Evastix

Package Leaflet: Information for the Patient

Evastix, 10 mg, Oral Disintegrating Tablets

Evastix, 20 mg, Oral Disintegrating Tablets

Ebastine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication has been Prescribed for a Specific Person. Do Not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Side Effects, Including those not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 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. Package Contents and Other Information

1. What is Evastix and What is it Used for

Ebastine is an Antihistamine Medication that Helps to Relieve Allergy Symptoms, 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 Symptoms of Seasonal Allergic Rhinitis (Hay Fever) and Perennial Allergic Rhinitis, Including Allergic Conjunctivitis. In Adults Aged 18 Years and Older, 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 the Patient is Allergic (Hypersensitive) to Ebastine or any of the Other Ingredients of this Medication (Listed in Section 6).

Warnings and Precautions

Before Starting to Take Evastix, Discuss with the Doctor if:

• The Patient has a Low Level of Potassium in the Blood;
• The Patient has Heart Rhythm Disorders (Known as Prolonged QTc Interval in the ECG), Which can Occur in Certain Heart Diseases;
• The Patient is Taking Certain Antibiotics (Macrolide Antibiotics, Such as Erythromycin) or Medications Used to Treat Fungal Infections (Antifungal Medications, Such as Ketoconazole and Itraconazole): See "Evastix and Other Medications" Below;
• The Patient has Severe Liver Impairment (Liver Failure).

Children and Adolescents

This Medication Should Only be Used in Children Aged 12 Years and Older. Do Not Give this Medication to Children Under 12 Years of Age, as the Safety and Efficacy of Use in this Age Group have not been Established.

Evastix and Other Medications

Tell the Doctor or Pharmacist About all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications the Patient Plans to Take. Evastix may Affect the Action of Other Medications or Certain Medications may Affect the Action of Evastix, Including:

• Ketoconazole, Itraconazole (Medications Used to Treat Fungal Infections);
• Erythromycin, Clarithromycin, or Josamycin (Antibiotics);
• Rifampicin (Medication 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, Therefore, these Tests Should not be Performed for 5-7 Days After Treatment has been Stopped.

Evastix with Food and Drink

Evastix can be Taken with or Without Food.

Pregnancy, Breast-feeding, and Fertility

If the Patient is Pregnant or Breast-feeding, Thinks they may be Pregnant, or is Planning to have a Child, they Should Consult the Doctor or Pharmacist Before Taking this Medication. The Current Experience of the Safety of the Unborn Child in Humans is Limited. Therefore, Evastix Should Only be Taken During Pregnancy if the Doctor Considers that the Expected Benefits Outweigh the Possible Risks. As a Precautionary Measure, it is Recommended to Avoid Taking Ebastine During Pregnancy. Evastix Should not be Taken by Breast-feeding Women, as it is not Known whether the Active Substance Passes into Breast Milk.

Driving and Using Machines

Most Patients Taking Evastix can Drive or Perform Other Activities that Require Quick Reactions. However, as with any Medication, the Individual Reaction to Evastix Should be Checked Before Driving or Performing Complex Activities, as Some Patients may Experience Drowsiness or Dizziness.

Excipients:

Evastix 10 mg Oral Disintegrating Tablets Contain 2.5 mg of Aspartame in each Tablet. Evastix 20 mg Oral Disintegrating Tablets Contain 5 mg of Aspartame in each Tablet. Aspartame is a Source of Phenylalanine. It may be Harmful to Patients with Phenylketonuria. This is a Rare Genetic Disorder in which Phenylalanine Accumulates in the Body due to its Impaired Elimination.

3. How to Take Evastix

Evastix Should Always be Taken Exactly as Advised by the Doctor or Pharmacist. If in Doubt, Consult the 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 Evastix 10 mg Tablet (10 mg Ebastine) Once a Day.

Two Evastix 10 mg Tablets or One Evastix 20 mg Tablet (20 mg Ebastine) Once a Day.

Urticaria

Adults Aged 18 Years and Older

One Evastix 10 mg Tablet (10 mg Ebastine) Once a Day.

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 Limited Experience with Doses Higher than 10 mg in Patients with Severe Liver 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 Needed. Evastix can be Taken with or Without Food. If the Patient Feels that the Effect of Evastix is too Strong or too Weak, they Should Inform the Doctor or Pharmacist. The Doctor will Decide on the Duration of Treatment.

