Package Insert: Information for the User

Ebastina Aurovitas 10 mg Bucodispersable Tablets EFG

Read this package insert carefully before starting to take this medication, 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 medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Ebastina is an antihistamine that helps to relieve allergy symptoms such as sneezing, runny nose, watery eyes, and itchy skin rashes (with itching).

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

Ebastina chewable tablets of 10 mg are also used in adults over 18 years of age to relieve itching and the development of hives in those cases of urticaria (hives).

Do not take Ebastina Aurovitas:

• 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 if:

• You have low levels of potassium in your blood.
• You have an abnormal heart rhythm pattern (prolongation of the QTc interval on the ECG), which may occur in some forms of heart disease.
• 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 the section “Other medications and Ebastina Aurovitas” below.
• You have severely impaired liver function (hepatic insufficiency).

Children and adolescents

This medication should only be used in children aged 12 years or older. Do not administer this medication to children under 12 years of age, as the safety and efficacy have not been established in this age group.

Other medications and Ebastina Aurovitas

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

Ebastina may affect or be affected by some medications containing the following active ingredient:

• Ketoconazole, itraconazole (medications for the treatment of fungal infections).
• Erythromycin, clarithromycin, or josamycin (antibiotic).
• 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 discontinuing treatment.

Taking Ebastina Aurovitas with food and beverages

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 to date regarding the safety for the fetus of using this medication in humans. For this reason, ebastina should only be taken during pregnancy when your doctor considers that the expected benefit outweighs the possible risks.

As a precaution, it is preferable to avoid using ebastina during pregnancy.

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

Driving and operating machinery

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 2.5 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that 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 of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

No dose adjustment is necessary in patients with altered renal function.

No dose adjustment is necessary in patients with mild or moderate liver function impairment.

No experience is available with doses greater than 10 mg in patients with severe liver insufficiency, therefore, the dose should not exceed 10 mg in these patients.

Place your tablet on your tongue where it dissolves in a matter of seconds, no water or other liquid is needed.

Ebastina can be taken with or without food.

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

Your doctor will decide the duration of treatment.

If you take moreEbastina Aurovitasthan you should

No specific antidote is available for the active ingredient ebastina.

In case of ebastina overdose, please consult your doctor. Depending on the severity of the intoxication, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeEbastina Aurovitas

If you forgot to take a dose, do not take an extra dose to compensate for the missed dose, take your

next dose when due and continue normally.

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop taking ebastine 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 may cause difficulty swallowing or breathing. These may be signs of an allergic 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):

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

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

• Allergic reactions (such as anaphylaxis and angioedema).
• Nervousness.
• Insomnia.
• Numbness.
• Dizziness.
• Decreased sensation of touch.
• Alteration of taste.
• Palpitations (irregular heartbeat, rapid heartbeat).
• Fast pulse.
• Abdominal pain.
• Vomiting.
• Nausea.
• Indigestion.
• Hepatitis (liver inflammation).
• Bile duct obstruction.
• 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):

• Alteration of the sense of touch.
• Eczema, skin inflammation.
• Menstrual pain.

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

• Weight gain.
• Increased appetite.

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 System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side 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.

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

This medication does not require special conditions for conservation.

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

Ebastina Aurovitas Composition

• The active ingredient is ebastina. Each buccal dispersible tablet contains 10 mg of ebastina.
• The other components are: microcrystalline cellulose (PH-102), mannitol (E-421), crospovidone (type A), aspartame, anhydrous colloidal silica, magnesium stearate, peppermint aroma.

Appearance of the product and packaging contents

Buccal dispersible tablet.

Uncoated white to off-white tablets, 6.7 mm in size, round and biconvex, engraved with ‘E 10’ on one face and smooth on the other.

Ebastina Aurovitas 10 mg buccal dispersible tablets EFG are available in blister packs.

Packaging sizes:10, 20, 30, 50, and 90 buccal dispersible tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer responsible:

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 medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Ebastina Aurovitas 10 mg buccal dispersible tablets EFG

France:EBASTINE ARROW LAB 10 mg, orodispersible tablet

Netherlands:Ebastine Aurobindo smelt 10 mg, orodispergeerbare tablets

Poland:Evastix

Portugal:Ebastina Generis

Last review date of this leaflet: July 2023

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