EBASTINE ARISTO 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Ebastina Aristo 10 mg Orodispersible 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:

1. What is Ebastina Aristo and what is it used for
2. What you need to know before you take Ebastina Aristo
3. How to take Ebastina Aristo
4. Possible side effects
5. Storage of Ebastina Aristo
6. Contents of the pack and other information

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

Ebastina Aristo is a medicine that relieves the symptoms of allergic reactions (antiallergics/antihistamines).

Ebastina Aristo is indicated:

• For the treatment of symptoms of allergic processes such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis.

• To relieve itching and the formation of hives in urticaria of unknown origin.

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

Do not take Ebastina Aristo:

• If you are allergic to ebastine, menthol (an ingredient of the peppermint flavor) or any of the other components of this medicine (listed in section 6).
• Ebastina Aristo 10 mg orodispersible tablets should not be administered in the treatment of urticaria in adolescents under 18 years of age, as there is limited experience in this age group, and no experience in children under 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking Ebastina Aristo:

Special care is required when taking ebastine:

• If you have low potassium levels in your blood.
• In case of certain alterations in your electrocardiogram (ECG) (known prolongation of the QTc interval), which may occur in some types of heart diseases.
• If you are concomitantly using certain antibiotics (such as erythromycin) or medications to treat fungal infections (such as ketoconazole, itraconazole) or antituberculars (e.g., rifampicin).
• If you have severe liver failure.

In some patients, prolonged treatment with ebastine may increase the risk of dental caries due to dry mouth. Therefore, the patient's oral hygiene is very important.

Other medicines and Ebastina Aristo

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

Concomitant administration of ebastine (the active substance of Ebastina Aristo) and certain antibiotics (such as erythromycin) or medications used to treat fungal infections (such as ketoconazole or itraconazole) may increase ebastine levels in the blood. Compared to the administration of ketoconazole or erythromycin alone, more noticeable changes may occur in your electrocardiogram (an increase in the QTc interval prolongation of approximately 10 mseg).

Concomitant administration of ebastine with rifampicin (an active principle for the treatment of tuberculosis) may cause a reduction in ebastine levels in the blood and therefore decrease its effect.

No interactions were observed with ebastine and

• Theophylline (an active principle for the treatment of asthma),
• Warfarin (an anticoagulant),
• Cimetidine (an active principle for the treatment of gastric ulcers),
• Diazepam (an active principle for the treatment of anxiety and tension) or
• Alcohol.

Taking Ebastina Aristo with food and drinks

When Ebastina Aristo is taken with food, it increases the concentration in the blood of the active metabolite of ebastine (carebastine). However, this does not affect the clinical efficacy.

Pregnancy and breastfeeding

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.

Pregnancy

To date, there are no data on human fetal safety. For this reason, during pregnancy, Ebastina Aristo should only be taken if your doctor recommends it, considering that the expected benefit is greater than the possible risk.

Breastfeeding

You should not take Ebastina Aristo during breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and using machines

Most patients treated with Ebastina Aristo may drive or perform activities that require a good reaction capacity. However, you should check how you react to Ebastina Aristo before driving or performing complex activities to identify any unusual reactions.

You may feel drowsy or dizzy. Also, read section 4 "Possible side effects”.

Ebastina Aristo orodispersible tablets contain Aspartame (E951)

This medicine contains0.53 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine, which 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.

Ebastina Aristo contains Sodium

Ebastina contains less than 1 mmol (23 mg) of sodium per orodispersible tablet; i.e., it is essentially “sodium-free”.

3. How to take Ebastina Aristo

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

Unless your doctor prescribes otherwise, the recommended dose in adults and children from 12 years of age is:

Patient with liver failure

No dose adjustment is required in patients with mild to moderate liver failure. In patients with severe liver failure, the dose of ebastine should not exceed 10 mg.

Patient with renal failure

In patients with reduced renal function, no dose adjustment is necessary for treatments of up to 5 days.

Method of administration

Ebastina Aristo can be taken with or without food.

Remove the tablet from the packaging just before taking it. With dry hands, press the orodispersible tablet to remove it from the blister and place the tablet on the tongue. The tablet will dissolve directly in the mouth and can be easily swallowed. It is not necessary to drink water or other liquids to take this medicine.

Duration of treatment

Your doctor will decide the duration of the treatment.

Consult your doctor if you think the effects of Ebastina Aristo are too strong or too weak.

If you take more Ebastina Aristo than you should

No specific antidote is known for ebastine.

In case of overdose of Ebastina Aristo, consult your doctor immediately. Depending on the severity of the poisoning, your doctor will take the necessary measures (monitoring of vital signs, including ECG with evaluation of the QT interval for at least 24 hours, symptomatic treatment, and gastric lavage if necessary).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ebastina Aristo

Do not take a double dose to make up for forgotten doses. Continue treatment as usual.

If you stop taking Ebastina Aristo

If you stop or interrupt treatment prematurely, it is possible that the symptoms of your disease may reappear.

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

4. Possible side effects

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

Possible side effects

The following side effects have been reported very frequently (may affect more than 1 in 10 people):

• Headache

The following side effects have been reported frequently (may affect up to 1 in 10 people):

• Dry mouth
• Drowsiness

The following side effects have been reported rarely (may affect up to 1 in 1,000 people):

• Allergic reactions (such as anaphylaxis (a severe and potentially life-threatening allergic reaction that requires immediate medical attention) and swelling, for example, of the throat, lips, or hands (angioedema))
• Nervousness, insomnia
• Dizziness, decreased sense of touch or sensitivity, altered taste
• Palpitations, rapid heartbeat
• Abdominal pain, vomiting, nausea, dyspepsia
• Liver disorders, cholestasis, abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
• Urticaria, skin rash, dermatitis
• Menstrual disorders
• Edema (swelling due to fluid accumulation), fatigue

Frequency not known (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 through the Spanish Medicines Vigilance System for Human Use, Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastina Aristo

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 EXP. The expiry date refers to the last day of the month shown.

Storage conditions

Store in the original package to protect the medicine 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 Aristo

The active substance is ebastine.

• 1 orodispersible tablet contains 10 mg of ebastine.
• The other ingredients are mannitol (Ph.Eur), cornstarch, colloidal silicon dioxide, sodium stearyl fumarate (Ph. Eur.), aspartame (E951), peppermint flavor.

Appearance of the product and pack contents

Ebastina Aristo orodispersible tablets are white and round, in Alu-PVC/PVDC blisters.

Packs of 10, 20, 30, 50, or 100 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

ARISTO PHARMA GMBH

Wallenroder Strasse 8-10

13435 Berlin, Germany

Manufacturer

Laboratorios Medicamentos Internacionales, S.A.

C/Solana, 26, Torrejón de Ardoz,

28850 Madrid, Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

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

Date of last revision of this leaflet: September 2024

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