EBASTINE ARISTO 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Ebastina Aristo 20 mg Orodispersible 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 Aristo and what is it used for
2. What you need to know before taking Ebastina Aristo
3. How to take Ebastina Aristo
4. Possible side effects
5. Storage of Ebastina Aristo
6. Contents of the pack and further information

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

Ebastina Aristo is a medication 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 taking Ebastina Aristo

Do not take Ebastina Aristo:

• If you are allergic to ebastine, menthol (an ingredient in the peppermint flavor aroma) or any of the other components of this medication (listed in section 6).
• Ebastina Aristo should not be used to treat urticaria in adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 or itraconazole) or antitubercular agents (e.g., rifampicin).
• If you have severe liver impairment.

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 medications and Ebastina Aristo

Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or may need to take/use any other medication.

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 blood levels. Compared to the administration of ketoconazole or erythromycin alone, more noticeable changes may occur in your electrocardiogram (approximately 10 mseg increase in QTc interval prolongation).

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

No interactions were observed between 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 blood concentration 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

To date, there are no human fetal safety data available. 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 potential risk.

Breastfeeding

Do not take Ebastina Aristo during breastfeeding, as it is unknown whether the medication passes into breast milk.

Driving and using machines

Most patients treated with Ebastina Aristo may drive or perform activities that require good reaction capacity. However, you should check how you react individually 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 containAspartame (E951)

This medication contains1.06 mg of aspartame per orodispersible 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 Aristo contains less than 1 mmol (23 mg) of sodium per orodispersible tablet; it is essentially "sodium-free”.

3. How to take Ebastina Aristo

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

• For this dose, the 10 mg Ebastina Aristo presentation is available.

Patient with liver impairment

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

Patient with renal impairment

In patients with decreased 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 pack 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 medication.

Duration of treatment

Your doctor will decide the duration of 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 medication 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 recur.

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 will experience 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 sensation of touch or sensitivity, altered taste
• Palpitations, rapid pulse
• 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 available data)

• Weight gain
• Increased appetite

Reporting of 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, Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ebastina Aristo

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Storage conditions

Store in the original packaging to protect the medication from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Contents of the pack and further 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 aroma.

Appearance of the product and packaging contents

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

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

Date of the last revision of this package leaflet:September 2024

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