EBASTINE FLAS CINFA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

ebastina flas cinfa10 mg orodispersible tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is ebastina flas cinfa and what is it used for
2. What you need to know before taking ebastina flas cinfa
3. How to take ebastina flas cinfa
4. Possible side effects
   1. Storage of ebastina flas cinfa

Contents of the pack and further information

1. What is ebastina flas cinfa and what is it used for

ebastina flas cinfa belongs to a group of medications called antihistamines (anti-allergics).

ebastina flas cinfa is indicated for the treatment of symptoms of allergic processes such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, sneezing), chronic urticaria, and allergic dermatitis.

2. What you need to know before taking ebastina flas cinfa

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 (the 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 of age.

Other medications and ebastina flas cinfa

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

The following medications may interfere with ebastina flas; in these cases, it may be necessary to change the dose or interrupt 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 decreased 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 have passed since treatment was discontinued.

Taking ebastina flas cinfa with food and drinks

You can take the orodispersible tablets with or without food. It is not necessary to ingest water or any other liquid.

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 medication.

Pregnancy

There is no experience in pregnant women, so it is recommended to consult with a doctor before taking ebastina flas. The doctor 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 using machines

No effects on psychomotor function have been observed in humans, nor on the ability to drive or use machinery, at the recommended therapeutic doses. However, since drowsiness and dizziness are among the side effects, observe your response to treatment before driving or using 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 case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

ebastina flas cinfa containslactose

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; that is, it is essentially "sodium-free".

3. How to take ebastina flas cinfa

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

Remember to take your medication.

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

Posology

Use in adults and children over 12 years of age

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

Use in patients with severe liver disease

The dose of 10 mg of ebastina per day should not be exceeded.

Method of administration

This medication is for oral administration.

The dose of ebastina flas is placed on the tongue, where it will dissolve quickly. It is not necessary to ingest water or any other liquid.

Immediately before taking it, carefully open the blister pack with dry hands and remove the tablet with care not to crush it. The dose should be taken immediately after the blister pack has been opened.

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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring this package leaflet with you and the remaining tablets, the case, and the complete box so that healthcare personnel can more easily identify the medication you have taken.

Treatment of poisoning with this medication consists of gastric lavage and administration of appropriate medication.

If you forget to take ebastina flas cinfa

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then follow your regular schedule. However, if it is almost time for your next dose, do not take the forgotten dose and wait for the next scheduled dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been observed in clinical trials and post-marketing experience:

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):

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

Frequency not known (cannot be estimated from available data):

• Weight gain
• Increased appetite

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of ebastina flas cinfa

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 stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of ebastina flas cinfa:

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

Appearance of the product and packaging contents

ebastina flas cinfa are white and round orodispersible tablets.

They are presented in aluminum/PA/PVC-aluminum blister packs, available in packs of 20 orodispersible tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

SEID, S.A.

Carretera de Sabadell a Granollers Km 15

08185 Lliçà de Vall – Barcelona

Spain

Date of the last revision of this package leaflet:November 2019

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

You can access detailed and updated information on this medication by scanning the QR code included in the package 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