Ebastine Aurobindo

Patient Information Leaflet

Ebastine Aurobindo 10 mg orodispersible tablets, 20 mg orodispersible tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What Ebastina Aurobindo 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 eyes.
In adults and children aged 12 years and older, Ebastina Aurobindo is used to relieve symptoms of seasonal
rhinitis (hay fever) and perennial allergic rhinitis, including cases of allergic conjunctivitis.
In adults aged over 18 years, Ebastina Aurobindo 10 mg is also used to relieve itching and the development
of wheals in urticaria (hives).

2. What you need to know before taking Ebastina Aurobindo

Do not take Ebastina Aurobindo

• If you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).
• If you have liver insufficiency (severe reduction in liver function).

The use of Ebastina Aurobindo is contraindicated during pregnancy and breastfeeding (see "Pregnancy and
breastfeeding").
Do not administer Ebastina Aurobindo to children under 12 years of age (see "Children and
adolescents").

Warnings and precautions

Talk to your doctor before taking Ebastina Aurobindo.

Use Ebastina Aurobindo with caution if:

• You have a condition that could increase the risk of heart problems, such as QT interval prolongation syndrome (a disorder affecting the heart's electrical activity that may lead to abnormal heart rhythms) or hypokalaemia (low potassium levels in the blood).
• You are being treated with medicines that increase the QT interval.
• You are being treated with azole antifungal medicines such as ketoconazole and itraconazole, or macrolide antibiotics such as erythromycin (see "Other medicines and Ebastina Aurobindo").
• You are being treated with anti-tuberculosis medicines such as rifampicin (see "Other medicines and Ebastina Aurobindo").
• You have renal insufficiency (reduced kidney function).
• You have mild or moderate hepatic insufficiency (reduced liver function) (see section 3 "How to take Ebastina Aurobindo").

Children and adolescents

This medicine should only be used in children aged 12 years and older.
Do not administer 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 Aurobindo

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

Use Ebastina Aurobindo with caution when taken together with:

• Ketoconazole (antifungal medicine) or erythromycin (antibiotic), both known to prolong the QT interval. This combination may increase ebastine blood levels and cause greater QT interval prolongation than with ketoconazole or erythromycin alone (see "Warnings and precautions").
• Rifampicin (anti-tuberculosis medicine). This combination may result in lower blood concentrations of Ebastina Aurobindo and therefore reduce its effectiveness.

Ebastina Aurobindo with food and alcohol

Ebastina Aurobindo can be taken regardless of meals.
No interactions between ebastine and alcohol have been reported.

Pregnancy and breastfeeding

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

Pregnancy
Do not take Ebastina Aurobindo during pregnancy (see "Do not take Ebastina Aurobindo"). Only limited data are available on the use of ebastine in pregnant women.

Breastfeeding
It is not known whether ebastine is excreted in human milk.
Do not take Ebastina Aurobindo during breastfeeding (see "Do not take Ebastina Aurobindo").

Driving and using machines

Ebastine, at the recommended doses, has not produced negative effects on driving or operating machinery.
Nevertheless, assess your response to ebastine before engaging in complex tasks, as drowsiness and dizziness may occur (see section 4 "Possible side effects").

Ebastina Aurobindo 10 mg contains 2.5 mg of aspartame per tablet.
Ebastina Aurobindo 20 mg contains 5 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot process it properly.

3. How to take Ebastina Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
Symptom Age Dosage
Allergic rhinitis Children from 12 years of age and adults One Ebastina Aurobindo 10 mg tablet (10 mg of
ebastinum) daily
In case of severe symptoms Two Ebastina Aurobindo 10 mg tablets or one
Ebastina Aurobindo 20 mg tablet (20 mg of
ebastinum) once daily
Urticaria Adults over 18 years of age One Ebastina Aurobindo 10 mg tablet (10 mg of
ebastinum) once daily
In patients with impaired renal function, no dose adjustment is required.
Mild or moderate hepatic impairment
Do not exceed a daily dose of 10 mg (see “Warnings and precautions”).
Ebastina Aurobindo may be taken regardless of meals.
Your doctor will decide the duration of treatment.
If you take more Ebastina Aurobindo than you should
In studies using high doses, up to 100 mg administered once daily, no clinically significant signs or
symptoms were observed. There is no specific antidote for ebastinum. Gastric lavage, monitoring of vital
functions including ECG (electrocardiogram), and symptomatic treatment may be carried out if necessary.
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to take Ebastina Aurobindo
Do not take a double dose to make up for the missed dose.
If you have any doubts 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 everyone experiences them.
Stop taking Ebastine Aurobindo 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 in swallowing or breathing. These may be signs of a hypersensitivity reaction to Ebastine Aurobindo 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 side effects, affecting more than 1 in 10 people

• Headache.

Common side effects, affecting up to 1 in 10 people

• Drowsiness.
• Dry mouth.

Uncommon side effects, affecting up to 1 in 100 people

• Nosebleed.
• Sore throat (pharyngitis).
• Runny nose (rhinitis).

Rare side effects, affecting up to 1 in 1,000 people

• Nervousness.
• Insomnia.
• Drowsiness.
• Dizziness.
• Dysaesthesia (sensory disturbance).
• Altered taste.
• Palpitations (fast heartbeat, irregular heartbeat).
• Increased heart rate.
• Abdominal pain.
• Vomiting.
• Nausea.
• Indigestion.
• Hepatitis (inflammation of the liver).
• Cholestasis (impaired bile flow).
• Abnormal liver function tests.
• Skin rash, hives, generalized rash.
• Menstrual disorders.
• Edema (fluid accumulation in tissues).
• Weakness (asthenia).

Very rare side effects, affecting up to 1 in 10,000 people

• Eczema, skin inflammation.
• Menstrual pain.

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

• Increased weight.
• Increased appetite.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or
pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ebastine Aurobindo

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 blister and packaging after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ebastina Aurobindo contains

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

Each orodispersible tablet contains 20 mg of ebastine.

• The other components are: microcrystalline cellulose (type-102), mannitol, crospovidone (type-A), aspartame, anhydrous colloidal silica, magnesium stearate, peppermint flavor.

Description of the appearance of Ebastina Aurobindo and package contents
Orodispersible tablets.
Ebastina Aurobindo 10 mg orodispersible tablets [size 6.7 mm]:
Uncoated, circular, biconvex tablets, white to almost white, with "E 10" engraved on one side and smooth on the other side.
Ebastina Aurobindo 20 mg orodispersible tablets [size 9.2 mm]:
Uncoated, circular, biconvex tablets, white to almost white, with "E 20" engraved on one side and smooth on the other side.
Ebastina Aurobindo 10 mg and 20 mg orodispersible tablets are available in blister packs.
Pack sizes:
10, 20 and 30 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Ebastina Aurobindo