EBASTINE ALTER 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ebastine Alter 20 mg Film-Coated Tablets EFG

ebastine

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• 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.

Package Leaflet Contents:

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

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

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

Ebastine is indicated for the treatment of symptoms 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 Alter

Do not take Ebastine Alter

• if you are allergic to the active substance of this medication 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 take ebastine.

This medication should be used with caution:

• if your electrocardiogram results are altered (prolongation of the QT interval).
• if you have altered potassium levels in your blood.
• if you have severe liver disease (see "How to take Ebastine").
• 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 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 have an acute allergic emergency, as ebastine (the active substance of this medication) takes 1 to 3 hours to take effect

Children

Ebastine 20 mg Tablets should not be administered to children under 12 years of age.

Other medications and Ebastine Alter

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

The following medications may interfere with ebastine; in these cases, it may be necessary to change the dose or discontinue treatment with 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 your 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 5-7 days after discontinuing treatment.

Taking Ebastine Alter with food and beverages

The tablets 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

In humans, no effects have been observed on psychomotor function or the ability to drive or operate machines at the recommended therapeutic doses. However, observe your response to the medication, as somnolence has occurred at usual doses in some cases. If this happens, refrain from driving and operating hazardous machinery.

Ebastine Alter 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 Alter

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

Remember to take your medication.

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

Dosage:

Use in adults and children over 12 years:The recommended dose is 1 tablet (10 mg of ebastine) 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 think the effect of Ebastine is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastine Alter 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) and go to the nearest hospital. Bring the remaining tablets, the box, and the complete package so that the healthcare staff can more easily identify the medication you have taken.

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

If you forget to take Ebastine Alter

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 your next scheduled dose.

If you stop taking Ebastine Alter

Your doctor will indicate the duration of your treatment with ebastine. Do not stop treatment before then, as your symptoms may worsen.

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

4. Possible side effects

Like all medications, ebastine can cause side effects, although not everyone experiences 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):

-Somnolence

-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
• 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, pharmacist, or nurse, even if they are possible side effects 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 Alter

Keep ebastine out of the sight and reach of children.

No special storage conditions are required.

Do not use ebastine after the expiration date stated on the package. 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 collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ebastine Alter 20 mg Tablets

• The active substance is ebastine. Each tablet contains 20 mg of ebastine.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, povidone 30, polysorbate 80, magnesium stearate, hypromellose, titanium dioxide (-171), and glycerol triacetate.

Appearance of the product and package contents

Ebastine Alter is presented in the form of white film-coated tablets for oral administration. Each PVC/Aluminum blister pack contains 20 tablets of 20 mg.

Other presentations

Ebastine Alter 10 mg film-coated tablets EFG

Marketing Authorization Holder and Manufacturer

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

Date of the last revision of this package leaflet:November 2024

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