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EBASTINE CINFA 10 mg FILM-COATED TABLETS

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About the medicine

How to use EBASTINE CINFA 10 mg FILM-COATED TABLETS

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

ebastine cinfa 10 mg film-coated tablets EFG

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

  • Keep this package leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is ebastine cinfa and what is it used for

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

ebastine cinfa is indicated for the symptomatic treatment of allergic processes such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, sneezing), chronic urticaria, and allergic dermatitis.

Doctor consultation

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2. What you need to know before taking ebastine cinfa

Do not take ebastine cinfa

If you are allergic to ebastine 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 ebastine cinfa.

This medication should be used with caution:

  • if your electrocardiogram results are altered (prolongation of the QT interval).
  • if you have altered potassium levels in your blood.
  • if you have severe liver disease (see "How to take ebastine cinfa" section).
  • if you are being treated with a type of medication used to treat fungal infections called azole antifungals or with medications used to treat certain infections called macrolide antibiotics (see "Other medications and ebastine cinfa" section).
  • if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

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

Children

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

Other medications and ebastine cinfa

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

The following medications may interfere with ebastine; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

  • Ebastine may increase the effect of other medications used to treat allergies (antihistamines).
  • Ebastine should be used with caution in patients being treated with medications called ketoconazole and itraconazole, used to treat fungal infections, or with an antibiotic used to treat certain infections called erythromycin (as they may cause an alteration in your electrocardiogram).
  • The antihistamine effect of ebastine may be decreased in patients being treated with a medication called rifampicin, used to treat tuberculosis.

No interactions have been described between ebastine and theophylline, warfarin, cimetidine, diazepam, and alcohol.

Interference with diagnostic tests

Ebastine 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 ebastine cinfa with food and beverages

The tablets can be taken with or without food.

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 medication.

Pregnancy

There is no experience in pregnant women, so it is recommended to consult a doctor before taking ebastine. The doctor will decide whether or not to start treatment.

Breastfeeding

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

Driving and using machines

No effects have been observed on psychomotor function or the ability to drive or use machines at the recommended therapeutic doses. However, since drowsiness and dizziness are among the side effects, observe your response to the medication before driving or using machines.

ebastine cinfa contains sodium

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

3. How to take ebastine cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with ebastine.

ebastine cinfa is not suitable for administration of doses less than 10 mg or for patients with swallowing problems.

Dosage

The recommended dose in adults and children over 12 years of age is 10 mg of ebastine (1 tablet of ebastine cinfa 10 mg) once a day, although some patients may require a dose of 20 mg (1 tablet of ebastine cinfa 20 mg) once a day.

Use in patients with severe liver disease: The dose should not exceed 10 mg of ebastine per day (1 tablet).

Method of administration

The ebastine tablets are for oral administration. They can be taken with or without food. The tablets should be swallowed whole, without chewing, with the help of a glass of liquid, preferably water.

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

If you think the effect of ebastine is too strong or too weak, inform your doctor or pharmacist.

If you take more ebastine cinfa than you should

Treatment of overdose with this medication consists of gastric lavage and administration of the appropriate medication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take ebastine cinfa

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then continue with your regular schedule. However, if it is almost time for your next dose, do not take the forgotten dose and wait for your next scheduled dose.

If you stop taking ebastine cinfa

Your doctor will indicate the duration of your treatment with ebastine. Do not stop treatment before then, as your symptoms may worsen.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medications, this medication 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 patients): headache.

Common (may affect up to 1 in 10 patients): drowsiness, dry mouth.

Rare (may affect up to 1 in 1,000 patients): hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema), nervousness, insomnia, dizziness, decreased sensation 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of ebastine cinfa

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 stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of ebastine cinfa

The active ingredient is ebastine. Each tablet contains 10 mg of ebastine.

The other ingredients are:

  • Core: anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
  • Coating: Opadry Y-1-7000 (hypromellose, titanium dioxide, and macrogol 400).

Appearance of the product and package contents

ebastine cinfa is presented in the form of white, cylindrical, biconvex, scored film-coated tablets with a code on one side.

It is presented in PVC/PVDC-Aluminum blisters. Each package contains 20 tablets.

Marketing Authorization Holder and 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:September 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67674/P_67674.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67674/P_67674.html

Online doctors for EBASTINE CINFA 10 mg FILM-COATED TABLETS

Discuss questions about EBASTINE CINFA 10 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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Endocrinology – Diabetes, thyroid, metabolism:
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Alexander Nazarchuk

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You can consult Dr. Nazarchuk for:

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Marta Reguero Capilla

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Dr Marta Reguero Capilla is an allergist and immunologist who works with both adults and children. She specialises in the diagnosis, treatment, and ongoing management of allergic and immune-related conditions through online consultations.

In her practice, Dr Reguero Capilla helps patients understand the causes of their symptoms, review test results, and choose appropriate treatment or monitoring strategies. Her consultations are suitable both for first-time assessments and for follow-up care over time.

Patients commonly consult Dr Marta Reguero Capilla for:

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Dr Reguero Capilla works in a structured and attentive manner, explaining medical decisions clearly and helping patients make informed choices about their own health or their child’s care.

When clinically appropriate, she may provide recommendations for further tests or referrals that patients can use within Spanish medical networks, including Sanitas and DKV, in accordance with the terms and conditions of those services.

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Frequently Asked Questions

Is a prescription required for EBASTINE CINFA 10 mg FILM-COATED TABLETS?
EBASTINE CINFA 10 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in EBASTINE CINFA 10 mg FILM-COATED TABLETS?
The active ingredient in EBASTINE CINFA 10 mg FILM-COATED TABLETS is ebastine. This information helps identify medicines with the same composition but different brand names.
How much does EBASTINE CINFA 10 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for EBASTINE CINFA 10 mg FILM-COATED TABLETS is around 4.4 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures EBASTINE CINFA 10 mg FILM-COATED TABLETS?
EBASTINE CINFA 10 mg FILM-COATED TABLETS is manufactured by Laboratorios Cinfa S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of EBASTINE CINFA 10 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether EBASTINE CINFA 10 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to EBASTINE CINFA 10 mg FILM-COATED TABLETS?
Other medicines with the same active substance (ebastine) include BACTIL 10 mg FILM-COATED TABLETS, BACTIL FLAS 10 mg ORAL LYOPHILIZED, BACTIL FORTE 20 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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