EBASTINE CINFA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

ebastina cinfa 20 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 ebastina cinfa and what is it used for
2. What you need to know before taking ebastina cinfa
3. How to take ebastina cinfa
4. Possible side effects
5. Storage of ebastina cinfa
6. Contents of the pack and further information

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

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

ebastina 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.

2. What you need to know before taking ebastina cinfa

Do not take ebastina cinfa

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 cinfa.

This medication should be used with caution:

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

Children

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

Other medications and ebastina 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 ebastina; in these cases, it may be necessary to change the dose or interrupt treatment with one of them:

• Ebastina may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastina 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 ebastina may be reduced in patients being treated with a medication called rifampicin, used to treat tuberculosis.

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

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 has been discontinued.

Taking ebastina cinfa with food and drinks

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 ebastina. The doctor will decide whether to start treatment or not.

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.

ebastina 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 ebastina 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 ebastina.

Dosage

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

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 cinfa 10 mg).

Method of administration:

The ebastina 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 ebastina is too strong or too weak, inform your doctor or pharmacist.

If you take more ebastina 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 ebastina cinfa

Do not take a double dose to make up for the 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 the next dose at the scheduled time.

If you stop taking ebastina cinfa

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 ebastina 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 SIGRE collection point at the pharmacy. 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. Contents of the pack and further information

Composition of ebastina cinfa

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

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 pack contents

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

It is presented in PVC/PVDC-Aluminum blisters. Each pack 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