EBASTINE KERN PHARMA 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Ebastine Kern Pharma 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 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.

Contents of the Package Leaflet

1. What is Ebastine Kern Pharma and what is it used for
2. What you need to know before taking Ebastine Kern Pharma
3. How to take Ebastine Kern Pharma
4. Possible side effects
5. Storage of Ebastine Kern Pharma
6. Package Contents and Additional Information

1. What is Ebastine Kern Pharma and what is it used for

Ebastine Kern Pharma belongs to a group of medications called antihistamines (antiallergics).

Ebastine 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 Ebastine Kern Pharma

Do not take Ebastine Kern Pharma

• 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 Ebastine Kern Pharma.

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 Ebastine Kern Pharma" 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 Ebastine Kern Pharma 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

Ebastine Kern Pharma should not be administered to children under 12 years of age.

Taking Ebastine Kern Pharma 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 Ebastine Kern Pharma; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

• Ebastine Kern Pharma may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastine Kern Pharma 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 Ebastine Kern Pharma 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

Ebastine Kern Pharma 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 Ebastine Kern Pharma with Food and Drinks

The tablets can be taken with or without food. It is not necessary to drink water or any other liquid.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or 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 your doctor before taking ebastine. Your 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 have been observed on psychomotor function or 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 the medication before driving or using machinery.

3. How to take Ebastine Kern Pharma

Follow your doctor's instructions for taking ebastine 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 ebastine. Do not discontinue treatment before this time, as your symptoms may worsen.

Dosage

Use in Adults and Children Over 12 Years

The recommended dose is 10 mg of ebastine per 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

The ebastine tablets are for oral administration and dissolve easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may dissolve.

The tablets should be taken as follows:

To avoid breaking the tablet, do not press against the cavity where the tablet is located. Carefully pull the metal coating from the corner indicated by the arrow (see figure) and remove the tablet from the blister pack. Place the tablet in your mouth. It will dissolve directly in your mouth, making it easy to swallow.

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

If you take more Ebastine Kern Pharma 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 tablets, 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.

If you forget to take Ebastine Kern Pharma

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 until it is time for your next 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, ebastine 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 or sensitivity, decreased or altered taste
• Palpitations, tachycardia
• Abdominal pain, vomiting, nausea, digestive problems
• Liver inflammation (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 possible side effects not listed in this package leaflet.

You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ebastine Kern Pharma

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 shown on the packaging 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 SIGRE Point at the pharmacy. If you have any questions, 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 Ebastine Kern Pharma

The active ingredient is ebastine. Each tablet contains 20 mg of ebastine.

The other ingredients are: Pearlitol flash (mannitol and cornstarch), microcrystalline cellulose (E-460), potato starch, hydroxypropylcellulose (E-463), macrogol 6000, colloidal silicon dioxide, glycerol monostearate, tutti-frutti flavor, sodium saccharin (E-954), and magnesium stearate (E-572).

Appearance of the Product and Package Contents

Ebastine Kern Pharma is presented in the form of white or almost white, round, flat tablets, and is packaged in aluminum-aluminum-polyamide-PVC blisters. Each package contains 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the Last Revision of this Package Leaflet:July 2023

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