Evastix

Package Leaflet: Information for the Patient

Evastix, 10 mg, orodispersible tablets

Evastix, 20 mg, orodispersible tablets

Ebastine

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Evastix and what is it used for
• 2. Important information before taking Evastix
• 3. How to take Evastix
• 4. Possible side effects
• 5. How to store Evastix
• 6. Contents of the pack and other information

1. What is Evastix and what is it used for

Ebastine is an antihistamine that helps to relieve the symptoms of allergies, such as sneezing, runny nose, itchy eyes, and itchy skin rashes. In adults and children aged 12 years and older, Evastix is used to relieve the symptoms of seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, including allergic conjunctivitis. In adults over 18 years of age, Evastix 10 mg is also used to relieve itching and reduce the development of blisters in urticaria.

2. Important information before taking Evastix

When not to take Evastix:

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

Warnings and precautions

Before taking Evastix, discuss with your doctor if:

• you have a low level of potassium in your blood;
• you have heart rhythm disturbances (known as QTc interval prolongation in the ECG), which can occur in some heart diseases;
• you are taking certain antibiotics (macrolide antibiotics, such as erythromycin) or medicines used to treat fungal infections (antifungal medicines, such as ketoconazole and itraconazole): see "Evastix with other medicines" below;
• you have severe liver function disorders (liver failure).

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 the safety and efficacy of ebastine in this age group have not been established.

Evastix with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take. Evastix may affect the action of other medicines or some medicines may affect the action of Evastix, especially those containing the following active substances:

• ketoconazole, itraconazole (medicines used to treat fungal infections);
• erythromycin, clarithromycin or josamycin (antibiotics);
• rifampicin (a medicine used to treat tuberculosis).

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

Effect on diagnostic tests

Evastix may affect the results of skin allergy tests, so they should not be performed for 5-7 days after treatment has stopped.

Evastix with food and drink

Evastix can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The available data on the use of ebastine in pregnant women are limited. Therefore, Evastix should only be used during pregnancy if your doctor considers it necessary. As a precautionary measure, it is recommended to avoid the use of ebastine during pregnancy. You should not take Evastix if you are breastfeeding, as it is not known whether ebastine passes into breast milk.

Driving and using machines

Most people taking Evastix can drive or use machines. However, as with any medicine, you should check your individual reaction to Evastix before driving or operating machinery, as some people may feel drowsy or dizzy.

Other ingredients:

Evastix 10 mg orodispersible tablets contain 2.5 mg of aspartame in each tablet. Evastix 20 mg orodispersible tablets contain 5 mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

3. How to take Evastix

Always take Evastix exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is: Indication Age Dose Allergic rhinitis In case of severe symptoms Children aged 12 years and older and adults One 10 mg Evastix tablet (10 mg ebastine) once daily. Two 10 mg Evastix tablets or one 20 mg Evastix tablet (20 mg ebastine) once daily. Urticaria Adults over 18 years of age One 10 mg Evastix tablet (10 mg ebastine) once daily. In patients with renal impairment, no dose adjustment is necessary. In patients with mild or moderate liver impairment, no dose adjustment is necessary. There is no experience with doses greater than 10 mg in patients with severe liver impairment; therefore, do not exceed the dose of 10 mg in these patients. Place the tablet on the tongue, where it will dissolve within a few seconds: no water or other liquid is needed. Evastix can be taken with or without food. If you feel that the effect of Evastix is too strong or too weak, tell your doctor or pharmacist. Your doctor will decide the duration of treatment.

Take more Evastix than recommended

There is no specific antidote for the active substance - ebastine. If you think you have taken too much Evastix, tell your doctor. Depending on the severity of the overdose, your doctor will start the appropriate treatment (monitoring of vital functions, including ECG monitoring for at least 24 hours, symptomatic treatment, and gastric lavage if necessary).

Miss a dose of Evastix

If you miss a dose, do not take an extra dose to make up for the missed dose, but take the next dose at the scheduled time and continue treatment as before. Do not take a double dose to make up for the missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Evastix can cause side effects, although not everybody gets them.

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

• -itching, hives, and swelling of the face, tongue, or throat, which may cause difficulty in swallowing or breathing. These may be symptoms of an allergic reaction, such as anaphylaxis and angioedema, which are rare side effects (may affect up to 1 in 1,000 people).

Other side 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)

• nosebleeds;
• sore throat (pharyngitis);
• runny nose (rhinitis).

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

• -allergic reactions (such as anaphylaxis and angioedema);
• nervousness;
• insomnia;
• drowsiness;
• dizziness;
• numbness;
• taste disturbances;
• palpitations (rapid or irregular heartbeat);
• rapid heartbeat;
• abdominal pain;
• vomiting;
• nausea;
• indigestion;
• hepatitis;
• cholestasis (bile flow disorder);
• abnormal liver function tests;
• rash, hives, generalized rash;
• menstrual disorders;
• edema (fluid accumulation in tissues);
• extreme weakness (asthenia).

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

• sensory disturbances;
• eczema, dermatitis;
• painful menstruation.

Frequency not known:(frequency cannot be estimated from the available data)

• -weight gain;
• -increased appetite.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Evastix

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. There are no special storage precautions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Evastix contains

• The active substance is ebastine. Each 10 mg orodispersible tablet contains 10 mg ebastine. Each 20 mg orodispersible tablet contains 20 mg ebastine.
• The other ingredients are: microcrystalline cellulose (PH-102), mannitol, crospovidone (Type A), aspartame (E 951), colloidal anhydrous silica, magnesium stearate, peppermint flavor.

What Evastix looks like and contents of the pack

Orodispersible tablet. Evastix, 10 mg, orodispersible tablets: [size: 6.7 mm]White or almost white, round, biconvex, uncoated tablets with "E 10" engraved on one side and smooth on the other. Evastix, 20 mg, orodispersible tablets: [size: 9.2 mm]White or almost white, round, biconvex, uncoated tablets with "E 20" engraved on one side and smooth on the other. Evastix is available in blisters packaged in a cardboard box. Pack sizes: 10, 20, 30, 50, and 90 orodispersible tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: [email protected] tel. +48 22 311 20 00

Manufacturer/Importer:

APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmaceutica, S.A. Rua João de Deus 19 2700-487 Amadora Portugal Arrow Generiques 26 avenue Tony Garnier 69007 Lyon France

This medicine is authorized in the Member States of the European Economic Area under the following names:

France: EBASTINE ARROW LAB 10 mg, comprimé orodispersible Netherlands: Ebastine Aurobindo smelt 10 mg, orodispergeerbare tabletten Poland: Evastix Portugal: Ebastina Generis Spain: Ebastina Aurovitas 10 mg / 20 mg comprimidos bucodispersables EFG

Date of last revision of the leaflet: 07.2023