Ebastine Kern Pharma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ebastine Kern Pharma 20 mg film-coated tablets EFG

Package leaflet:

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

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

Ebastine belongs to a group of medicines known as antihistamines (antiallergic agents).

Ebastine is indicated for the symptomatic treatment of allergic conditions such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, and sneezing), chronic urticaria, and allergic dermatitis.

2. What you need to know before starting Ebastine Kern Pharma

Do not take Ebastine Kern Pharma:

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

Warnings and precautions:

Talk to your doctor or pharmacist before taking Ebastine Kern Pharma.

This medicine should be taken with caution:

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

• If you have abnormal 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 medicine used to treat fungal infections called azole antifungals, or with medicines used to treat certain infections called macrolide antibiotics (see section “Taking Ebastine Kern Pharma with other medicines”).

• If you are being treated with rifampicin, a medicine used to treat tuberculosis.

• Do not use this medicine for acute allergic emergencies, as ebastine (the active substance in this medicine) takes 1 to 3 hours to take effect.

Children

Ebastine Kern Pharma must not be administered to children under 12 years of age. In this patient group, an oral solution formulation is recommended.

Other medicines and Ebastine Kern Pharma

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

The following medicines may interact with Ebastine Kern Pharma; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines:

• Ebastine Kern Pharma may enhance 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 a macrolide antibiotic called erythromycin used to treat certain infections (as they may cause abnormalities in your electrocardiogram).

• The antihistaminic effect of Ebastine Kern Pharma may be reduced in patients taking a medicine called rifampicin, used to treat tuberculosis.

No interactions have been reported between ebastine and theophylline, warfarin, cimetidine, diazepam, or alcohol.

Interference with diagnostic tests

Ebastine Kern Pharma may interfere with skin allergy test results; therefore, such tests should not be performed until 5–7 days after stopping treatment.

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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

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

Breastfeeding:

It is unknown whether the medicine passes into breast milk; therefore, Ebastine Kern Pharma should not be used during breastfeeding.

Driving and using machines

No effects on psychomotor function or on the ability to drive or operate machinery have been observed at recommended therapeutic doses. However, since somnolence and dizziness are listed among the adverse effects, you should assess your response to the medication before driving or operating machinery.

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

3. How to take Ebastina Kern Pharma

Follow exactly the administration instructions given to you by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate how long your treatment with ebastine should last.

Dosage

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

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

Method of administration:

This medicine is for oral use. The tablets can be taken with or without food, taken with 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 Ebastina Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number 915 620 420 (indicating the medicine and the amount ingested), or go to the nearest hospital. Bring any remaining tablets, the outer carton, and the full packaging so that healthcare personnel can easily identify the medicine you have taken.

Treatment of poisoning by this medicine consists of gastric lavage and administration of appropriate medication.

If you forget to take Ebastina Kern Pharma

Do not take a double dose to make up for missed doses.

Take the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for your next dose, do not take the missed dose and wait until the next scheduled dose.

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

4. Possible adverse effects

Like all medicines, Ebastine Kern Pharma may cause adverse effects, although not everyone will experience them.

The following adverse 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

Uncommon (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 disorders
• 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 of 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 leaflet.

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

5. Storage of Ebastine Kern Pharma

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use Ebastine Kern Pharma after the expiry date stated on the container, following “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Ebastine Kern Pharma

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

The other components are:

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

Appearance of the product and contents of the container

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

Marketing Authorization 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 (Navarre) - Spain

Date of the most recent review of this leaflet: July 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es