Package Insert: Information for the Patient

Ebastina Sandoz 10 mg Buccodispersible Tablets EFG

Ebastina Sandoz 20 mg Buccodispersible Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Ebastina is an antihistamine that helps to relieve the symptoms of allergy such as: urge to sneeze, runny nose, watery eyes, itching due to skin rash.

Ebastina is used in adults and children over 12 years of age to relieve the symptoms of allergic rhinitisallergicspring(hay fever)andperennial allergic rhinitis, including caseswithallergic conjunctivitis.

Ebastinatabletsof10mgare also used in adults over 18 years of age to relieve the symptoms of itching and the development of hives in those cases of urticaria(hives).

Do not take Ebastina Sandoz:

• If you are allergic toebastinaor to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ebastina Sandoz if:

• You are already taking certain antibiotics or medications used to treat fungal infections: see section“Taking Ebastina Sandoz with other medications”later on,
• You have severely impaired liver function (hepatic insufficiency).

Children and adolescents

This medication should only be used in children aged 12 years or older. Do not administer this medication to children under 12 years of age as the safety and efficacy have not been established in this patient group.

Taking Ebastina Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Theconcomitant administrationofebastinaandrifampicin(antitubercular agent) may result in a decrease in the levelsofebastinain the blood and therefore a decrease in the effect.

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

Taking Ebastina Sandoz with food and beverages

Ebastina Sandoz can be taken with or without food.

Pregnancy, breastfeeding, and fertility

There are not enough data available today regarding the safety for the fetus of the use of this medication in humans. For this reason, ebastina should only be taken during pregnancy in cases where your doctor considers that the benefit outweighs the possible risks.

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

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Ebastina Sandoz contains lactose, aspartame, and sodium.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains 2.5 mg of aspartame (E951) per 10 mg tablet and 5 mg of aspartame (E951) per 20 mg tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains less than 23 mg of sodium (1 mmol) per buccal dispersible tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

No dose adjustment is necessary in patients with altered renal function.

No dose adjustment is necessary in patients with mild or moderate liver function impairment.

There is no experience with doses greater than 10 mg in patients with severe liver insufficiency, therefore the dose should not exceed 10 mg in this type of patient.

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

Each blister contains the tablets separated by a perforation line.

Cut one of the blisters along the perforation line (Figure 1)

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

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

Place your tablet on your tongue where it dissolves in a matter of seconds, no water or other liquid is needed.

Ebastina can be taken with or without food.

Your doctor will indicate the duration of treatment.

If you take more Ebastina Sandoz than you should

There is no specific antidote for the active ingredient ebastina.

In case of overdose with ebastina, please consult your doctor. Depending on the severity of the intoxication, your doctor will initiate the necessary measures (monitoring of vital body 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 medication and the amount ingested.

If you forgot to take Ebastina Sandoz

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

Severe allergic reactions to ebastina are rare (may affect up to 1 in 1,000 people).

Other adverse effects include:

Very frequent adverse effectsmay affect more than 1 in 10 people

• headache.

Frequent adverse effectsmay affect up to 1 in 10 people

• drowsiness
• dry mouth.

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

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

Unknown frequency: cannot be estimated from available data

• weight gain,
• increased appetite.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister packandinthecontainer after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Ebastina Sandoz Composition

• The active ingredient is ebastina.
• • Ebastina Sandoz 10 mg: Each buccal dispersible tablet contains 10 mg of ebastina.
  • Ebastina Sandoz 20 mg: Each buccal dispersible tablet contains 20 mg of ebastina.
• The other components are microcrystalline cellulose, lactose monohydrate, cornstarch, sodium croscarmellose, aspartame (E951), peppermint aroma, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and packaging contents

Buccal dispersible 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 and placed in cardboard containers.

Packaging sizes:

Ebastina Sandoz 10 mg:

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

Ebastina Sandoz 20 mg:

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Manufacturer with marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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 AlbatrosB, 1st floor, Alcobendas, 28108

Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the

following names:

Bélgica: Ebastine Sandoz 10 mg orodispergeerbare tabletten

Italia: Ebastina Sandoz

Suecia: Ebastine Sandoz, 10 mg munsönderfallande tablett

Ebastine Sandoz, 20 mg munsönderfallande tablett

Revision dateofthisleaflet:August 2020

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/