EBASTINE FORTE CINFALAB 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ebastina Forte Cinfalab 20 mg Film-Coated Tablets

ebastina

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Package Leaflet Contents

1. What is Ebastina Forte Cinfalab and what is it used for
2. What you need to know before taking Ebastina Forte Cinfalab
3. How to take Ebastina Forte Cinfalab
4. Possible side effects
5. Storage of Ebastina Forte Cinfalab
6. Package Contents and Additional Information

1. What is Ebastina Forte Cinfalab and what is it used for

Ebastina belongs to a group of medicines called antihistamines (anti-allergics).

Ebastina is indicated for the relief of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and watery eyes) and urticaria (hives) that occur with mild symptoms in adults and adolescents from 12 years of age, when a dose of 10 mg is not sufficient.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Ebastina Forte Cinfalab

Do not take Ebastina Forte Cinfalab

If you are allergic to ebastina or any of the other components of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take ebastina:

• if your electrocardiogram results are altered.
• if you have high potassium levels in your blood.
• if you suffer from severe liver disease (see "How to take Ebastina Forte Cinfalab" section).
• 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 "Other Medicines and Ebastina Forte Cinfalab" section).
• if you are being treated with rifampicin, a type of medicine used to treat tuberculosis.

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

In case you experience symptoms such as throat tightness, difficulty breathing, hoarseness, or difficulty speaking, wheezing, low blood pressure, repeated vomiting, and/or loss of consciousness, you should seek urgent medical attention due to the risk of anaphylaxis.

Children

Ebastina should not be administered to children under 12 years of age.

Other Medicines and Ebastina Forte Cinfalab

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

Especially if you are being treated with any of the medicines mentioned below, as it may be necessary to change the dose or interrupt treatment with one of them:

• medicines used to treat allergies (antihistamines) because ebastina may increase their effect.
• ketoconazole and itraconazole, used to treat fungal infections, or erythromycin, an antibiotic used to treat certain infections, as they may cause an alteration in your electrocardiogram.
• rifampicin, used to treat tuberculosis, as it may decrease the antihistamine effect of ebastina.

Interference with Diagnostic Tests

Ebastina may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after treatment is discontinued.

Taking Ebastina Forte Cinfalab with Food and Drinks

Taking the medicine with food or drinks does not affect its efficacy.

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 limited data on the use of the medicine in pregnant women. As a precautionary measure, it is preferable to avoid the use of ebastina during pregnancy.

Breastfeeding

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

Driving and Using Machines

No effects on psychomotor function or the ability to drive or use machinery have been observed 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.

Ebastina Forte Cinfalab contains Sodium

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

3. How to take Ebastina Forte Cinfalab

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Dosage

Use in Adults and Adolescents over 12 years of age

1 tablet (20 mg of ebastina) once a day. Usually, 1 tablet of 10 mg of ebastina once a day is sufficient to control symptoms.

Use in Patients with Severe Liver Disease

The dose should not exceed 10 mg of ebastina per day. In this case, it is recommended to use the 10 mg presentation (Ebastina Cinfalab 10 mg film-coated tablets).

Method of Administration

This medicine is taken orally.

The tablets can be taken with or without food, with the help of a glass of water.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

You should consult a doctor if it worsens or does not improve after 7 days.

If you take more Ebastina Forte Cinfalab than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

4. Possible Side Effects

Like all medicines, this medicine 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 of touch 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 package 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 Ebastina Forte Cinfalab

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

This medicine does not require special storage conditions.

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

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

6. Package Contents and Additional Information

Ebastina Forte Cinfalab Composition

The active ingredient is ebastina. Each tablet contains 20 mg of ebastina.

The other ingredients are:

• Core: anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Coating: hypromellose, titanium dioxide (E-171), and macrogol.

Appearance of the Product and Package Contents

Ebastina Forte Cinfalab 20 mg film-coated tablets are presented in the form of white, cylindrical, biconvex tablets, scored on one side and with the code "Eb2" on the other.

They are presented in PVC/PVDC-Aluminum blisters. Each package contains 10 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet: May 2023

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