Leaflet: information for the patient

Ebastel 1 mg/ml oral solution

ebastina

• Read this leaflet carefully before you start taking this medicine, because 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

6.Contents of the pack and additional information

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 runny nose, 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 ingredients 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 abnormal potassium levels in your blood.
• if you have severe liver disease (see "How to take Ebastel" section).
• 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" section).
• 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 ebastine (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastel 1 mg/ml Oral Solution should not be administered to children under 2 years.

Other medications and Ebastel

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 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 solution 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. They 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 containsparahydroxybenzoic acid methyl ester (E-219), parahydroxybenzoic acid propyl ester (E-217), sorbitol (E-420), hydrogenated ricin oil and benzoic acid (E-210)

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester (E-219) and parahydroxybenzoic acid propyl ester (E-217).

This medication contains 700 mg of sorbitol (E-420) per 10 ml.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

This medication contains 0.00028 mg of benzoic acid (E-210) (contained in the simethicone emulsion) in each 10 ml.

This medication contains less than 23 mg of sodium (1 mmol) per 10 ml; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Ebastel.

Dosage

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

Use in children from2 to12 years:

Use in children from6 to11 years: the recommended dose is 1 dose of 5 ml (5 mg of ebastine) once a day.

Use in children from2 to5 years: the recommended dose is 2.5 ml (2.5 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 dose of 10 ml).

Administration Form

This medication is for oral administration.

In the package, a graduated dosing cup is included to measure the amount of medication to be taken. Swallow the dose and wash the cup after each use.

It can be administered directly or mixed with 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 bottle and the complete box so that the healthcare staff can identify the medication 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 the usual schedule. However, if there are only a few hours left until 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.

During 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
• 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 Medicinal Products 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 packagingafter 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 andthe medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need.This will help protect the environment.

Ebastel Composition

• The active ingredient is ebastina. Each milliliter of oral solution contains 1 mg of ebastina.
• The other components (excipients) are lactic acid (E-270), hydrogenated ricin oil polioxy, sucralose, anethol, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), glycerol (E-422), 70% sorbitol solution (E-420), and simethicone emulsion (purified water, simethicone, polioxyethylen sorbitan triestearate (E-436), methylcellulose (E-461), polyethylene glycol stearate, glycerol monoestearate (E-471), xanthan gum (E-415), benzoic acid (E-210), sulfuric acid (E-513), sorbic acid (E-200)), sodium hydroxide (E-524), and purified water.

Appearance of the product and contents of the packaging

Ebastel is a clear, practically colorless liquid with an anise-like odor for oral administration.

Each package contains a 120 ml oral solution bottle and a graduated dosing cup.

Other presentations

Ebastel 10 mg Film-coated tablets

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)

or

Manufacturer

ALMIRALL HERMAL GMBH Scholtzstrasse 3 D-21465 Reinbek (Germany)

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/