Ebastel 1 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ebastel 1 mg/ml oral solution

ebastine

• Read the entire 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, 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, since it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

1. What Ebastel is and what it is used for

2. What you need to know before taking Ebastel

3. How to take Ebastel

4. Possible side effects

5. How to store Ebastel

6. Contents of the pack and other information

1. What Ebastel is and what it is used for

Ebastel belongs to a group of medicines called antihistamines (antiallergic agents).

Ebastel 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, sneezing), chronic urticaria, and allergic dermatitis.

2. What you need to know before taking Ebastel

Do not take Ebastel

• if you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Ebastel.

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 Ebastel”).
• 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 Ebastel with other medicines”).
• if you are being treated with rifampicin, a 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

Ebastel 1 mg/ml Oral Solution must not be given to children under 2 years of age.

Other medicines and Ebastel

Tell 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 Ebastel; in such cases it may be necessary to adjust the dose or discontinue treatment with one of them:

• Ebastel may increase the effect of other medicines used to treat allergies (antihistamines).
• Ebastel should be used with caution in patients taking medicines called ketoconazole and itraconazole, used to treat fungal infections, or the antibiotic erythromycin, used to treat certain infections (as they may cause changes in your electrocardiogram).
• The antihistaminic effect of Ebastel 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

Ebastel may interfere with skin allergy test results; therefore, it is recommended not to perform these tests until 5–7 days after stopping treatment.

Taking Ebastel with food and drink

The solution can be taken with or without food.

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 a doctor before taking Ebastel. The 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 use of machines

At the recommended therapeutic doses, no effects on psychomotor function or on the ability to drive or operate machinery have been observed in humans. However, since somnolence and dizziness are listed among the adverse effects, you should assess your response to the medication before driving or operating machinery.

Ebastel contains sodium methyl para-hydroxybenzoate (E-219), sodium propyl para-hydroxybenzoate (E-217), sorbitol (E-420), hydrogenated polyoxyl castor oil, and benzoic acid (E-210)

It may cause allergic reactions (possibly delayed) as it contains sodium methyl para-hydroxybenzoate (E-219) and sodium propyl para-hydroxybenzoate (E-217).

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

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

This medicine may cause stomach discomfort and diarrhoea due to the presence of hydrogenated polyoxyl castor oil.

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

This medicine contains less than 23 mg of sodium (1 mmol) per 10 ml; therefore, it is essentially “sodium-free”.

3. How to take Ebastel

Follow exactly the instructions for use of this medicine 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 take Ebastel.

Dosage

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

Use in children aged 2 to 12 years:

Use in children aged 6 to 11 years: The recommended dose is 1 dose of 5 ml (5 mg of ebastine) once daily.

Use in children aged 2 to 5 years: The recommended dose is 2.5 ml (2.5 mg of ebastine) once daily.

Use in patients with severe liver disease: The dose should not exceed 10 mg of ebastine per day (1 dose of 10 ml).

Method of administration

This medicine is for oral use.

The package includes a graduated dosing cup to measure the amount of medicine to be taken. Swallow the dose and rinse the cup after each use.

It can be taken directly or mixed with water.

If you think that the effect 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, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number 915 620 420 (indicating the medicine and the amount ingested), or go to the nearest hospital. Take the container 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 Ebastel

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 dosing schedule. However, if it is almost time for your next dose, do not take the missed dose and wait to 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, Ebastel 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 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 may 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 Ebastel

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

Do not store above 30°C.

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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ebastel

• The active substance is ebastine. Each ml of oral solution contains 1 mg of ebastine.
• The other components (excipients) are lactic acid (E-270), polyoxyl hydrogenated castor oil, sucralose, anethole, methylparaben sodium salt (E-219), propylparaben sodium salt (E-217), glycerol (E-422), 70% sorbitol solution (E-420), simethicone emulsion (purified water, simethicone, polyoxyethylene sorbitan tristearate (E-436), methylcellulose (E-461), polyethylene glycol stearate, glycerol monostearate (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 container

Ebastel is a clear, practically colourless liquid with an aniseed odour for oral administration.

Each pack contains a bottle with 120 ml of oral solution 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)

Date of the most recent review of this leaflet: May 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/