Ask a doctor about a prescription for EBASTINE AUROVITAS 20 mg ORALLY DISINTEGRATING TABLETS
Package Leaflet: Information for the User
Ebastina Aurovitas 20 mg Oral Disintegrating Tablets EFG
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
Contents of the Package Leaflet
Ebastina is an antihistamine that helps relieve allergy symptoms such as sneezing, runny nose, tearing, and itchy skin rashes.
Ebastina 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.
Do not take Ebastina Aurovitas:
Warnings and Precautions
Consult your doctor before starting to take ebastina if:
Children and Adolescents
This medication should only be used in children over 12 years of age. Do not give this medication to children under 12 years of age, as safety and efficacy have not been established in this age group.
Other Medications and Ebastina Aurovitas
Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medications.
Ebastina may affect or be affected by some medications that contain the following active ingredients:
No interactions have been described between ebastina and theophylline, warfarin, cimetidine, diazepam, or 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 treatment has been discontinued.
Taking Ebastina Aurovitas with Food and Drinks
You can take ebastina with or without food.
Pregnancy, Breastfeeding, and Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
There is limited experience with the safety of this medication for the fetus in humans. For this reason, ebastina should only be taken during pregnancy if your doctor considers that the expected benefit outweighs the potential risks.
Do not take ebastina if you are breastfeeding, as it is unknown whether the active ingredient passes into breast milk.
Driving and Using Machines
Most patients treated with ebastina can drive or perform other activities that require good 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 Aurovitas contains Aspartame
This medication contains 5 mg of aspartame in each 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 properly.
Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.
The recommended dose is:
Indication | Age | Dose |
Allergic Rhinitis In case of intense symptoms | Children over 12 years of age and adults | One Ebastina Aurovitas 10 mg tablet (10 mg of ebastina) once a day. Two Ebastina Aurovitas 10 mg tablets or one Ebastina Aurovitas 20 mg tablet (20 mg of ebastina) once a day. |
Urticaria | Adults over 18 years of age | One Ebastina Aurovitas 10 mg tablet (10 mg of ebastina) once a day. |
In patients with impaired renal function, no dose adjustment is necessary.
In patients with mild or moderate liver impairment, no dose adjustment is necessary.
There is no experience with doses greater than 10 mg in patients with severe liver failure, so the dose should not exceed 10 mg in these patients.
Place the tablet on your tongue, where it dissolves in a matter of seconds; it is not necessary to take water or any other liquid.
Ebastina can be taken with or without food.
If you think the effect of ebastina is too strong or too weak, inform your doctor or pharmacist.
Your doctor will decide the duration of treatment.
If you take more Ebastina Aurovitas 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 poisoning, 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, pharmacist, or call the Toxicology Information Service immediately, phone: 91 562 04 20, indicating the medication and the amount taken.
If you forget to take Ebastina Aurovitas
If you forget to take a dose, do not take an extra dose to make up for the missed dose; take your next dose when it is due and continue normally.
Do not take a double dose to make up for missed doses.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medications, this medication can cause side effects, although not everyone gets them.
Stop taking ebastina and contact your doctor immediately or go to the nearest hospital if you experience the following:
Other side effects include:
Very common(may affect more than 1 in 10 people):
Common(may affect up to 1 in 10 people):
Uncommon(may affect up to 1 in 100 people):
Rare(may affect up to 1 in 1,000 people):
Very rare(may affect up to 1 in 10,000 people):
Frequency not known(frequency cannot be estimated from available data):
Reporting Side Effects
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.
Keep this medication out of sight and reach of children.
Do not use this medication after the expiration date shown on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.
This medication does not require special storage conditions.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
Composition of Ebastina Aurovitas
Appearance of the Product and Package Contents
Oral disintegrating tablet.
White to off-white, uncoated tablets, 9.2 mm in size, round, and biconvex, engraved with 'E 20' on one face and smooth on the other.
Ebastina Aurovitas 20 mg oral disintegrating tablets EFG are available in blister packs.
Package sizes:10, 20, 30, 50, and 90 oral disintegrating tablets.
Not all package sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain
Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Or
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
Or
Arrow Generiques – Lyon
26 avenue Tony Garnier,
Lyon, 69007
France
This medication is authorized in the Member States of the European Economic Area under the following names:
Spain: Ebastina Aurovitas 20 mg oral disintegrating tablets EFG
Poland: Evastix
Portugal: Ebastina Generis
Date of the last revision of this package leaflet: July 2023
Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)
The average price of EBASTINE AUROVITAS 20 mg ORALLY DISINTEGRATING TABLETS in October, 2025 is around 8.79 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for EBASTINE AUROVITAS 20 mg ORALLY DISINTEGRATING TABLETS – subject to medical assessment and local rules.