EBASTINE VIATRIS 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Ebastina Viatris 20 mg Oral Dispersible Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Ebastina Viatris and what is it used for
2. What you need to know before you take Ebastina Viatris
3. How to take Ebastina Viatris
4. Possible side effects
5. Storage of Ebastina Viatris

Contents of the pack and other information

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

Ebastina is an antihistamine that helps to relieve the symptoms of allergy such as sneezing, runny nose, itchy eyes, and itchy skin rashes.

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

2. What you need to know before you take Ebastina Viatris

Do not take Ebastina Viatris

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

Warnings and precautions

Consult your doctor before taking Ebastina Viatris

• If you are already taking certain antibiotics or medicines used to treat fungal infections: see section "Other medicines and Ebastina Viatris" below.
• If you have severe liver function disorders (liver failure).

Ebastina may cause dry mouth. Therefore, for long-term treatment, good oral hygiene (brushing teeth with fluoride toothpaste twice a day) is important to prevent the risk of caries.

Children and adolescents

This medicine can only be taken by children from 12 years of age. Do not give to children under 12 years of age, as safety and efficacy have not been established in this age group.

Other medicines and Ebastina Viatris

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

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

Taking ebastina at the same time as rifampicin (a medicine against tuberculosis) may reduce the levels of ebastina 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 drinks

You can take ebastina independently of meal times.

Pregnancy and breastfeeding

To date, the existing experience regarding safety for the fetus in humans is limited. For this reason, you should only take this medicine during pregnancy if the expected benefit outweighs the possible risks.

Do not take ebastina if you are breastfeeding, as it is not known whether the active substance passes into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Ebastina Viatris contains lactose

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

Ebastina Viatris contains aspartame (E-951)

This medicine contains 5 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly).

3. How to take Ebastina Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

In patients with renal insufficiency, no dose adjustment is necessary.

In patients with mild to moderate liver insufficiency, no dose adjustment is necessary.

There is no experience with doses above 10 mg in patients with severe liver 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 separate tablets in blisters. Separate one blister with its tablet along the dotted line (Figure 1).

Carefully remove the blister sheet from the indicated corner (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 independently of meal times.

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 substance ebastina.

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

If you forget to take Ebastina Viatris

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking ebastina 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)

• Somnolence.
• Dry mouth.

Uncommon (may affect up to 1 in 100 people)

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

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

• Nervousness, insomnia.
• Abnormal or decreased sense of touch.
• Taste disorders.
• Palpitations, rapid pulse.
• Abdominal pain, nausea, indigestion.
• Vomiting.
• Abnormal liver function test.
• Liver inflammation.
• Bile flow disorders causing itching, yellow eyes, and skin.
• Rash, annoying rash, skin inflammation.
• Menstrual disorders.
• Edema (water retention in tissues), weakness (asthenia).
• Dizziness.

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

• Hives, eczema.
• Painful menstruation.

Frequency not known(cannot be estimated from the available data)

• Increased appetite.
• Weight gain.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's 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 Viatris

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

Do not use this medicine after the expiry date which is stated on the carton after CAD or EXP. The expiry date is the last day of the month shown.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastina Viatris

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

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

Appearance and packaging of the product

Oral dispersible tablets.

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

Available pack sizes:

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

Perforated unit dose blisters containing 10, 15, 20, 30, 40, 50, 98, and 100 oral dispersible tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain Ebastina Viatris 20 mg oral dispersible tablets EFG

Italy Ebastina Mylan Pharma

Sweden Ebastine Generics 20 mg oral dispersible tablets

Date of last revision of this leaflet:November 2020

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