Prospect: Information for the User

Ebastina Viatris 20 mg Bucodispersable Tablets EFG

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Contents of the package and additional information

Ebastina is an antihistamine that helps to relieve allergy symptoms such as sneezing, nasal discharge, itchy eyes, and skin rashes with itching.

In adults and children 12 years of age or older, ebastina is used to relieve symptoms of seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, including cases with allergic conjunctivitis.

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 before starting to take Ebastina Viatris

• If you are already taking certain antibiotics or medications used to treat fungal infections: see the section "Other medicationsand Ebastina Viatris" later.
• If you have severe liver function abnormalities (liver insufficiency).

Ebastina may cause dry mouth. Therefore, for long-term treatment, it is essential to maintain good oral hygiene (teeth should be cleaned with fluoride toothpaste twice a day) to prevent the risk of cavities.

Children and adolescents

This medication can only be taken by children aged 12 and above. Do not administer to children under 12 years, as safety and efficacy have not been demonstrated in this age group.

Other medications and Ebastina Viatris

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

Taking ebastina and erythromycin (antibiotic) or ketoconazole, itraconazole (active principles for the treatment of fungal infections) at the same time may lead to higher levels of ebastina in the blood.

The simultaneous administration of ebastina with rifampicin (tuberculosis medication) may reduce ebastina levels in the blood and, therefore, reduce its effects.

It is not recommended to use ebastina at the same time as clarithromycin or josamycin (antibiotics).

Taking Ebastina Viatris with food and beverages

You can take ebastina regardless of meal times.

Pregnancy and breastfeeding

Up to the present, the existing experience regarding safety for the human fetus is limited. For this reason, you should only take this medication during pregnancy if the expected benefit outweighs the potential risks.

Do not take ebastina if you are breastfeeding, as the active substance is unknown to pass into breast milk.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Most patients treated with ebastina can drive or perform other activities that require good reaction ability. However, like other medications, you should check your individual reaction after taking ebastina before driving or performing complex activities, as some patients may experience drowsiness or dizziness.

Ebastina Viatris contains lactose

This medication contains lactose. If your doctor has indicated that you suffer from intolerance to certain sugars, consult with them before taking this medication.

Ebastina Viatris contains aspartame (E-951)

This medication contains 5 mg of aspartame in each tablet.Aspartame containsa source of phenylalaninethat may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

The recommended dose is:

No dose adjustment is necessary in patients with renal insufficiency.

No dose adjustment is necessary in patients with mild to moderate hepatic insufficiency.

There is no experience with doses higher than 10 mg in patients with severe hepatic insufficiency, so these patients should not take more than 10 mg per day.

Do not push the tablet out of the blister, as this will crush it.

Each strip contains tablets separated by perforations in blisters. Separate one blister with your tablet by the dotted line (Figure 1).

With care, remove the strip from the blister, starting from the corner indicated by the arrow (Figures 2 and 3).

Keep your hands dry and take the tablet from the strip.

Place the tablet on the tongue where it will disperse in a matter of seconds: no water or other liquid is needed.

You can take ebastina regardless of meals.

Your doctor will decide the duration of treatment.

If you take more Ebastina Viatris than you should

There is no specific antidote for the active ingredient ebastina.

If you have taken a dose higher than prescribed by your doctor or in case of overdose, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount used. Depending on the severity of the intoxication, they will initiate the necessary measures (monitoring of vital functions of the body, including ECG monitoring for a minimum of 24 hours, symptomatic treatment and gastric lavage), if necessary.

If you forgot to take Ebastina Viatris

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking ebastine and contact your doctor immediately or go to the nearest hospital if the following occurs:

• Severe allergic reaction that causes swelling of the face, tongue, or throat and may cause difficulty swallowing or breathing.

Other side effects include:

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

• Headache.

Common (may affect up to 1 in 10 people)

• Drowsiness.
• Dry mouth.

Uncommon (may affect up to 1 in 100 people)

• Sore throat (pharyngitis), nasal discharge (rhinitis), nosebleed.

Rare (may affect up to 1 in 1,000 people)

• Nervousness, insomnia.
• Alterations or decrease in sense of touch.
• Disturbances of taste.
• Palpitations, rapid pulse.
• Abdominal pain, nausea, indigestion.
• Vomiting.
• Abnormal liver function test.
• Inflammation of the liver.
• Problems with bile elimination causing itching, yellow eyes and skin.
• Rash, itchy rash, skin inflammation.
• Menstrual disorders.
• Edema (accumulation of water in tissues), weakness (asthenia).
• Dizziness.

Very rare(may affect up to 1 in 10,000people)

-Urticaria, eczema.

-Dysmenorrhea.

Unknown frequency(cannot be estimated from available data)

• Increased appetite.
• Weight gain.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Ebastina Viatris Composition

The active ingredient is ebastina. Each buccal dispersible tablet contains 20 mg of ebastina.

The other components are: microcrystalline cellulose, lactose monohydrate, cornstarch, sodium croscarmellose, aspartame (E-951), peppermint flavor, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the package

Buccal dispersible tablets.

White, biconvex, round tablets, engraved with “E20” on one face and flat on the other.

Available package sizes:

Continuous blisters containing 10, 15, 20, 30, 40, 50, 98, and 100 buccal dispersible tablets.

Single-dose perforated blisters containing 10, 15, 20, 30, 40, 50, 98, and 100 buccal dispersible tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

4042 Debrecen

Hungary

or

Teva Pharma, S.L.U.

C/ C, 4 - Polígono Industrial Malpica

50016 – Zaragoza

Spain

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the European Economic Area member states with the following names:

SpainEbastina Viatris 20 mg buccal dispersible tablets EFG

ItalyEbastina Mylan Pharma

SwedenEbastine Generics 20 mgsublingual tablet

Last review date of this leaflet:November 2020

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/