EBASTINE VIATRIS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ebastina Viatris 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.

• 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 as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ebastina Viatris and what is it used for
2. What you need to know before taking Ebastina Viatris
3. How to take Ebastina Viatris
4. Possible side effects
5. Storage of Ebastina Viatris
6. Contents of the pack and further information

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

Ebastina belongs to a group of medications called antihistamines.

Ebastina Viatris 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, itching of the nose, itching of the eyes, tearing, sneezing).
• Chronic urticaria.
• Allergic dermatitis.

2. What you need to know before taking Ebastina Viatris

Do not take Ebastina Viatris

• If you are allergic to ebastina 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 Ebastina Viatris.

This medication should be used with caution:

Do not use this medication if you have an acute allergic emergency, as ebastina (the active ingredient of this medication) 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 medications and Ebastina Viatris

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 Ebastina; in these cases, it may be necessary to change the dose or interrupt 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 5-7 days after treatment has been discontinued.

Taking Ebastina Viatris 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 medication.

.

Pregnancy

There is no experience in pregnant women, so it is recommended to consult a doctor before taking ebastina. 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 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 Viatris 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 Ebastina Viatris

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

Remember to take your medication.

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.

Posology:

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

If you take more Ebastina Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 914 620 420 (indicating the medication and the amount ingested) 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 medication you have taken.

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

If you forget to take Ebastina Viatris

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then continue with 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 have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Ebastina 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)

• 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.
• 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 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 help provide more information on the safety of this medication.

5. Storage of Ebastina Viatris

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging 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 packaging and any unused medication in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ebastina Viatris 10 mg

• The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, povidone 30, polysorbate 80, magnesium stearate (E470B), hypromellose (E464), titanium dioxide (E171), and glycerol triacetate.

Appearance of the product and packaging contents

Ebastina Viatris is presented in the form of white film-coated tablets. Each PVC/Aluminum blister pack contains 20 tablets.

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Laboratorios ALTER, S.A.

C/ Mateo Inurria, 30

28036 – Madrid

Spain

Date of the last revision of this package leaflet:MAY 2025

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