Leaflet: information for the user

Ebastina Flas Cinfa10 mg buccal dispersible tablets EFG

Read this 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must 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 Flas Cinfa and what it is used for

2.What you need to knowbefore starting to takeebastina Flas Cinfa

3.How to take ebastina Flas Cinfa

4.Possible side effects

1. Storage ofebastina Flas Cinfa

Contents of the pack and additional information

ebastina flas cinfa belongs to a group of medicines called antihistamines (antiallergics).

ebastina flas cinfa is indicated for the treatment of symptoms of allergic processes such as seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

Do not takeebastina flas cinfa

• 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 flas cinfa.

This medication should be used with caution:

• If your electrocardiogram results are altered (prolongation of the QT interval).
• If you have altered potassium levels in your blood.
• If you have severe liver disease (see section 3 “How to take ebastina flas cinfa”).
• If you are being treated with a type of medication used to treat fungal infections called azole antifungals or with medications used to treat certain infections called macrolide antibiotics (see section “Other medications and ebastina flas cinfa”).
• If you are being treated with rifampicin, a type of medication used to treat tuberculosis.

Do not use this medication if you have an acute allergic emergency, as ebastina (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastina flas should not be administered to children under 12 years old.

Other medications and ebastina flas cinfa

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

The medications listed below may interact with ebastina flas; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

• Ebastina flas may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastina flas should be used with caution in patients being treated with medications called ketoconazole and itraconazole used to treat fungal infections, or with an antibiotic used to treat certain infections called erythromycin (as they may cause an alteration in your electrocardiogram).
• The antihistamine effect of ebastina flas may be reduced in patients being treated with a medication called rifampicin used to treat tuberculosis.

No interactions have been described between ebastina and theophylline, warfarin, cimetidine, diazepam, and alcohol.

Interference with diagnostic tests

Ebastina flas may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after discontinuing treatment.

Taking ebastina flas cinfa with food and drinks

You can take the buccal tablets with or without food. No water or other liquid is required.

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

No experience has been reported in pregnant women, so it is recommended to consult a doctor before taking ebastina flas. This will decide whether or not to start treatment.

Breastfeeding

It is unknown whether the medication passes into breast milk, so it should not be used during breastfeeding.

Driving and operating machinery

No effects have been observed on human psychomotor function, nor on the ability to drive or operate machinery, at the recommended therapeutic doses. However, given that drowsiness and dizziness are among the adverse effects, observe your response to treatment before driving or operating machinery.

ebastina flas cinfa contains aspartame (E-951)

This medication contains 2.50 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

ebastina flas cinfa contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

ebastina flas cinfa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with ebastina flas.

Dosage

Use in adults and children over 12 years old

The recommended dose is 1 buccal dispersible tablet (10 mg of ebastina) once a day.

Use in patients with severe liver disease

The dose of ebastina should not exceed 10 mg per day.

Administration form

This medication is for oral administration.

The ebastina flas dose should be placed on the tongue, where it will dissolve quickly. No water or other liquid is required.

Immediately before taking, carefully open the blister pack with dry hands, and carefully remove the tablet without crushing it. The dose should be taken immediately after opening the blister pack.

If you take more ebastina flas cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring this leaflet with you and the remaining tablets, the container, and the complete box so that healthcare personnel can identify the medication you have taken more easily.

The treatment of intoxication by this medication consists of gastric lavage and administration of the appropriate medication.

If you forgot to take ebastina flas cinfa

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled 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 may experience them.

In clinical trials and post-marketing experience, the following adverse effects have been observed:

Very Frequent (may affect more than 1 in 10 people):

• Headache

Frequent (may affect up to 1 in 10 people):

• Drowsiness
• Dry mouth

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

• Hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema)
• Nervousness, insomnia
• Dizziness, decreased sense of touch or sensitivity, decreased or altered taste.
• Palpitations, tachycardia.
• Abdominal pain, vomiting, nausea, digestive problems.
• Inflammation of the liver (hepatitis), cholestasis, abnormal liver function test results (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin).
• Urticaria, skin rash, dermatitis.
• Menstrual disorders.
• Edema (swelling due to fluid accumulation), 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.

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of ebastina flas cinfa:

• The active ingredient is ebastina. Each buccal dispersible tablet contains 10 mg of ebastina.
• The other components (excipients) are: l actosa monohydrate, microcrystalline cellulose 101, croscarmellose sodium, aspartame (E-951), magnesium stearate (E-470b), anhydrous colloidal silica (E-551), and peppermint aroma.

Appearance of the product and content of the packaging

ebastina flas cinfa are white and round buccal dispersible tablets.

They are presented in Aluminio/PA/PVC-Aluminio blisters, available in packs of 20 buccal dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing :

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

SEID, S.A.

Carretera de Sabadell a Granollers Km 15

08185 Lliçà de Vall – Barcelona

Spain

Date of the last review of this leaflet: November 2019

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81904/P_81904.html

QR code to: https://cima.aemps.es/cima/dochtml/p/81904/P_81904.html