EBASTINA 10 mg Orally Disintegrating Tablets

2. What you need to know before you take Ebastine Aurovitas

Do not take Ebastine Aurovitas:

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

Warnings and precautions

Consult your doctor before taking ebastine if:

• You have low levels of potassium 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 medicines used to treat fungal infections (antifungal agents such as ketoconazole and itraconazole): see section "Other medicines and Ebastine Aurovitas" below.
• You have severely impaired liver function (liver failure).

Children and adolescents

This medicine should only be used in children from 12 years of age. Do not give this medicine to children under 12 years of age since the safety and efficacy in this age group have not been established.

Other medicines and Ebastine Aurovitas

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

Ebastine may affect or be affected by some medicines that contain the following active substances:

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

No interactions have been described between ebastine and theophylline, warfarin, cimetidine, diazepam or alcohol.

Interference with diagnostic tests

Ebastine may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5 to 7 days after stopping treatment.

Taking Ebastine Aurovitas with food and drinks

You can take ebastine with or without food.

Pregnancy, breastfeeding and fertility

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.

There is limited experience with the safety of this medicine in humans during pregnancy. For this reason, ebastine should only be taken during pregnancy if your doctor considers that the expected benefit is greater than the potential risk.

As a precautionary measure, it is preferable to avoid the use of ebastine during pregnancy.

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

Driving and using machines

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

Ebastine Aurovitas contains aspartame

This medicine contains 2.5 mg of aspartame in each tablet.

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

3. How to take Ebastine Aurovitas

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, 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 hepatic impairment, no dose adjustment is necessary.

There is no experience with doses greater than 10 mg in patients with severe hepatic impairment, therefore the dose should not exceed 10 mg in this type of patient.

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

Ebastine can be taken with or without food.

If you think that the action of ebastine is too strong or too weak, inform your doctor or pharmacist.

Your doctor will decide the duration of treatment.

If you take more Ebastine Aurovitas than you should

There is no specific antidote for the active substance ebastine.

In case of overdose with ebastine, please consult your doctor. Depending on the severity of the poisoning, your doctor will initiate the necessary measures (monitoring of vital 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, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ebastine Aurovitas

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

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

• Itching, urticaria 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).
• Rapid pulse.
• 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 the available data):

• Weight gain.
• Increased appetite.

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 via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Aurovitas

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 blister and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 Ebastine Aurovitas

• The active substance is ebastine. Each orodispersible tablet contains 10 mg of ebastine.
• 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 contents of the pack

Orodispersible tablet.

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

Ebastine Aurovitas 10 mg orodispersible tablets EFG are available in blister packs.

Pack sizes:10, 20, 30, 50 and 90 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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

Spain: Ebastine Aurovitas 10 mg orodispersible tablets EFG

France: EBASTINE ARROW LAB 10 mg, orodispersible tablet

Netherlands: Ebastine Aurobindo smelt 10 mg, orodispersible tablets

Poland: Evastix

Portugal: Ebastina Generis

Date of last revision of this leaflet: July 2023

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