EBASTINE ALTER 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Ebastina Alter 10 mg film-coated tablets EFG

ebastina

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 of illness as you.
• If you experience any 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 Ebastina Alter and what is it used for
2. What you need to know before taking Ebastina Alter
3. How to take Ebastina Alter
4. Possible side effects
5. Storage of Ebastina Alter
6. Package contents and additional information

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

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

Ebastina 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 Ebastina Alter

Do not take Ebastina Alter

• if you are allergic to the active substance of this medicine 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 take ebastina.

This medicine 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 Ebastina Alter" section).

if you are being treated with a type of medicine used to treat fungal infections called azole antifungals or with medicines used to treat certain infections called macrolide antibiotics (see "Taking ebastina with other medicines" section).

• if you are being treated with rifampicin, a type of medicine used to treat tuberculosis.

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

Children

Ebastina 10 mg film-coated tablets should not be administered to children under 12 years of age.

Other medicines and Ebastina Alter

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

The following medicines may interfere 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 medicines used to treat allergies (antihistamines).

• Ebastina should be used with caution in patients being treated with medicines 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 antihistaminic effect of ebastina may be reduced in patients being treated with a medicine 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 5-7 days after discontinuing treatment.

Ebastina Alter with food and drinks

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 medicine.

Pregnancy

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

Breastfeeding

It is unknown 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 machinery 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 machinery.

Ebastina Alter 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 Ebastina Alter

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

Remember to take your medicine.

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

Ebastina 10 mg film-coated tablets are not suitable for administration of doses less than 10 mg of ebastina, nor for patients with swallowing problems.

Dosage:

Use in adults and children over 12 years:The recommended dose is 1 tablet (10 mg of ebastina) once a day.

Use in patients with severe liver disease:The dose should not exceed 10 mg of ebastina per day (1 tablet).

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 ebastina is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastina 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 medicine and the amount taken) or go to the nearest hospital. 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 Ebastina Alter

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then follow your usual 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 Ebastina Alter

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

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

4. Possible side effects

Like all medicines, ebastina 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
• 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 of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, 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 Ebastina Alter

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

No special storage conditions are required.

Do not use ebastina after the expiration date stated on the packaging. 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 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 Ebastina Alter 10 mg tablets

• The active substance is ebastina. Each tablet contains 10 mg of ebastina.
• 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

Ebastina Alter is presented in the form of white film-coated tablets for oral administration. Each PVC/Aluminum blister pack contains 20 tablets of 10 mg.

Other presentations

Ebastina Alter 20 mg film-coated tablets EFG

Marketing authorization holder and manufacturer

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

Date of last revision of this leaflet:November 2024

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