Product Information for the Patient

Ebastina Forte Cinfalab 20 mg Film-Coated Tablets

Ebastina

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this product information or those indicated by your doctor or pharmacist.

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

Ebastina belongs to a group of medications called antihistamines (antiallergics).

Ebastina is indicated for the relief of allergic rhinoconjunctivitis (stuffy nose, itchy nose, nasal discharge, nasal congestion, and red, watery eyes) and urticaria (hives) with mild symptoms in adults and adolescents 12 years and older, when a dose of 10 mg is insufficient.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not take Ebastina Forte Cinfalab

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take ebastina:

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

In case you experience symptoms such as throat constriction, difficulty breathing, hoarseness, or difficulty speaking, wheezing ("popping" sounds while breathing), low blood pressure, repeated vomiting, and/or loss of consciousness, seek urgent medical assistance due to the risk of anaphylaxis.

Children

Ebastina should not be administered to children under 12 years old.

Other medications and Ebastina Forte Cinfalab

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

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

• Medications used to treat allergies (antihistamines) as ebastina may increase their effect.
• Ketoconazole and itraconazole, used to treat fungal infections, or with erythromycin 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 discontinuing treatment.

Taking Ebastina Forte Cinfalab with food and drinks

The taking of the medication with food or drinks does not affect its efficacy.

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 limited data available on the use of the medication in pregnant women. As a precaution, it is recommended to avoid using ebastina during pregnancy.

Breastfeeding

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

Driving and operating machinery

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

Ebastina Forte Cinfalab contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Dosage

Use in adults and adolescents over 12 years old

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

Use in patients with severe liver disease

Do not exceed the dose of 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).

Administration form

This medication is taken orally.

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

The groove is only for breaking the tablet if it is 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 Toxicological Information Service, phone 915 620 420 indicating the medication and the amount ingested.

Like all medications, this medication may 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):

• 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
• 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 for Pharmacovigilance of Medicinal Products 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.

This medication does not require special storage conditions.

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. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ebastina Forte Cinfalab

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

The other components are:

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

Appearance of the product and content of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: May 2023

The detailed information of this medication is available on the website oftheSpanish Agency of Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)