Package Insert: Information for the Patient

Ebastina Sandoz 10 mg Bucodispersable Tablets EFG

Ebastina Sandoz 20 mg Bucodispersable 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 allergy symptoms such as: urge to sneeze, runny nose, watery eyes, and itching due to hives on the skin.

Ebastina is used in adults and children over 12 years of age to relieve symptoms of allergic rhinitisseasonal(hay fever) and perennial allergic rhinitis,includingcasesof allergic conjunctivitis.

Ebastinatabletsof10mgare also used in adults over 18 years of age to relieve symptoms of itching and the development of wheals in 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 the 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.

The concomitant administration of ebastina and rifampicin (antitubercular agent) may lead to a decrease in the levels of ebastina in 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 currently insufficient data on the safety of this medication for the fetus in humans. Therefore, ebastina should only be taken during pregnancy in cases where your doctor considers that the benefits outweigh the potential 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, think 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, as 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 a certain sugar intolerance, consult with them 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 due to the body's inability 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 impaired renal function.

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

There is no experience with doses higher than 10 mg in patients with severe hepatic 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 separately in individual compartments separated by a perforation line.

Cut one of the compartments 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 compartment.

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 packandonthecontainer 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 containers and unused medications at the SIGRE point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of containers and unused medications. This 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 contents of the package

Buccal dispersible tablet.

Ebastina Sandoz 10 mg:

White, biconvex, round, 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, 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 packaged in cardboard boxes.

Package 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 package 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 Albatros B, 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

Last revision date of this leaflet:August 2020

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/