Evastix

Package leaflet: Information for the patient

Evastix, 10 mg, orodispersible tablets
Evastix, 20 mg, orodispersible tablets
Ebastinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Evastix is and what it is 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 Evastix is and what it is used for

Ebastine is an antihistamine medicine that helps relieve allergy symptoms such as sneezing,
runny nose, watery eyes, and itchy skin rashes.
In adults and children aged 12 years and older, Evastix is used to relieve 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 wheals in urticaria.

2. Important information before using Evastix

When not to use Evastix:

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

Warnings and precautions
Before starting treatment with Evastix, consult your doctor if:

• the patient has low blood potassium levels;
• the patient has been diagnosed with heart rhythm disorders (known as QTc prolongation on ECG), which may occur in certain heart diseases;
• the patient is 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;
• the patient has severe liver function impairment (liver failure).

Children and adolescents
This medicine should only be used in children aged 12 years and older. This medicine should not be given to children under 12 years of age, as safety and efficacy have not been established in this age group.
Evastix with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Evastix may affect the action of other medicines, or certain medicines may affect the action of Evastix, when they contain 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 observed between ebastine and theophylline, warfarin, cimetidine, diazepam, or alcohol.
Effect on diagnostic test results
Evastix may affect the results of skin allergy tests; therefore, such tests should not be performed within 5–7 days after treatment has ended.
Evastix with food and drink
Evastix can be taken independently of meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Current experience regarding safety for the unborn child in humans is limited. Therefore, during pregnancy, Evastix should only be used if the doctor considers that the expected benefit outweighs the possible risk associated with its use.
As a precautionary measure, it is recommended to avoid using ebastine during pregnancy.
Evastix should not be used in breastfeeding women, as it has not been established whether the active substance passes into breast milk.
Driving and operating machinery
Most patients taking Evastix can drive vehicles or perform other activities requiring quick reactions. However, as with any medicine, the individual response to Evastix should be assessed before the patient drives a vehicle or performs complex tasks, since some patients may experience drowsiness or dizziness.
Excipients:
Evastix 10 mg orodispersible tablets contain 2.5 mg of aspartame per tablet.
Evastix 20 mg orodispersible tablets contain 5 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

3. How to use Evastix

Evastix should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dosage of the medicine:

| Indication | Age | Dosage | |------------|-----|--------| | Allergic rhinitis | Children aged 12 years and older, and adults | One tablet of Evastix 10 mg (10 mg ebastine) once daily. | | In case of severe symptoms | Two tablets of Evastix 10 mg or one tablet of Evastix 20 mg (20 mg ebastine) once daily. | | Chronic urticaria | Adults over 18 years of age | One tablet of Evastix 10 mg (10 mg ebastine) once daily. |

There is no need to adjust the dose in patients with renal impairment.

In patients with mild or moderate hepatic impairment, there is no need to adjust the dose.

There is limited experience with doses higher than 10 mg in patients with severe hepatic impairment; therefore, the dose should not exceed 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 required.

Evastix may be taken regardless of meals.

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

Your doctor will determine the duration of treatment.

Overdose of Evastix

There is no specific antidote for the active substance, ebastine.

If a patient suspects an overdose of Evastix, they should inform their doctor immediately.

Depending on the severity of intoxication, the doctor will initiate appropriate treatment (monitoring of vital functions, including ECG monitoring for at least 24 hours, symptomatic treatment, and gastric lavage if necessary).

Missed dose of Evastix

If a dose is missed, do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time and continue treatment as before.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking Evastix and immediately contact a doctor or go to hospital if the patient experiences:

• itching, hives, and swelling of the face, tongue, or throat, which may cause difficulty in swallowing or breathing. These may be symptoms of hypersensitivity reactions such as anaphylaxis and drug-induced angioedema, which are rare side effects (may occur in less than 1 in 1,000 people).

Other side effects include:
Very common: (may affect more than 1 in 10 people)

• headache.

Common: (may affect less than 1 in 10 people)

• drowsiness;
• dry mouth.

Uncommon: (may affect less than 1 in 100 people)

• nosebleeds;
• sore throat (pharyngitis);
• nasal discharge (rhinitis).

Rare: (may affect less than 1 in 1,000 people)

• hypersensitivity reactions (such as anaphylaxis and angioedema);
• nervousness;
• insomnia;
• drowsiness;
• dizziness;
• decreased sensation;
• taste disturbances;
• palpitations (rapid heartbeat, irregular heartbeat);
• increased heart rate;
• abdominal pain;
• vomiting;
• nausea;
• indigestion;
• hepatitis;
• cholestasis (impaired bile flow);
• abnormal liver function test results;
• rash, hives, generalized rash;
• menstrual disorders;
• edema (fluid accumulation in tissues);
• extreme weakness (asthenia).

Very rare: (may affect less than 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 of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Reporting side effects helps 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 stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Evastix contains

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

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, embossed with the code
"E 10" on one side and smooth on the other side.
Evastix, 20 mg, orodispersible tablets: [size: 9.2 mm]
White or almost white, round, biconvex, uncoated tablets, embossed with the code
"E 20" on one side and smooth on the other side.
Evastix is available in blister packs contained in cardboard packaging.
Pack sizes: 10, 20, 30, 50 and 90 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in 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