EBASTINE NORMON 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ebastine Normon 20 mg film-coated 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, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Ebastine Normon is indicated for the symptomatic treatment 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 Ebastine Normon

Do not take Ebastine Normon

• If you are allergic to ebastine 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 Ebastine 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 Ebastine 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 Ebastine 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 ebastine (the active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastine Normon should not be administered to children under 12 years of age.

Taking Ebastine 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 Ebastine Normon; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

• Ebastine Normon may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastine 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 Ebastine Normon may be reduced in patients being treated with a medication called rifampicin, used to treat tuberculosis.

No interactions have been described between ebastine and theophylline, warfarin, cimetidine, diazepam, and alcohol.

Interference with diagnostic tests

Ebastine 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 Ebastine Normon with food and drinks

The tablets can be taken with or without food.

Pregnancy and breastfeeding

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.

Pregnancy

There is no experience in pregnant women, so it is recommended to consult a doctor before taking Ebastine 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.

Ebastine Normon contains lactose and sodium

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

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

3. How to take Ebastine Normon

Follow the administration instructions for this medication exactly 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 Ebastine Normon.

Ebastine Normon film-coated tablets are not suitable for administration of doses less than 10 mg of ebastine, nor for patients with swallowing problems.

Dosage

Use in adults and children over 12 years:The usual dose is 10 mg of ebastine once a day, although some patients 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 ebastine per day. In this case, the 10 mg presentation is recommended.

Method of administration

This medication is for oral administration.

The tablets can be taken with or without food, with the help of a glass of water.

If you think the effect of Ebastine Normon is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastine Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service, phone 915 620 420 (indicating the medication and the amount ingested), or go to the nearest hospital. Bring the remaining tablets, the box, and the complete packaging so that the healthcare staff can more 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 Ebastine Normon

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then follow your usual schedule. However, if it is almost time for your next dose, do not take the forgotten dose and wait for your next scheduled dose.

If you have any other questions about the use of this product, 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 possible side effects 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 Ebastine Normon

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

Store below 30 °C.

Do not use this medication after the expiration date shown 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 medications in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ebastine Normon

• The active ingredient is ebastine. Each tablet contains 20 mg of ebastine.
• The other ingredients are: lactose monohydrate, crospovidone, sodium starch glycolate, magnesium stearate, methacrylic acid copolymer, titanium dioxide (E-171), talc, and macrogol 6000.

Appearance of the product and contents of the pack

Ebastine Normon 20 mg is presented in the form of film-coated tablets for oral administration. The tablets are white or almost white, round, biconvex, and have the inscription E20. Each pack contains 20 film-coated tablets.

Marketing authorization holder and manufacturerLABORATORIOS NORMON, S.A.

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

Other presentations

Ebastine Normon 10 mg film-coated tablets EFG

Date of the last revision of this package leaflet:January 2022

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 about 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/68486/P_68486.html