Ebastine Kern Pharma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ebastine Kern Pharma 10 mg film-coated tablets EFG

Package leaflet contents

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. How to store 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 treatment of symptoms associated with 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 to take Ebastina Kern Pharma

Do not take Ebastina 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

Consult your doctor or pharmacist before starting to take Ebastina Kern Pharma.

This medicine should be used with caution:

• If your electrocardiogram (ECG) results are abnormal (prolongation of the QT interval).
• If you have abnormal levels of potassium in your blood.
• If you suffer from severe liver disease (see section “How to take Ebastina 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 Ebastina Kern Pharma with other medicines”).
• If you are being treated with rifampicin, a type of medicine used to treat tuberculosis.

Do not use this medicine if you have an acute, urgent allergic reaction, as ebastine (the active substance of this medicine) takes 1 to 3 hours to take effect.

Children

Ebastina 10 mg tablets should not be administered to children under 12 years of age.

Other medicines and Ebastina 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 Ebastina Kern Pharma: in these cases it may be necessary to adjust the dose or discontinue treatment with one of them:

• Ebastine may increase the effect of other medicines used to treat allergy (antihistamines).
• Ebastine should be used with caution in patients receiving treatment with medicines called ketoconazole and itraconazole, used to treat fungal infections, or with a macrolide antibiotic called erythromycin (as they may cause abnormalities in your electrocardiogram).
• The antihistaminic effect of this medicine may be reduced in patients receiving treatment with 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 may interfere with the results of skin allergy tests; therefore, it is advisable not to perform such tests until 5–7 days after stopping treatment.

Taking Ebastina 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 treatment should be initiated.

Breastfeeding:

It is unknown whether the medicine passes into breast milk; therefore, it 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 the 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, i.e., essentially “sodium-free”.

3. How to take Ebastina Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate how long you should take ebastine.

Dosage

Use in adults and adolescents: the recommended dose is 1 ebastine tablet daily (10 mg of ebastine).

Use in patients with severe liver disease: the dose must not exceed 10 mg of ebastine per day (1 tablet).

Method of administration:

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

If you think that 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 carton, and the full packaging so that healthcare professionals can more easily identify the medicine you have taken.

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

4. Possible adverse effects

Like all medicines, ebastine 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

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
• 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 may also report them directly via the Spanish Pharmacovigilance System for 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 the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastine Kern Pharma

The active substance is ebastine. Each tablet contains 10 mg of ebastine.

The other components are:

• Core: anhydrous colloidal 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 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 (Navarra) - Spain

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

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