Package Insert: Information for the Patient

Ebastina Normon 10 mg Buccodispersible Tablets EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication 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 package insert. See section 4.

1. What is Ebastina Normon and how is it used

2. What you need to know before starting to take Ebastina Normon

3. How to take Ebastina Normon

4. Possible adverse effects

5. Storage of Ebastina Normon

6. Contents of the package and additional information

Ebastina Normon belongs to a group of medications known as antihistamines (antiallergics).

Ebastina Normon 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 nasal discharge, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

Do not take Ebastina Normon

• 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 Normon.

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 a severe liver disease (see section “How to take Ebastina Normon”).
• 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 Ebastina Normon 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 ebastina (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastina Normon should not be administered to children under 12 years old.

Taking Ebastina Normon with other medications

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

The medications listed below may interact with Ebastina Normon; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

• Ebastina Normon may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastina Normon 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 Normon may be reduced 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 Normon may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after discontinuing treatment.

Taking Ebastina Normon with food and drinks

The buccal tablets can be taken with or without food. No water or other liquid is required.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

No experience has been reported in pregnant women, so it is recommended to consult a doctor before taking Ebastina Normon. The doctor will decide whether or not to start treatment.

Breastfeeding

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

Driving and operating machinery

In men, no effects have been observed on psychomotor function or on the ability to drive or operate machinery at the recommended therapeutic doses. However, given that drowsiness and dizziness are among the adverse effects, observe your response to the medication before driving or operating machinery.

Ebastina Normon contains glucose, benzyl alcohol, and sodium

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

It mayand harm teeth.

This medication contains 0.1 mg of benzyl alcohol in each tablet.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been linked to the risk of severe adverse effects that include respiratory problems (“breathing difficulty”) in children.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Ebastina Normon.

Dosage

Use in adults and children over 12 years old

The recommended dose is one buccal dispersible tablet (10 mg of ebastina) once a day.

Use in patients with severe liver disease

The dose should not exceed 10 mg of ebastina per day (1 buccal dispersible tablet of 10 mg).

Administration form

Ebastina Normon tablets are for oral administration and easily disintegrate, so they should be handled with care. Do not handle the tablets with wet hands because they may disintegrate.

If you estimate that the action of Ebastina Normon is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastina Normon 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 ingested) or go to the nearest hospital. Bring the remaining buccal dispersible tablets, the packaging, and the complete box so that healthcare personnel can identify the medication more easily.

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

If you forgot to take Ebastina Normon

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait to take the next dose at the scheduled time.

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

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:

Very frequent (may affect more than 1 in 10 people):

-Headache

Frequent (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

-Inflammation of the liver (hepatitis), cholestasis, abnormal liver function tests (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin)

-Urticaria, skin rash, dermatitis

-Menstrual disorders

-Edema (swelling due to fluid accumulation), fatigue

Unknown frequency (cannot be estimated from available data):

• Weight gain
• Increased appetite

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 of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on 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 packaging 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. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Ebastina Normon Composition

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

The other components are: Pearlitol flash (contains mannitol, cornstarch), microcrystalline cellulose (E-460), carboxymethylstarch, hydroxypropylcellulose (E-463), macrogol 6000, colloidal silica, glyceryl monostearate, tutti frutti essence (contains glucose and benzyl alcohol), sodium saccharin (E-954), and magnesium stearate (E-572).

Product appearance and packaging contents

Ebastina Normon is presented in the form of white or almost white, round, and flat tablets, and is packaged in aluminum/aluminum-polyamide-PVC blisters. Each package contains 20 tablets.

Marketing authorization holder and manufacturer responsible

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leafletMay 2024

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76306/P_76306.html