent container with a volume of 0.6 ml.

Each carton contains 10, 20, 30, or 60 single-dose containers.

Only some sizes of containers may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Local Representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 4

28108 Alcobendas

Madrid. Spain.

Tel: 91 – 657 63 00

Responsible for manufacturing:

DR. GERHARD MANN. CHEM.

Brunsbütteler Damm 165/173,

13581 Berlin.

Germany

This medication is authorized in the member states of the European Economic Area with the following names:

NL:Azelergo0.5 mg/ml oogdruppels, oplossing

LU:Azelergo0.5 mg/ml collyre en solution en récipient unidose

PT:Vivilin

ES:Vividrin 0.5 mg/ml colirio en solución en envase unidosis

EE:Vividrin

This prospectus has been reviewed as ofMay 2021

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