VIVIDRIN 0.5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Vividrin 0.5 mg/ml Eye Drops Solution

azelastine hydrochloride

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• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Vividrin and what is it used for
2. What you need to know before you use Vividrin
3. How to use Vividrin
4. Possible side effects
5. Storage of Vividrin
6. Contents of the pack and further information

1. What is Vividrin and what is it used for

Vividrin contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antiallergics (antihistamines). Antihistamines prevent the effects of substances such as histamine, which the body produces as part of an allergic reaction. Azelastine has been shown to reduce ocular inflammation.

This medicine can be used for the treatment and prevention of ocular disorders caused by hay fever (seasonal allergic conjunctivitis, which manifests with redness, itching of the eyes or tearing) in adults and children from 4 years of age.

Vividrin can be used for ocular disorders caused by allergy to dust mites or animal hair (perennial allergic conjunctivitis) in adults and children from 12 years of age.

This medicine is a preservative-free solution.

2. What you need to know before you use Vividrin

Do not use Vividrin:

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

Warnings and precautions

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

• If you are not sure that 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, as it may be an infection rather than an allergy.
• If symptoms worsen or last more than 48 hours without significant improvement, despite using this medicine.
• If you wear contact lenses.

This medicine is not intended for the treatment of eye infections.

Children and adolescents

For the treatment of ocular disorders caused by hay fever (seasonal allergic conjunctivitis):

Do not give this medicine to children under 4 years of age, as its safety and efficacy have not been established.

For the treatment of ocular disorders caused by allergy (perennial allergic conjunctivitis):

Do not give this medicine to children under 12 years of age, as its safety and efficacy have not been established.

Other medicines and Vividrin

Although it is not known if Vividrin can be affected by other medicines, inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Pregnancy and breastfeeding

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

Driving and using machines

You may experience blurred vision for a short time when using Vividrin. If this happens, wait until your vision is clear before driving or using machinery.

Remove your contact lenses before applying the eye drops and wait at least 15 minutes before putting them back in.

3. How to use Vividrin

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Remember

• Vividrin should only be applied to the eyes.

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•Use in adults and children from 4 years of age.

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

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•Use in adults and children from 12 years of age.

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

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How to use Vividrin eye drops

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When you are about to use these eye drops, wash your hands well before opening the container and follow these steps:

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If you forget to use Vividrin

Use the eye drops as soon as you remember and apply the next dose at the usual time.

Do not apply a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These effects include:

• Common (may affect up to 1 in 10 people): mild irritation (stinging, itching, tearing) in the eyes after using this medicine. These effects should not last long.
• Uncommon (may affect up to 1 in 100 people): bitter taste in the mouth. This effect should disappear quickly, especially if you take a drink.
• Rare (may affect up to 1 in 10,000 people): allergic reaction (such as rash and itching).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vividrin

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

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date is the last day of the month stated.

Do not store above 25°C.

Do not freeze.

After opening:Do not use this medicine if the bottle was opened more than 3 months ago. This medicine should not be stored above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to a pharmacy for disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Vividrin

Each milliliter contains 0.5 mg/ml of azelastine hydrochloride. Each drop contains 0.0216 mg of azelastine hydrochloride.

The other ingredients are sorbitol, hypromellose, disodium edetate, sodium hydroxide, and purified water.

Appearance of the product and contents of the pack

Vividrin is a clear solution.

Vividrin is presented in a plastic bottle with a dispenser system and a cap. One bottle contains 10 ml of solution.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Bausch + Lomb Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer

Laboratoire Chauvin

Zone Industrielle De Ripotier

50 Avenue Jean Monnet

07200 Aubenas

France

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 4

28108 Alcobendas

Madrid, Spain.

Tel: 91 – 657 63 00

This medicine is authorised in the Member States of the EEA under the following names

Germany: Vividrin Azelastin MDO 0,5 mg/ml Augentropfen, Lösung

Austria: Vividrin Azelastin MDO 0,5 mg/ml Augentropfen, Lösung

Czech Republic: Ocuazel

Spain: Vividrin 0,5 mg/ml colirio en solución

Croatia: Vivialle 0,5 mg/ml kapi za oko, otopina

Hungary: Vivialle 0,5 mg/ml oldatos szemcsepp

Italy: Vividrin occhi 0,5 mg/ml collirio, soluzione

Poland: Azel-Drop Free

Portugal: Vivilin, 0.5 mg/ml Colírio, Solução

Slovakia: Ocuazel

Date of last revision of this package leaflet: February 2025

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