Ebastine Flas Stada 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ebastina Flas Stada 10 mg orodispersible tablets EFG

Read the entire 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 must not be given to other people, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Ebastine is a medicine used for the treatment of allergies (antihistamine). It helps control the symptoms of an allergic reaction.

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

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

Do NOT take Ebastina Flas Stada

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ebastina Flas Stada:

• if you have an abnormal heart rhythm (known as QTc prolongation on the ECG), which may occur in certain 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 Flas Stada with other medicines" below
• if you have severe liver function impairment.

Children and adolescents

• Ebastine should only be used in children aged 12 years and older, as safety and efficacy have not been established in younger age groups.
• Ebastine should not be used for the treatment of urticaria (hives) in patients under 18 years of age, as safety and efficacy have not been established in this age group.

Taking Ebastina Flas Stada with other medicines

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

Ebastine may affect or be affected by other medicines containing 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 Flas Stada with food and drink

• Ebastine may be taken with or without food.

Pregnancy and breastfeeding

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

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

• In general, ebastine has no influence on the ability to drive or operate machinery.
• In very 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 Flas Stada contains sodium

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

3. How to take Ebastina Flas Stada

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

For adults and adolescents aged 12 years or older:

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

Urticaria (hives)

Adults aged 18 years or older:

• 10 mg of ebastine (1 orodispersible tablet of ebastine 10 mg) once daily.

Use in children and adolescents

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

Ebastine must not be used for the treatment of urticaria (hives) in patients under 18 years of age.

Patients with renal impairment

Dose adjustment is not necessary in patients with renal impairment.

Patients with severe hepatic impairment

The dose must not exceed 10 mg in these patients.

Patients with mild to moderate hepatic impairment

Dose adjustment is not necessary in patients with mild to moderate hepatic impairment.

Method of administration

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

Duration of treatment

Your doctor will decide the duration of treatment with ebastine.

If you take more Ebastina Flas Stada than you should

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

If you forget to take Ebastina Flas Stada

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

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 may cause adverse effects, although not everyone will experience them.

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

• Headache

Common (may affect up to 1 in 10 people)

• Somnolence
• Dry mouth

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

• Allergic reactions (such as anaphylaxis and angioedema)
• Nervousness, insomnia
• Dizziness, reduced sensation of touch or sensitivity (hypoesthesia), reduced or altered taste (dysgeusia)
• Increased 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 of adverse effects

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

5. Storage of Ebastine Flas Stada

This medicine does not require any special storage conditions.

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.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastina Flas Stada

• The active substance is ebastine. Each orodispersible tablet contains 10 mg of ebastine.
• The other components (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), mint flavour*, neotame (E-961), magnesium stearate (E-572).

*Flavour composition: natural flavouring, nature-identical flavouring, acacia gum (E-414), maltodextrin, sodium benzoate (E-211), butylated hydroxyanisole (E-320).

Appearance of the product and contents of the pack

Ebastina Flas Stada 10 mg are white to off-white orodispersible tablets, round, flat with bevelled edges, approximately 8.50 mm in diameter and 2.20 mm thick, marked "10" on one side and smooth on the other.

The orodispersible tablets are packaged in peelable blisters made of OPA/Alu/PVC – Paper/PET/Alu. Ebastina Flas Stada 10 mg is available in carton boxes containing 20 and 30 orodispersible 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: NOTAXO 10 mg, orodispergeerbare tablet

Italy: Ebastina EG 10 mg, compressa orodispersibile

Spain: Ebastina Flas Stada 10 mg orodispersible tablets EFG

Date of the most recent review of this leaflet: July 2019

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