EBASTINE NORMON 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Ebastina Normon 20 mg Oral Disintegrating 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 should not be given 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 Normon and what is it used for
2. What you need to know before taking Ebastina Normon
3. How to take Ebastina Normon
4. Possible side effects
5. Storage of Ebastina Normon
6. Package Contents and Additional Information

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

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

Ebastina Normon 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 taking Ebastina Normon

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 potassium levels in your blood.
• If you have severe liver disease (see "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 "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 (the 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 of age.

Taking Ebastina Normon with other medications

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

The following medications may interfere 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 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 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 oral disintegrating tablets can be taken with or without food. It is not necessary to ingest water or any other liquid.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or 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 with a doctor before taking Ebastina Normon. 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 have been observed on psychomotor function or the ability to drive or operate machinery at the recommended therapeutic doses. However, since drowsiness and dizziness are among the side 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 may harm your teeth.

This medication contains 0.2 mg of benzyl alcohol per 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 can accumulate in your body and cause side effects (metabolic acidosis).

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

Benzyl alcohol has been linked to the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

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

3. How to take Ebastina Normon

Follow the exact instructions for administration of this medication as indicated by your doctor. If in 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:The recommended dose is 10 mg of ebastina once a day, although some people may require a dose of 20 mg once a day.

Use in patients with severe liver disease:The dose should not exceed 10 mg of ebastina per day. In this case, it is recommended to use the 10 mg presentation.

Method of administration

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

If you think the effect of Ebastina Normon is too strong or too weak, tell 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 Toxicology Information Service, phone 91 562 04 20, (indicating the medication and the amount ingested) or go to the nearest hospital. Bring the remaining oral disintegrating tablets, the case, and the complete box so that the healthcare staff can easily identify the medication you have taken.

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

If you forget to take Ebastina Normon

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 the 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
• 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 help provide more information on the safety of this medication.

5. Storage of Ebastina Normon

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 stated on the packaging after "EXP". 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 the pharmacy. If in doubt, 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 Normon

The active ingredient is ebastina. Each tablet contains 20 mg of ebastina.

The other ingredients are: Pearlitol flash (contains mannitol, corn starch), microcrystalline cellulose (E-460), sodium carboxymethyl starch (Type A), hydroxypropylcellulose (E-463), macrogol 6000, colloidal silicon dioxide, glycerol monostearate, tutti frutti flavor (contains glucose and benzyl alcohol), sodium saccharin (E-954), and magnesium stearate (E-572).

Appearance of the Product and Package 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

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this package leaflet:May 2024

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

You can access detailed and updated information on this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76307/P_76307.html