EBASTINE TEVA GROUP 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ebastine Teva Group 10 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

Contents of the Package Leaflet:

1. What is Ebastine Teva Group and what is it used for
2. What you need to know before taking Ebastine Teva Group
3. How to take Ebastine Teva Group
4. Possible side effects
5. Storage of Ebastine Teva Group
6. Package Contents and Additional Information

1. What is Ebastine Teva Group and what is it used for

Ebastine belongs to a group of medications called antihistamines (anti-allergics).

This medication is used to relieve nasal symptoms (sneezing, nasal itching, nasal discharge, nasal congestion, urge to sneeze) and eye symptoms (red and tearful eyes) associated with seasonal and perennial allergic rhinitis, for adults and adolescents from 12 years old.

You should consult a doctor if your condition worsens or does not improve after 7 days.

2. What you need to know before taking Ebastine Teva Group

Do not take Ebastine Teva Group

• if you are allergic to ebastine or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ebastine Teva Group:

• if your electrocardiogram results are altered (prolongation of the QT interval).
• if you have high potassium levels in your blood.
• if you suffer from severe liver disease (see "How to take Ebastine Teva Group" section).
• if you are being treated with a type of medication used to treat fungal infections called azole antifungals or with medications used to treat certain infections called macrolide antibiotics (see "Taking Ebastine Teva Group with other medications" section).
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

Do not use this medication if you have an acute allergic emergency, as ebastine (the active ingredient of this medication) takes 1 to 3 hours to take effect.

In case you experience symptoms such as throat tightness, difficulty breathing, hoarseness, or difficulty speaking, wheezing, low blood pressure, repeated vomiting, and/or loss of consciousness, you should seek urgent medical attention due to the risk of anaphylaxis.

Children

Ebastine Teva Group should not be administered to children under 12 years old.

Taking Ebastine Teva Group with other medications

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

The medications mentioned below may interfere with ebastine; in these cases, it may be necessary to change the dose or interrupt treatment of one of them:

• Ebastine may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastine should be used with caution in patients being treated with medications called ketoconazole and itraconazole, used to treat fungal infections, or with an antibiotic used to treat certain infections called erythromycin (as they may cause an alteration in the electrocardiogram),
• The antihistamine effect of ebastine may be decreased in patients being treated with a medication called rifampicin used to treat tuberculosis.

No interactions have been described between ebastine and theophylline, warfarin, cimetidine, diazepam, and alcohol.

Interference with diagnostic tests

Ebastine may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5 to 7 days after treatment has been discontinued.

Taking Ebastine Teva Group with food and beverages

This medication can be taken with or without food.

Pregnancy and Breastfeeding

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.

Pregnancy

There is no experience in pregnant women, so it is recommended to consult a doctor before taking ebastine. The doctor will decide whether or not to start treatment.

Breastfeeding

It is unknown whether the medication passes into breast milk, so it should not be used during breastfeeding.

Driving and using machines

No effects have been observed on psychomotor function or the ability to drive or use machines at the recommended therapeutic doses. However, since drowsiness and dizziness are among the side effects, observe your response to the medication before driving or using machines.

Ebastine Teva Group contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Ebastine Teva Group

Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

This medication is not suitable for administration of doses less than 10 mg of ebastine, nor for patients with swallowing problems.

Dosage

Use in adults and adolescents over 12 years old

The recommended dose is 1 tablet (10 mg of ebastine) once a day, although some patients may need a dose of 20 mg once a day.

Use in patients with severe liver disease

The dose should not exceed 10 mg of ebastine per day (1 tablet).

Method of administration:

This medication is for oral administration.

The tablets can be taken with or without food, with the help of a glass of water.

If you take more Ebastine Teva Group than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the remaining tablets, the box, and the complete package so that healthcare personnel can more easily identify the medication you have taken.

Treatment for poisoning with this medication consists of gastric lavage and administration of appropriate medication.

If you forget to take Ebastine Teva Group

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

Take the forgotten dose when you remember and then follow your regular schedule. However, if it is close to the time for your next dose, do not take the forgotten dose and wait for the next scheduled dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

In clinical trials and post-marketing experience, the following side effects have been observed:

Very common (may affect more than 1 in 10 people):

• headache.

Common (may affect up to 1 in 10 people):

• drowsiness,
• dry mouth.

Rare (may affect up to 1 in 1,000 people):

• hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema),
• nervousness, insomnia,
• dizziness, decreased sensation of touch or sensitivity, decreased or altered taste,
• palpitations, tachycardia,
• abdominal pain, vomiting, nausea, digestive problems,
• liver inflammation (hepatitis), reduction or obstruction of bile flow from the liver (cholestasis), abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase, and bilirubin),
• hives, skin rash, dermatitis,
• menstrual disorders,
• edema (swelling due to fluid accumulation), fatigue.

Frequency not known (cannot be estimated from available data):

• weight gain,
• increased appetite.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ebastine Teva Group

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ebastine Teva Group

• The active ingredient is ebastine. Each tablet contains 10 mg of ebastine.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, povidone 30, polysorbate 80, magnesium stearate, hypromellose, titanium dioxide (E171), and glycerol triacetate.

Appearance of the product and package contents

Ebastine Teva Group is presented in the form of white, lenticular-shaped film-coated tablets. PVC/Aluminum blister pack containing 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U. C/ Anabel Segura, 11 Edificio Albatros B 1ª planta

Alcobendas 28108, Madrid (Spain)

Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

Date of the last revision of this package leaflet:December 2022

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