Ebastine Sandoz 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ebastine Sandoz 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet:

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

1. What Ebastina Sandoz is and what it is used for

Ebastine belongs to a group of medicines known as antihistamines (antiallergic agents).

Ebastine is indicated for the symptomatic treatment of allergic conditions such as:

• seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, sneezing),
• chronic urticaria,
• allergic dermatitis.

2. What you need to know before starting to take Ebastine Sandoz

Do not take Ebastine Sandoz

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take ebastine:

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

Do not use this medicine if you have an acute allergic emergency, as ebastine (the active substance of this medicine) takes 1 to 3 hours to take effect.

Children

Ebastine must not be given to children under 12 years of age.

Taking Ebastine Sandoz with other medicines

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

The following medicines may interact with ebastine; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines:

• ebastine may increase the effect of other medicines used to treat allergy (antihistamines),
• ebastine should be used with caution in patients taking medicines called ketoconazole and itraconazole, used to treat fungal infections, or with a macrolide antibiotic called erythromycin used to treat certain infections (as they may cause abnormalities in your ECG),
• the antihistaminic effect of ebastine may be reduced in patients taking a medicine called rifampicin used to treat tuberculosis.

No interactions have been reported between ebastine and theophylline, warfarin, cimetidine, diazepam, or alcohol.

Interference with diagnostic tests

Ebastine may interfere with skin allergy tests; therefore, such tests should not be performed until 5 to 7 days after stopping treatment.

Taking Ebastine Sandoz with food and drink

This medicine may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is no experience in pregnant women; therefore, it is recommended to consult a doctor before taking ebastine. The doctor will decide whether or not treatment should be initiated.

Breastfeeding

It is unknown whether the medicine passes into breast milk; therefore, Ebastine Sandoz must not be used during breastfeeding.

Driving and using machines

In humans, no effects on psychomotor function or on the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, since somnolence and dizziness are listed among the adverse effects, you should assess your response to the medication before driving or operating machinery.

Ebastine Sandoz contains lactose

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

3. How to take Ebastina Sandoz

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate how long your treatment with ebastine should last.

Ebastine is not suitable for doses lower than 10 mg, nor for patients who have difficulty swallowing.

Dosage

Use in adults and children over 12 years of age: the recommended dose is 1 tablet (10 mg of ebastine) once daily.

Use in patients with severe liver disease: the dose of ebastine should not exceed 10 mg per day (1 tablet).

Method of administration

This medicine is for oral use.

The tablets may be taken with or without food, taken with a glass of water.

If you think that the effect of ebastine is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastina Sandoz than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested. Bring any remaining tablets, the outer carton, and the full packaging so that healthcare professionals can more easily identify the medicine you have taken.

Treatment of poisoning with this medicine consists of gastric lavage and administration of appropriate medication.

If you forget to take Ebastina Sandoz

Do not take a double dose to make up for forgotten doses. Take the missed dose as soon as you remember, then continue with your regular dosing schedule. However, if it is almost time for your next dose, do not take the missed dose and wait until the next scheduled dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed in clinical trials and post-marketing experience:

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

• headache.

Common (may affect up to 1 in 10 people)

• somnolence,
• 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 disturbances,
• liver inflammation (hepatitis), cholestasis, abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase and bilirubin),
• urticaria, skin rash, dermatitis,
• menstrual disorders,
• edema (swelling due to fluid accumulation), fatigue.

Frequency not known (cannot be estimated from available data)

• weight gain,
• increased appetite.

Reporting of 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 leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Sandoz

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines and their packaging, ask your pharmacist for advice. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastine Sandoz

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

Core: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, povidone 30, polysorbate 80, magnesium stearate.

Coating: hypromellose, titanium dioxide, glyceryl triacetate.

Appearance of the product and contents of the pack

Ebastine Sandoz is presented as white, film-coated, lens-shaped tablets. It is packaged in PVC/aluminum blister packs containing 20 tablets of 10 mg.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Laboratorios ALTER, S.A.
Mateo Inurria, 30
28036 Madrid
Spain

Date of the most recent revision of this leaflet: May 2019.

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