EBASTEL FORTE 20 MG ORAL LYOPHILISATES FOR SOLUTION

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Ebastel Forte Flas 20 mg Oral Lyophilisates

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, consult 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, because 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 Forte Flas is and what it is used for
2. What you need to know before taking Ebastel Forte Flas
3. How to take Ebastel Forte Flas
4. Possible adverse effects
5. How to store Ebastel Forte Flas
6. Contents of the pack and other information

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

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

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

2. What you need to know before starting to take 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 (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 Forte Flas”).
• 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 Forte Flas 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, urgent allergic reaction, as ebastine (the active substance in this medicine) takes 1 to 3 hours to take effect.

Children

Ebastel Forte Flas must not be given to children under 12 years of age.

Taking Ebastel Forte Flas with other medicines

Inform 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 Forte Flas; in such cases, it may be necessary to adjust the dose or discontinue 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 abnormalities in your electrocardiogram).
• The antihistaminic effect of Ebastel Forte Flas 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 Forte Flas may interfere with the results of skin allergy tests; therefore, such tests should not be performed until 5–7 days after stopping treatment.

Taking Ebastel Forte Flas with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 Forte Flas. 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 using machines

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

Ebastel Forte Flas contains aspartame

This medicine contains 2 mg of aspartame per oral lyophilisate. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Ebastel Forte Flas

Follow exactly the administration instructions for Ebastel Forte Flas provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate how long your treatment with Ebastel Forte Flas should last.

Dosage

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

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

Method of administration

This medicine is for oral use.

1. Do not remove the oral lyophilisate from its packaging until you are ready to take it.
2. Do not push the lyophilisate out through the packaging. Immediately before taking the dose, with dry hands, open the blister pack by carefully lifting the foil from one blister at the point where it is unsealed (Figure 1).
3. Pull the tab to peel back the foil (Figure 2).
4. Carefully push the lyophilisate upwards (without touching it) (Figure 3).
5. Carefully remove the lyophilisate (Figure 4).
6. The dose should be taken immediately after opening the blister. Place the oral lyophilisate on the tongue, where it will dissolve rapidly, and swallow it with saliva. Do not take water or any other liquid.

Figure 1 Figure 2 Figure 3 Figure 4

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

If you take more Ebastel Forte Flas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at 915 620 420 (indicating the medicine and the amount ingested), or go to the nearest hospital. Bring any remaining lyophilisates, the carton, and the full packaging so that healthcare professionals can easily identify the medicine you have taken.

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

If you forget to take Ebastel Forte Flas

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 schedule. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual 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 Forte Flas may produce adverse effects, although not everyone experiences 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 through the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse 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 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 a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastel Forte Flas

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

Appearance of the product and contents of the pack

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

Other presentations

Ebastel Flas 10 mg Oral lyophilisates

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/Mod. P.03.1 (16/02/15)