Package Leaflet: Information for the User

Ebastina Kern Pharma 20 mg Film-Coated Tablets

Ebastina belongs to a group of medications known as antihistamines (antiallergics).

Ebastina is indicated for the symptomatic treatment of allergic processes such as seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

Do not take Ebastina Kern Pharma:

• 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 Kern Pharma.

This medication should be taken with caution:

• If your electrocardiogram results are altered (prolongation of the QT interval).

• If you have altered potassium levels in the blood.
• If you have severe liver disease (see the section “How to take Ebastina Kern Pharma”).
• 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 section “Taking Ebastina Kern Pharma with other medications”).
• 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 (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastina Kern Pharma should not be administered to children under 12 years of age. In this group of patients, it is recommended to administer the oral solution presentation.

Other medications and Ebastina Kern Pharma

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

The medications listed below may interact with Ebastina Kern Pharma; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

• Ebastina Kern Pharma may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastina 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 Ebastina Kern Pharma may be reduced 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 Kern Pharma may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after discontinuing treatment.

Taking Ebastina Kern Pharma with food and beverages:

The tablets can be taken with or without food.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

There is no experience in pregnant women, so it is recommended to consult a doctor before taking ebastina. The doctor will decide whether it is advisable to start treatment.

Breastfeeding

The medication is unknown to pass into breast milk, so it should not be used during breastfeeding.

Driving and operating machinery

No effects have been observed on psychomotor function, or on the ability to drive or operate machinery, at the recommended therapeutic doses. However, given that drowsiness and dizziness are among the adverse effects, observe your response to the medication before driving or operating machinery.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. 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.

Dosage

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

Use in patients with severe liver disease:Do not exceed a dose of 10 mg of ebastina per day (1 10 mg tablet).In this case, it is recommended to use the 10 mg presentation.

Administration form:

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

If you estimate that the action of ebastina is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastina Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicological Information Service, phone 915 620 420 (indicating the medication and the amount ingested) or go to the nearest hospital. Bring the remaining tablets, the packaging, and the complete box so that the healthcare staff can identify the medication more easily.

The treatment of intoxication by this medication consists of gastric lavage and administration of the appropriate medication.

If you forgot to take Ebastina Kern Pharma

Do not take a double dose to compensate for the missed doses.

Take the missed dose as soon as you remember and then continue with your regular schedule. However, if there are only a few hours left until the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

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

Like all medications, Ebastina Kern Pharma may produce adverse effects, although not all people will experience them.

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

Very frequent (may affect more than 1 in 10 people):

- Headache

Frequent (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

- Inflammation of the liver (hepatitis), cholestasis, abnormal liver function test results (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin)

- Urticaria, skin rash, dermatitis

- Menstrual disorders

- Edema (swelling due to fluid accumulation), fatigue

Unknown frequency (cannot be estimated from available data):

- Weight gain

- Increased appetite

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus.

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

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

No special storage conditions are required.

Do not use Ebastina Kern Pharma after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Ebastina Kern Pharma Composition

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

The other components are:

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

Product appearance and packaging content

Ebastina Kern Pharma is presented in the form of scored tablets, coated with a film. Each package contains 20 tablets.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

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

31620 Huarte - Pamplona (Navarra)-Spain

Last review date of this leaflet:july 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es