EBASTINE STADA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ebastina STADA 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 the package leaflet:

1. What is Ebastina Stada 10 mg tablets and what is it used for

1. What you need to know before taking Ebastina Stada 10 mg tablets
2. How to take Ebastina Stada 10 mg tablets
3. Possible side effects

1. Storage of Ebastina Stada 10 mg tablets
2. Package contents and additional information

1. What is Ebastina Stada 10 mg tablets and what is it used for

Ebastina, the active ingredient of Ebastina Stada 10 mg, belongs to a group of medications called antihistamines (antiallergics).

Ebastina Stada 10 mg is indicated for the 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, and allergic dermatitis.

2. What you need to know before taking Ebastina Stada 10 mg tablets

Do not take Ebastina Stada 10 mg:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ebastina Stada

This medication should be used with caution:

• if your electrocardiogram results are altered (prolongation of the QT interval).
• if you have high levels of potassium in your blood.
• if you have severe liver disease (see "How to take Ebastina Stada").
• 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 "Other medications and Ebastina Stada 10 mg").
• 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 ebastina (the active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

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

Other medications and Ebastina Stada 10 mg

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

The following medications may interfere with ebastina; in these cases, it may be necessary to change the dose or interrupt treatment with one of them:

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

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

Interference with diagnostic tests

Ebastina Stada may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after treatment has been discontinued.

Taking Ebastina Stada 10 mg with food and beverages

The tablets 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 Ebastina Stada. 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 on psychomotor function or the ability to drive or use machinery have been observed at the recommended therapeutic doses. However, since drowsiness and dizziness are among the side effects, observe your response to the medication before driving or using machinery.

Important information about some of the ingredients of Ebastina Stada

This medication does not contain gluten.

Ebastina Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free).

3. How to take Ebastina Stada 10 mg tablets

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

Your doctor will indicate the duration of your treatment with Ebastina Stada 10 mg. Do not stop treatment before, as your symptoms may worsen.

Remember to take your medication.

Dosage

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

Use in children between 6 and 11 years:The recommended dose is half a tablet (5 mg) once a day.

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

Method of administration

This medication is for oral administration.

The tablets should be swallowed whole, without chewing, with the help of a glass of liquid, preferably water.

If you think the effect of Ebastina Stada 10 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastina Stada 10 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

Treatment of overdose of this medication consists of gastric lavage and administration of appropriate medication. Carry this package leaflet with you.

If you forget to take Ebastina Stada 10 mg

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 your 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 of touch 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 Ebastina Stada 10 mg tablets

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the package 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. 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 Ebastina Stada 10 mg

• The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.

• The other ingredients are microcrystalline cellulose, stearyl macroglycerides, sodium starch glycolate (potato starch) gluten-free, magnesium stearate, purified water, white opadry.

Appearance of the product and package contents

The Ebastina Stada 10 mg tablets are oblong, biconvex, white, and scored. The tablet can be divided into two equal halves.

The packages contain 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer:

Generis Farmacêutica S.A.

Rua João de Deus nº 19, Venda Nova

2700-487 Amadora

Portugal

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

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