Ebastine Normon 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Ebastina Normon 10 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor, pharmacist or nurse.
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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.
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If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Ebastina Normon is and what it is used for
- What you need to know before taking Ebastina Normon
- How to take Ebastina Normon
- Possible side effects
- How to store Ebastina Normon
- Contents of the pack and other information
1. What Ebastina Normon is and what it is used for
Ebastina Normon belongs to a group of medicines called antihistamines (antiallergic agents).
Ebastina Normon 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, and sneezing), chronic urticaria, and allergic dermatitis.
2. What you need to know before taking Ebastina Normon
Do not take Ebastina Normon
- 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 Ebastina Normon.
This medicine should be used with caution:
- If your electrocardiogram (ECG) results are abnormal (prolongation of the QT interval).
- If you have high levels of potassium in your blood.
- If you suffer from severe liver disease (see section “How to take Ebastina Normon”).
- If you are being treated with a type of medicine used to treat fungal infections known as azole antifungals, or with medicines used to treat certain infections called macrolide antibiotics (see section “Taking Ebastina Normon 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 in this medicine) takes 1 to 3 hours to take effect.
Children
Ebastina Normon 10 mg must not be administered to children under 12 years of age.
Other medicines and Ebastina Normon
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The following medicines may interfere with Ebastina Normon; in such cases it may be necessary to adjust the dose or discontinue treatment with one of them:
- Ebastina Normon may increase the effect of other medicines used to treat allergy (antihistamines).
- Ebastina Normon should be used with caution in patients receiving treatment with medicines called ketoconazole and itraconazole, used to treat fungal infections, or with an antibiotic used to treat certain infections called erythromycin (as they may cause abnormalities in your electrocardiogram).
- The antihistaminic effect of Ebastina Normon may be reduced in patients receiving treatment with 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
Ebastina Normon may interfere with the results of skin allergy tests; therefore, it is advised not to perform these tests until 5–7 days after stopping treatment.
Taking Ebastina Normon with food and drinks
The tablets can 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 Ebastina Normon. The doctor will decide whether or not treatment should be started.
Breastfeeding
It is unknown whether the medicine passes into breast milk; therefore, it should not be used during breastfeeding.
Driving and using machines
At the recommended therapeutic doses, no effects on psychomotor function or the ability to drive or operate machinery have been observed in humans. However, since somnolence and dizziness are listed among the adverse effects, monitor your response to the medication before driving or operating machinery.
Ebastina Normon contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.
3. How to take Ebastina Normon
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will determine the duration of your treatment with Ebastina Normon.
Ebastina Normon film-coated tablets are not suitable for doses lower than 10 mg of ebastine, 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 should not exceed 10 mg of ebastine 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 Ebastina Normon is too strong or too weak, tell your doctor or pharmacist.
If you take more Ebastina Normon than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone 915 620 420 (indicating the medicine and the amount ingested), or go to the nearest hospital. Take any remaining tablets, the outer carton, and the full packaging so that healthcare professionals can 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 Normon
Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience 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 of 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 Pharmacovigilance System for 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 Normon
Keep this medicine out of sight and reach of children.
Store below 30 ºC.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to 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 a pharmacy's SIGRE collection point. If you have any doubts, 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 Normon
- The active substance is ebastine. Each tablet contains 10 mg of ebastine.
- The other components (excipients) are: Tablet core: lactose monohydrate, crospovidone, sodium starch glycolate from potato, magnesium stearate. Coating: butylated basic methacrylate copolymer, titanium dioxide (E-171), talc, and macrogol 6000.
Appearance of the product and contents of the pack
Ebastine Normon 10 mg is presented as film-coated tablets for oral administration. The tablets are white or almost white, round, biconvex, and printed with "E10". Each pack contains 20 film-coated tablets.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Other presentations
Ebastine Normon 20 mg film-coated tablets EFG
Date of the most recent review of this leaflet: February 2026.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68485/P_68485.html