EBASTINE ALTER 20 MG FILM-COATED TABLETS EFG

Package Leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ebastina Alter 20 mg film-coated tablets EFG

ebastine

Read the entire leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Ebastina Alter is and what it is used for

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

Ebastine is indicated for the treatment of symptoms associated with 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,
• allergic dermatitis.

2. What you need to know before taking Ebastine Alter

Do not take Ebastine Alter

• if you are allergic to the active substance of this medicine or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before starting to take ebastine.

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 “How to take Ebastine Alter”).
• 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 Alter with other medicines”).
• if you are being treated with rifampicin, a type of 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.

Children

Ebastine 20 mg Tablets should not be administered to children under 12 years of age.

Other medicines and Ebastine Alter

Inform 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 a macrolide antibiotic used to treat certain infections called erythromycin (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 the results of skin allergy tests; therefore, it is recommended not to perform these tests until 5–7 days after stopping treatment.

Taking Ebastine Alter with food and drinks

The tablets 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 initiated.

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 use machinery have been observed in men. However, monitor your response to the medication, as drowsiness has occurred in some cases at usual doses. If this occurs, refrain from driving and operating dangerous machinery.

Ebastine Alter 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 Alter

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

Remember to take your medicine.

Your doctor will advise you on the duration of your treatment with ebastine.

Dosage:

Use in adults and children over 12 years of age: The recommended dose is 1 tablet (10 mg of ebastine) once daily.

Use in patients with severe liver disease: The dose should not exceed 10 mg of ebastine per day (1 tablet).

Method of administration:

This medicine is for oral use.

The tablets can be taken with or without food, with a glass of water.

If you feel that the effect of Ebastine is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastine Alter 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 (indicating the medicine and the amount ingested), and go to the nearest hospital. Take any remaining tablets, the outer carton, and the complete packaging so that healthcare professionals can more 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 Alter

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 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 stop taking Ebastine Alter

Your doctor will advise you on the duration of your treatment with ebastine. Do not stop treatment early, as your symptoms may worsen.

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

4. Possible adverse effects

Like all medicines, ebastine 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 of touch or sensitivity, reduced 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, pharmacist, or nurse, 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 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 Alter

Keep ebastine out of the sight and reach of children.

No special storage conditions are required.

Do not use ebastine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastine Alter 20 mg tablets

• 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 pack

Ebastine Alter is presented as white film-coated tablets for oral administration. Each PVC/aluminum blister pack contains 20 tablets of 20 mg.

Other presentations

Ebastine Alter 10 mg film-coated tablets EFG

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

Manufacturers

Laboratorios Alter, S.A.

C/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 revision of this leaflet: November 2024

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