Ebastine Sandoz 10 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ebastine Sandoz 10 mg orodispersible tablets EFG
Ebastine Sandoz 20 mg orodispersible 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Ebastine Sandoz is and what it is used for
- What you need to know before taking Ebastine Sandoz
- How to take Ebastine Sandoz
- Possible adverse effects
- How to store Ebastine Sandoz
- Contents of the pack and other information
1. What Ebastina Sandoz is and what it is used for
Ebastine is an antihistamine that helps relieve allergy symptoms such as sneezing, runny nose, watery eyes, and itching due to skin rashes.
Ebastine is used in adults and children over 12 years of age to relieve symptoms of seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, including cases with allergic conjunctivitis.
Ebastine 10 mg tablets are also used in adults over 18 years of age to relieve itching and hives in cases of urticaria (hives).
2. What you need to know before taking 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
Ebastine may cause dry mouth. Therefore, for long-term treatment, good oral hygiene is important (teeth should be brushed twice daily with fluoride toothpaste) to prevent the risk of dental caries.
Talk to your doctor or pharmacist before taking Ebastine Sandoz if:
- You are already taking certain antibiotics or medicines used to treat fungal infections: see section “Taking Ebastine Sandoz with other medicines**”** below,
- You have severely impaired liver function (hepatic insufficiency).
Children and adolescents
This medicine should only be used in children aged 12 years and older. Do not give this medicine to children under 12 years of age, as safety and efficacy have not been established in this patient group.
Other medicines and Ebastine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Ebastine may enhance the effect of other medicines used for the treatment of allergy (antihistamines).
If you take ebastine together with erythromycin (an antibiotic), ketoconazole, or itraconazole (active substances used to treat fungal infections), blood levels of ebastine may increase.
Concomitant administration of ebastine and rifampicin (an antituberculosis agent) may lead to decreased blood levels of ebastine and consequently reduced effectiveness.
No interactions between ebastine and theophylline, warfarin, cimetidine, diazepam, or alcohol have been reported.
Taking Ebastine Sandoz with food and drinks
Ebastine Sandoz can be taken with or without food.
Pregnancy, breastfeeding, and fertility
There are currently insufficient data on the safety of using this medicine during pregnancy in humans. For this reason, ebastine should only be taken during pregnancy if your doctor considers that the benefit outweighs the possible risks.
Do not take ebastine during breastfeeding, as it is unknown whether the active substance is excreted in breast milk.
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.
Driving and using machines
Most patients taking ebastine can drive or carry out other activities requiring reaction ability. However, as with other medicines, you should assess your individual response to ebastine before driving or performing complex tasks, since some patients may experience drowsiness or dizziness.
Ebastine Sandoz contains lactose, aspartame, and sodium.
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains 2.5 mg of aspartame in each 10 mg tablet and 5 mg of aspartame in each 20 mg tablet. Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet, i.e., essentially "sodium-free".
3. How to take Ebastina Sandoz
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Recommended dose:
Allergic rhinitis | Age | Dosage |
Allergic rhinitis | Children from 12 years of age and adults | One 10 mg ebastine tablet (10 mg of ebastine) once daily. |
Urticaria | Adults over 18 years of age | One 10 mg ebastine tablet (10 mg of ebastine) once daily. |
Never take more than one dose of an orodispersible tablet per day.
Do not take other antihistamines together with Ebastina Sandoz.
In patients with impaired renal function, no dose adjustment is necessary.
In patients with mild or moderate hepatic impairment, no dose adjustment is necessary.
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 these patients.
Do not press the tablet to remove it from the blister, as it may break.
Each blister contains the tablets separately in compartments divided by a perforated line.
Cut one of the blisters along the dotted line (Figure 1).
Then, carefully remove the aluminum foil by peeling it away starting from the corner indicated by an arrow (Figures 2 and 3).
Keep your hands dry when removing the tablet from the blister.
Place the tablet on your tongue, where it dissolves within seconds; it is not necessary to take water or any other liquid.
Ebastine may be taken with or without food.
Your doctor will determine the duration of your treatment.
If you take more Ebastina Sandoz than you should
There is no specific antidote for the active substance ebastine.
In case of overdose with ebastine, please consult your doctor. Depending on the severity of intoxication, your doctor will initiate appropriate 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Ebastina Sandoz
Do not take a double dose to make up for missed doses.
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 can cause adverse effects, although not everyone experiences them.
Stop taking Ebastina Sandoz and contact your doctor immediately or go to the nearest hospital if the following occurs:
Severe allergic reaction causing itching and swelling of the face, tongue or throat, which may cause difficulty swallowing or breathing, or low blood pressure. Severe allergic reactions with ebastine are rare (may affect up to 1 in 1,000 people).
Other adverse effects include:
Very common adverse effects: may affect more than 1 in 10 people
- Headache.
Common adverse effects: may affect up to 1 in 10 people
- Drowsiness
- Dry mouth.
Uncommon adverse effects: may affect up to 1 in 1,000 people
- Nervousness, insomnia,
- Dizziness, dysaesthesia (sensory disturbance), decreased sense of touch, taste disturbance,
- Palpitations, rapid pulse,
- Abdominal pain, vomiting, nausea, indigestion,
- Liver inflammation (hepatitis), problems with bile excretion (cholestasis), abnormal liver function tests,
- Skin rash, hives, skin inflammation,
- Menstrual disorders,
- Oedema (swelling due to fluid accumulation in tissues), weakness (asthenia).
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 Pharmacovigilance System for Human Medicinal Products: http://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.
Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be taken to a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ebastine Sandoz
- The active substance is ebastine.
- Ebastine Sandoz 10 mg: each orodispersible tablet contains 10 mg of ebastine.
- Ebastine Sandoz 20 mg: each orodispersible tablet contains 20 mg of ebastine.
- The other components are microcrystalline cellulose, lactose monohydrate, maize starch, sodium croscarmellose, aspartame (E951), mint flavour, colloidal anhydrous silica, and magnesium stearate.
Nature of the product and contents of the pack
Orodispersible tablet.
Ebastine Sandoz 10 mg:
White, biconvex, round tablets, approximately 6.7 mm in diameter, marked with “E10” on one side and smooth on the other.
Ebastine Sandoz 20 mg:
White, biconvex, round tablets, approximately 9.2 mm in diameter, marked with “E20” on one side and smooth on the other.
The tablets are packaged in OPA/Alu/PVC/Alu blisters contained in cardboard cartons.
Pack sizes:
Ebastine Sandoz 10 mg:
10, 20, 30, 40, 50, 90, 98 or 100 orodispersible tablets.
Ebastine Sandoz 20 mg:
10, 15, 20, 30, 40, 50, 98 or 100 orodispersible tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Ebastine Sandoz 10 mg orodispergeerbare tabletten
Italy: Ebastina Sandoz
Sweden: Ebastine Sandoz, 10 mg munsönderfallande tablett
Ebastine Sandoz, 20 mg munsönderfallande tablett
Date of the most recent revision of this leaflet: 03/2026
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/