EBASTINE VIATRIS 20 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ebastine Viatris 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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 and must not be given to other people, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Ebastine belongs to a group of medicines known as antihistamines.

Ebastina Viatris is indicated for the symptomatic treatment of allergic conditions such as:

• Seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, and sneezing).
• Chronic urticaria.
• Allergic dermatitis.

2. What you need to know before taking Ebastine Viatris

Do not take Ebastine Viatris

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ebastine Viatris.

This medicine should be used with caution:

• If your electrocardiogram (ECG) results are abnormal (prolonged QT interval).
• If you have abnormal blood potassium levels.
• If you suffer from severe liver disease (see section “How to take Ebastine Viatris”).
• 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 section “Taking Ebastine Viatris with other medicines”).
• If you are being treated with rifampicin, a medicine used to treat tuberculosis.

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

Children

Ebastine 20 mg tablets should not be given to children under 12 years of age.

Other medicines and Ebastine Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may interact with Ebastine; in such cases it may be necessary to adjust the dose or discontinue treatment with one of them:

• Ebastine may enhance the effect of other medicines used to treat allergy (antihistamines).
• Ebastine should be used with caution in patients taking medicines called ketoconazole and itraconazole, used to treat fungal infections, or with a macrolide antibiotic used to treat certain infections called erythromycin (as they may cause abnormalities in your electrocardiogram).
• The antihistaminic effect of Ebastine may be reduced in patients taking a medicine called rifampicin, used to treat tuberculosis.

No interactions have been reported between ebastine and theophylline, warfarin, cimetidine, diazepam, or alcohol.

Interference with diagnostic tests

Ebastine may interfere with the results of skin allergy tests; therefore, it is recommended not to perform these tests until 5–7 days after stopping treatment.

Taking Ebastine Viatris with food and drink

The tablets can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

There is no experience in pregnant women; therefore, it is recommended to consult a doctor before taking ebastine. Your doctor will decide whether or not treatment should be started.

Breastfeeding

It is unknown whether the medicine passes into breast milk; therefore, it should not be used during breastfeeding.

Driving and using machines

In men, no effects on psychomotor function or on the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, since somnolence and dizziness are listed among the adverse effects, you should assess your response to the medicine before driving or operating machinery.

Ebastine Viatris contains lactose

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

3. How to take Ebastina Viatris

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will advise you on the duration of your treatment with ebastine.

Dosage:

Use in adults and children over 12 years of age: The recommended dose is 10 mg once daily, although some patients may require a dose of 20 mg once daily.

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 ebastine formulation.

Method of administration:

This medicine is for oral use. The tablets may be taken with or without food, taken with a glass of water.

If you think that the effect of ebastine is too strong or too weak, inform 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, call the Poison Information Service at telephone number 914 620 420 (indicating the medicine and the amount ingested), or go to the nearest hospital. Bring any remaining tablets, the outer carton, and the full packaging so that healthcare professionals can easily identify the medicine you have taken.

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

If you forget to take Ebastina Viatris

Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for your next dose, do not take the missed dose and wait until the next scheduled dose.

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

4. Possible adverse effects

Like all medicines, Ebastine may cause adverse effects, although not everyone experiences them.

The following adverse 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 disturbances.
• 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 of 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 leaflet. You may also report them directly via the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Viatris

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your usual pharmacy. Ask your pharmacist how to properly discard containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastine Viatris 20 mg

• The active substance is ebastine. Each tablet contains 20 mg of ebastine.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, povidone 30, polysorbate 80, magnesium stearate (E470B), hypromellose (E464), titanium dioxide (E171), and glyceryl triacetate.

Appearance of the product and contents of the pack

Ebastine Viatris is presented as white film-coated tablets. Each PVC/aluminum blister pack contains 20 tablets.

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Laboratorios ALTER, S.A.

C/ Mateo Inurria, 30

28036 – Madrid

Spain

Date of the most recent revision of this leaflet: MAY 2025

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