EBASTINE AUROVITAS 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Ebastina Aurovitas 20 mg Oral Disintegrating 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 Aurovitas and what is it used for
2. What you need to know before taking Ebastina Aurovitas
3. How to take Ebastina Aurovitas
4. Possible side effects
5. Storage of Ebastina Aurovitas
6. Package Contents and Additional Information

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

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

Ebastina is used in adults and children over 12 years of age to relieve symptoms of seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, including cases with allergic conjunctivitis.

2. What you need to know before taking Ebastina Aurovitas

Do not take Ebastina Aurovitas:

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

Warnings and Precautions

Consult your doctor before starting to take ebastina if:

• You have low potassium levels in your blood.
• You have an abnormal heart rhythm (known prolongation of the QTc interval in the ECG), which can occur in some forms of heart disease.
• If you are already taking certain antibiotics (macrolide antibiotics such as erythromycin) or medications used to treat fungal infections (antifungal agents such as ketoconazole and itraconazole): see section "Other Medications and Ebastina Aurovitas" below.
• You have severely impaired liver function (liver failure).

Children and Adolescents

This medication should only be used in children over 12 years of age. Do not give this medication to children under 12 years of age, as safety and efficacy have not been established in this age group.

Other Medications and Ebastina Aurovitas

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

Ebastina may affect or be affected by some medications that contain the following active ingredients:

• Ketoconazole, itraconazole (medications for the treatment of fungal infections).
• Erythromycin, clarithromycin, or josamycin (antibiotics).
• Rifampicin (medication used to treat tuberculosis).

No interactions have been described between ebastina and theophylline, warfarin, cimetidine, diazepam, or 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 to 7 days after treatment has been discontinued.

Taking Ebastina Aurovitas with Food and Drinks

You can take ebastina with or without food.

Pregnancy, Breastfeeding, and Fertility

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.

There is limited experience with the safety of this medication for the fetus in humans. For this reason, ebastina should only be taken during pregnancy if your doctor considers that the expected benefit outweighs the potential risks.

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

Driving and Using Machines

Most patients treated with ebastina can drive or perform other activities that require good reaction ability. However, as with 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 Aurovitas contains Aspartame

This medication contains 5 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Ebastina Aurovitas

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose is:

In patients with impaired renal function, no dose adjustment is necessary.

In patients with mild or moderate liver impairment, no dose adjustment is necessary.

There is no experience with doses greater than 10 mg in patients with severe liver failure, so the dose should not exceed 10 mg in these patients.

Place the tablet on your tongue, where it dissolves in a matter of seconds; it is not necessary to take water or any other liquid.

Ebastina can be taken with or without food.

If you think the effect of ebastina is too strong or too weak, inform your doctor or pharmacist.

Your doctor will decide the duration of treatment.

If you take more Ebastina Aurovitas than you should

There is no specific antidote for the active ingredient ebastina.

In case of overdose with ebastina, please consult your doctor. Depending on the severity of the poisoning, your doctor will initiate the necessary measures (monitoring of vital body functions, including ECG monitoring for at least 24 hours, symptomatic treatment, and gastric lavage), if necessary.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Ebastina Aurovitas

If you forget to take a dose, do not take an extra dose to make up for the missed dose; take your next dose when it is due and continue normally.

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Stop taking ebastina and contact your doctor immediately or go to the nearest hospital if you experience the following:

• Itching, hives, and swelling of the face, tongue, or throat that can cause difficulty swallowing or breathing. These can be signs of a hypersensitivity reaction such as anaphylaxis and angioedema, which are rare side effects (may affect up to 1 in 1,000 people).

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):

• Nosebleeds.
• Sore throat (pharyngitis).
• Nasal discharge (rhinitis).

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

• Hypersensitivity reactions (such as anaphylaxis and angioedema).
• Nervousness.
• Insomnia.
• Numbness.
• Dizziness.
• Altered sense of touch.
• Altered taste.
• Palpitations (rapid or irregular heartbeat).
• Fast heartbeat.
• Abdominal pain.
• Vomiting.
• Nausea.
• Indigestion.
• Hepatitis (inflammation of the liver).
• Cholestasis (altered bile flow).
• Abnormal liver function tests.
• Skin rash, hives, generalized rash.
• Menstrual disorders.
• Edema (fluid accumulation in tissues).
• Weakness (asthenia).

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

• Altered sense of touch.
• Eczema, skin inflammation.
• Menstrual pain.

Frequency not known(frequency 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 Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ebastina Aurovitas

• The active ingredient is ebastina. Each oral disintegrating tablet contains 20 mg of ebastina.
• The other ingredients are: microcrystalline cellulose (PH-102), mannitol (E-421), crospovidone (type A), aspartame, colloidal anhydrous silica, magnesium stearate, peppermint flavor.

Appearance of the Product and Package Contents

Oral disintegrating tablet.

White to off-white, uncoated tablets, 9.2 mm in size, round, and biconvex, engraved with 'E 20' on one face and smooth on the other.

Ebastina Aurovitas 20 mg oral disintegrating tablets EFG are available in blister packs.

Package sizes:10, 20, 30, 50, and 90 oral disintegrating tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Ebastina Aurovitas 20 mg oral disintegrating tablets EFG

Poland: Evastix

Portugal: Ebastina Generis

Date of the last revision of this package leaflet: July 2023

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