TEBARAT 0.5 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

Tebarat 0.5 mg/ml eye drops, solution in single-dose containers

Azelastine hydrochloride

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

• 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Tebarat and what is it used for

Tebarat contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antiallergics (antihistamines).

Antihistamines prevent the effects of substances like histamine, which the body produces as part of an allergic reaction. Azelastine has been shown to reduce ocular inflammation.

Tebarat is used for the treatment and prevention of ocular disorders caused by hay fever (seasonal allergic conjunctivitis) in adults and children from 4 years of age.

Tebarat is also used for the treatment of ocular disorders caused by allergy to substances such as house dust mites or animal hair (perennial allergic conjunctivitis) in adults and children from 12 years of age.

You should consult your doctor if your symptoms worsen or do not improve after 2 days.

Tebarat is not suitable for the treatment of ocular infections.

2. What you need to know before you use Tebarat

Do not use Tebarat:

• If you are allergic (hypersensitive) to the active substance (azelastine) 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 Tebarat:

• If you are not sure that your ocular 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 your symptoms worsen or last for more than 48 hours without significant improvement, despite using Tebarat.

It is recommended not to wear contact lenses until the signs and symptoms of allergic conjunctivitis have disappeared.

Children and adolescents

For the treatment of ocular disorders caused by hay fever (seasonal allergic conjunctivitis): Do not administer this medicine to children under 4 years of age, as the safety and efficacy have not been established.

For the treatment of ocular disorders caused by allergy (perennial allergic conjunctivitis): Do not administer this medicine to children under 12 years of age, as the safety and efficacy have not been established.

Using Tebarat with other medicines

Although it is not known if Tebarat can interact with other medicines, inform your doctor or pharmacist if you are using, have recently used or might use any other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

After applying Tebarat, your vision may become blurred for a short time. If this happens, wait until your vision returns to normal before driving or using machines.

3. How to use Tebarat

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Remember:

Tebarat should only be applied to the eyes.

The recommended dose is:

Ocular disorders caused by seasonal allergic conjunctivitis

• Use in adults and children from 4 years of age.
• The recommended 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 Tebarat as a preventive measure before going outside.

Ocular disorders caused by perennial allergic conjunctivitis

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

Relief from the symptoms of allergic conjunctivitis should be observed within 15-30 minutes.

Instructions for the proper use of Tebarat

To facilitate the application of the eye drops, it may be helpful to sit in front of a mirror so that you can see what you are doing. Administer Tebarat to your child or to other people who you think are unable to do so properly.

Duration of treatment

If possible, you should use Tebarat regularly until your symptoms have disappeared.

Do not use Tebarat for more than 6 weeks.

If you use more Tebarat than you should

If you have administered too much Tebarat in your eyes, you are unlikely to have problems.

Generally, overdosing does not produce side effects. However, if you have applied an excessive amount of product and are concerned about this, consult your doctor. In case of accidental ingestion, consult your doctor, pharmacist or call the Toxicology Information Service, phone 91 562 04 20, or go to the Emergency Department of the nearest hospital.

If you forget to use Tebarat

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

Do not use a double dose to make up for forgotten doses.

If you stop using Tebarat

If you stop using Tebarat, your symptoms will probably come back.

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

4. Possible side effects

Like all medicines, Tebarat 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 Tebarat. 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 (rash and itching).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines Agency website: http://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tebarat

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

Store the vial in its carton to protect it from moisture.

Once the ampoule is opened, the medicine must be used within 12 hours. Any unused contents must be discarded.

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

The shelf life after opening the sachet is 3 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Tebarat

• The active substance is azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg of azelastine hydrochloride.
• The other ingredients are hypromellose, liquid sorbitol, disodium edetate, sodium hydroxide, polyvinyl alcohol and purified water.

Appearance and packaging of the product

Tebarat is an aqueous sterile solution without preservative; clear, colorless and comes in packs of 10, 20, 30 and 40 single-dose containers.

Each single-dose container contains 0.25 ml of solution. The single-dose containers should be kept in the aluminum sachet for greater protection.

Not all pack sizes may be marketed.

Marketing authorisation holder

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona – Spain

Manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona – Spain

Or

PHARMALOOP, S.L.

C/Bolivia, 15 – Polig Industrial Azque

28806 Alcalá de Henares – Madrid (Spain)

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

Date of last revision of this package leaflet: October 2021.

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