EBASTINE GADOR 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Ebastina Gador 20 mg Oral Disintegrating Tablets EFG

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Ebastina Gador contains the active substance ebastine. It belongs to a group of medicines called antihistamines.

Ebastina Gador is indicated for the treatment of symptoms 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 you take Ebastina Gador

Do not take Ebastina Gador• If you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Ebastina Gador.

• If your electrocardiogram results are altered.
• If you have low potassium levels in your blood.
• If you suffer from severe liver disease.
• If you are being treated with a type of medicine used to treat fungal infections called azole antifungals or with macrolide antibiotics.
• If you are being treated with rifampicin, a type of medicine used to treat tuberculosis.

If you experience an acute allergic emergency, Ebastina Gador takes 1 to 3 hours to develop its effects.

Children

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

Taking Ebastina Gador with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

This is because Ebastina Gador may interfere with the way some medicines work and some of them may affect Ebastina Gador.

• Ebastina Gador may increase the effect of other antihistamine medicines.
• Ebastina Gador should be used with caution in patients when ebastine is administered at the same time as ketoconazole and itraconazole, or erythromycin.
• The effect of Ebastina Gador may be affected by a medicine called rifampicin, which is used to treat tuberculosis.

Interference with diagnostic tests

Ebastina Gador may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days have passed since the treatment was discontinued.

Taking Ebastina Gador with food and drinks

You can take oral disintegrating tablets with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No effects on psychomotor function have been observed in humans, nor on the ability to drive or use machinery, at the recommended therapeutic doses. However, since the side effects include drowsiness and dizziness, observe your response to treatment before driving or using machinery.

Ebastina Gador oral disintegrating tablets contain aspartame (E-951)

This medicine contains 5 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Ebastina Gador oral disintegrating tablets contain lactose

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

3. How to take Ebastina Gador

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many oral disintegrating tablets you should take and the duration of your treatment. This will depend on your condition and age. The recommended dose is as follows:

Use in adults and children over 12 years

The recommended dose in adults and children over 12 years is 1 oral disintegrating tablet (10 mg) once a day, although some patients may need 1 oral disintegrating tablet of 20 mg once a day.

Use in patients with severe liver disease

It is not recommended to exceed the dose of 10 mg per day. In these patients, it is recommended to use the 10 mg oral disintegrating tablet presentation.

If you think the effect of Ebastina Gador is too strong or too weak, consult your doctor or pharmacist.

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

If you take more Ebastina Gador 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 medicine and the amount taken.

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

If you forget to take Ebastina Gador

Do not take a double dose to make up for forgotten doses. Take the forgotten dose as soon as you remember and then continue taking this medicine with your usual schedule. If it is almost time for your next dose, do not take the forgotten dose, and wait for the next dose at the scheduled time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed in clinical trials and post-marketing experience:

Rare (>1/10,000 to <1/1,000):

• Drowsiness
• Dry mouth

Very rare (<1/10,000):

• Nervousness
• Insomnia
• Dizziness, decreased sensitivity, headache.
• Palpitations, tachycardia.
• Vomiting, abdominal pain, nausea, digestive problems.
• Abnormal liver function tests.
• Menstrual disorders.
• Urticaria, skin rash, dermatitis.
• Edema, fatigue.

Frequency not known (cannot be estimated from the available data):

- weight gain

- increased appetite

Do not worry about this list of possible side effects. You may not experience any of them. If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Agency's online platform: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastina Gador

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastina Gador:- The active substance is ebastine. Ebastina Gador oral disintegrating tablets contain 20 mg of ebastine. - The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose 101, sodium croscarmellose, aspartame (E-951), magnesium stearate, anhydrous colloidal silica, peppermint flavor.

Appearance and packaging of the product

Ebastina Gador 20 mg oral disintegrating tablets: white, round oral disintegrating tablets packaged in blisters.

Pack size: 20 oral disintegrating tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Qualix Pharma S.L

C/ de la Botánica 137-139

08908 L’Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer:

SEID, S.A.

Carretera de Sabadell a Granollers Km 15

08185 Lliçà de Vall – Barcelona

Spain

This medicine is authorized in the EEA Member States under the following names:

Date of the last revision of this package leaflet: December 2023