Package Insert: Information for the Patient

Ebastina Sandoz 10 mg Film-Coated Tablets

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 to you alone, 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.

Table of Contents:

1. What Ebastina Sandoz is and for what it is used
2. What you need to know before starting to take Ebastina Sandoz
3. How to take Ebastina Sandoz
4. Possible adverse effects
5. Storage of Ebastina Sandoz
6. Contents of the package and additional information

Ebastina belongs to a group of medications called antihistamines (antiallergics).

Ebastina is indicated for the symptomatic treatment of allergic processes such as:

• seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, urge to sneeze),
• chronic urticaria,
• allergic dermatitis.

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Do not take Ebastina Sandoz

• if you are allergic to ebastina or 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:

• if your electrocardiogram results are altered (prolongation of the QT interval),
• if you have high levels of potassium in your blood,
• if you have a severe liver disease (see section “How to take Ebastina Sandoz”),
• if you are being treated with a type of medication used to treat fungal infections called azole antifungals or with medications used to treat certain infections called macrolide antibiotics (see section “Taking Ebastina Sandoz with other medications”),
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

Do not use this medication if you have an acute allergic emergency, as ebastina (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastina should not be administered to children under 12 years.

Taking Ebastina Sandoz with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The medications listed below may interact with ebastina, in these cases it may be necessary to change the dose or discontinue treatment with one of them:

• ebastina may increase the effect of other medications used to treat allergies (antihistamines),
• ebastina should be used with caution in patients being treated with medications called ketoconazole and itraconazole, used to treat fungal infections, or with an antibiotic used to treat certain infections called erythromycin (as they may cause an alteration in your electrocardiogram),
• the antihistamine effect of ebastina may be reduced in patients being treated with a medication called rifampicin used to treat tuberculosis.

No interactions have been described between ebastina and theophylline, warfarin, cimetidine, diazepam, and alcohol.

Interference with diagnostic tests

Ebastina may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5 to 7 days after discontinuing treatment.

Taking Ebastina Sandoz with food and drinks

This medication can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

There is no experience in pregnant women, so it is recommended to consult a doctor before taking ebastina. They will decide whether or not to start treatment.

Breastfeeding

It is unknown whether the medication passes into breast milk, so it should not be used during breastfeeding.

Driving and operating machinery

In men, no effects have been observed on psychomotor function, or on the ability to drive or operate machinery at the recommended therapeutic doses. However, given that drowsiness and dizziness are among the adverse effects, observe your response to the medication before driving or operating machinery.

Ebastina Sandoz contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with ebastina.

Ebastina is not suitable for doses lower than 10 mg, nor for patients with swallowing problems.

Dosage

Use in adults and children over 12 years:The recommended dose is 1 tablet (10 mg of ebastina) once a day.

Use in patients with severe liver disease:Do not exceed a dose of 10 mg of ebastina per day (1 tablet).

Administration Form

This medication is for oral administration.

Tablets can be taken with or without food, with the help of a glass of water.

If you estimate that the action of ebastina is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastina Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.Bring the remaining tablets, the packaging, and the complete box in a way that healthcare personnel can easily identify the medication taken.

The treatment of intoxication by this medication consists of gastric lavage and administration of the appropriate medication.

If you forgot to take Ebastina Sandoz

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

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 may experience them.

In clinical trials and post-marketing experience, the following adverse effects have been observed:

Very Frequent(may affect more than 1 in 10 people)

• Headache.

Frequent(may affect up to 1 in 10 people)

• Drowsiness,
• Dry mouth.

Rare(may affect up to 1 in 1,000 people)

• Hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema),
• Nervousness, insomnia,
• Dizziness, decreased sensation to touch or sensitivity, decreased or altered taste,
• Palpitations, tachycardia,
• Abdominal pain, vomiting, nausea, digestive problems,
• Liver inflammation (hepatitis), cholestasis, abnormal liver function tests (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin),
• Urticaria, skin rash, dermatitis,
• Menstrual disorders,
• Edema (swelling due to fluid accumulation), fatigue.

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 to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://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.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Ebastina Sandoz Composition

• The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.
• The other components (excipients) are:

Core: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, povidone 30, polisorbate 80, magnesium stearate,

Coating: hypromellose, titanium dioxide, triacetin

Product appearance and packaging contents

Ebastina Sandoz is presented in the form of coated tablets with a white, lenticular film coating. It is packaged in PVC/Aluminum blisters containing 20 tablets of 10 mg.

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

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet: May 2019.

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