Ebastine Aristo 20 mg orodispersible tablet EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ebastine Aristo 20 mg orodispersible tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Package leaflet contents:

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

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

Ebastina Aristo is a medication that relieves symptoms of allergic reactions (antiallergic/antihistamine).

Ebastina Aristo is indicated:

• For the treatment of symptoms of allergic conditions such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis.
• For relief of itching and hives in urticaria of unknown origin.

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

Do not take Ebastina Aristo:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ebastina Aristo:

Special care is required when taking ebastine:

• If you have low blood potassium levels.
• If you have certain abnormalities in your electrocardiogram (ECG) (known QTc interval prolongation), which may occur in certain types of heart disease.
• If you are concurrently using certain antibiotics (macrolide antibiotics such as erythromycin) or medicines used to treat fungal infections (antifungals such as ketoconazole, itraconazole) or antituberculosis medicines (e.g. rifampicin).
• If you have severe hepatic insufficiency.

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

Other medicines and Ebastina Aristo

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

Concomitant administration of ebastine (active substance in Ebastina Aristo) with certain antibiotics (e.g. erythromycin) or medicines used to treat fungal infections (e.g. ketoconazole or itraconazole) may increase ebastine blood levels. Compared to administration of ketoconazole or erythromycin alone, more noticeable changes in the electrocardiogram may occur (increase in QTc interval prolongation by approximately 10 msec).

Concomitant administration of ebastine with rifampicin (active substance for the treatment of tuberculosis) may reduce ebastine blood levels and thus decrease its effect.

No interactions were observed between ebastine and:

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

Taking Ebastina Aristo with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

To date, there are no safety data available on human fetuses. For this reason, during pregnancy Ebastina Aristo should only be taken if your doctor considers that the expected benefit outweighs the potential risk.

Breastfeeding

Do 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 can drive or perform activities requiring good reaction ability. However, you should assess your individual response to Ebastina Aristo before driving or performing complex tasks, in order to identify any unusual reactions.

You may feel drowsy or dizzy. See also section 4. "Possible side effects".

Ebastina Aristo orodispersible tablets contain aspartame (E951)

This medicine contains 1.06 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Ebastina Aristo contains sodium

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

3. How to take Ebastina Aristo

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Unless otherwise prescribed by your doctor, the recommended dose for adults and children from 12 years of age is:

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

Patients with hepatic impairment

Dosage adjustment is not required in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the dose of ebastine should not exceed 10 mg.

Patients with renal impairment

In patients with reduced renal function, dosage adjustment is not necessary for treatments lasting up to 5 days.

Instructions for use

Ebastine Aristo may be taken with or without food.

Remove the tablet from the packaging immediately before taking it. With dry hands, press the orodispersible tablet out of the blister and place it 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 determine the duration of treatment.

Consult your doctor if you consider the effects of Ebastine Aristo to be too strong or too weak.

If you take more Ebastine Aristo than you should

There is no known specific antidote for ebastine.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ebastine Aristo

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

If you stop treatment with Ebastine Aristo

If you stop or interrupt treatment prematurely, symptoms of your condition may reappear.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Possible adverse effects

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

• Headache

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

• Dry mouth
• Drowsiness

The following adverse 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 requiring immediate medical treatment) and swelling, for example of the throat, lips, or hands (angioedema))
• Nervousness, insomnia
• Dizziness, reduced sense of touch or sensitivity, taste disturbances
• 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Aristo

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Storage conditions

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastine Aristo

The active substance is ebastine.

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

Appearance of the product and contents of the pack

Ebastine Aristo orodispersible tablets are white, round tablets, packed in Alu-PVC/PVDC blisters.

Pack sizes: 10, 20, 30, 50 or 100 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: September 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/