EBASTINE TEVAGEN 20 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Ebastine Tevagen 20 mg film-coated tablets EFG

Read this leaflet carefully before starting to take 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if they have the same symptoms as you.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Ebastine Tevagen and what is it used for
2. What you need to know before taking Ebastine Tevagen
3. How to take Ebastine Tevagen
4. Possible side effects
5. Storage of Ebastine Tevagen
6. Package contents and additional information

1. What is Ebastine Tevagen and what is it used for

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

Ebastine is indicated for the symptomatic treatment of allergic processes such as:

• seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, sneezing),
• chronic urticaria,
• allergic dermatitis.

2. What you need to know before taking Ebastine Tevagen

Do not take Ebastine Tevagen

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

Warnings and precautions

Consult your doctor or pharmacist before taking ebastine:

This medicine should be used with caution:

• if your electrocardiogram results are altered (prolongation of the QT interval),
• if you have high potassium levels in your blood,
• if you have a severe liver disease (see section "How to take Ebastine Tevagen"),
• if you are being treated with a type of antifungal medication called azoles or with antibiotics called macrolides (see section "Taking Ebastine Tevagen with other medicines"),
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

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

Children

Ebastine should not be given to children under 12 years of age. In this age group, it is recommended to administer ebastine 1 mg/ml oral solution.

Other medicines and Ebastine Tevagen

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

The following medicines may interact with ebastine, and it may be necessary to change the dose or discontinue treatment with one of them:

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

No interactions have been reported 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 stopping treatment.

Taking Ebastine Tevagen with food and drinks

This medicine can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Driving and using machines

In humans, 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 Tevagen contains lactose

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

3. How to take Ebastine Tevagen

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with ebastine.

Dosage

Use in adults and adolescents over 12 years:

The recommended dose is 10 mg of ebastine once a day, although some patients may require 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. In this case, it is recommended to use the 10 mg presentation (ebastine 10 mg tablets).

Method of administration

This medicine is for oral administration.

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

If you think the effect of ebastine is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastine Tevagen than you should

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

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

If you forget to take Ebastine Tevagen

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 almost 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects have been observed in clinical trials and post-marketing experience:

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 or sensitivity, decreased or altered taste,
• palpitations, tachycardia,
• abdominal pain, vomiting, nausea, digestive problems,
• liver inflammation (hepatitis), cholestasis, abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase, and bilirubin),
• urticaria, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Tevagen

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Ebastine Tevagen

• The active ingredient is ebastine. Each tablet contains 20 mg of ebastine.
• The other ingredients (excipients) are:

Core: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (from corn), povidone 30, polysorbate 80, magnesium stearate,

Coating: hypromellose, titanium dioxide (E171), glycerol triacetate.

Appearance of the product and package contents

Ebastine Tevagen is presented in the form of white, lenticular-shaped film-coated tablets.

Each PVC/Aluminum blister pack contains 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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 leaflet: March 2022

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