Package Insert: Information for the Patient

Ebastel 10 mg Film-Coated Tablets

ebastina

• Read this 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 for you only and should not be given to others, even if they 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.

Ebastel belongs to a group of medications known as antihistamines (antiallergics).

Ebastel 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 nasal discharge, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

Do not take Ebastel

• if you are allergic to ebastine 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 Ebastel.

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 the blood.
• if you have severe liver disease (see "How to take Ebastel").
• if you are being treated with a type of antifungal medication called azoles or with a type of antibiotic called macrolides (see "Taking Ebastel 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 are experiencing an acute allergic emergency, as ebastine (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastel 10 mg Tablets should not be administered to children under 12 years of age.

Other medications and Ebastel

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

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

• Ebastel may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastel 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 Ebastel may be reduced in patients being treated with a medication called rifampicin used to treat tuberculosis.

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

Interference with diagnostic tests

Ebastel 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 Ebastel with food and drinks

The tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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 a doctor before taking Ebastel. This will decide whether or not to start treatment.

Breastfeeding

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

Driving and operating machinery

In men, no effects have been observed on psychomotor function, or on the ability to drive or operate machinery, 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.

Ebastel contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as 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 Ebastel.

Ebastel 10 mg Film-Coated Tablets is not suitable for administration of doses lower than 10 mg of ebastine, nor for patients with swallowing problems.

Dosage

Use in adults and children over 12 years:The recommended dose is 1 tablet (10 mg of ebastine) once a day.

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

Administration Form

This medication is for oral administration.

Tablets can be taken with or without food, with the help of a glass of water.

If you estimate that the action of Ebastel is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastel than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicological Information Service, phone 915 620 420 (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 the healthcare staff can identify the medication you have taken more easily.

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

If you forgot to take Ebastel

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, Ebastel may produce adverse effects, although not everyone will 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 sensation of touch or sensitivity, decreased or altered taste
• Palpitations, tachycardia
• Abdominal pain, vomiting, nausea, digestive problems
• Inflammation of the liver (hepatitis), cholestasis, abnormal liver function test results (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
• Urticaria, skin rash, dermatitis
• M 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 effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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.

Do not store at a temperature above30°C.

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.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications.This will help protect the environment..

Ebastel Composition

• The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.
• The other components (excipients) are:Tablet core:celulosa microcristalina (E-460i), pregelatinized cornstarch, lactose monohydrate, croscarmelosa sodium (E-468) and magnesium stearate (E-572).Coating: hypromellose (E-464), macrogol 6.000 and titanium dioxide (E-171).

Product appearance and packaging contents

Ebastel is presented in the form of coated tablets with a film for oral administration, packaged in PVC/Aluminum blisters. The tablets are circular, white in color, and have a face marked with E10.

Each package contains 20 coated tablets.

Other presentations

Ebastel 1 mg/ml Oral Solution

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Last review date of this leaflet: May 2019

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