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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

azelastine hydrochloride

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• If you do not feel better or if your condition worsens after 48 hours, consult your doctor.

Contents of the leaflet

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

1. What Vividrin is and what it is used for

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

This medicine is used in the following situations:

• Treatment and prevention of ocular disorders caused by hay fever (seasonal allergic conjunctivitis) in adults and children from 4 years of age.
• Treatment of ocular disorders caused by allergy to house dust mites or animal dander (perennial allergic conjunctivitis) in adults and children from 12 years of age.

This medicine is not suitable for the treatment of ocular infections.

2. What you need to know before starting to use Vividrin

Do not use Vividrin:

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

Warnings and precautions

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

• If you are unsure whether your eye symptoms are caused by an allergy. In particular, if only one eye is affected, if your vision has worsened, or if you have eye pain without nasal symptoms, this may be an infection rather than an allergy.
• If symptoms worsen or last longer than 48 hours without significant improvement despite using this medicine.
• If you wear contact lenses.

Children and adolescents

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

This medicine must not be used in children under 12 years of age for the treatment of eye disorders caused by allergy to house dust mites or animal hair (perennial allergic conjunctivitis).

Other medicines and Vividrin

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

It is unknown whether this medicine may be affected by other medicines.

Pregnancy, breastfeeding and fertility

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

Driving and using machines

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

3. How to use Vividrin

Follow exactly the instructions for using this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember: this medicine is for use in the eyes only.

The recommended dose is:

Eye disorders caused by hay fever (seasonal allergic conjunctivitis)

Use in adults and children from 4 years of age.

The usual dose is one drop in each eye, morning and evening.

If you anticipate exposure to pollen, you may take the usual dose of this medicine before going outdoors as a preventive measure.

Eye disorders caused by allergy (non-seasonal [perennial] allergic conjunctivitis)

Use in adults and children from 12 years of age.

The usual dose is one drop in each eye, morning and evening.

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 (applying the eye drops)

To help ensure correct application of the eye drops, it may be helpful the first few times to sit in front of a mirror so you can see what you are doing.

1. Wash your hands.

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

3. Carefully separate one single-dose unit from the top of the strip (Fig. 1) and open it. Twist and separate the top part of the single-dose unit (without pulling it off) (Fig. 2).

4. Tilt your head backwards.

Fig. 1 Fig. 2

1. Gently pull down the lower eyelid.
2. Carefully place one drop into the middle of the lower eyelid. Make sure the container does not touch the eye to avoid contamination (Fig. 3).

Fig. 3.

1. Release the lower eyelid and gently press the inner corner of the eye against the bridge of the nose. While pressing the nose with your finger, blink slowly several times to help spread the drop across the eye surface.
2. Wipe away any excess medicine with a tissue.
3. Repeat the procedure with the other eye.

Duration of treatment

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

Do not use this medicine for longer than 6 weeks.

If you use more Vividrin than you should:

If you accidentally use too much Vividrin in your eye, you are unlikely to have any problems. If you have any concerns, consult your doctor. In case of accidental ingestion of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to use Vividrin

Use your eye drops as soon as you remember. Then apply the next dose at the usual scheduled time. Do not use a double dose to make up for a forgotten dose.

If you stop using Vividrin

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

Mild eye irritation (stinging, itching, tearing) after using this medicine. 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 beverage.

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

Allergic reaction (such as rash and itching).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the cardboard box and on the container, following «EXP».

Use the single-dose container only once.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at 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 will help protect the environment.

Do not store above 25 °C.

6. Contents of the pack and other information

Composition of Vividrin

• The active substance is azelastine hydrochloride.

Each millilitre contains 0.5 mg of azelastine hydrochloride.

Each drop contains 0.018 mg of azelastine hydrochloride.

• The other components are:

70 % sorbitol solution (non-crystallisable), hypromellose, disodium edetate, sodium hydroxide and water for injections.

Appearance of Vividrin and contents of the pack

This medicine is a colourless and transparent solution supplied in single-dose containers made of transparent LDPE with a volume of 0.6 ml.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

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

Manufacturer:

DR. GERHARD MANN. CHEM.

Brunsbütteler Damm 165/173,

13581 Berlin.

Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Azelergo 0.5 mg/ml eye drops, solution

LU: Azelergo 0.5 mg/ml eye drops solution in single-dose container

PT: Vivilin

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

EE: Vividrin

This leaflet was last reviewed in May 2021

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