EBASTINE KERN PHARMA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ebastine Kern Pharma 20 mg Film-Coated Tablets EFG

Contents of the Package Leaflet:

1. What is Ebastine Kern Pharma and what is it used for
2. What you need to know before you take Ebastine Kern Pharma
3. How to take Ebastine Kern Pharma
4. Possible side effects
5. Storage of Ebastine Kern Pharma
6. Contents of the pack and further information

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

Ebastine belongs to a group of medicines called antihistamines (anti-allergics).

Ebastine is indicated for the symptomatic treatment 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 you take Ebastine Kern Pharma

Do not take Ebastine Kern Pharma:

• If you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Consult your doctor or pharmacist before taking Ebastine Kern Pharma.

This medicine should be taken 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 "How to take Ebastine Kern Pharma").
• if you are being treated with a type of antifungal medication called azole antifungals or with antibiotics used to treat certain infections called macrolides (see section "Taking Ebastine Kern Pharma with other medicines").
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.
• Do not use this medicine if you have an acute allergic emergency, as ebastine (the active ingredient of this medicine) takes 1 to 3 hours to take effect.

Children

Ebastine Kern Pharma should not be given to children under 12 years of age. In this group of patients, an oral solution formulation is recommended.

Other medicines and Ebastine Kern Pharma

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

The following medicines 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 medicines used to treat allergies (antihistamines).
• Ebastine Kern Pharma should be used with caution in patients being treated with

medicines 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 reduced in patients being treated with a medicine 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.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

There is no experience in pregnant women, so it is recommended to consult a doctor before taking ebastine. The doctor will decide whether or not to start treatment.

Breastfeeding:

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

Driving and using machines

No effects on psychomotor function or the ability to drive or use machinery have been observed 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.

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

3. How to take Ebastine Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

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

Dosage:

Use in adults and adolescents:The recommended dose is 10 mg of ebastine once a day, although some patients may require a dose of 20 mg once a day.

Use in patients with severe liver disease:The dose should not exceed 10 mg of ebastine per day (1 tablet of 10 mg). In this case, it is recommended to use the 10 mg formulation.

Method of administration:

This medicine is for oral administration. The tablets can be taken with or without food, with the help of a glass of water.

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, call the Toxicology Information Service, phone 915 620 420 (indicating the medicine and the amount taken), or go to the nearest hospital. Bring the remaining tablets, the box, and the complete packaging so that healthcare personnel can more easily identify the medicine you have taken.

Treatment of poisoning with this medicine 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 continue with your usual 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ebastine Kern Pharma can cause side effects, although not everybody gets 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):

• 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 the available data):

• Weight gain
• Increased appetite

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Kern Pharma

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

No special storage conditions are required.

Do not use Ebastine Kern Pharma after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ebastine Kern Pharma

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

The other ingredients are:

• Core: colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Coating: hypromellose, titanium dioxide, and macrogol 400.

Appearance of the product and pack contents

Ebastine Kern Pharma is presented as film-coated, scored tablets. Each pack contains 20 tablets.

Marketing Authorisation Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte - Pamplona (Navarra) - Spain

Date of the last revision of this leaflet:July 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es