Tebarat 1 mg/ml nasal spray solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tebarat 1 mg/ml nasal spray solution

azelastine hydrochloride

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

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

Leaflet contents:

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. Storage of Tebarat
6. Contents of the pack and additional information

1. What Tebarat is and what it is used for

Tebarat contains azelastine hydrochloride, which belongs to a group of medicines called antihistamines.

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

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

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

Do not use Tebarat

If you are allergic to the active substance (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 Tebarat if you are unsure whether your condition is caused by an allergy.

Children and adolescents

Tebarat is not recommended for children under 6 years of age.

Other medicines and Tebarat

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

Specific interactions have not been studied.

Pregnancy, breastfeeding and fertility

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.

Due to the nasal route of administration and the low doses administered, minimal systemic (general) exposure is expected. However, as with all medicines, precautions should be taken when using this medicine during pregnancy and breastfeeding.

Driving and use of machines

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

3. How to use Tebarat

Always follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose (for adults and children over 6 years of age) is one spray (0.14 ml) of Tebarat in each nostril, twice daily. This corresponds to a daily dose of 0.56 mg of azelastine hydrochloride.

Use in elderly patients: specific studies have not been conducted.

Instructions for use

If you use more Tebarat than you should

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

Overdose reactions are not expected with nasal administration.

Animal studies show that toxic doses may produce effects on the Central Nervous System, such as excitement, tremor, or convulsions. If this were to occur in humans, symptomatic and supportive treatment would be initiated. If the overdose is recent, gastric lavage is recommended.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Tebarat

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

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

If you stop using Tebarat

Do not stop treatment abruptly.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody experiences them.

These effects include:

• Common (may affect up to 1 in 10 people): a bitter taste may occur after administration, frequently due to incorrect application, for example, with the head tilted too far backwards during administration.
• Uncommon (may affect up to 1 in 100 people): nasal mucosa irritation may occur, with symptoms such as burning, itching, sneezing, epistaxis (minor nosebleeds).
• 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 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 can 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.

Do not use this medicine after the expiry date stated on the label of the bottle and on the outer carton after EXP. The expiry date refers to the last day of the month indicated.

Do not use Tebarat more than 60 days after opening the bottle.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Tebarat

• The active substance is azelastine hydrochloride 1 mg per ml.
• The other components are hypromellose, disodium edetate, citric acid, sodium hydrogen phosphate heptahydrate, sodium chloride, and purified water.

Appearance of the medicinal product and contents of the container

Tebarat is a clear, colourless solution available in 20 ml amber glass bottles equipped with a metering valve, containing a nasal spray solution.

Marketing Authorisation Holder

Laboratorios Salvat, S.A.

Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona – Spain

Manufacturer

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

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

Spain Tebarat 1 mg/ml solution for nasal spray

Italy Tebarat

Portugal Tebarat 1 mg/ml solution for nasal spray

Date of the most recent revision of this leaflet:

August 2022

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