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

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

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

Azelastine hydrochloride

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Tebarat is and what it is used for

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

Antihistamines prevent the effects of substances such as histamine that 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 eye disorders caused by hay fever (seasonal allergic conjunctivitis) in adults and children aged 4 years and older.

Tebarat is also used for the treatment of eye disorders caused by allergies to substances such as house dust mites or animal fur (perennial allergic conjunctivitis) in adults and children aged 12 years and older.

You should consult your doctor if your condition worsens or does not improve after 2 days.

Tebarat is not suitable for the treatment of eye infections.

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

Do not use Tebarat:

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

• 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 Tebarat.

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

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 safety and efficacy have not been established.

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

Use of Tebarat with other medicines

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

Pregnancy and breastfeeding

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

Driving and using machines

After applying Tebarat, your vision may become blurred for a short period of time. If this occurs, wait until your vision returns to normal before driving or operating machinery.

3. How to use Tebarat

Always follow exactly the instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Please remember:

Tebarat should only be applied to the eyes.

Recommended dose:

Ocular disorders caused by seasonal allergic conjunctivitis

• For use in adults and children aged 4 years and older.
• The recommended dose is one drop in each eye, morning and evening.

If you anticipate exposure to pollen, you may administer the normal dose of Tebarat before going outdoors as a preventive measure.

Ocular disorders caused by allergy (perennial non-seasonal allergic conjunctivitis)

• For use in adults and children aged 12 years and older.
• The recommended dose is one drop in each eye, morning and evening.

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

Relief of allergic conjunctivitis symptoms should occur within 15 to 30 minutes.

Instructions for the proper use of Tebarat

To facilitate the administration of the eye drops, it may be helpful to sit in front of a mirror the first few times, so you can see what you are doing. Administer Tebarat to your child or to other individuals whom you believe 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 longer than 6 weeks.

If you use more Tebarat than you should

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

Overdosing usually does not cause adverse effects. However, if an excessive amount of the product has been applied and you are concerned, consult your doctor. In case of accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, or go to the nearest hospital emergency department.

If you forget to use Tebarat

Use your eye drops as soon as you remember, and then administer the next dose at your usual scheduled 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 are likely to return.

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

4. Possible adverse effects

Like all medicines, Tebarat may produce adverse effects, although not everyone will experience them.

These effects include:

• Common (may affect between 1 and 10 out of 100 patients treated): Mild eye irritation (stinging, itching, tearing) after using Tebarat. These effects should not last long.
• Uncommon (may affect between 1 and 10 out of 1,000 patients treated): Bitter taste in the mouth. This effect should disappear quickly, especially if you drink a beverage.
• Very rare (may affect less than 1 out of 10,000 patients treated): Allergic reaction (rash and itching).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es.

By reporting adverse 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 inside its box to protect it from moisture.

After opening the ampoule, the medicine should be used within 12 hours. Any unused portion must be discarded.

Do not use this medicine after the expiry date which is stated on the box after EXP. The expiry date refers to the last day of the month indicated.

The shelf life after opening the sachet is 3 months.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other 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 components are hypromellose, liquid sorbitol, disodium edetate, sodium hydroxide, polyvinyl alcohol, and purified water.

Appearance of the product and contents of the pack

Tebarat is a sterile, preservative-free aqueous eye drop solution; transparent and colourless, available in pack sizes of 10, 20, 30, and 40 single-dose units.

Each single-dose unit contains 0.25 ml of solution. The single-dose units must be kept within the aluminium pouch for added protection.

Not all pack sizes mentioned above may be marketed.

Marketing Authorization 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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: October 2021.

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