Ebastine Gador 20 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ebastina Gador 20 mg orodispersible tablets EFG

Read all of this 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, ask 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.

Contents of the leaflet

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

1. What Ebastina Gador is and what it is 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 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, and allergic dermatitis.

2. What you need to know before taking Ebastina Gador

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Ebastina Gador if:

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

If you have an acute allergic reaction requiring urgent treatment, Ebastina Gador takes 1 to 3 hours to produce its effects.

Children

• Ebastina Gador must not be given to children under 12 years of age.

Taking Ebastina Gador with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is because Ebastina Gador may interfere with the way some medicines work, and some of these medicines 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 or itraconazole, or erythromycin.
• The effect of Ebastina Gador may be affected by a medicine called rifampicin used to treat tuberculosis.

Interference with diagnostic tests

Ebastina Gador 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 Ebastina Gador with food and drink

You may take orodispersible tablets with or without food.

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

No effects on psychomotor function, or on the ability to drive or use machinery, have been observed in humans at the recommended therapeutic doses. However, since adverse effects such as drowsiness and dizziness have been reported, observe your response to treatment before driving or using machinery.

Ebastina Gador orodispersible tablets contain aspartame (E-951)

This medicine contains 5 mg of aspartame per tablet.

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

Ebastina Gador orodispersible tablets contain lactose

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

3. How to take Ebastina Gador

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

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

Use in adults and children over 12 years of age

The recommended dose for adults and children over 12 years of age is 1 orodispersible tablet (10 mg) once daily, although some patients may require one orodispersible tablet of 20 mg once daily.

Use in patients with severe liver disease

Doses exceeding 10 mg per day are not recommended. In these patients, the 10 mg orodispersible tablet formulation is recommended.

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

If you have any further 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, 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 taken.

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

If you forget to take Ebastina Gador

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

• Somnolence
• 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 available data):

-weight gain

-increased appetite

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you do experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Ebastine Gador

Keep this medicine out of sight and reach of children.

No special storage conditions required.

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 in your pharmacy. If you are unsure, 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 Ebastina Gador: - The active substance is ebastine. Ebastina Gador orodispersible tablets contain 20 mg of ebastine. - The other components (excipients) are: lactose monohydrate, microcrystalline cellulose 101, sodium croscarmellose, aspartame (E-951), magnesium stearate, colloidal anhydrous silica, peppermint flavor.

Appearance of the product and contents of the pack

Ebastina Gador 20 mg orodispersible tablets: white, round orodispersible tablets presented in blisters.

Pack size: 20 orodispersible 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 medicinal product is authorized in the EEA Member States under the following names:

Date of the latest review of this leaflet: December 2023