


Ask a doctor about a prescription for EBASTINE KERN PHARMA 20 mg FILM-COATED TABLETS
Package Leaflet: Information for the User
Ebastine Kern Pharma 20 mg Film-Coated Tablets EFG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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Contents of the Package Leaflet:
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.
Do not take Ebastine Kern Pharma:
Warnings and precautions:
Consult your doctor or pharmacist before taking Ebastine Kern Pharma.
This medicine should be taken with caution:
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:
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).
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".
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.
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):
Common (may affect up to 1 in 10 people):
Rare (may affect up to 1 in 1,000 people):
Frequency not known (cannot be estimated from the available data):
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.
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.
Composition of Ebastine Kern Pharma
The active substance is ebastine. Each tablet contains 20 mg of ebastine.
The other ingredients are:
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
The average price of EBASTINE KERN PHARMA 20 mg FILM-COATED TABLETS in November, 2025 is around 8.79 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for EBASTINE KERN PHARMA 20 mg FILM-COATED TABLETS – subject to medical assessment and local rules.