Package Insert: Information for the Patient

Ebastel Forte Flas 20 mg Lyophilized Oral Tablets

Ebastina

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, even if they have the same symptoms as you, as it may harm them.,sinceit may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

6. Contents of the Package and Additional Information

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

Ebastel Forte Flas 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 Forte Flas

• 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 Forte Flas.

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 Forte Flas").
• if you are being treated with a type of antifungal medication called azoles or with a type of antibiotic called macrolides (see "Taking Ebastel Forte Flas 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 Forte Flas should not be administered to children under 12 years old.

Taking Ebastel Forte Flas 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 Ebastel Forte Flas; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

• Ebastel Forte Flas may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastel Forte Flas 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 Forte Flas 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 Forte Flas 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 Forte Flas with food and drinks

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

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 Forte Flas. They will decide whether to start treatment or not.

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 Forte Flas contains aspartame

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

Follow exactly the administration instructions for Ebastel Forte Flas 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 Forte Flas.

Dosage

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

Use in patients with severe liver disease:Do not exceed a dose of 10 mg of ebastina per day.In this caseit is recommended to use the 10 mg presentation (Ebastel Flas 10 mgLiofilizados orales).

Administration form

This medication is for oral administration.

1.Do not remove the oral liofilizado from the packaging until you are ready to take it.

2.Do not extract the dose from the oral liofilizado by pressing on it. Immediately before taking, with dry hands, open the blister packaging by carefully lifting the sheet from the pocket where it is detached (Figure 1).

3.Stretch the tab to detach it (Figure 2).

4.Press the liofilizado upwards carefully (without touching it) (Figure 3).

5.Extract the liofilizado carefully (Figure 4).

6.The dose should be taken immediately after opening the blister. Place the oral liofilizado on the tongue, where it will dissolve quickly and swallow it with saliva. Do not take water or another liquid.

Figure 1Figure 2Figure 3Figure 4

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

If you take more Ebastel Forte Flas thanyou 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 oral liofilizados, the packaging 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 Forte Flas

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then follow your usual 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 time it is due.

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

Like all medications, Ebastel Forte Flas can produce adverse effects, although not all people may 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):

• Allergic reactions: 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 tests (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 of 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.Deposit the packaging and 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 medications you no longer need.This will help protect the environment..

Composition of Ebastel Forte Flas

• The active principle is ebastina. Each lyophilized oral form contains 20 mg of ebastina.
• The other components (excipients) are gelatine (E-441), mannitol (E-421), aspartame (E-951) and peppermint aroma.

Appearance of the product and content of the packaging

Ebastel Forte Flas is presented in the form of a lyophilized oral form. The lyophilized form is round and white in color. Each package contains 20 lyophilized oral forms.

Other presentations

Ebastel Flas 10 mg Lyophilized oral forms

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 - Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of the last review of this leaflet: May 2019

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/Mod. P.03.1 (16/02/15)