EBASTINE SANDOZ 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ebastine Sandoz 10 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of thepackage leaflet:

1. What is Ebastine Sandoz and what is it used for
2. What you need to know before taking Ebastine Sandoz
3. How to take Ebastine Sandoz
4. Possible side effects
5. Storage of Ebastine Sandoz
6. Package contents and additional information

1. What is Ebastine Sandoz and what is it used for

Ebastine belongs to a group of medications called antihistamines (antiallergics).

Ebastine is indicated for the symptomatic treatment of allergic processes such as:

• seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, sneezing),
• chronic urticaria,
• allergic dermatitis.

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2. What you need to know before taking Ebastine Sandoz

Do not take Ebastine Sandoz

• if you are allergic to ebastine 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 ebastine:

• if your electrocardiogram results are altered (prolongation of the QT interval),
• if you have high potassium levels in your blood,
• if you have a severe liver disease (see section "How to take Ebastine Sandoz"),
• if you are being treated with a type of medication used to treat fungal infections called azole antifungals or with medications used to treat certain infections called macrolide antibiotics (see section "Taking Ebastine Sandoz with other medications"),
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

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

Children

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

Taking Ebastine Sandoz with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The following medications may interfere with ebastine, and it may be necessary to change the dose or discontinue treatment with one of them:

• ebastine may increase the effect of other medications used to treat allergies (antihistamines),
• ebastine 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 ebastine may be reduced in patients being treated with a medication called rifampicin, used to treat tuberculosis.

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

Interference with diagnostic tests

Ebastine may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5 to 7 days after discontinuing treatment.

Taking Ebastine Sandoz with food and beverages

This medication can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 ebastine. The doctor will decide whether to start treatment or not.

Breastfeeding

It is unknown whether the medication passes into breast milk, so it should not be used during breastfeeding.

Driving and using machines

In humans, no effects have been observed on psychomotor function or the ability to drive or use machines at the recommended therapeutic doses. However, since somnolence and dizziness are among the side effects, observe your response to the medication before driving or using machines.

Ebastine Sandoz contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Ebastine Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medication.

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

Ebastine is not suitable for administration of doses less than 10 mg or for patients with swallowing problems.

Dosage

Use in adults and children over 12 years:the recommended dose is 1 tablet (10 mg of ebastine) once a day.

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

Method of administration

This medication is for oral administration.

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

If you think the effect of ebastine is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastine Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. Bring the remaining tablets, the box, and the complete packaging so that the healthcare personnel can more easily identify the medication you have taken.

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

If you forget to take Ebastine Sandoz

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then follow your regular schedule. However, if it is almost time for your next dose, do not take the forgotten dose and wait for the next scheduled dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side 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)

• drowsiness,
• 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 problems,
• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ebastine Sandoz

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Ebastine Sandoz

• The active ingredient is ebastine. Each tablet contains 10 mg of ebastine.
• The other components (excipients) are:

Core: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, povidone 30, polysorbate 80, magnesium stearate,

Coating: hypromellose, titanium dioxide, glycerol triacetate

Appearance of the product and package contents

Ebastine Sandoz is presented in the form of white, lenticular-shaped film-coated tablets. It is packaged in PVC/Aluminum blister packs containing 20 tablets of 10 mg.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of the last revision of this package leaflet: May 2019.

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