Ebastine Forte Flas Stada 20 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Ebastina Forte Flas Stada 20 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ebastina Forte Flas Stada is and what it is 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 aged 12 years and older for the treatment of seasonal or perennial allergic rhinitis, with or without 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 Forte Flas Stada

Do NOT take Ebastina Forte Flas Stada

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

Warnings and precautions

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

• if you have an abnormal heart rhythm (known as QTc interval prolongation on 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 section "Taking Ebastina Forte Flas Stada with other medicines" below
• if you have severe impairment of liver function.

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.

Taking Ebastina Forte Flas Stada with other medicines

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

Ebastine may interact with, 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 Forte Flas Stada with food and drinks

• 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 otherwise decided by your doctor.

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 machinery.

Ebastina Forte 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 Forte Flas Stada

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

Recommended dose:

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 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 (1 orodispersible tablet of ebastine 20 mg) once daily.

Use in children and adolescents

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

Patients with renal impairment

Dosage 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

Dosage 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 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 Forte Flas Stada than you should

• In case of overdose or accidental ingestion, consult 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 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 Ebastina Forte Flas Stada

Do not take a double dose to make up for missed doses. Take the next dose at your regular 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 experiences 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, decreased sensation of touch or sensitivity (hypoesthesia), decreased 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 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: https://www.notificaram.es. By reporting adverse 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 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to 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 Forte Flas Stada

• The active substance is ebastine. Each orodispersible tablet contains 20 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), hydrated colloidal silica (E-551), mint flavour*, neotame (E-961), magnesium stearate (E-572).

*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 Forte Flas Stada 20 mg are orodispersible tablets, white to off-white in colour, round, flat with bevelled edges, approximately 11 mm in diameter and 2.70 mm thick, marked with "20" on one side and smooth on the other.

The orodispersible tablets are packed in peelable blisters made of OPA/Alu/PVC – Paper/PET/Alu.

Ebastina Forte Flas Stada 20 mg is available in carton packs 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 20 mg, orodispergeerbare tablet

Italy: Ebastina EG 20 mg, compressa orodispersibile

Spain: Ebastina Forte Flas Stada 20 mg orodispersible tablets EFG

Date of the most recent revision 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 Medical Devices (AEMPS) http://www.aemps.gob.es/