Ebastine Kern Pharma 10 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Ebastine Kern Pharma 10 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, ask 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, as it may 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 to take 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 to take Ebastine 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 blood potassium levels.
• If you suffer from 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, urgent allergic reaction, 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 interrupt treatment with one of them:

• Ebastine Kern Pharma may increase the effect of other medicines used to treat allergies (antihistamines).
• Ebastine Kern Pharma should be used with caution in patients treated with medicines called ketoconazole and itraconazole used to treat fungal infections, or with a macrolide antibiotic used to treat certain infections called erythromycin (as they may cause abnormalities in your electrocardiogram).
• The antihistaminic effect of Ebastine Kern Pharma may be reduced in patients treated 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 Kern Pharma 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 Ebastine Kern Pharma with food and drink

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 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 your doctor before taking ebastine. Your 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 medicine before driving or operating machinery.

3. How to take Ebastine Kern Pharma

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

Remember to take your medicine.

Your doctor will tell you how long to continue treatment with Ebastine Kern Pharma. Do not stop treatment earlier, as your symptoms may worsen.

Dosage

Use in adults and children over 12 years of age

The recommended dose is one orodispersible tablet (10 mg of ebastine) once daily.

Use in patients with severe liver disease

The dose should not exceed 10 mg of ebastine per day (1 orodispersible tablet of 10 mg).

Method of administration

Ebastine tablets are for oral use and dissolve easily, so they must be handled carefully. 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 against the cavity where the tablet is held. Carefully pull the metallic foil 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and amount ingested), or go to the nearest hospital. Bring any remaining tablets, the carton, 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 appropriate medication.

If you forget to take Ebastine Kern Pharma

Do not take a double dose to make up for forgotten 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 scheduled time for the next 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 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 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 may also report them directly through 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 is the last day of the month indicated.

Medicines must not be disposed of via wastewater or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. 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: Pearlitol flash (mannitol and corn starch), microcrystalline cellulose (E-460), potato starch, hydroxypropylcellulose (E-463), macrogol 6000, colloidal silica, glycerol monostearate, tutti frutti flavour, sodium saccharin (E-954) and magnesium stearate (E-572).

Appearance of the product and contents of the container

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