Package Insert: Information for the User

Ebastina Viatris 10 mg Film-Coated Tablets

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Ebastina belongs to a group of medications called antihistamines.

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

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:

• If your electrocardiogram results are altered (prolongation of the QT interval).
• If you have altered potassium levels in your blood.
• If you have a severe liver disease (see "How to take Ebastina Viatris").
• If you are being treated with a type of antifungal medication called azoles or with a type of antibiotic called macrolides (see "Taking Ebastina Viatris 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 ebastina (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastina 10 mg tablets should not be administered to children under 12 years old.

Other medications and Ebastina Viatris

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

The following medications may interact 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 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 discontinuing treatment.

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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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Pregnancy

There is no experience in pregnant women, so it is recommended to consult a doctor before taking ebastina. The doctor will decide whether it is advisable 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 operating machinery

In men, there have been no observed effects on psychomotor function, or on the ability to drive or operate machinery, at the recommended therapeutic doses. However, since drowsiness and dizziness are among the adverse effects, observe your response to the medication before driving or operating machinery.

Ebastina Viatris contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 lower 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: Do not exceed a dose of 10 mg of ebastina per day (1 tablet).

Administration form:

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 estimate that the action of ebastina 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 or call the Toxicological Information Service, phone 914 620 420 (indicating the medication and the amount ingested) or go to the nearest hospital. Bring the remaining tablets, the packaging, and the complete box so that the healthcare staff can identify the medication taken more easily. .

The treatment of intoxication by this medication consists of gastric lavage and administration of the appropriate medication.

If you forgot to take Ebastina Viatris:

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

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

Like all medications, Ebastina can produce adverse effects, although not all people may experience them.

In clinical trials and post-marketing experience, the following adverse effects have been observed:

Very Frequent(may affect more than 1 in 10 people)

• Headache.

Frequent(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 sense of touch or sensitivity, decreased or altered taste.
• Palpitations, tachycardia.
• Abdominal pain, vomiting, nausea, digestive problems.
• Liver inflammation (hepatitis), cholestasis, abnormal liver function test results (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin).
• Urticaria, skin rash, dermatitis.
• Menstrual disorders.
• Edema (swelling due to fluid accumulation), fatigue.
• .

Unknown Frequency(cannot be estimated from available data)

• Weight gain.
• Increased appetite.

Reporting Adverse Effects

If you experienceany type ofadverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Ebastina Viatris 10 mg Composition

-The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.

-The other components (excipients) are: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized cornstarch, povidone 30, polisorbate 80, magnesium stearate (E470B), hypromellose (E464), titanium dioxide (E171), and triacetin.

Product appearance and packaging contents

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

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for Manufacturing

Laboratorios ALTER, S.A.

C/ Mateo Inurria, 30

28036 – Madrid

Spain

Last review date of this leaflet:May 2025

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