EBASTINE QUASSET 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Ebastina Quasset 20 mg Oral Disintegrating 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, pharmacist, or nurse.
• This medication has been prescribed to you only and should not be given to others

even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor, pharmacist, or nurse, even if it is

a side effect not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. Package Contents and Additional Information

1. What is Ebastina Quasset and what is it used for

Ebastina Quasset belongs to a group of medications called antihistamines (antiallergics).

Ebastina Quasset 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 Quasset

Do not takeEbastina Quasset

• 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 Ebastina Quasset.

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 "How to take Ebastina Quasset" 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 "Taking Ebastina Quasset 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 in this medication) takes 1 to 3 hours to take effect.

Children

• Ebastina Quasset should not be administered to children under 12 years of age.

Taking Ebastina Quasset with other medications

Inform 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 ebastine; in these cases, it may be necessary to change the dose or interrupt treatment with one of them:

• Ebastina Quasset may increase the effect of other medications used to treat allergies (antihistamines).

• Ebastina Quasset should be used with caution in combination 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 Quasset 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

Ebastina Quasset 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 Ebastina Quasset with Food and Drinks

This medication can be taken with or without food. It is not necessary to ingest water or any other liquid.

Pregnancy, Breastfeeding, and Fertility

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 ebastine. 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 operate machinery at the recommended therapeutic doses. However, since drowsiness and dizziness are among the side effects, observe your response to treatment before driving or operating machinery.

Ebastina Quasset Oral Disintegrating Tablets contain aspartame (E-951)

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Ebastina Quasset Oral Disintegrating Tablets containlactose

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.

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

3. How to Take Ebastina Quasset

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with ebastine.

Dosage

Use in Adults and Children Over 12 Years

The recommended dose is 10 mg of ebastine once a day, although some people may require a dose of 20 mg once a day.

Use in Patients with Severe Liver Disease

Do not exceed the dose of 10 mg of ebastine per day. In this case, it is recommended to use the 10 mg presentation.

Method of Administration

This medication is for oral administration.

If You Take More Ebastina Quasset 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) or go to the nearest hospital. Bring the remaining oral lyophilizates, the case, and the complete box so that the healthcare staff 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. Bring this package leaflet with you.

If You Forget to Take Ebastina Quasset

Do not take a double dose to make up for forgotten doses. Take the forgotten dose as soon as you remember and then continue taking this medication with your usual 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, 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 it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ebastina Quasset

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any doubts, 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 Ebastina Quasset:

• The active ingredient is ebastine. Ebastina Quasset Oral Disintegrating Tablets contain 20 mg of ebastine.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose 101, sodium croscarmellose, aspartame (E-951), magnesium stearate, anhydrous colloidal silica, peppermint flavor.

Appearance of the Product and Package Contents

Ebastina Quasset 20 mg is presented in the form of white, round oral disintegrating tablets with a diameter of 9 mm, packaged in blisters.

Package size: 20 oral disintegrating tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

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:September 2020

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