EBASTINE FORTE STADA 20 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before taking Ebastina Forte Flas Stada

Do not take Ebastina Forte Flas Stada

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

Warnings and precautions

Consult your doctor or pharmacist before taking Ebastina Forte Flas Stada:

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

Children and adolescents

Ebastina should only be used by children aged 12 years or older, as its safety and efficacy have not been established in this age group.

Taking Ebastina Forte Flas Stada with other medicines

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

Ebastina may affect or be affected by other medicines that contain the following active substances:

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

Taking Ebastina Forte Flas Stada with food and drinks

• Ebastina 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 medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

• In general, ebastina 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 medicine, do not drive or use tools or machines.

Ebastina Forte Flas Stada contains sodium

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

3. How to take Ebastina Forte Flas Stada

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, 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 aged 12 years or older:

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

Use in children and adolescents

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

Patients with renal insufficiency

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

Patients with severe liver insufficiency

The dose should not exceed 10 mg in these patients.

Patients with mild to moderate liver insufficiency

Patients with mild to moderate liver insufficiency 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 swallow water or any other liquid; 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 ebastina.

If you take more Ebastina Forte Flas Stada than you should

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

If you forget to take Ebastina Forte 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 of touch 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

Unknown frequency (cannot be estimated from the 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 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 medicine.

5. Storage of Ebastina Forte Flas Stada

This medicine does not require special storage conditions.

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

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

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

6. Package contents and additional information

Composition of Ebastina Forte Flas Stada

• The active ingredient is ebastina. Each oral dispersible tablet contains 20 mg of ebastina.
• 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), sodium croscarmellose (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

Ebastina Forte Flas Stada 20 mg are oral dispersible tablets, white to off-white, round, flat with beveled edges, approximately 11 mm in diameter and 2.70 mm in thickness, marked on one side with "20" and smooth on the other side.

The oral dispersible tablets are packaged in peelable OPA/Alu/PVC - Paper/PET/Alu blisters.

Ebastina Forte Flas Stada 20 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands: NOTAXO 20 mg, orodispersible tablet

Italy: Ebastina EG 20 mg, orodispersible tablet

Spain: Ebastina Forte Flas Stada 20 mg oral dispersible tablets EFG

Date of the last revision of this leaflet:July 2019

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/