Package Leaflet: Information for the User

Tebarat 0.5 mg/mL eye drops in single-dose containers

Azelastine hydrochloride

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

• Keep this leaflet, as 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, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Tebarat contains the active ingredient, hydrochloride of azelastine, which belongs to a group of medications 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 demonstrated a reduction in ocular inflammation.

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

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

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

Tebarat is not suitable for the treatment of ocular infections..

You should not use Tebarat:

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tebarat:

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

Children and adolescents

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

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

Using Tebarat with other medications

Although it is unknown whether Tebarat may interact with other medications, inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

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

Driving and operating machinery

After applying Tebarat, your vision may become blurry for a short period of time. If this happens, wait for your vision to return to normal before driving or operating machinery.

Follow exactly the instructions for this medication as indicated by 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:

Allergic conjunctivitis seasonal

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

Allergic conjunctivitis (perennial) non-seasonal

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 be observed within 15-30 minutes.

Instructions for proper use of Tebarat

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

Treatment duration

Use Tebarat regularly until your symptoms have disappeared, if possible.

Do not use Tebarat for more than 6 weeks.

If you use more Tebarat than you should

If you have administered too much Tebarat to your eyes, you are likely to have no problems.

Generally, overdosing does not produce adverse effects. However, if you have applied excessive amounts of the product and are concerned for this reason, consult your doctor. In case of accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, or go to the nearest hospital emergency room.

If you forget to use Tebarat

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

Do not use a double dose to compensate for missed doses.

If you interrupt treatment with Tebarat

If you stop using Tebarat, your symptoms are likely to recur.

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

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

These effects include:

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usehttp://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.

Store the vial within its box to protect it from moisture.

Once the ampule is opened, the medication must be used before 12 hours. Any unused content must be discarded.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Expiration, once the package is opened, is 3 months.

Medications should not be disposed of through drains or trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Tebarat

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

Appearance of the product and contents of the package

Tebarat is a sterile, preservative-free aqueous solution eye drop; transparent, colorless, and is available in formats 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 stored within the aluminum overwrap for greater protection.

It may be that not all product formats mentioned above are marketed.

Holder of the marketing authorization

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona – Spain

Responsible for manufacturing

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

Last review date of this leaflet: October 2021.

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