Package Insert: Information for the Patient

Ebastina Kern Pharma 10 mg Bucodispersable Tablets EFG

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

Ebastina Kern Pharma belongs to a group of medications known as antihistamines (antiallergics).

Ebastina is indicated for the treatment of symptoms of allergic processes such as seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

Do not take Ebastina Kern Pharma

• if you are allergic to ebastina or any of the other components of this medication (listed in section 6).

Warnings and precautions

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

This medication should be used with caution:

• If your electrocardiogram results are altered (prolongation of the QT interval).
• If you have altered potassium levels in your blood.
• If you have severe liver disease (see section “How to take Ebastina Kern Pharma?”).
• If you are being treated with a type of antifungal medication called azoles or with a type of antibiotic called macrolides (see section “Taking Ebastina Kern Pharma with other medications”).
• If you are being treated with rifampicin, a type of medication used to treat tuberculosis.

Do not use this medication if you have an acute allergic emergency, as ebastina (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastina Kern Pharma should not be administered to children under 12 years old.

Taking Ebastina Kern Pharma with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

The following medications may interact with Ebastina Kern Pharma; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

• Ebastina Kern Pharma may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastina Kern Pharma should be used with caution in patients being treated with medications 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).
• The antihistamine effect of Ebastina Kern Pharma may be reduced in patients being treated with a medication called rifampicin used to treat tuberculosis.

No interactions have been described between ebastina and theophylline, warfarin, cimetidine, diazepam, and alcohol.

Interference with diagnostic tests

Ebastina Kern Pharma may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after discontinuing treatment.

Taking Ebastina Kern Pharma with food and drinks

The tablets can be taken with or without food. No water or other liquid is required.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

There is no experience in pregnant women, so it is recommended to consult with your doctor before taking ebastina. Your doctor will decide whether to continue or discontinue treatment.

Breastfeeding

It is unknown whether the medication passes into breast milk, so it should not be used during breastfeeding.

Driving and operating machinery

No effects on psychomotor function or the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, given that drowsiness and dizziness are among the adverse effects, observe your response to the medication before driving or operating machinery.

Follow exactly the administration instructions for ebastina indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Ebastina Kern Pharma. Do not suspend treatment beforehand, as your symptoms may worsen.

Dosage

Use in adults and children over 12 years old

The recommended dose is one buccodispersible tablet (10 mg of ebastina) once a day.

Use in patients with severe liver disease

The daily dose of 10 mg of ebastina should not be exceeded (1 buccodispersible tablet of 10 mg).

Administration form

Ebastina tablets are for oral administration and dissolve easily, so they should be handled with care. Do not manipulate the tablets with wet hands, as they may dissolve.

The tablets should be taken as follows:

To avoid breaking the tablet, do not press it against the cavity where it is stored. Gently pull the metal cover from the indicated corner with 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 estimate that the action of ebastina is too strong or too weak, inform 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 or call the Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested) or go to the nearest hospital. Bring the remaining tablets, the packaging, and the complete box so that healthcare personnel can easily identify the medication taken.

The treatment of intoxication by this medication consists of gastric lavage and administration of the appropriate medication.

If you forgot to take Ebastina Kern Pharma

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

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

Like all medications, ebastine may produce adverse effects, although not all people experience them.

In clinical trials and post-marketing experience, the following adverse effects have been observed:

Very common (may affect more than 1 in 10 people):

• Headache

Common (may affect up to 1 in 10 people):

• Drowsiness
• 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 sense of touch or sensitivity, decreased or altered taste
• Palpitations, tachycardia
• Abdominal pain, vomiting, nausea, digestive problems
• Liver inflammation (hepatitis), cholestasis, abnormal liver function test results (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
• Urticaria, skin rash, dermatitis
• Menstrual disorders
• Edema (swelling due to fluid accumulation), fatigue

Unknown frequency (cannot be estimated from available data):

• Weight gain
• Increased appetite

Reporting Adverse Effects

If you experience any type of adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Ebastina Kern Pharma Composition

The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.

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

Product appearance and packaging content

Ebastina Kern Pharma is presented in the form of white or almost white, round, and flat tablets, and are packaged in aluminum/aluminum-poliamide-PVC blisters. Each package contains 20 tablets.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer responsible

Laboratorios Normon, S.A.

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

Last review date of this prospectus:July 2023

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