Leaflet: information for the user

Ebastina Aristo 10 mg buccal dispersible tablets EFG

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to knowbefore starting to takeEbastina Aristo

3.How to take Ebastina Aristo

4.Possible side effects

5.Storage of Ebastina Aristo

6.Contents of the pack and additional information

Ebastina Aristo is a medication that relieves 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 associated or not with allergic conjunctivitis.

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

Do not take Ebastina Aristo:

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

Warnings and precautions

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

Special care is required when taking ebastina:

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

In some patients, prolonged treatment with ebastina 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

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

The concomitant administration of ebastina (active substance of Ebastina Aristo and certain antibiotics (e.g. erythromycin) or medications used in the treatment of fungal infections (e.g ketoconazole or itraconazole) may elevate ebastina levels in the blood. In comparison with the administration of ketoconazole or erythromycin separately, more notable changes may occur in your electrocardiogram (increase of the prolongation of the QTc interval by approximately 10 mseg).

The concomitant administration of ebastina with rifampicin (active principle for the treatment of tuberculosis) may cause a reduction of ebastina levels in the blood and therefore, decrease its effect.

No interactions were observed with ebastina and

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

Taking Ebastina Aristo with food and beverages

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

There are no safety data available in human fetuses. 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.

Lactation

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

Driving and operating machinery

Most patients treated with Ebastina Aristo may be able to drive or perform activities that require good reaction capacity. However, you must check how your individual reactions are to Ebastina Aristo before driving or performing complex activities to identify unusual reactions.

You may feel drowsy or dizzy. Read also section 4 "Possible adverse effects”.

Ebastina Aristo buccal tablets contain Aspartame (E951)

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

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Ebastina Aristo contains Sodium

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

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

Unless your doctor prescribes another schedule, the recommended dose in adults and children 12 years and older is:

Patients with liver insufficiency

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

Patients with renal insufficiency

No dose adjustment is necessary in patients with renal insufficiency for treatments up to 5 days.

Mode of use

Ebastine Aristo can be taken with or without food.

Remove the tablet from the packaging just before taking it. With dry hands, press the tablet bucodispersable 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. No water or other liquids are needed to take this medication.

Duration of treatment

Your doctor will decide the duration of treatment.

Consult your doctor if you consider that the effects ofEbastine Aristoare too strong or too weak.

If you take more Ebastine Aristo than you should

No specific antidote is known for ebastine.

In case of overdose of Ebastine Aristo, consult your doctor immediately. Depending on the severity of the intoxication, 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 forgot to take Ebastine Aristo

Do not take a double dose to compensate for the missed doses. Continue treatment as usual.

If you interrupt treatment with Ebastine Aristo

If you stop or interrupt treatment before time, it is possible that your disease symptoms will reappear.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Possible Adverse Effects

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

• Headache

The following adverse effects have been reported frequently (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 that requires immediate medical treatment) and swelling, for example, of the throat, lips, or hands (angioedema))
• Nervousness, insomnia
• Dizziness, decreased sensation of touch or sensitivity, alteration of taste
• Palpitations, rapid pulse
• Abdominal pain, vomiting, nausea, indigestion
• Liver dysfunction, cholestasis, abnormal liver function test results (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
• Urticaria, skin rash, dermatitis
• M menstrual disorders
• Edema (swelling due to fluid accumulation), fatigue

Unknown frequency (cannot be estimated from available data)

• Weight gain
• Increased appetite

Reporting Adverse Effects

If you experience any type of adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es. By reporting adverse 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 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 drains or trash.Deposit the packaging and medications you no longer need at thepharmacy's SIGREpoint. In case of doubt,ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Ebastina Aristo

The active ingredient is ebastina.

• 1 buccal dispersible tablet contains 10 mg of ebastina.
• The other components are mannitol (Ph.Eur), cornstarch, colloidal silicon dioxide, sodium stearate fumarate (Ph. Eur.), aspartame (E951), peppermint flavor.

Appearance of the product and contents of the packaging

Ebastina Aristo buccal dispersible tablets are white and round tablets, in Alu-PVC/PVDC blisters

Packaging with 10, 20, 30, 50 or 100 buccal dispersible tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

ARISTO PHARMA GMBH

Wallenroder Strasse 8-10

13435 Berlin, Germany

Responsible for manufacturing

Laboratorios Medicamentos Internacionales, S.A.

C/Solana, 26, Torrejón de Ardoz,

28850 Madrid, Spain

For more information about this medication, please contact 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 with the following names:

Last review date of this leaflet: September 2024

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/