Ebastine Normon 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ebastina Normon 10 mg orodispersible tablets EFG

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents

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

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

Ebastina Normon belongs to a group of medicines known as antihistamines (antiallergic agents).

Ebastina Normon is indicated for the treatment of symptoms associated with allergic conditions such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, and sneezing), chronic urticaria, and allergic dermatitis.

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

Do not take Ebastine Normon

• If you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ebastine Normon.

This medicine should be used with caution:

• If your electrocardiogram (ECG) results are abnormal (prolongation of the QT interval).
• If you have high levels of potassium in your blood.
• If you suffer from severe liver disease (see section “How to take Ebastine Normon”).
• If you are being treated with a type of medicine used to treat fungal infections called azole antifungals, or with medicines used to treat certain infections called macrolide antibiotics (see section “Taking Ebastine Normon with other medicines”).
• If you are being treated with rifampicin, a medicine used to treat tuberculosis.

Do not use this medicine if you have an acute allergic emergency, as ebastine (the active ingredient in this medicine) takes 1 to 3 hours to take effect.

Children

Ebastine Normon must not be given to children under 12 years of age.

Taking Ebastine Normon with other medicines

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

The following medicines may interact with Ebastine Normon; in such cases, it may be necessary to adjust the dose or interrupt treatment with one of them:

• Ebastine Normon may increase the effect of other medicines used to treat allergy (antihistamines).
• Ebastine Normon should be used with caution in patients taking medicines called ketoconazole or itraconazole, used to treat fungal infections, or with a macrolide antibiotic called erythromycin used to treat certain infections (as they may cause changes in your electrocardiogram).
• The antihistaminic effect of Ebastine Normon may be reduced in patients taking a medicine called rifampicin, used to treat tuberculosis.

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

Interference with diagnostic tests

Ebastine Normon may interfere with the results of skin allergy tests; therefore, it is advisable not to perform these tests until 5–7 days after stopping treatment.

Taking Ebastine Normon with food and drinks

Orodispersible tablets can be taken with or without food. There is no need to take water or any other liquid.

Pregnancy and breastfeeding

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

Pregnancy

There is no experience in pregnant women; therefore, it is recommended to consult a doctor before taking Ebastine Normon. The doctor will decide whether or not treatment should be started.

Breastfeeding

It is unknown whether the medicine passes into breast milk; therefore, it should not be used during breastfeeding.

Driving and using machines

In clinical studies, no effects on psychomotor function or on the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, since somnolence and dizziness are listed among the adverse effects, you should assess your response to the medication before driving or operating machinery.

Ebastine Normon contains glucose, benzyl alcohol and sodium

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

It may harm teeth.

This medicine 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 the body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems (“gasping syndrome”), in children.

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

3. How to take Ebastina Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will advise you on the duration of treatment with Ebastina Normon.

Dosage

Use in adults and children over 12 years of age

The recommended dose is one orodispersible tablet (10 mg of ebastine) once daily.

Use in patients with severe liver disease

The dose should not exceed 10 mg of ebastine per day (1 orodispersible tablet of 10 mg).

Method of administration

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

If you feel that the effect 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20 (indicating the medicine and the amount ingested), or go to the nearest hospital. Take any remaining orodispersible tablets, the outer carton, and the full packaging so that healthcare professionals can easily identify the medicine you have taken.

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

If you forget to take Ebastina Normon

Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, then continue with your regular dosing schedule. However, if it is almost time for the next dose, do not take the missed dose and wait until the next scheduled dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse 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):

• Somnolence
• 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 disturbances
• Inflammation of the liver (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 of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Normon

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastine Normon

The active substance is ebastine. Each tablet contains 10 mg of ebastine.

The other components are: Pearlitol flash (contains mannitol, corn starch), microcrystalline cellulose (E-460), potato starch carboxymethyl starch, hydroxypropylcellulose (E-463), macrogol 6000, colloidal silica, glycerol monostearate, tutti frutti flavour (contains glucose and benzyl alcohol), sodium saccharin (E-954) and magnesium stearate (E-572).

Appearance of the product and contents of the pack

Ebastine Normon is presented as white or almost white, round, flat tablets, packed in aluminium/aluminium-polyamide-PVC blisters. Each pack contains 20 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76306/P_76306.html