Leaflet: information for the patient

Ebastina Normon 10 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse even if they are not listed in this leaflet.See section 4.

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

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

3. How to take Ebastina Normon

4. Possible side effects

5. Storage of Ebastina Normon

6. Contents of the pack and additional information

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

Ebastina Normon is indicated for the symptomatic treatment 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 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 "How to take Ebastina Normon").
• If you are being treated with a type of antifungal medication called azoles or with a type of antibiotic called macrolides (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 (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 following medications 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 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 tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be 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 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, since drowsiness and dizziness are among the adverse effects, observe your response to the medication before driving or operating machinery.

Ebastina 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 him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it 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.

Ebastina Normon film-coated tablets are not suitable for administration of doses lower than 10 mg of ebastina, nor for patients with swallowing problems.

Dosage

Use inadults and children over 12 years:Theusual dose is 10 mg of ebastina once a day, although some patients may require a dose of 20 mgonce a day.

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

Administration form

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 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, call the Toxicological Information Service, phone 915 620 420 (indicating the medication and the amount ingested) or go to the nearest hospital. Bring the remaining tablets, the packaging and the complete box so that the healthcare staff can identify the medication you have taken more easily.

The treatment of intoxication by 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 usual schedule. However, if there are only a few hours left until the next dose, do not take the missed dose and wait until you take the next dose at the time it is due.

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

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

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

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):

• Allergic reactions: 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 test results (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 theSpanish System for 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.

Store below 30 °C.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines 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: lactose monohydrate, crospovidone, sodium starch glycolate, magnesium stearate, basic butylated methacrylate copolymer, titanium dioxide (E-171), talc, and macrogol 6000.

Product appearance and packaging contents

Ebastina Normon 10 mg is presented in the form of coated tablets for oral administration. The tablets are white or almost white, round, biconvex, and have the imprint E10. Each package contains 20 coated tablets.

Marketing authorization holder and manufacturer responsibleLABORATORIOS NORMON, S.A.

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

Other presentations

Ebastina Normon 20 mg coated tablets EFG

Last review date of this prospectus:January 2022.

Detailed and updated information about 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 about this medication by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68485/P_68485.html

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