Ebastine Aurovitas 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ebastina Aurovitas 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 others, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet

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

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

Ebastine is an antihistamine that helps relieve allergy symptoms such as sneezing, runny nose, watery eyes, and itchy skin rashes.

Ebastine is used in adults and children over 12 years of age to relieve symptoms of seasonal rhinitis (hay fever) and perennial allergic rhinitis, including cases with allergic conjunctivitis.

Ebastine 10 mg orodispersible tablets are also used in adults over 18 years of age to relieve itching and the development of hives in cases of urticaria (rash).

2. What you need to know before taking Ebastina Aurovitas

Do not take Ebastina Aurovitas:

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

Warnings and precautions

Consult your doctor before starting ebastine if:

• You have low levels of potassium in your blood.
• You have an abnormal heart rhythm pattern (known QTc prolongation on ECG), which may occur in certain forms of heart disease.
• You are already taking certain antibiotics (macrolide antibiotics such as erythromycin) or medicines used to treat fungal infections (antifungal agents such as ketoconazole and itraconazole): see section “Other medicines and Ebastina Aurovitas” below.
• You have severely impaired liver function (hepatic insufficiency).

Children and adolescents

This medicine should only be used in children aged 12 years and older. Do not give this medicine to children under 12 years of age, as safety and efficacy have not been established in this age group.

Other medicines and Ebastina Aurovitas

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

Ebastine may be affected by, or may affect, some medicines containing the following active substances:

• Ketoconazole, itraconazole (medicines for the treatment of fungal infections).
• Erythromycin, clarithromycin, or josamycin (antibiotics).
• Rifampicin (a medicine used to treat tuberculosis).

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

Interference with diagnostic tests

Ebastine may interfere with the results of skin allergy tests. Therefore, it is recommended not to perform such tests until 5 to 7 days after stopping treatment.

Taking Ebastina Aurovitas with food and drink

You may take ebastine with or without food.

Pregnancy, breastfeeding, and fertility

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.

There is limited experience to date regarding the safety of this medicine for the fetus in humans. For this reason, ebastine should only be taken during pregnancy if your doctor considers that the expected benefit outweighs the possible risks.

As a precautionary measure, it is preferable to avoid the use of ebastine during pregnancy.

Do not take ebastine while breastfeeding, as it is unknown whether the active substance passes into breast milk.

Driving and use of machines

Most patients treated with ebastine can drive or carry out other activities requiring good reaction capability. However, as with other medicines, you should assess your individual response to ebastine before driving or performing complex tasks, since some patients may experience drowsiness or dizziness.

Ebastina Aurovitas contains aspartame

This medicine contains 2.5 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Ebastine Aurovitas

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

Recommended dose is:

In patients with impaired renal function, dose adjustment is not necessary.

In patients with mild or moderate hepatic impairment, dose adjustment is not necessary.

There is no experience with doses exceeding 10 mg in patients with severe hepatic impairment; therefore, the dose should not exceed 10 mg in these patients.

Place the tablet on your tongue, where it dissolves within seconds; it is not necessary to take water or any other liquid.

Ebastine may be taken with or without food.

If you think that the effect of ebastine is too strong or too weak, inform your doctor or pharmacist.

Your doctor will decide the duration of your treatment.

If you take moreEbastina Aurovitas than you should

There is no specific antidote for the active substance ebastine.

In case of overdose with ebastine, please consult your doctor. Depending on the severity of intoxication, your doctor will initiate appropriate measures (monitoring of vital body functions, including ECG monitoring for at least 24 hours, symptomatic treatment, and gastric lavage), if necessary.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeEbastina Aurovitas

If you forget to take a dose, do not take a double dose to make up for the missed dose. Take your next dose at the scheduled time and continue as usual.

Do not take a double dose to compensate for missed doses.

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.

Stop taking ebastine and contact your doctor immediately or go to the nearest hospital if you experience the following:

• Itching, hives, and swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing. These may be signs of a hypersensitivity reaction such as anaphylaxis and angioedema, which are rare adverse effects (may affect up to 1 in 1,000 people).

Other adverse effects include:

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

• Headache.

Common (may affect up to 1 in 10 people):

• Drowsiness.
• Dry mouth.

Uncommon (may affect up to 1 in 100 people):

• Nosebleed.
• Sore throat (pharyngitis).
• Nasal discharge (rhinitis).

Rare (may affect up to 1 in 1,000 people):

• Hypersensitivity reactions (such as anaphylaxis and angioedema).
• Nervousness.
• Insomnia.
• Numbness.
• Dizziness.
• Decreased sense of touch.
• Taste disturbance.
• Palpitations (fast heartbeat, irregular heartbeat).
• Rapid pulse.
• Abdominal pain.
• Vomiting.
• Nausea.
• Indigestion.
• Hepatitis (inflammation of the liver).
• Cholestasis (impaired bile flow).
• Abnormal liver function test results.
• Skin rash, hives, generalized rash.
• Menstrual disorders.
• Edema (fluid accumulation in tissues).
• Weakness (asthenia).

Very rare (may affect up to 1 in 10,000 people):

• Disturbance of touch sensation.
• Eczema, skin inflammation.
• Menstrual pain.

Frequency not known (frequency 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Ebastine Aurovitas

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

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastina Aurovitas

• The active substance is ebastine. Each orodispersible tablet contains 10 mg of ebastine.
• The other components are: microcrystalline cellulose (PH-102), mannitol (E-421), crospovidone (type A), aspartame, colloidal anhydrous silica, magnesium stearate, peppermint flavour.

Nature of the product and pack contents

Orodispersible tablet.

Uncoated tablets, white to off-white, 6.7 mm in size, round and biconvex, engraved with 'E 10' on one side and smooth on the other.

Ebastina Aurovitas 10 mg orodispersible tablets EFG are available in blister packs.

Pack sizes: 10, 20, 30, 50 and 90 orodispersible tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Spain: Ebastina Aurovitas 10 mg orodispersible tablets EFG

France: EBASTINE ARROW LAB 10 mg, comprimé orodispersible

Netherlands: Ebastine Aurobindo smelt 10 mg, orodispergeerbare tabletten

Poland: Evastix

Portugal: Ebastina Generis

Date of the most recent review of this leaflet: July 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)