EBASTEL FORTE 20 mg ORAL LYOPHILIZED

Introduction

Patient Information Leaflet

Ebastel Forte Flas 20 mg Oral Lyophilisates

Ebastine

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

Contents of the Leaflet:

1. What is Ebastel Forte Flas and what is it used for
2. What you need to know before taking Ebastel Forte Flas
3. How to take Ebastel Forte Flas
4. Possible side effects
5. Storage of Ebastel Forte Flas

1. Package contents and additional information

1. What is Ebastel Forte Flas and what is it used for

Ebastel Forte Flas belongs to a group of medicines called antihistamines (anti-allergics).

Ebastel Forte Flas is indicated for the treatment of symptoms of allergic processes such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, sneezing), chronic urticaria, and allergic dermatitis.

2. What you need to know before taking Ebastel Forte Flas

Do not take Ebastel Forte Flas

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ebastel Forte Flas.

This medicine 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 "How to take Ebastel Forte Flas").
• if you are taking a type of medicine used to treat fungal infections called azole antifungals or medicines used to treat certain infections called macrolide antibiotics (see "Taking Ebastel Forte Flas with other medicines").
• if you are taking rifampicin, a type of medicine used to treat tuberculosis.

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

Children

Ebastel Forte Flas should not be administered to children under 12 years of age.

Taking Ebastel Forte Flas with other medicines

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

The following medicines may interfere with Ebastel Forte Flas; in these cases, it may be necessary to change the dose or interrupt treatment with one of them:

• Ebastel Forte Flas may increase the effect of other medicines used to treat allergies (antihistamines).
• Ebastel Forte Flas should be used with caution in patients taking medicines 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 Forte Flas may be reduced in patients taking a medicine 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 Forte Flas may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after stopping treatment.

Taking Ebastel Forte Flas with food and drinks

The oral lyophilisate can be taken with or without food. It is not necessary to drink water or any other liquid.

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, so it is recommended to consult with a doctor before taking Ebastel Forte Flas. The doctor will decide whether or not to start treatment.

Breastfeeding

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

Driving and using machines

In humans, no effects have been observed on psychomotor function or the ability to drive or use machinery at the recommended therapeutic doses. However, since somnolence and dizziness are among the side effects, observe your response to the medication before driving or using machinery.

Ebastel Forte Flas contains aspartame

This medicine contains 2 mg of aspartame in each oral lyophilisate. Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Ebastel Forte Flas

Follow the instructions for taking Ebastel Forte Flas exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Ebastel Forte Flas.

Dosage

Use in adults and children over 12 years:The recommended dose is 10 mg of ebastine once a day, although some people may require a dose of 20 mg once a day.

Use in patients with severe liver disease:The dose should not exceed 10 mg of ebastine per day. In this case, it is recommended to use the 10 mg presentation (Ebastel Flas 10 mg Oral Lyophilisates).

Method of administration

This medicine is for oral administration.

1. Do not remove the oral lyophilisate from the packaging until you are ready to take it.
2. Do not extract the dose from the oral lyophilisate by pressing on it. Immediately before taking, with dry hands, open the blister pack by carefully lifting the foil from the point where it is detached (Figure 1).
3. Stretch the tab to detach it (Figure 2).
4. Press the lyophilisate carefully upwards (without touching it) (Figure 3).
5. Remove the lyophilisate carefully (Figure 4).
6. The dose should be taken immediately after opening the blister pack. Place the oral lyophilisate on your tongue, where it will dissolve quickly, and swallow it with your saliva. Do not drink water or any other liquid.

Figure 1 Figure 2 Figure 3 Figure 4

If you think the effect of Ebastel Forte Flas is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastel Forte Flas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service, phone 915 620 420 (indicating the medicine and the amount taken), or go to the nearest hospital. Bring the remaining oral lyophilisates, the case, and the complete box so that the healthcare staff can easily identify the medicine you have taken.

Treatment of poisoning with this medicine consists of gastric lavage and administration of the appropriate medication.

If you forget to take Ebastel Forte Flas

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then follow your regular schedule. However, if it is almost time for your next dose, do not take the forgotten dose and wait for the next scheduled dose.

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

4. Possible side effects

Like all medicines, Ebastel Forte Flas can cause side effects, although not everyone gets them.

The following side 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 or sensitivity, decreased or altered taste
• Palpitations, tachycardia
• Abdominal pain, vomiting, nausea, digestive problems
• 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 side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastel Forte Flas

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Ebastel Forte Flas

• The active ingredient is ebastine. Each oral lyophilisate contains 20 mg of ebastine.
• The other ingredients (excipients) are gelatin (E-441), mannitol (E-421), aspartame (E-951), and peppermint flavor.

Appearance of the product and package contents

Ebastel Forte Flas is presented in the form of an oral lyophilisate. The lyophilisate is round and white. Each package contains 20 oral lyophilisates.

Other presentations

Ebastel Flas 10 mg Oral Lyophilisates

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)

Date of last revision of this leaflet: May 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/Mod. P.03.1 (16/02/15)