Ebastine Teva Group 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ebastine Teva Group 20 mg film-coated tablets EFG

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

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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.

Contents of the leaflet:

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 adverse effects
5. How to store Ebastine Teva Group
6. Contents of the pack and other information

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

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

This medicine is used to relieve nasal symptoms (sneezing, nasal itching, runny nose, nasal congestion) and ocular symptoms (red, watery eyes) associated with seasonal and perennial allergic rhinitis in adults and adolescents aged 12 years and older, when a 10 mg dose is not sufficient.

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 taking Ebastine Teva Group:

• if your electrocardiogram (ECG) results are abnormal (prolonged QT interval).
• if you have high levels of potassium in your blood.
• 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, urgent allergic reaction, as ebastine (the active ingredient 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, you must seek urgent medical assistance 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 discontinue treatment with one of them:

• Ebastine may increase the effect of other medicines used to treat allergy (antihistamines).
• Ebastine should be used with caution in patients taking medicines called ketoconazole and itraconazole, used to treat fungal infections, or with an antibiotic used to treat certain infections called erythromycin (as they may cause abnormalities 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, it is recommended not to perform such tests 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 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

At the recommended therapeutic doses, no effects on psychomotor function, or on the ability to drive or operate machinery, have been observed in men. However, since somnolence and dizziness are listed among the adverse effects, you should assess 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 that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ebastine Teva Group

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Dosage

Use in adults and adolescents over 12 years of age:

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

Method of administration

This medicine is for oral use.

The tablets can be taken with or without food, taken with 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 telephone number 91 562 04 20, indicating the medicine and the amount ingested. Bring any remaining tablets, the outer carton, and the full packaging so that healthcare professionals can easily identify the medicine you have taken.

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, 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, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce 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 of touch or sensitivity, decreased or altered taste,
• palpitations, tachycardia,
• abdominal pain, vomiting, nausea, digestive disturbances,
• 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 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 Teva Group

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 the SIGRE Point at your pharmacy. If you are in doubt, 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 additional information

Composition of Ebastina Teva Group

• The active substance is ebastine. Each tablet contains 20 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

Ebastina Teva Group is presented as white, film-coated, lens-shaped tablets. Each PVC/aluminum blister pack contains 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 the most recent review of this leaflet: December 2022

Detailed 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