Ebastine Kern Pharma 20 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ebastine Kern Pharma 20 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents

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

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

Ebastina Kern Pharma belongs to a group of medicines called antihistamines (antiallergic agents).

Ebastine is indicated for the treatment of symptoms 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

Consult your doctor or pharmacist before starting Ebastine Kern Pharma.

This medicine should be used with caution:

• If your electrocardiogram (ECG) results are abnormal (prolonged QT interval).
• If you have abnormal blood potassium levels.
• 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 type of medicine used to treat tuberculosis.

Do not use this medicine if you have an acute allergic emergency, 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.

Taking Ebastine Kern Pharma with other medicines

Inform 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 them:

• Ebastine Kern Pharma may increase the effect of other medicines used to treat allergy (antihistamines).
• Ebastine Kern Pharma should be used with caution in patients taking medicines called ketoconazole or itraconazole, used to treat fungal infections, or the antibiotic 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 the results of skin allergy tests; therefore, it is recommended not to perform such tests until 5–7 days after stopping treatment.

Taking Ebastine Kern Pharma with food and drinks

The tablets can be taken with or without food. It is not necessary to take water or any other liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 your doctor before taking ebastine. Your doctor will decide whether or not to start treatment.

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 observe your response to the medication before driving or operating machinery.

3. How to take Ebastine Kern Pharma

Follow exactly the ebastine dosing instructions provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will determine the duration of your ebastine treatment. Do not stop treatment early, as your symptoms may worsen.

Dosage

Use in adults and children over 12 years of age

The usual recommended dose is 10 mg of ebastine once daily, although some individuals may require a dose of 20 mg once daily.

Use in patients with severe liver disease

The dose should not exceed 10 mg of ebastine per day. In this case, the 10 mg formulation is recommended.

Method of administration

Ebastine tablets are for oral use and dissolve easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

The tablets should be taken as follows:

To avoid breaking the tablet, do not press on the cavity where the tablet is located. Carefully pull the metallic backing from the corner indicated by the arrow (see figure) and remove the tablet from the blister. Place the tablet in the mouth. It will dissolve directly in the mouth, making it very easy to swallow.

If you feel that the effect of ebastine is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastine Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at 91 562 04 20 (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 personnel can easily identify the medicine you have taken.

Treatment of poisoning with this medicine includes gastric lavage and administration of appropriate medication.

If you forget to take Ebastine 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, skip the missed dose and take the next dose at the scheduled time.

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 may cause adverse effects, although not everyone experiences 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 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 a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 20 mg of ebastine.

The other components are: Pearlitol flash (mannitol and corn starch), microcrystalline cellulose (E-460), potato starch, hydroxypropylcellulose (E-463), macrogol 6000, colloidal silica, glycerol monostearate, tutti frutti flavor, sodium saccharin (E-954), and magnesium stearate (E-572).

Appearance of the product and contents of the pack

Ebastine Kern Pharma is presented as white or almost white, round, flat tablets, packed in aluminum/aluminum-polyamide-PVC blisters. Each pack contains 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (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