Ebastine Flas Cinfa 20 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

ebastina flas cinfa 20 mg orodispersible tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the leaflet

1. What ebastina flas cinfa is and what it is used for
2. What you need to know before taking ebastina flas cinfa
3. How to take ebastina flas cinfa
4. Possible side effects
5. How to store ebastina flas cinfa

Contents of the pack and other information

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

Ebastine flas cinfa belongs to a group of medicines called antihistamines (antiallergic agents).

Ebastine flas cinfa is indicated for the treatment of symptoms of allergic conditions such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, and sneezing), chronic urticaria, and allergic dermatitis.

2. What you need to know before taking ebastina flas cinfa

Do not take ebastina flas cinfa

• If you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take ebastina flas cinfa.

This medicine should be used with caution:

• If your electrocardiogram (ECG) results are abnormal (prolongation of the QT interval).
• If you have abnormal blood potassium levels.
• If you suffer from severe liver disease (see section 3 “How to take ebastina flas cinfa”).
• If you are being treated with a type of medicine used to treat fungal infections called azole antifungals, or with medicines used to treat certain infections called macrolide antibiotics (see section “Other medicines and ebastina flas cinfa”).
• If you are being treated with rifampicin, a medicine used to treat tuberculosis.

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

Children

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

Other medicines and ebastina flas cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may interact with ebastina flas; in such cases it may be necessary to adjust the dose or discontinue treatment with one of them:

• Ebastina flas may increase the effect of other medicines used to treat allergies (antihistamines).
• Ebastina flas should be used with caution in patients taking medicines called ketoconazole and itraconazole, used to treat fungal infections, or with a macrolide antibiotic called erythromycin, used to treat certain infections (as they may cause abnormalities in your electrocardiogram).
• The antihistaminic effect of ebastina flas may be reduced in patients taking a medicine called rifampicin, used to treat tuberculosis.

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

Interference with diagnostic tests

Ebastina flas may interfere with the results of skin allergy tests. Therefore, it is recommended not to perform such tests until 5–7 days after stopping treatment.

Taking ebastina flas cinfa with food and drink

You may take the orodispersible tablets with or without food. It is not necessary to take water or any other liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is no experience in pregnant women; therefore, it is recommended to consult a doctor before taking ebastina flas. The doctor will decide whether or not treatment should be started.

Breastfeeding

It is unknown whether the medicine passes into breast milk; therefore, it should not be used during breastfeeding.

Driving and using machines

No effects on psychomotor function, or on the ability to drive or operate machinery, have been observed in humans at the recommended therapeutic doses. However, since drowsiness and dizziness are listed among the adverse effects, you should assess your response to the treatment before driving or operating machinery.

ebastina flas cinfa contains aspartame (E-951)

This medicine contains 5.00 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

ebastina flas cinfa contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

ebastina flas cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take ebastina flas cinfa

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate how long your treatment with ebastina flas should last.

Dosage

Use in adults and children over 12 years of age

The recommended dose is 1 orodispersible tablet (10 mg of ebastine) once daily, although some individuals may require a dose of 20 mg once daily.

Use in patients with severe liver disease

The dose should not exceed 10 mg of ebastine per day. In this case, it is recommended to use the 10 mg formulation (ebastina flas cinfa orodispersible tablets).

Administration method

This medicine is for oral use.

The ebastina flas tablet should be placed on the tongue, where it will dissolve rapidly. It is not necessary to take water or any other liquid.

Immediately before taking the dose, carefully open the blister pack with dry hands and remove the tablet without crushing it. The dose should be taken immediately after opening the blister.

If you take more ebastina flas cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Bring this leaflet with you, along with any remaining tablets, the carton, and the complete packaging so that healthcare professionals can easily identify the medicine you have taken.

Treatment of poisoning with this medicine consists of gastric lavage and administration of appropriate medication.

If you forget to take ebastina flas cinfa

Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, then continue with your regular dosing schedule. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the scheduled time.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed in clinical trials and post-marketing experience:

Very common (may affect more than 1 in 10 people):

• Headache

Common (may affect up to 1 in 10 people):

• Somnolence
• Dry mouth

Rare (may affect up to 1 in 1,000 people):

• 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 disorders.
• 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 of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ebastine flas cinfa

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ebastina flas cinfa

• The active substance is ebastine. Each orodispersible tablet contains 20 mg of ebastine.
• The other components (excipients) are: monohydrate lactose, microcrystalline cellulose 101, sodium croscarmellose, aspartame (E-951), magnesium stearate (E-470b), colloidal anhydrous silica (E-551), and mint flavour.

Appearance of the product and contents of the pack

ebastina flas cinfa are white, round orodispersible tablets.

They are presented in aluminum/PA/PVC-aluminum blisters, available in packs of 20 orodispersible 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

SEID, S.A.

Carretera de Sabadell a Granollers Km 15

08185 Lliçà de Vall – Barcelona

Spain

Date of the most recent review of this package leaflet: November 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81905/P_81905.html

QR code link: https://cima.aemps.es/cima/dochtml/p/81905/P_81905.html