Leaflet: information for the user

Ebastina Teva Group 20 mg film-coated tablets EFG

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

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

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

Ebastina belongs to a group of medications called antihistamines (antiallergics).

This medication is used to relieve nasal (stuffy nose, sneezing, runny nose, nasal congestion) and ocular (red, itchy eyes) symptoms associated with seasonal and perennial allergic rhinitis, for adults and adolescents 12 years and older, when a dose of 10 mg is not sufficient.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not take Ebastina Teva Group

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

Warnings and precautions

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

• if your electrocardiogram results are altered (prolongation of the QT interval).
• if you have high levels of potassium in your blood.
• if you have severe liver disease (see "How to take Ebastina Teva Group").
• 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 Ebastina Teva Group with other medications").
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

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

In case you experience symptoms such as throat constriction, difficulty breathing, hoarseness, or difficulty speaking, wheezing ("popping" sounds while breathing), low blood pressure, repeated vomiting, and/or loss of consciousness, seek urgent medical assistance due to the risk of anaphylaxis.

Children

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

Taking Ebastina Teva Group with other medications

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

The following medications may interact with ebastina; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

• Ebastina may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastina 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 your electrocardiogram).
• The antihistamine effect of ebastina may be reduced in patients being treated with a medication called rifampicin, used to treat tuberculosis.

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

Interference with diagnostic tests

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

Taking Ebastina Teva Group with food and drinks

This medication can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 ebastina. They 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 operating machinery

In men, no effects have been observed on psychomotor function, or on the ability to drive or operate machinery at the recommended therapeutic doses. However, given that drowsiness and dizziness are among the adverse effects, observe your response to the medication before driving or operating machinery.

Ebastina 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.

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

Dosage

Use in adults and adolescents over 12 years:

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

Use in patients with severe liver disease:

Do not exceed a dose of 10 mg of ebastina per day. In this case, it is recommended to use the 10 mg presentation (ebastina 10 mg tablets).

Administration form

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 Ebastina Teva Group than you should

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. Bring the remaining tablets, the packaging, and the complete box so that healthcare personnel can identify the medication taken more easily.

If you forgot to take Ebastina Teva Group

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then follow the usual schedule. However, if there are only a few hours left until the next dose, do not take the missed dose and wait to take the next dose at the scheduled time.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

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

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

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

• Headache.

Frequent (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 (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin),
• Urticaria, skin rash, dermatitis,
• Menstrual disorders,
• Edema(swelling due to fluid accumulation), fatigue.

Unknown frequency (cannot be estimated from available data):

-Weight gain,

-Increased appetite.

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 Medicines for Human Use: https://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.

This medication does not require special storage conditions.

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

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

Ebastina CompositionTeva Group

• The active ingredient is ebastina. Each tablet contains 20 mg of ebastina.
• The other components (excipients) are: Lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, povidone 30, polisorbate 80, magnesium stearate, hypromellose, titanium dioxide (E171), and triacetin.

Product appearance and packaging contents

Ebastina Teva Group is presented in the form of coated tablets with a white, lenticular film. Each PVC/Aluminum blister pack contains 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Alcobendas 28108, Madrid (Spain)

Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

Last review date of this leaflet:December 2022

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