Label: Information for the user

Tebarat 1 mg/ml nasal spray solution

Azelastine hydrochloride

Read this label carefully before starting to use this medicine because it contains important information for you.

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

Tebarat contains azelastine hydrochloride, which belongs to a group of medicationsknown as antihistamines.

Antihistamines prevent the effects of substances such as histamine and other substances the body produces as part of an allergic reaction, which cause symptoms like sneezing, runny nose, itching, or nasal obstruction. Azelastine hydrochloride also has an additional anti-inflammatory effect.

Tebarat is used for the treatment of symptoms of seasonal allergic rhinitis and acute exacerbations (attacks) of perennial allergic rhinitis in adults, adolescents, and children aged 6 years and older.

You should not use Tebarat

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tebarat, if you are unsure whether your symptoms are caused by an allergy.

Children and adolescents

Tebarat is not recommended for children under 6 years old.

Other medications and Tebarat

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

No specific interactions have been studied.

Pregnancy, breastfeeding, and fertility

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

Due to the nasal administration route and low doses administered, minimal systemic (general) exposure is expected. However, as with all medications, precautions should be taken during use in pregnancy and breastfeeding.

Driving and operating machinery

No effects on the ability to drive or operate machinery have been described with the use of Tebarat.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose (adults and children over 6 years old) is a spray (0.14 ml) of Tebarat in each nasal passage, twice a day. This corresponds to a daily dose of 0.56 mg of azelastine hydrochloride.

Use in elderly people: no specific studies have been conducted.

Usage instructions

If you use more Tebarat than you should

If you have sprayed too much Tebarat into your nasal passages, consult your doctor or pharmacist.

No adverse effects of overdose are anticipated with nasal administration.

Animal studies show that toxic doses can produce symptoms on the Central Nervous System, such as e.g. excitement, tremor, convulsions. If this occurs in humans, symptomatic and supportive treatment will be initiated. If the overdose is recent, a gastric lavage is recommended.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Tebarat

Do not take a double dose to compensate for the missed doses.

If you forgot to use your medication, use it as soon as you remember and take the next dose 12 hours later, if necessary.

If you interrupt treatment with Tebarat

Do not stop treatment abruptly.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

These effects include:

• Frequent (may affect up to 1 in 10 people): a bitter taste may appear after administration due to incorrect application, for example, with the head too far back during administration.
• Infrequent (may affect up to 1 in 100 people): irritation of the nasal mucosa may occur with symptoms such as itching, sneezing, runny nose, and epistaxis (small nasal hemorrhages).
• Rare (may affect up to 1 in 1,000 people): nausea.
• Very rare (may affect up to 1 in 10,000 people): hypersensitivity, dizziness, fatigue, weakness, rash, pruritus, urticaria.

Reporting 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 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 on the safety of this medication.

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

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

Do not use Tebarat after 60 days of opening the bottle.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tebarat

• The active ingredient isazelastina hydrochloride1 mg per ml.
• The other components arehypromellose,disodium edetate,citric acid,hydrogen phosphateof sodium heptahydrate, sodium chloride, and purified water.

Appearance of the product and content of the container

Tebarat is a colorless and transparent solution that is presented in amber glass bottles of 20ml provided with a dosing valve, containing a nasal spray solution.

Holder of the marketing authorization

Laboratorios Salvat, S.A.

Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona – Spain

Responsible for manufacturing

Pharmaloop, S.L.

C/ Bolivia, 15 – Polig Industrial Azque

28806 Alcalá de Henares

Madrid – Spain

Laboratorios Salvat, S.A.

C/ Gall, 30-36

08950 – Esplugues de Llobregat (Barcelona)

Spain

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

SpainTebarat 1 mg/ml nasal spray solution

ItalyTebarat

PortugalTebarat 1 mg/ml nasal spray solution

Revision date of this leaflet:

August 2022

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