Prospect: information for the user

Ebastina Gador 20 mg buccal dispersible tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

Ebastina Gador contains the active substance ebastina. 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 associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

Do not take Ebastina Gador
• If you are allergic to ebastina 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 Ebastina Gador.

• If your electrocardiogram results are altered.
• If you have low levels of potassium in your blood.
• If you have severe liver disease.
• If you are being treated with a type of antifungal medication called azoles or macrolide antibiotics.
• If you are being treated with rifampicin, a type of medication 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 old.

Taking Ebastina Gador with other medications

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

This is because Ebastina Gador may interfere with the action of some medications and some may affect Ebastina Gador.

• Ebastina Gador may increase the effect of other antihistamines.
• Ebastina Gador should be used with caution in patients when ebastina is administered at the same time with ketoconazole, itraconazole, or erythromycin.
• The effect of Ebastina Gador may be affected by a medication called rifampicin 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 after stopping treatment.

Taking Ebastina Gador with food and drinks

You can take buccal dispersible tablets with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

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.

Driving and operating machinery

No effects on psychomotor function have been observed in humans at the recommended therapeutic doses. However, given that drowsiness and dizziness are among the adverse effects, observe your response to treatment before driving or operating machinery.

Ebastina Gador buccal dispersible tablets contain aspartame (E-951)

This medication contains 5 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Ebastina Gador buccal dispersible tablets contain lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many buccal tablets to 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 old

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

Use in patients with severe liver disease

Do not exceed a dose of 10 mg per day. In these patients, it is recommended to use the 10 mg buccal tablet presentation.

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

If you have any other doubts about the use of this medication, 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

The treatment of poisoning by this medication consists of gastric lavage and administration of the appropriate medication. Carry this leaflet with you.

If you forgot to take Ebastina Gador

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as you remember and then continue taking this medication at your usual schedule. If there is little time left for your next dose, do not take the missed dose and wait to take the next dose at the time it is due.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

In clinical trials and post-marketing experience, the following adverse effects have been observed:

Rare (>1/10,000 to <1

- Drowsiness

- Dry mouth

Very rare (<1

- 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.

Unknown frequency (cannot be estimated from available data):

- Weight gain

- Increased appetite

Do not worry about this list of possible adverse effects. You may not experience any of them. If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Ebastina Gador:
- The active ingredient is ebastina. Ebastina Gador buccal dispersible tablets contain 20 mg of ebastina.
- The other components (excipients) are: lactose monohydrate, microcrystalline cellulose 101, croscarmellose sodium, aspartame (E-951), magnesium stearate, anhydrous colloidal silica, peppermint aroma.

Appearance of the product and contents of the packaging

Ebastina Gador 20 mg buccal dispersible tablets: white and round buccal dispersible tablets packaged in blisters.

Packaging size: 20 buccal dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Qualix Pharma S.L

C/ de la Botánica 137-139

08908 L’Hospitalet de Llobregat (Barcelona)

Spain

Responsible for manufacturing:

SEID, S.A.

Carretera de Sabadell a Granollers Km 15

08185 Lliçà de Vall – Barcelona

Spain

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

Last review date of this leaflet: December 2023