Package Leaflet: Information for the User

ebastina cinfa 10 mg film-coated tablets

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

ebastina cinfa is indicated for the symptomatic treatment of allergic processes such as seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

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 (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

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

Other medications and ebastina cinfa

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

The medications listed below may interact with ebastina; in these cases, it may be necessary to change the dose or discontinue 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 discontinuing treatment.

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, or think you may be 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. This 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 operating machinery

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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

Ebastina cinfa is not suitable for administration of doses lower than 10 mg, nor for patients with swallowing problems.

Dosage

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

Use in patients with severe liver disease: Do not exceed a dose of 10 mg of ebastina per day (1 tablet).

Administration form

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

The groove is only for breaking the tablet if it is difficult to swallow whole.

If you estimate that the action of ebastina is too strong or too weak, inform your doctor or pharmacist.

If you take more ebastina cinfa than you should

The treatment of this medication overdose 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take ebastina cinfa

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then continue with your regular schedule. However, if there are only a few hours left until the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

If you interrupt treatment with ebastina cinfa

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

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

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 frequent (may affect more than 1 in 10 patients): headache.

Frequent (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 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 or pharmacist, 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 the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of ebastina cinfa

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

The other components are:

• Nucleus: 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 content of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:September 2021

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

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

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