Overdose of Evastix

There is no Specific Antidote for the Active Substance - Ebastine. If the Patient Suspects that they have Taken too Much Evastix, they Should Inform the Doctor. Depending on the Severity of the Overdose, 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, the Patient Should not Take a Double Dose to Make up for the Missed Dose, but Should Take the Next Dose at the Scheduled Time and Continue Treatment as Before. If the Patient has any Further Questions on the Use of this Medication, they Should Ask the Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Evastix can Cause Side Effects, although not Everybody gets them.

Stop Taking Evastix and Contact the Doctor or Go to the Hospital Immediately if the Patient Experiences:

• -Itching, Hives, and Swelling of the Face, Tongue, or Throat, which can 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 Occur in Less than 1 in 1,000 People).

Other Side Effects Include:

Very Common:(May Occur in More than 1 in 10 People)

• -Headache.

Common:(May Occur in Less than 1 in 10 People)

• -Drowsiness;
• -Dry Mouth.

Uncommon:(May Occur in Less than 1 in 100 People)

• Nosebleeds;
• Sore Throat (Pharyngitis);
• Runny Nose (Rhinitis).

Rare:(May Occur in Less than 1 in 1,000 People)

• -Allergic Reactions (Such as Anaphylaxis and Angioedema);
• Restlessness;
• Insomnia;
• Drowsiness;
• Dizziness;
• Numbness;
• Taste Disturbances;
• Palpitations (Rapid or Irregular Heartbeat);
• Increased Heart Rate;
• Abdominal Pain;
• Vomiting;
• Diarrhea;
• Indigestion;
• Hepatitis;
• Cholestasis (Impaired Bile Flow);
• Abnormal Liver Function Tests;
• Rash, Urticaria, Widespread Rash;
• Menstrual Disorders;
• Edema (Fluid Accumulation in Tissues);
• Extreme Weakness (Asthenia).

Very Rare:(May Occur in Less than 1 in 10,000 People)

• Sensation Disorders;
• Eczema, Dermatitis;
• Painful Menstruation.

Frequency Not Known:(Frequency Cannot be Estimated from the Available Data)

• -Weight Gain;
• -Increased Appetite.

Reporting Side Effects

If the Patient Experiences any Side Effects, Including those not Listed in this Package Leaflet, they Should Inform the 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, it is Possible to Gather More Information on the Safety of the Medication.

5. How to Store Evastix

Keep the Medication out of the Sight and Reach of Children. Do not Use this Medication After the Expiration Date Stated on the Carton and Blister After: EXP. The Expiration Date Refers to the Last Day of the Month. There are no Special Precautions for the Storage of the Medication. Medications Should not be Disposed of via Wastewater or Household Waste. Ask the Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Evastix Contains

• The Active Substance of Evastix is Ebastine. Each 10 mg Oral Disintegrating Tablet Contains 10 mg of Ebastine. Each 20 mg Oral Disintegrating Tablet Contains 20 mg of Ebastine.
• Other Ingredients: Microcrystalline Cellulose (PH-102), Mannitol, Crospovidone (Type A), Aspartame (E 951), Silica Colloidal Anhydrous, Magnesium Stearate, Peppermint Flavor.

What Evastix Looks Like and Contents of the Package

Oral Disintegrating Tablet.

Evastix, 10 mg, Oral Disintegrating Tablets: [Size: 6.7 mm]

White or Almost White, Round, Biconvex, Uncoated Tablets with the Engraving "E 10" on one Side and Smooth on the Other Side.

Evastix, 20 mg, Oral Disintegrating Tablets: [Size: 9.2 mm]

White or Almost White, Round, Biconvex, Uncoated Tablets with the Engraving "E 20" on one Side and Smooth on the Other Side. Evastix is Available in Blisters Packaged in a Carton. Pack Sizes: 10, 20, 30, 50, and 90 Oral Disintegrating 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 Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

France:

EBASTINE ARROW LAB 10 mg, Orodispersible Tablet

Netherlands:

Ebastine Aurobindo Smelt 10 mg, Orodispersible Tablets

Poland:

Evastix

Portugal:

Ebastina Generis

Spain:

Ebastina Aurovitas 10 mg / 20 mg, Orodispersible Tablets EFG

Date of Last Revision of the Package Leaflet: 07.2023