Ebastine Forte Cinfalab 20 mg film-coated tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Ebastina Forte Cinfalab 20 mg Film-coated Tablets

ebastine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Always follow exactly the instructions for use of this medicine as described in this leaflet or as provided by your doctor or pharmacist.

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

Package leaflet

1. What Ebastina Forte Cinfalab is and what it is 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. How to store Ebastina Forte Cinfalab
6. Contents of the pack and other information

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

Ebastine belongs to a group of medicines known as antihistamines (antiallergic agents).

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

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

2. What you need to know before starting to take Ebastina Forte Cinfalab

Do not take Ebastina Forte Cinfalab

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take ebastine:

• if your electrocardiogram (ECG) results are abnormal.
• if you have high levels of potassium in your blood.
• if you suffer from severe liver disease (see section “How to take Ebastina Forte Cinfalab”).
• 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 “Other medicines and Ebastina Forte Cinfalab”).
• 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, urgent allergic reaction, as ebastine (the active substance in this medicine) takes 1 to 3 hours to take effect.

If you experience symptoms such as throat tightness, difficulty breathing, hoarseness, difficulty speaking, wheezing (“whistling” when breathing), low blood pressure, repeated vomiting and/or loss of consciousness, you must seek urgent medical assistance due to the risk of anaphylaxis.

Children

Ebastine must not be given to children under 12 years of age.

Other medicines and Ebastina Forte Cinfalab

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Especially if you are being treated with any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment with one of them:

• medicines used to treat allergies (antihistamines), because ebastine 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 abnormalities in your electrocardiogram.
• rifampicin, used to treat tuberculosis, as it may reduce the antihistaminic effect of ebastine.

Interference with diagnostic tests

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

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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Limited data are available regarding the use of this medicine in pregnant women. As a precautionary measure, it is advisable to avoid using ebastine during pregnancy.

Breastfeeding

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

Driving and use of machines

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, you should observe your response to the medication before driving or operating machinery.

Ebastina Forte Cinfalab contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Ebastina Forte Cinfalab

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Dosage

Use in adults and adolescents over 12 years of age

1 tablet (20 mg of ebastine) once daily. Generally, 1 tablet of 10 mg of ebastine once daily is sufficient to control symptoms.

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 formulation (Ebastina Cinfalab 10 mg film-coated tablets).

Method of administration

This medicine is taken orally.

The tablets may be taken with or without food, with a glass of water.

The tablet's score line is intended only for dividing the tablet if you have difficulty swallowing it whole.

Consult a doctor if your condition worsens or if you do 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 at telephone number 915 620 420, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine 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):

• Drowsiness
• Dry mouth

Uncommon (may affect up to 1 in 1,000 people):

• Hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema)
• Nervousness, insomnia
• Dizziness, reduced sensation of touch or sensitivity, reduced 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 Ebastine 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 EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastina Forte Cinfalab

The active substance is ebastine. Each tablet contains 20 mg of ebastine.

The other components are:

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

Nature and contents of the container

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

They are packed in PVC/PVDC-Aluminum blisters. Each pack 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 most recent revision of this leaflet: May 2023

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