EBASTINE SANDOZ 20 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before you take Ebastina Sandoz

Do not take Ebastina Sandoz:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ebastina Sandoz if:

• you are already taking certain antibiotics or medicines used to treat fungal infections: see section "Taking Ebastina Sandoz with other medicines"later,
• you have severely impaired liver function (liver failure).

Children and adolescents

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

Taking Ebastina Sandoz with other medicines

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

If you take ebastina with erythromycin (an antibiotic), ketoconazole or itraconazole (active substances for the treatment of fungal infections), it may increase the levels of ebastina in your blood.

Taking ebastina and rifampicin (an antitubercular agent) together may lead to a decrease in the levels of ebastina in your blood and therefore a decrease in its effect.

It is not recommended to use ebastina at the same time as clarithromycin or josamycin (antibiotics).

Taking Ebastina Sandoz with food and drink

Ebastina Sandoz can be taken with or without food.

Pregnancy, breastfeeding and fertility

There are no sufficient data on the safety of this medicine in human pregnancy. For this reason, ebastina should only be taken during pregnancy if your doctor considers that the benefit outweighs the potential risks.

Do not take ebastina if you are breastfeeding, as it is not known whether the active substance is excreted in breast milk.

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.

Driving and using machines

Most patients taking ebastina can drive or perform other activities that require attention. However, as with other medicines, you should check your individual reaction after taking ebastina before driving or performing complex activities, as some patients may experience drowsiness or dizziness.

Ebastina Sandoz contains lactose, aspartame and sodium.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

This medicine contains 2.5 mg of aspartame (E951) per 10 mg tablet and 5 mg of aspartame (E951) per 20 mg tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly).

This medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet, which is essentially "sodium-free".

3. How to take Ebastina Sandoz

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is:

In patients with impaired renal function, 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 failure, therefore the dose should not exceed 10 mg in these patients.

Do not press the tablet to remove it from the blister, as it may break.

Each blister contains the tablets separately in separate alveoli separated by a perforation line.

Cut one of the alveoli along the dotted line (Figure 1)

Then, carefully remove the aluminum foil, separating it at the corner indicated by an arrow (Figures 2 and 3).

Keep your hands dry to remove the tablet from the alveolus.

Place your tablet on your tongue where it dissolves in a matter of seconds, you do not need to take water or any other liquid.

Ebastina can be taken with or without food.

Your doctor will indicate the duration of the treatment.

If you take more Ebastina Sandoz than you should

There is no specific antidote for the active substance ebastina.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ebastina Sandoz

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

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

Severe allergic reaction that causes itching and swelling of the face, tongue, or throat and may cause difficulty swallowing or breathing.

Severe allergic reactions with ebastina are rare (may affect up to 1 in 1000 people).

Other side effects include:

Very common side effectsmay affect more than 1 in 10 people

• headache.

Common side effectsmay affect up to 1 in 10 people

• drowsiness
• dry mouth.

Rare side effectsmay affect up to 1 in 1,000 people

• nervousness, insomnia,
• dizziness, decreased sense of touch, altered taste,
• palpitations, rapid pulse,
• abdominal pain, vomiting, nausea, indigestion,
• liver inflammation (hepatitis), bile elimination problems (cholestasis), abnormal liver function tests,
• skin rash, hives, skin inflammation,
• menstrual disorders,
• edema (swelling due to fluid accumulation in tissues), weakness (asthenia).

Frequency not known: cannot be estimated from the available data

• weight gain,
• increased appetite.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastina Sandoz

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 carton after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastina Sandoz

• The active substance is ebastina.
• • Ebastina Sandoz 10 mg: each orodispersible tablet contains 10 mg of ebastina.
  • Ebastina Sandoz 20 mg: each orodispersible tablet contains 20 mg of ebastina.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, corn starch, sodium croscarmellose, aspartame (E951), peppermint flavor, colloidal anhydrous silica, and magnesium stearate.

Appearance and packaging

Orodispersible tablet.

Ebastina Sandoz 10 mg:

White, biconvex, round tablets, approximately 6.7 mm in diameter, marked with "E10" on one face and smooth on the other face.

Ebastina Sandoz 20 mg:

White, biconvex, round tablets, approximately 9.2 mm in diameter, marked with "E20" on one face and smooth on the other face.

The tablets are packaged in OPA/Alu/PVC/Alu blisters packaged in cartons.

Package sizes:

Ebastina Sandoz 10 mg:

10, 20, 30, 40, 50, 90, 98, or 100 orodispersible tablets.

Ebastina Sandoz 20 mg:

10, 15, 20, 30, 40, 50, 98, or 100 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor, Alcobendas, 28108

Madrid

Spain

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

Belgium:Ebastine Sandoz 10 mg orodispersible tablets

Italy:Ebastina Sandoz

Sweden:Ebastine Sandoz, 10 mg orodispersible tablets

Ebastine Sandoz, 20 mg orodispersible tablets

Date of last revision of this leaflet:August 2020

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