Ebastine Teva Group 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ebastine Teva Group 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.

• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

• You should consult a doctor if you worsen or do not improve after 7 days of treatment.

Leaflet contents:

1. What Ebastine Teva Group is and what it is used for
2. What you need to know before taking Ebastine Teva Group
3. How to take Ebastine Teva Group
4. Possible side effects
5. How to store Ebastine Teva Group
6. Contents of the pack and other information

1. What Ebastine Teva Group is and what it is used for

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

This medicine is used to relieve nasal symptoms (sneezing, nasal itching, runny nose, nasal congestion, urge to sneeze) and ocular symptoms (red, watery eyes) associated with seasonal and perennial allergic rhinitis in adults and adolescents aged 12 years and older.

You should consult a doctor if your condition worsens or does not improve after 7 days.

2. What you need to know before taking Ebastine Teva Group

Do not take Ebastine Teva Group

• 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 Ebastine Teva Group:

• if your electrocardiogram (ECG) results are abnormal (prolongation of the QT interval).
• if you have high blood potassium levels.
• if you have severe liver disease (see section “How to take Ebastine Teva Group”).
• 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 “Taking Ebastine Teva Group with other medicines”).
• 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 substance in this medicine) takes 1 to 3 hours to take effect.

If you experience symptoms such as throat tightness, difficulty breathing, hoarseness, difficulty speaking, wheezing (“whistling” when breathing), low blood pressure, repeated vomiting and/or loss of consciousness, seek urgent medical attention due to the risk of anaphylaxis.

Children

Ebastine Teva Group must not be given to children under 12 years of age.

Taking Ebastine Teva Group with other medicines

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 ebastine; in such cases, it may be necessary to adjust the dose or interrupt treatment with one or more of them:

• Ebastine may increase the effect of other medicines used to treat allergies (antihistamines).
• Ebastine should be used with caution in patients taking ketoconazole or itraconazole, medicines used to treat fungal infections, or the antibiotic erythromycin, used to treat certain infections (as they may cause changes in your electrocardiogram).
• The antihistaminic effect of ebastine 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

Ebastine may interfere with skin allergy test results; therefore, such tests should not be performed until 5 to 7 days after stopping treatment.

Taking Ebastine Teva Group with food and drinks

This medicine can be taken with or without food.

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

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 the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, since somnolence and dizziness are listed among the adverse effects, observe your response to the medication before driving or operating machinery.

Ebastine Teva Group contains lactose

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

3. How to take Ebastine Teva Group

Follow exactly the administration instructions for this medicine as described in this leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

This medicine is not suitable for doses lower than 10 mg of ebastine, nor for patients who have difficulty swallowing.

Dosage

Use in adults and adolescents over 12 years of age

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

Use in patients with severe liver disease

The dose must not exceed 10 mg of ebastine per day (1 tablet).

Method of administration:

This medicine is for oral use.

The tablets may be taken with or without food, accompanied by a glass of water.

If you take more Ebastine Teva Group than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested. Bring 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 Ebastine Teva Group

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 your next dose, do not take the missed dose and wait until the next scheduled dose.

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 can cause adverse effects, although not everyone will experience 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.

Uncommon (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 problems,
• liver inflammation (hepatitis), reduction or obstruction of bile flow from the liver (cholestasis), abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase, and bilirubin),
• urticaria, 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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Teva Group

Keep this medicine out of 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 should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Ebastine Teva Group

• The active substance is ebastine. Each tablet contains 10 mg of ebastine.
• The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, povidone 30, polysorbate 80, magnesium stearate, hypromellose, titanium dioxide (E171) and glyceryl triacetate.

Appearance of the product and contents of the container

Ebastine Teva Group is presented as white, film-coated, biconvex tablets. Packaged in PVC/aluminum blisters containing 20 tablets.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.
C/ Anabel Segura, 11 Edificio Albatros B 1st floor
Alcobendas 28108, Madrid (Spain)

Manufacturer

Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid (Spain)

or

Laboratorios Alter, S.A.
C/ Zeus, 6 Polígono Industrial R2
28880 Meco (Madrid)
Spain

Date of latest revision of this leaflet: December 2022

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