EBASTINE CINFA 10 mg FILM-COATED TABLETS
How to use EBASTINE CINFA 10 mg FILM-COATED TABLETS
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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
- What is ebastine cinfa and what is it used for
- What you need to know before taking ebastine cinfa
- How to take ebastine cinfa
- Possible side effects
- Storage of ebastine cinfa
- 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.
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.
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
- Country of registration
- Average pharmacy price4.4 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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