EBASTINE FLAS STADA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Ebastine Flas Stada 10 mg Oral Dispersible 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 doubts, 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 Ebastine Flas Stada and what is it used for
2. What you need to know before taking Ebastine Flas Stada
3. How to take Ebastine Flas Stada
4. Possible side effects
5. Storage of Ebastine Flas Stada
6. Package Contents and Additional Information

1. What is Ebastine Flas Stada and what is it used for

Ebastine is a medication used to treat allergies (antihistamine). It helps control the symptoms of an allergic reaction.

It is indicated in adults and children 12 years of age or older for the treatment of seasonal or perennial allergic rhinitis (hay fever) with or without allergic conjunctivitis (eye inflammation), and for the treatment of urticaria (hives) in adults over 18 years of age.

2. What you need to know before taking Ebastine Flas Stada

DO NOT take Ebastine Flas Stada

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

Warnings and Precautions

Consult your doctor or pharmacist before taking Ebastine Flas Stada:

• if you have an abnormal heart rhythm (known as QTc interval prolongation on the ECG), which can occur in some types of heart disease
• if you have high potassium levels in your blood.
• if you are already taking certain antibiotics or medications used to treat fungal infections: see the section "Taking Ebastine Flas Stada with other medications" below.
• if you have severe liver function disorders.

Children and Adolescents

• Ebastine should only be used by children 12 years of age or older, as its safety and efficacy have not been established in this age group.
• Ebastine should not be used to treat urticaria (hives) in patients under 18 years of age, as its safety and efficacy have not been established in this age group.

Taking Ebastine Flas Stada with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

Ebastine may affect or be affected by other medications that contain the following active ingredients:

• certain antifungals (medications used to treat fungal infections) such as ketoconazole and itraconazole
• certain macrolide antibiotics (medications used to treat bacterial infections) such as erythromycin
• rifampicin (a medication used to treat tuberculosis)

Taking Ebastine Flas Stada with food and drinks

• Ebastine can be taken with or without food.

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

• There is no experience with the use of ebastine in pregnant women
• Therefore, ebastine should not be used during pregnancy unless your doctor decides otherwise.

Breastfeeding

• It is unknown whether ebastine passes into breast milk,
• Therefore, ebastine should not be used during breastfeeding.

Driving and Using Machines

• Generally, ebastine has no influence on the ability to drive or use machinery.
• In rare cases, drowsiness and fainting have been reported. If you feel tired while taking this medication, do not drive or use tools or machines.

Ebastine Flas Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per oral dispersible tablet; this is, essentially "sodium-free".

3. How to take Ebastine Flas Stada

Follow your doctor's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose is:

For the treatment of allergic rhinitis (hay fever) with or without allergic conjunctivitis (eye inflammation)

For adults and adolescents 12 years of age or older:

• 10 mg of ebastine (1 oral dispersible tablet of ebastine 10 mg) once a day. In cases of severe symptoms, the dose may be increased to 20 mg of ebastine (2 oral dispersible tablets of ebastine 10 mg) once a day.

Urticaria (hives)

Adults 18 years of age or older:

• 10 mg of ebastine (1 oral dispersible tablet of ebastine 10 mg) once a day.

Use in Children and Adolescents

Ebastine should not be used in children under 12 years of age.

Ebastine should not be used to treat urticaria (hives) in patients under 18 years of age.

Patients with Renal Impairment

Patients with renal impairment do not need to adjust the dose.

Patients with Severe Liver Impairment

The dose should not exceed 10 mg in these patients.

Patients with Mild to Moderate Liver Impairment

Patients with mild to moderate liver impairment do not need to adjust the dose.

Method of Administration

• The oral dispersible tablet should be placed on the tongue, where it will dissolve. It is not necessary to take water or any other liquid, but if you wish, you can drink a glass of water or another beverage after taking the tablet.
• The oral dispersible tablet should be carefully removed from the blister pack with dry hands and without crushing, and taken immediately.

Duration of Treatment

Your doctor will decide the duration of treatment with ebastine.

If you take more Ebastine Flas Stada than you should

• In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service at 915 620 420 (indicating the medication and the amount taken), or go to the nearest hospital. Your doctor will decide what to do. Monitoring of vital functions, including electrocardiographic monitoring for at least 24 hours, and symptomatic treatment may be necessary.
• If you experience symptoms related to the central nervous system, intensive care may be required.

If you forget to take Ebastine Flas Stada

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you have any other doubts 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 gets them.

Very Common (may affect more than 1 in 10 people)

• Headache

Common (may affect up to 1 in 10 people)

• Drowsiness
• Dry mouth

Rare (may affect up to 1 in 1,000 people)

• Allergic reactions (such as anaphylaxis and angioedema)
• Nervousness, Insomnia
• Dizziness, decreased sensation or sensitivity (hypoesthesia), decreased or altered taste (dysgeusia)
• Fast heart rate (tachycardia), palpitations
• Nausea, abdominal pain, vomiting, dyspepsia
• Hepatitis, cholestasis, abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
• Skin rash and urticaria, skin inflammation (dermatitis)
• Menstrual disorders
• Edema, fatigue

Not Known (frequency cannot be estimated from available data)

• Weight gain
• Increased appetite

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

5. Storage of Ebastine Flas Stada

This medication does not require special storage conditions.

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

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ebastine Flas Stada

• The active ingredient is ebastine. Each oral dispersible tablet contains 10 mg of ebastine.
• The other ingredients (excipients) are: Hypromellose (E-464), povidone (E-1201), poloxamer, gelatin, calcium carmellose, crospovidone (E-1202), mannitol (E-421), microcrystalline cellulose (E-460), croscarmellose sodium (E-468), colloidal hydrated silica (E-551), peppermint flavor*, neotame (E-961), magnesium stearate (E-572).

*Composition: natural flavoring, identical natural flavoring, acacia gum (E-414), maltodextrin, sodium benzoate (E-211), butylated hydroxyanisole (E-320).

Appearance of the Product and Package Contents

Ebastine Flas Stada 10 mg are oral dispersible tablets, white to off-white, round, flat with beveled edges, approximately 8.50 mm in diameter and 2.20 mm in thickness, marked with "10" on one side and smooth on the other.

The oral dispersible tablets are packaged in peelable OPA/Alu/PVC - Paper/PET/Alu blisters. Ebastine Flas Stada 10 mg is available in cartons containing 20 and 30 oral dispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares (Madrid)

Spain

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

Netherlands: NOTAXO 10 mg, orodispersible tablet

Italy: Ebastina EG 10 mg, orodispersible tablet

Spain: Ebastina Flas Stada 10 mg oral dispersible tablets EFG

Date of the last revision of this package leaflet:July 2019

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/