EBASTEL FLAS 10 mg ORAL LYOPHILIZATES

Introduction

Package Leaflet: Information for the Patient

Ebastel Flas 10 mg Oral Lyophilisates

Ebastine

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

• 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 not listed in this package leaflet.

Contents of the Package Leaflet:

1. What is Ebastel Flas and what is it used for
2. What you need to know before taking Ebastel Flas
3. How to take Ebastel Flas
4. Possible side effects
5. Storage of Ebastel Flas
6. Package contents and additional information

1. What is Ebastel Flas and what is it used for

Ebastel Flas belongs to a group of medications called antihistamines (anti-allergics).

Ebastel Flas 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 Ebastel Flas

Do not take Ebastel Flas

• if you are allergic to ebastine 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 Ebastel Flas.

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 the "How to take Ebastel Flas" section).
• 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 the "Taking Ebastel Flas with other medications" section).
• 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 ebastine (the active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastel Flas should not be administered to children under 12 years of age.

Taking Ebastel Flas with other medications

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

The following medications may interfere with Ebastel Flas; in these cases, it may be necessary to change the dose or interrupt treatment with one of them:

• Ebastel Flas may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastel 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 Ebastel Flas may be decreased in patients being treated with a medication called rifampicin used to treat tuberculosis.

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

Interference with diagnostic tests

Ebastel Flas may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after treatment has been discontinued.

Taking Ebastel Flas with food and drinks

The oral lyophilisate can be taken 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 Ebastel 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

In humans, no effects have been observed on psychomotor function or the ability to drive or use machinery at the recommended therapeutic doses. However, since somnolence and dizziness are among the side effects, observe your response to the medication before driving or using machinery.

Ebastel Flas contains aspartame

This medication contains 1 mg of aspartame in each oral lyophilisate. 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.

3. How to take Ebastel Flas

Follow your doctor's instructions for taking Ebastel Flas exactly. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Ebastel Flas.

Dosage

Use in adults and children over 12 years:The recommended dose is 1 oral lyophilisate (10 mg of ebastine) once a day.

Use in patients with severe liver disease:Do not exceed the dose of 10 mg of ebastine per day (1 oral lyophilisate).

Method of administration

This medication is for oral administration.

1. Do not remove the oral lyophilisate from the packaging until you are about to take it.
2. Do not extract the dose from the oral lyophilisate by pressing on it. Immediately before taking, with dry hands, open the blister pack by carefully lifting the foil from the point where it is detached (Figure 1).
3. Stretch the tab to detach it (Figure 2).
4. Press the lyophilisate carefully upwards (without touching it) (Figure 3).
5. Remove the lyophilisate carefully (Figure 4).
6. The dose should be taken immediately after opening the blister pack. Place the oral lyophilisate on your tongue, where it will dissolve quickly, and swallow it with your saliva. Do not take water or any other liquid.

Figure 1 Figure 2 Figure 3 Figure 4

If you think the effect of Ebastel Flas is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastel Flas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service, phone 915 620 420 (indicating the medication and the amount ingested), or go to the nearest hospital. Bring the remaining oral lyophilisates, 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 the appropriate medication.

If you forget to take Ebastel Flas

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 your 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, Ebastel Flas can cause side effects, although not everyone gets them.

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

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):

• Hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema)
• Nervousness, insomnia
• Dizziness, decreased sensation 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, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ebastel Flas

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

No special storage conditions are required.

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 point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Ebastel Flas

• The active ingredient is ebastine. Each oral lyophilisate contains 10 mg of ebastine.
• The other ingredients (excipients) are gelatin (E-441), mannitol (E-421), aspartame (E-951), and peppermint flavor.

Appearance of the product and package contents

Ebastel Flas is presented in the form of oral lyophilisates. The lyophilisate is round and white. Each package contains 20 oral lyophilisates.

Other presentations

Ebastel Forte Flas 20 mg Oral Lyophilisates

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of the last revision of this package leaflet: May 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/Mod. P.03.1 (16/02/15)