


Ask a doctor about a prescription for EBASTINE FORTE CINFALAB 20 mg FILM-COATED TABLETS
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.
Package Leaflet Contents
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.
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:
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:
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".
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.
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):
Common (may affect up to 1 in 10 people):
Rare (may affect up to 1 in 1,000 people):
Frequency Not Known (cannot be estimated from available data):
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.
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.
Ebastina Forte Cinfalab Composition
The active ingredient is ebastina. Each tablet contains 20 mg of ebastina.
The other ingredients are:
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/)
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for EBASTINE FORTE CINFALAB 20 mg FILM-COATED TABLETS – subject to medical assessment and local rules.