Patient Information Leaflet

Ebastina Forte Flas Stada 20 mg Buccal 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. Do 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 is Ebastina Forte Flas Stada and what is it used for

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

3.How to take Ebastina Forte Flas Stada

4.Possible side effects

5.Storage of Ebastina Forte Flas Stada

6.Contents of the pack and additional information

Ebastina is a medication used for the treatment of allergies (antihistamine). It helps to 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) associated or not with allergic conjunctivitis (inflammation of the eye), and for the treatment of urticaria (hives) in adults 18 years of age or older.

Do not take Ebastina Forte Flas Stada

-if you are allergic to ebastina or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ebastina Forte Flas Stada:

-if you have an abnormal heart rhythm pattern (known as QTc prolongation on the ECG), which may 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 medications used to treat fungal infections: see the section "Taking Ebastina Forte Flas Stada with other medications" below.

-if you have severe liver function abnormalities.

Children and adolescents

Ebastina 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.

Taking Ebastina Forte Flas Stada with other medications

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

Ebastina may affect or be affected by other medications containing the following active ingredients:

-certain antimycotics (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 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

• The passage of ebastina into breast milk is unknown.
• Ebastina should not be used during breastfeeding.

Driving and operating machinery

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

Ebastina Forte Flas Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per buccal dispersible tablet; that is, 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.

The recommended dose is:

For the treatment of allergic rhinitis (hay fever) associated or not with allergic conjunctivitis (inflammation of the eye)

For adults and adolescents 12 years of age or older:

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

Use in children and adolescents

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

Patients with severe renal insufficiency

Patients with severe renal insufficiency, no dose adjustment is necessary.

Patients with severe hepatic insufficiency

The dose should not exceed 10 mg in these patients.

Patients with mild to moderate hepatic insufficiency

Patients with mild to moderate hepatic insufficiency, no dose adjustment is necessary.

Administration form

-The buccal dispersible tablet should be placed on the tongue, where it will dissolve. No water or other liquid is required, if desired, you can drink a glass of water or other beverage after taking the tablet.

-The buccal dispersible tablet should be carefully removed from the blister with dry hands and without crushing and should be taken immediately.

Treatment duration

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 Toxicological Information Service, phone 915 620 420 (indicating the medication and the amount ingested) or go to the nearest hospital. Your doctor will decide what to do. Monitoring of vital body functions, including electrocardiographic monitoring for at least 24 hours and symptomatic treatment may be necessary.
• If you present symptoms related to the central nervous system, intensive care may be required.

If you forgot to take Ebastina Forte Flas Stada

Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time.

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

Like all medications, this medication may produce adverse effects, although not all people will experience 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)
• Accelerated heart rate (tachycardia), palpitations
• Nausea, abdominal pain, vomiting, indigestion
• Hepatitis, cholestasis, abnormal liver function test results (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
• Skin rash and urticaria, skin inflammation (dermatitis)
• Menstrual disorders
• Edema, fatigue

Unknown (frequency cannot be estimated from available data)

• Weight gain
• Increased appetite

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special conditions for conservation.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Ebastina Forte Flas Stada

-The active ingredient is ebastina. Each buccal dispersible tablet contains 20 mg of ebastina.

-The other components (excipients) are: Hypromellose (E-464), povidone (E-1201), poloxamer, gelatin, calcium carmelose, crospovidone (E-1202), mannitol (E-421), microcrystalline cellulose (E-460), sodium croscarmellose (E-468), hydrated colloidal silica (E-551), peppermint flavor*, neotame (E-961), magnesium stearate (E-572).

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

Appearance of the product and contents of the package

Ebastina Forte Flas Stada 20 mg are white to off-white, round, flat, beveled-edge buccal dispersible tablets with a diameter of approximately 11 mm and a thickness of 2.70 mm, marked on one side with “20” and smooth on the other side.

The buccal dispersible tablets are packaged in peelable blisters of OPA/Alu/PVC – Paper/PET/Alu.

Ebastina Forte Flas Stada 20 mg is available in packs containing 20 and 30 buccal dispersible tablets.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

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 with the following names:

Netherlands:NOTAXO 20 mg, orodispergeerbare tablet

Italy:Ebastina EG 20 mg, compressa orodispersibile

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

Date of the last review of this leaflet:July 2019

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/